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- Life Sciences
Covington offers one of the largest and most comprehensive life sciences industry-focused practices in the world. Our clients, spanning all industry sectors and ranging from startup ventures to multinational corporations and trade associations, trust us with their most challenging business problems. They know that they can rely on Covington for practical, efficient solutions rooted in a sophisticated knowledge of their business that only comes from deep immersion in the industry and decades of dedicated service.
We advise clients throughout a product’s life cycle, going beyond the traditional legal services offered by other firms to facilitate efficient and effective research and development, ensure successful launch and commercialization, and maximize the product’s franchise. Our multi-disciplinary "life cycle management" approach enables us to quickly assimilate our clients’ regulatory, intellectual property and commercial goals, identify potential issues and develop creative and novel approaches to maximize value for our clients.
Our team includes more than a hundred lawyers who devote substantially all of their time to work on behalf of pharmaceutical, biotech and medical device clients. Many of our lawyers have previously served in leadership positions with the major industry regulatory bodies (including several high-ranking officials with the FDA), in-house with major manufacturers (including two former life sciences General Counsel), or within industry trade associations. Our broad background and depth of experience ensures that when clients come upon a problem that they have not seen before or anticipated, chances are that we have.
State health information privacy laws
Advising a multinational pharmaceutical company on state privacy issues relating to a vaccine outreach program.
Specialty Pharma cross-border licensing agreement
Salix Pharmaceuticals in its licensing agreement with Alfa Wasserman S.p.A., by which Salix has licensed rights in the United States and Canada to an extended intestinal release (EIR) formulation of rifaximin.
Binding Corporate Rules for global pharmaceutical company
Assisting GSK plc in its adoption of Binding Corporate Rules (BCRs) in order to permit the company to transfer personal data globally. We helped develop GSK’s privacy compliance program, obtain the UK data protection authority’s approval and continue assisting GSK during the subsequent implementation.
Bellicum Pharmaceuticals IPO and Follow-On Offering
Represented Jefferies, Citi and Piper Jaffray, in the $140 million initial public offering by Bellicum Pharmaceuticals, Inc. on Nasdaq and a $[TBD] million follow-on public offering of common stock.
Clinical Stage Cellular Therapeutics Company in Series B Funding
Advised Cell Medica Ltd. in its £50 million series B funding round. Cell Medica Ltd. is a cellular immunotherapy company which develops, manufactures and markets patient-specific products for the treatment of cancer and infectious diseases.
Bristol-Myers Squibb €1.15 billion Eurobond Offering
Represented Bristol-Myers Squibb in its €1.15 billion registered public offering of investment grade debt securities, and a cash “waterfall” tender offer for $500 million aggregate principal amount of certain of its outstanding debt securities.
Advising clients on pricing and contracting under Veteran’s Health Care Act programs, including VA FSS, 340B, and Tricare
Advice to numerous clients regarding compliance with the statutory and contractual pricing obligations under the Veteran’s Health Care Act (VHCA), including performing gap analyses, providing policies and training, and assisting with investigations and disclosures.
Athyrium Capital Structured Debt and Investment in Skin Care Company
Represented Athyrium Capital in a structured debt facility and equity investment in Tria Beauty, Inc., a company that develops and sells personal laser skin care products.
AstraZeneca in Development of Medical Outcomes Data Research and Analytics System
Represented AstraZeneca in a technology and data collaboration for the development of a new medical outcomes data research and analytics system with Healthcore.
American Airlines IT Outsourcing
Represented American Airlines in a sole-sourced outsourcing of all information technology services between American Airlines and Sabre, Inc. and its subsequent renegotiation with HP and Sabre.
Canadian IP trade dispute
Life sciences companies are being negatively impacted as a result of patent practices in Canada that are leading to the premature invalidation of pharmaceutical patents. We represent a major life sciences company in a dispute under the North American Free Trade Agreement (NAFTA) seeking compensation for losses suffered by Canada’s internationally inconsistent patent practices.
Advising Large Public Companies and Investors on Corporate Governance Matters
Represented boards in the pharmaceuticals, consumer goods, health insurance, home equipment, advertising, motor vehicles, network communications, and technology industries as well as hedge funds, public pension funds, and other investors with respect to corporate governance developments regarding board and committee composition, crisis management, cybersecurity, internal controls, shareholder proposals, proxy access, political spending, and other sensitive disclosures and similar matters.
Advising clients on the negotiation and performance of contracts with the Biomedical Advanced Research and Development Authority, the Defense Threat Reduction Agency, and the National Institutes of Health
Advised multiple clients on matters arising from their negotiation and performance of manufacturing and research and development contracts relating to various pandemic and Chemical, Biological, Radiological and Nuclear (CBRN) threats, including matters relating to government indemnification or liability protection for unusually hazardous risks, compliance with cost standards and principles, and protection of intellectual property.
Advising clients in complex transactional work with life sciences portfolios involving government contracts
Advised multiple clients on unique government contracting considerations in the sale or licensure of their life sciences portfolios to companies with a broad range of government contracting experience.
Advice on the collection and use of employee data
Advised a major pharmaceutical client on the collection and use of its employees’ biometric information and social security numbers for internal purposes.
Allergan Acquisition of Aesthetics Biopharmaceuticals Company
Represented Allergan in its $2.1 billion acquisition of KYTHERA Biopharmaceuticals, Inc.
Athyrium Acquisition Financing
Represented Investment Funds affiliated with Athyrium Capital Management in a $100 million senior secured credit financing transaction for Cipher Pharmaceuticals to fund acquisitions.
AstraZeneca Investment in Respiratory Franchise
Represented AstraZeneca on its up to $2.1 billion transfer of rights to Almirall’s respiratory franchise for an initial consideration of $875 million on completion, and up to $1.22 billion in development, launch, and sales-related milestones.
AstraZeneca Acquisition of Diabetes Products
Represented AstraZeneca in its $4.3 billion acquisition of its diabetes collaboration from Bristol Myers Squibb.
UCB in its $1.23 billion sale of its U.S. specialty generics subsidiary
Represented Brussels-based UCB in the sale of its U.S. specialty generics subsidiary Kremers Urban Pharmaceuticals, Inc., to Lannett Company, Inc., for an upfront cash payment of $1.23 billion.
Whistleblower retaliation case
Successfully argued a whistleblower retaliation case arising under the False Claims Act in the U.S. Court of Appeals for the Fourth Circuit on behalf of a pharmaceutical company after winning dismissal at summary judgment stage.
Whistleblower discrimination summary judgment win
Won summary judgment and Ninth Circuit affirmance of a whistleblower/discrimination case brought against a major pharmaceutical company.
Wellbutrin XL Antitrust Litigation
Represented Valeant Pharmaceuticals Int’l, Inc. in antitrust class action alleging wrongful exclusion of generic competition.
Hatch-Waxman Victory for Omeros Corporation
Representation of Omeros Corporation in Hatch-Waxman patent litigation against Par Pharmaceutical concerning Par's application to make a generic version of the drug Omidria®, a combination drug solution used to maintain pupil dilation during cataract surgery and reduce post-operative pain. The case involved Omeros' only approved drug. Following trial, Par settled the matter on favorable terms for Omeros.
Vioxx insurance arbitrations
Representing Merck in two related London arbitrations involving insurance coverage for claims relating to Vioxx.
Victory for BMS and Eli Lilly in Copyright Infringement Matter
Secured a sweeping victory for our clients BMS and Eli Lilly. In 2006, BMS/Lilly hired Consumer Health Information Corporation (“CHIC”) to develop patient education materials for their injectable diabetes drug BYETTA. The contract expressly designated these as works made for hire and assigned CHIC’s interest in these materials to BMS/Lilly. BMS/Lilly later terminated CHIC, and CHIC sued for copyright infringement in D.C. district court in 2008, but voluntarily dismissed the action in 2009. Last July, CHIC sued again in the Southern District of Indiana. In an attempt to avoid the contractual ownership provisions, CHIC alleged “economic duress” and sought rescission. CHIC's infringement claim sought to recover our clients' profits, allegedly “in excess of several billions of dollars.” Judge Pratt dismissed the complaint with prejudice, ruling that two separate statutes of limitation barred CHIC’s infringement claim. First, the Court held that the claim was barred by the Copyright Act’s three-year statute of limitations. The Court accepted Covington’s argument that, because the case turned on ownership, not use, the continuing violation doctrine did not apply. The Court pointedly noted the inequity of allowing CHIC to wait while BMS/Lilly developed a market only to “pounce on the prize” years later. Separately, the Court held that the ownership provisions expressly assigned ownership to BMS/Lilly, and that CHIC’s attempted rescission was barred by California’s four-year statute of limitations. The Court also rejected CHIC’s outrageous attempt to invoke equitable tolling by arguing that its own (former) attorneys had dismissed its 2008 action without its consent and subsequently concealed the dismissal from CHIC.
Policy advice in South Africa
We assisted a large trade association engage with the South African government on a number of issues, including IP and other issues related to the life sciences sector.
Victory in “Stock Drop” lawsuit
Persuaded Third Circuit to vacate a district court's certification of a class of participants in a "stock drop" lawsuit against our client Schering Plough that alleged breach of fiduciary duty for imprudent retention of a company stock fund in a 401(k) plan. In re Schering Plough Corp. ERISA Litig., 589 F.3d 588 (3d Cir. 2009).
Pharmaceutical Regulations as Hazardous Waste
Advise pharmaceutical companies regarding the regulations of pharmaceuticals as hazardous waste under RCRA.
Pharmaceutical public policy and government affairs
We advise a major pharmaceuticals and health care products company on a wide range of U.S. issues, including Medicare/Medicaid coverage and reimbursement matters related to medical devices, reauthorization of nutrition programs and food labeling policy and tax policy and assist them in advancing their domestic legislative and policy objectives. We also provide global public policy advocacy in countries around the world and in international regulatory bodies.
Pharmaceutical marketing programs
Advising global pharmaceutical companies on HIPAA and state privacy issues relating to pharmaceutical marketing programs.
Pharmaceutical manufacturer
We represented a pharmaceutical manufacturer during debate on the Patient Protection and Affordable Care Act (ACA) with regard to Medicare payment reform provisions.
Trial Win for Salix in Pharma License Agreement Dispute
Won defense verdict for Salix following two-week jury trial in New York State Court. Collaboration partner Napo alleged failures to use “commercially reasonable efforts” to bring licensed drug to market. Despite seeking $260 million and contract termination, Napo recovered nothing.
Won TRO Fight for Lilly in Co-Promotion Dispute Regarding Important Diabetes Drug
Successfully defended Lilly against contract and antitrust claims brought by Amylin relating to an injectable diabetes treatment. We convinced the court to dissolve a TRO and deny a preliminary injunction, allowing Lilly to proceed with promotional activities for important medicine.
Pohlad Family’s Acquisition of PaR Systems
Represented the Minnesota-based Pohlad family as regulatory counsel in its acquisition of PaR Systems, a leading provider of integrated robotic automation and specialized material handling solutions. We handled government contracts matters for the Pohlad family.
Genentech, Inc. ITC Section 337 Investigation
Representation of Genentech in the ITC Section 337 Investigation: Recombinantly Produced Human Growth Hormone, USITC Inv. No. 337-TA-358 (Complainant).
Nidek ITC Section 337 Investigation
Representation of Nidek in the ITC Section 337 Investigation: Excimer Laser Systems for Vision Correction Surgery and Components Thereof and Methods for Performing Such Surgery, Inv. No. 337-TA- 419 (Respondent).
Meretek Diagnostics ITC Section 337 Investigation
Representation of Meretek Diagnostics in the ITC Section 337 Investigation: Breath Test Systems for the Detection of Gastrointestinal Disorders, USITC Inv. No. 337-TA-495 (Complainant).
Q-Med Aktiebolag ITC Section 337 Investigation
Representation of Q-Med Aktiebolag in the ITC Section 337 Investigation: Injectable Implant Compositions, USITC Inv. No. 337-TA-515 (Respondent).
Roche ITC Section 337 Investigation
Representation of Roche in the ITC Section 337 Investigation: Recombinant Human Erythropoietin, USITC Inv. No. 337-TA-568 (Respondent).
MStar Semiconductor ITC Section 337 Investigation
Representation of MStar Semiconductor in the ITC Section 337 Investigation: Display Controllers with Upscaling Functionality and Products Containing the Same, USITC Inv. No. 337-TA-481 (Respondent).
Obtained Dismissal with Prejudice of Two Cases Against Pharmaceutical Companies
Obtained dismissal with prejudice of two cases against pharmaceutical companies alleging false advertising, unfair competition, and fraud claims. Jarrett v. InterMune (9th Cir. 2011); Ostergard v. Adams Respiratory Therapeutics, Inc. (C.D. Cal. 2008).
Silica and asbestos liability claims
Counseling companies with rising volumes of asbestos and silica liability claims in the energy, automotive, construction, mining, respiratory protection, and railroad industries.
Sanofi Aventis in Trademark Infringement and False Advertising Suit
Representation of sanofi aventis in a trademark infringement and false advertising suit involving its FERRLECIT product and Watson Pharmaceutical’s use and advertising of NULECIT.
$52 Million Jury Verdict for Caliper Life Sciences in Trade Secret Misappropriation
Representation of Caliper Life Sciences in which we secured a $52 million jury verdict of trade secret misappropriation in California state court related to microfluidics technology. Two related patent infringement cases settled shortly thereafter on terms favorable to our client.
Asacol® Defense Against Generic
Representation of Warner Chilcott in successfully defending Asacol®, the leading treatment for ulcerative colitis, against ANDAs seeking approval to market a generic version of the drug.
Appellate counsel to Eli Lilly and Co before the Second Circuit
Covington obtained a ruling from the appellate court that Lilly was entitled to summary judgment on plaintiffs’ claims and that the “third party payor” plaintiffs’ claims related to Zyprexa pricing could not proceed as a class action, as initially certified by the district court.
Defense of VIMPAT Patent for Research Corporation Technologies Inc., Harris FRC Corporation, and UCB, Inc.
Represented Research Corporation Technologies, Inc., and licensees Harris FRC Corporation, and UCB, Inc. in a series of six IPR proceedings filed by various generics companies, challenging the patent claiming Vimpat®, UCB’s anti-epileptic drug. The first petition, filed by Actavis, Inc. in 2014, was denied institution. The second petition, filed by Argentum Pharmaceuticals LLC in 2015, was later joined to another four IPR petitions filed by Alembic Pharmaceuticals, Breckenridge Pharmaceutical, and Mylan Pharmaceuticals. The PTAB entered a final written decision on March 22, 2017 entirely rejecting all the challenges and upholding all claims of the patent. In concurrent district court litigation (in which we also represented UCB), the court rejected all the generics’ invalidity arguments in August 2016.
Reinstating Medicaid coverage
We assisted several pharmaceutical manufacturers in reinstating Medicaid coverage for products dropped from the program by the Centers for Medicare & Medicaid Services (CMS).
Reexamination, CBM and Litigation Victories for Ariba, Inc.
Representation of Ariba, Inc. as patent owner in a CBM proceeding relating to operating resource management systems. Covington also represents Ariba in the co-pending litigation. The CBM proceeding was terminated following successful settlement of the patent infringement aspect of the litigation. We have also represented Ariba as requester in two inter partes reexamination proceedings relating to a business-to-business electronic clearinghouse. All original patent claims, as well as claims added during both reexamination proceedings, were rejected. Favorable settlement for Ariba was promptly obtained pursuant to filing of the reexamination requests.
Animal Health Class Action
Representation of Merck in a class action alleging injuries from a product manufactured to regulate diabetes in animals.
Bradley Pharmaceuticals in Trademark Litigation
Representation of Bradley Pharmaceuticals in trademark litigation, including a preliminary injunction hearing, involving the KERALAC mark in the United States District Court for the Eastern District of Pennsylvania.
AstraZeneca in $1.26 Billion Acquisition of Ardea Biosciences
Representation of AstraZeneca in its $1.26 billion acquisition of Ardea Biosciences. Under the agreement, AstraZeneca will pay $32 per share for all of the outstanding shares of Ardea. AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. Ardea is a biotechnology company based in San Diego, California, focused on the development of small-molecule therapeutics for the treatment of serious diseases.
AstraZeneca/Bristol-Myers Squibb diabetes alliance
Representation of AstraZeneca in its strategic diabetes alliance with Bristol-Myers Squibb, including with respect to collaboration arrangements for the development and commercialization of Amylin Pharmaceuticals’ portfolio of diabetes products following BMS’s acquisition of Amylin in a deal valued at $7 billion (approximately half the cost of which was borne by AstraZeneca).
Amylin Pharmaceuticals, Inc. v. Eli Lilly and Company
Covington successfully represented Eli Lilly and Company in a significant commercial dispute with a business partner. The U.S. Court of Appeals for the Ninth Circuit affirmed the District Court’s denial of Amylin’s motion for a preliminary injunction that would have limited the medications that Lilly’s diabetes sale force could promote.
Representation of AstraZeneca in favorable outcome in Seroquel litigation
Counsel for AstraZeneca in the Seroquel litigation, including obtaining a defense jury verdict in the first case to go to trial.
Accutane litigation
Represented Hoffmann-La Roche Inc. in defending mass tort claims involving the prescription acne medication Accutane. In addition to considerable trial level success, Covington has obtained thirteen consecutive appellate victories for Roche in the Accutane litigation.
AbbVie/Calico $1.5B collaboration
Assisting AbbVie in structuring and negotiating a novel collaboration with the Google-backed life sciences start-up company Calico to form a $1.5 billion to fund a program focused on aging and age-related diseases.
HR operations audit for multinational pharmaceutical client
Conducted a detailed review of the human resources operations of a large pharmaceutical company to assess compliance with data protection and privacy laws and regulations in both the US and EU, in anticipation of possible certification under the US-EU Safe Harbor regime. Our extensive written report described potential compliance issues and recommended specific remedial actions.
Horizon Discovery on Sage Labs Acquisition
Representation of Horizon Discovery Group plc, an AIM listed international life science company supplying research tools and services to organizations engaged in genomics research and the development of personalized medicines, on the acquisition of Sage Labs Inc. for a total of approximately $48 million (£29 million), comprising up to $16 million in cash and up to $32 million in new ordinary shares. The acquired business will be known as Sage Labs Inc., a wholly owned subsidiary of Horizon Discovery Group plc. The acquisition creates a fully integrated translational genomics platform and significantly expands Horizon’s product, service and research offerings.
Accutane product liability claims
Secured trial, expert, adequacy, and appeals wins imperiling thousands product liability claims against client Hoffmann-La Roche involving the prescription medication Accutane.
Abbot Laboratories - AbbVie de-merger
Advising Abbott Laboratories in relation to all privacy aspects of its global de-merger, involving the division of the company into a research-based business, AbbVie.
Allergy Therapeutics on Alerpharma Acquisition and £20 Million Placing
Representation of Allergy Therapeutics plc, the AIM-listed specialty pharmaceutical company, in its acquisition of Alerpharma, S.A. a Spanish-based allergy immunotherapy company which previously spun out from Spanish biopharmaceutical company, Zeltia S.A. Covington also advised Allergy Therapeutics on its recent £20.8 million placing of ordinary shares with institutional investors. The proceeds of the placing are being used to progress the clinical development of the company’s lead product, Pollinex Quattro Grass, through to FDA approval and planned launch in the United States in 2019.
In re Zyprexa Products Liability Litigation
Covington successfully represented Eli Lilly and Company in a major RICO class action involving the prescription drug, Zyprexa. After the District Court denied Lilly’s motion for summary judgment and certified a class of tens of thousands of “third party payor” plaintiffs, the U.S. Court of Appeals for the Second Circuit reversed those decisions, holding that the case could not proceed as a class action, and that Lilly was entitled to summary judgment on plaintiffs’ claim that the price of Zyprexa was too high.
In re Schering Plough Corporation ERISA Litig., 589 F.3d 585 (3d Cir. 2009)
We secured the reversal of a class certification order in a “stock drop” lawsuit claiming breaches of fiduciary duty in the administration of a company retirement savings plan.
In re K-Dur Antitrust Litigation
Representing Schering-Plough (now Merck) in multi-district class action litigation challenging so-called reverse payment settlements of pharmaceutical patent litigation. Obtained denial of certification of indirect purchaser class, after which indirect purchasers voluntarily dismissed their case. The team previously defeated the FTC at trial in an action on the same facts, and will now have the opportunity to resolve the direct purchaser portion of the case under a recent Supreme Court decision.
International arbitration against Canada under NAFTA
Representation of Eli Lilly and Company in an international arbitration against Canada under Chapter 11 of the North American Free Trade Agreement. Lilly seeks $500 million in compensation for the expropriation of its patent rights under Canada’s unique promise utility doctrine and other treaty violations.
Food and Cosmetics Labeling Class Actions
Represented numerous food and cosmetics companies in responding to demand letters and class actions under the California Consumer Legal Remedies Act and Unfair Competition Law arising out of alleged false and misleading statements on labels and marketing materials.
Global health privacy advice
Advised pharmaceutical companies in the United States and Europe on data privacy issues, including questions relating to genetic testing programs and the development of genomics databases, the sourcing and handling of human tissue and biological samples for research purposes, patient outreach, and marketing activities.
Genetic diagnostics strategic alliance
Illumina in a strategic alliance with Genomics England for a four-year project to decode 100,000 human genomes.
Genentech cancer medication product liability claims
National counsel to Genentech defending claims related to its cancer medications, Rituxan and Avastin.
Oxycontin Litigation
Representation of Purdue Pharma in class action litigation in multiple states alleging violations of consumer protection laws in the marketing of OxyContin.
Privacy issues related to patent data migration
Assisted another large pharmaceutical company in dealing with privacy issues resulting from the migration of patient data from a clinical study to a web based platform.
Pradaxa products liability litigation
Served as lead MDL counsel for Boehringer Ingelheim in the Pradaxa products liability litigation.
Position Paper Concerning Potential Amendments
Assist the client in preparation of a position paper concerning potential amendments to anti-circumvention provisions of Section 1201 of the Digital Millennium Copyright Act and in preparation of comments to the Copyright Office on proposed exemptions to Section 1201.
Health privacy to pharma companies in China
Advised a multinational biopharmaceutical company operating in China on privacy and property ownership issues related to the collection and sharing of biological samples in clinical trials.
Health privacy litigation
Advised a large pharmaceutical company in connection with litigation involving the alleged infringement of patient privacy by a pharmacy chain that collects personal information about prescription drug users.
Hatch-Waxman settlement investigation and class action
AstraZeneca in an FTC investigation and private antitrust class action litigation concerning settlements of Hatch-Waxman patent litigation involving Nexium.
GSK pharma investigation
Represented GlaxoSmithKline in successfully resolving one of the largest criminal and civil investigations involving pharmaceutical industry marketing practices.
GSK DOJ pharmaceutical investigation
Represented GlaxoSmithKline (GSK) in resolving a complex criminal and civil investigation by the United States Department of Justice. The multi-faceted investigation had a broad focus, including issues relating to GSK’s sales and marketing practices for numerous products, its regulatory submissions relating to Avandia, and the company’s use of the nominal price exception under the Medicaid Rebate Program.
Government of Puerto Rico
We assisted the Government of Puerto Rico during debate on the Patient Protection and Affordable Care Act (ACA) in its efforts to secure parity in federal funding of its Medicaid program.
Merck Merger with Schering-Plough
Representation of Merck in its $41 billion merger with Schering-Plough.
Merck ITC and District Court Litigation
Representation of Merck & Co. before the ITC and in the Eastern District of Virginia in cases involving Merck’s blockbuster NuvaRing® contraceptive product. After the first day of the evidentiary hearing, the complainant dismissed their ITC complaint and subsequently dismissed their district court complaint as well. Certain Vaginal Ring Birth Control Devices.
Merck class action claims
Counsel to Merck Animal Health defending purported class action claims related to its animal diabetes medication, Vestulin.
Medicare Part D coverage for pharma product
We assisted a pharmaceutical company in obtaining Medicare Part D coverage for its previously excluded product, using an integrated regulatory and legislative strategy.
Medical student placement litigation
We represented an alliance of medical colleges to affirm the validity of the medical student placement program that had been under attack in litigation and, after a successful legislative initiative, won dismissal of the lawsuit.
Medical device company legislative support
We assisted a medical device company in its efforts to secure Medicare pass-through coverage of its innovative diagnostic device.
Privacy issues relating to clinical trials
Assisted several large pharmaceutical companies with a variety of privacy issues relating to clinical trials, further use of data and pharmacovigilance reporting.
Prescription Labelling Class Action
Represented Eli Lilly in a consumer fraud class action alleging that the labelling for one of its prescription medicines was inadequate and misleading.
McCarrell v. Hoffmann-LaRoche Inc. and Roche Laboratories Inc.
Covington scored a major victory for Hoffmann-La Roche when, for the second time, the firm convinced the New Jersey Appellate Division to reverse a 2010 state court verdict in a case regarding side effects of the manufacturer’s drug Accutane. Covington has prevailed in all thirteen appeals in the Accutane litigation and has obtained reversals of all six adverse jury verdicts that have received appellate review.
More than $1 billion in recoveries for Dow Corning
Obtained more than $1 billion in recoveries for Dow Corning through a number of large settlements in court-appointed mediation related to breast implant liabilities.
Janssen Pharmaceuticals Hatch-Waxman Litigation
Representation of Johnson & Johnson subsidiary Janssen Pharmaceuticals in Hatch-Waxman litigation against Lupin relating to the Ortho Tri-Cyclen® Lo patent. After a full trial on the merits, the court held that the patent was valid and enforceable. We subsequently obtained a highly favorable settlement for our client.
Off-label promotion and reporting investigations
Representation of GlaxoSmithKline in global settlement of three investigations relating to off-label promotion, safety reporting and price reporting.
Numerous Clients in Managing U.S. and Global Trademark Portfolios
Advise on cutting edge trademark strategies, domain name, social media, and keyword advertising issues, manage U.S. and global portfolios, and provided trademark advisory and prosecution services to leading US and global brand owners, including: American Automobile Association (AAA); AOL, Inc.; Astelllas US; Business Software Alliance; Dale & Thomas Popcorn; Expedia, Inc.; FeraDyne Outdoors; German American Chambers of Commerce; Lewis Bakeries, Inc.; Merck & Co. Inc.; Microsoft Corporation; National Basketball Association; National Football League; National Geographic Society; National Hockey League; Public Broadcasting Service; Phi Beta Kappa Society; Promontory Financial Group; and U.S. Soccer Federation.
Salix Pharmaceuticals in $2.6 Billion of Santarus, Inc.
Representation of Salix Pharmaceuticals, Ltd. in its acquisition of Santarus, Inc. for a total value of approximately $2.6 billion. The transaction closed on January 2, 2014. According to Carolyn Logan, Salix President and Chief Executive Officer, “The acquisition of Santarus is a transformational event for Salix and an important milestone in our growth as the leading gastroenterology-focused specialty pharmaceutical company in the United States.”
Reversal of FDA denial of period of exclusivity
Representation of Amarin in the first known reversal of an FDA denial of a 5-year period of new chemical entity (NCE) exclusivity since the enactment of the Hatch-Waxman Amendments in 1984, in connection with Amarin’s Vascepa drug for lowering triglyceride levels.
Mitigating the impact of the Ebola crisis on operations in Africa
We advised an asset management firm on mitigating the impact of the Ebola crisis on its operations in Liberia.
International Global Mobility Advice
Assisted a life sciences company with international assignments, including relevant cross-border corporate and individual tax risks and immigration requirements.
King Pharmaceuticals Acquisition by Pfizer
Representation of King Pharmaceuticals in its $3.6 billion acquisition by Pfizer.
University of Pennsylvania Royalty Monetization
Represented University of Pennsylvania in the structured sale of a portion of its worldwide royalty interests in Juxtapid.
Valuation of R&D materials imported into the United States
Assisted a life sciences company in connection with a substantial prior disclosure concerning the proper Customs valuation of certain R&D materials imported into the United States.
Comprehensive privacy policies
Assisted pharmaceutical companies in developing global comprehensive privacy policies aligned with federal (HIPAA, Food & Drug Administration, and National Institutes of Health) regulations, state and European law, and best practices.
Large commercial award for Merck
Representation of Merck in ad hoc London arbitrations against various insurers that produced a disclosed recovery of approximately US$590 million, plus US$45 million in fees and interest, for prescription drug liabilities — reportedly one of the largest commercial awards in Europe in recent years.
Clinical trial defense
Counsel to pharmaceutical and biotech clients defending individuals’ claims arising out of their participation in our clients’ clinical trial programs.
Coordinated monitoring and advocacy at the multinational, international and national levels
A highly innovative pharmaceuticals company was concerned about the public debate and policy proposals made to address antimicrobial resistance, as these could seriously curtail its future business. Working together with external partners, we monitor and participate in discussions at the G7, WHO, EU and national levels (in the UK and Germany), with several successes already at proposing alternative solutions more favorable to our client.
Leading role in OxyContin suits
National coordinating counsel to Purdue Pharma defending scores of suits filed in state and federal courts around the country by plaintiffs who claim injury from having used – in most cases abused – the company’s OxyContin pain relief prescription medication.
“Co-Generators” Listing for RCRA Purposes
Advise pharmaceutical manufacturer regarding listing of multiple generators of waste as “co-generators” for RCRA purposes.
Cymbalta trials
National Counsel to Eli Lilly and Co. defending products liability and consumer protection claims related to its antidepressant Cymbalta.
European data privacy
Represent an ad hoc consortium of U.S. and European pharmaceutical and medical device companies concerned about data privacy issues in Europe, including the Eastern European Member States such as Hungary, Poland, and the Czech Republic.
FCPA investigation for Fortune 500 life sciences company
Engaged by a Fortune 500 Life Sciences company to coordinate the investigation of suspected FCPA violations in various countries, including Brazil, and to advise the company’s Internal Audit Department on conducting FCPA audits to ensure compliance.
Developing a corporate responsibility program
We assisted a pharmaceutical company on assessing which NGOs they should consider working with in Kenya to implement a corporate responsibility program aimed at improving public health.
False Claims Act litigation and appellate defense
Successful defense of Pfizer in both the district court and the court of appeals on a series of claims by a relator concerning Genotropin.
Employment aspects of life sciences-sector acquisition
Advised Consort Medical plc on employment and benefits issues arising from its £230 million acquisition of Aesica Holdco Ltd.
Employment advice to AstraZeneca in major acquisition
Provided international employment law advice to AstraZeneca in relation to its acquisition of Bristol-Myers Squibb’s interests in the companies’ global diabetes alliance across 40 jurisdictions.
Alkermes Global Pharmaceutical Portfolio
Managing the worldwide patent portfolios of Alkermes companies relating to sustained-release pharmaceutical formulations in products such as VIVITROL®, RISPERDAL® CONSTA®, and BYDUREON®. We obtained pivotal patents in Canada, China, Europe, Japan, and the United States covering the BYDUREON product, a sustained-release formulation indicated for the treatment of Type 2 diabetes.
Sanofi/Verily Life Sciences Transaction
Representation of Sanofi in connection with obtaining clearances from the European Commission and in China, Korea, Switzerland, Taiwan, Turkey and Ukraine for its collaboration with Google Life Sciences, Inc., now Verily, relating to diabetes management products and services.
AstraZeneca Transactions
Representation of AstraZeneca in relation to the creation of a $3.4 billion diabetes joint venture with BMS, and the subsequent acquisition of sole control over that venture; in its acquisition of the rights to Almirall’s respiratory franchise (for initial consideration of $875 million and up to $1.22 billion in development, launch and sales-related milestones); assisting in the acquisition of the Takeda respiratory portfolio; and in relation to the creation of an oncology joint venture with Fujifilm Kyowa Kirin Biologics (FKB).
Orange Book Listed Patents in Reexamination Proceedings
We represented Alkermes, Inc., the top patent owner of Orange Book listed patents in reexamination, in ex parte reexamination proceedings and worldwide opposition proceedings initiated by competitors. Six of the seven patents successfully emerged from reexamination and remain listable for the VIVITROL® and RISPERDAL® CONSTA® products.
FDCA, FTC Act, and Lanham Act Compliance for life sciences companies
Advising distributors of prescription drugs and medical devices concerning compliance with the Food, Drug, and Cosmetic Act, FTC Act, and Lanham Act advertising standards.
Global compliance
Conducted a detailed review of the human resources operations of a large pharmaceutical company to assess compliance with data protection and privacy laws and regulations in both the U.S. and EU, in anticipation of possible certification under the U.S.-EU Safe Harbor regime. Our extensive written report described potential compliance issues and recommended specific remedial actions.
Indivior $1.6 billion Demerger
Represented Indivior plc in its $1.6 billion demerger transaction from Reckitt Benckiser Group plc and listing on the LSE.
Illumina Decoding UK-based Human Genome
Represented Illumina on a strategic alliance with Genomics England for a four-year project to decode 100,000 human genomes in the UK.
Horizon Discovery Group IPO on AIM
Represented Horizon Discovery Group plc in its £68.6 million initial public offering on AIM.
HealthSouth Senior Notes Offering
Represented HealthSouth Corporation in its public offering of $300 million of its 5.125% senior notes due 2023.
HealthpointCapital in IPO of Portfolio Company
Represented HealthpointCapital Partners as a selling shareholder in Alphatec Holdings, Inc.'s underwritten public offering of 18.4 million shares of common stock for total proceeds to HealthpointCapital and Alphatec of approximately $85 million.
HealthpointCapital in Acquisition and Exit of French Company
Represented HealthpointCapital in its minority investment in ScientX and subsequent acquisition of its France-based parent through a tender offer.
Healthcare Services and Solutions Collaboration Agreement with MedCPU
Represented Healthcare Services and Solutions in a collaboration agreement with MedCPU for the development of a new clinical-decision support system and related services.
Health IT Company in Series A and B Funding
Advised Kit Check, Inc. in its $10.4 million Series A financing led by New Leaf Ventures and in its Series B financing led by Kaiser Permanente.
Data breach notification requirements
Advised a global pharmaceutical company on the data breach notification requirements in more than 80 countries, following a security breach affecting employees in Europe, Asia and the Americas.
Dendreon
Represented potential stalking horse bidder in bidding and auction process established for the Section 363 sale of substantially all of the assets of this Chapter 11 debtor.
Eli Lilly Notes Offering
Represented Eli Lilly and Company in a $1 billion registered offering of notes, consisting of $600 million of 1.950% notes due 2019 and $400 million of 4.650% notes due 2044.
Emory University Royalty Monetization
Represented Emory University in a ground-breaking sale of its royalty interests in Emtriva for $540 million, the first royalty monetization conducted by auction and IDD’s 2005 Healthcare Deal of the Year.
Eli Lilly in €2.1 billion Euronotes Offering
Represented Eli Lilly and Company in its €2.1 billion notes offering consisting of €600 million 1.000% Notes Due 2022, €750 million 1.625% Notes Due 2026, €750 million 2.125% Notes Due 2030.
Electronic Medical Records System
Represented a Hospital Network in connection with the negotiation of a license and service agreement for an enterprise-wide Electronic Medical Records (EMR) system.
Duke University Royalty Monetization
Represented Duke University in the sale of a portion of its worldwide royalty interests in Myozyme and Lumizyme.
Negotiation and vetting of state contracts for healthcare exchanges and MMIS
We helped a major client negotiate contracts with state healthcare exchanges in Maryland and several other states, and navigate the procurement rules and risk areas unique to many state exchanges. We have also advised clients regarding intellectual property and other issues specific to state MMIS procurements.
Negotiated cooperative research and development agreements (CRADAs)
Advised major pharmaceutical, consumer products, and energy companies, as well as universities, concerning IP rights under CRADAs for technology transfers at national laboratories.
Navigation of Organizational Conflicts of Interest
We have helped major contractors navigate the specific Organizational Conflicts of Interest (OCI) rules and requirements imposed by the Centers for Medicare and Medicaid Services (CMS), the Defense Health Agency, and other agencies. When CMS rolled out its new approach to OCIs, including its new standard clause and required forms, we helped a major CMS contractor comment on key aspects of the approach.
Navigation of multiple issues related to healthcare.gov
In the wake of the failed launch of healthcare.gov, we helped a major health IT company navigate compliance and other issues related to its healthcare.gov contract and efforts to remediate the website and related IT systems.
Navigation of issues specific to CMS Recovery Audit Contracting
We helped a client navigate a range of issues unique to RAC contracts with the Centers for Medicare and Medicaid Services (CMS).
OrbiMed Advisors Debt Financings
Represented OrbiMed Advisors in a number of proposed and completed debt financings, including a $25 million secured loan to, and synthetic royalty purchase from, Bacterin International Holdings, Inc.
Kite Pharma IPO and Follow-On Offering
Represented Jefferies, Credit Suisse and Cowen and Company, as underwriters, in a $127.5 million initial public offering by Kite Pharma, Inc. on Nasdaq and a $188 million follow-on public offering of common stock.
Kennedy Trust Royalty Monetization
Represented The Kennedy Trust for Rheumatology Research (a UK charitable trust which currently funds a major research institute at Oxford University) in the structured sale of a portion of its worldwide royalty interests in Remicade and Simponi.
Issuer’s or Underwriters’ Counsel in 22 recent IPOs
In 2014 and 2015 to date, we have represented issuers or underwriters in 22 initial public offerings, including IPOs for UniQure, Horizon Discovery Group, Bankwell Financial Group, Bellicum Pharmaceuticals, Kite Pharma, Indivior plc and Automobile Association.
Iran Sanctions Investigation for Pharmaceutical Company
Conducted an Iran sanctions investigation for a major pharmaceutical company.
Iran and Sudan Sanctions Advice
Secured export licenses enabling leading pharmaceutical companies to sell millions of dollars’ worth of medical products to Iran and Sudan, and permitting consumer products companies to export agricultural commodities to those countries.
Investors in its Funding of Clinical Cancer Genomics Company
Advised Imperial Innovations, Cambridge Innovation Capital and Johnson & Johnson Development Corporation in a £4 million funding round for Inivata, a clinical cancer genomics company spun out from Cancer Research UK.
Lombard Medical IPO and Re-Domiciliation
Represented Lombard Medical in its $55 million initial public offering on Nasdaq and re-domiciliation.
Life Sciences Investors in Series C Funding of Development Stage Biotech Company
Advised Imperial Innovations and SROne on a £25 million Series C funding round in portfolio company PsiOxus Therapeutics which is developing innovative oncolytic immuno-oncology treatments for cancer.
OrbiMed Product Launch Financing
Represented investment funds affiliated with OrbiMed Advisors in connection with a $90 million senior secured credit facility to Iroko Pharmaceuticals to finance the commercial launch of a pharmaceutical product.
Northwestern University Royalty Monetization
Represented Northwestern University, and an inventor affiliated with Northwestern University, in a series of royalty monetizations (structured both as sales and as financings through special purpose vehicles), including Northwestern’s 2007 sale of a portion of its worldwide royalty interest in Lyrica for $700 million, the largest monetization of a royalty stream for a single pharmaceutical product.
Kit Check Pharmacy Automation System Distribution
Represented Kit Check in the development of their service and customer agreements for hospitals and business partners relating to Kit Check’s pharmacy kit automation system and services.
Johnson & Johnson $2 billion Investment Grade Debt Offering
Represented Johnson & Johnson in a $2 billion registered public offering of its investment grade debt securities.
MedImmune in Series A Funding of Clinical-Stage Pharmaceutical Company
Advised MedImmune Ventures as lead investor in the Series A Preferred Stock financing of G1 Therapeutics. G1 Therapeutics uses small molecule therapies that act by a novel mechanism to potentially prevent the hematological side effects of exposure to ionizing radiation and cancer chemotherapy, as well as other possible uses.
Colbeck Capital in Secured Debt Financing
Represented Colbeck Capital Management LLC, as the arranger of the secured debt financing for Kadmon Pharmaceutical’s acquisition of Three Rivers Pharmaceuticals.
Representation of Teva Pharmaceuticals
We represented Teva in its strategic partnership with IBM, which enabled it to become the first multinational pharmaceutical company to deploy IBM’s Watson Health Cloud as its global technology platform. As part of the partnership, a joint Teva-IBM research team will work together using “big data” and machine-learning tools to develop disease models and advanced therapeutic solutions, including solutions designed to collect and analyze real world evidence. The deployment of these models and solutions will enable Teva to provide insights and real-time feedback directly to care providers and patients via mobile devices in order to achieve treatment optimizations and improved patient outcomes.
Trade association guidance
Providing litigation counsel to several industry trade associations, including Consumer Healthcare Products Association (CHPA), Pharmaceutical Research and Manufacturers of America (PhRMA), and Distilled Spirits Council of the United States (DISCUS).
Acquisition of Leading Pharmaceutical Contract Development and Manufacturing Company
Represented Consort Medical plc on its £230 million acquisition, of Aesica Holdco Limited and its operating subsidiaries from Silverfleet Capital and management shareholders.
Acquisition of IP Assets via Bankruptcy Estate Auction
Represented a global pharmaceutical company in its acquisition of the IP assets of a medical devices and diagnostics company through a competitive auction administered by a U.S. bankruptcy court.
Legislative Victory in a 2016 FDA Nutrition Facts Panel Rule
When the 2016 Nutrition Facts Panel final rule required manufacturers to submit evidence demonstrating that their products met new standards, our client, a Midwestern food ingredients company, immediately complied. However, they were told the FDA would not be able to review the data in time to renew the company’s contracts. Faced with losing its domestic customers for its flagship products, we organized a robust appropriations strategy involving a series of high-level communications. Through our efforts, the FDA delayed compliance long enough to allow for due process. The company was able to swiftly renew its contracts with its biggest customers.
Verscend’s Aquisition of a GDIT Business
Represented Verscend Technologies as regulatory counsel in its acquisition of General Dynamics IT’s commercial health insurance payer-focused products. We handled government contracts matters for Verscend.
Magellan’s Acquisition of AFSC
Represented Magellan Health as regulatory counsel during its $117.5 million acquisition of Armed Forces Services Corporation (AFSC), a provider of behavioral health and specialty services to the Department of Defense and other U.S. government agencies. We handled government contracts and national security matters for Magellan.
Famy Care Sale of Women’s Health Business
Represented Famy Care Limited in its $750 million sale of its women's health business to Mylan Laboratories Limited.
Covington Avoids IPR Trial for AstraZeneca SYMBICORT® Patent
Represented AstraZeneca in defeating Complex Innovations’ attack on a patent covering SYMBICORT® inhalation aerosol for asthma and COPD. On July 24, 2017, the Patent Trial and Appeal Board denied institution of an IPR trial as to every challenged claim. The PTAB largely followed the arguments Covington presented in the preliminary response when determining that the petition failed to demonstrate a reasonable likelihood of prevailing at trial.
The Walter and Eliza Hall Institute of Medical Research Royalty Monetization
Represented The Walter and Eliza Hall Institute of Medical Research in the sale of a portion of its royalty interests in Venetoclax for up to U.S. $325 million (A$406 million), consisting of an up-front payment of U.S. $250 million and up to U.S. $75 million of additional payments upon the attainment of certain milestones, the largest royalty monetization by a non-profit institution outside the United States.
LifeArc Royalty Monetization
Represented LifeArc (formerly, MRC Technology), a UK-based medical research charity, in the structured sale of a portion of its royalty interests in Keytruda for U.S. $150 million.
Dana Farber Cancer Institute Royalty Monetization
Represented Dana-Farber Cancer Institute in the sale of a portion of its royalty interests in various Programmed Death Ligand-1 (PD-L1) cancer drugs for an up-front payment of $100 million and up to $68 million of additional payments upon the satisfaction of certain conditions.
Trade Compliance Program for a Life Sciences Company
Assisted a leading life sciences company in the design and implementation of global trade compliance program.
Salix Pharmaceuticals Transactions
Represented Salix Pharmaceuticals in antitrust issues related to its $2.6 billion acquisition of Santarus, Inc., another specialty pharmaceutical company focused on gastrointestinal treatments and in its $300 million acquisition of Oceana Therapeutics, LCC.
GammaDelta Therapeutics on Strategic Collaboration with Takeda
GammaDelta Therapeutics Limited on a strategic collaboration with Takeda to develop GammaDelta Therapeutics’ novel T cell platform, which is based on the unique properties of gamma delta (γδ) T cells derived from human tissues.
Multimillion Dollar Jury Verdict in Trade Secret Dispute for Former CEO of a Medical Device Company
Representation of the former CEO of a medical device company in defeating claims of theft of trade secret and employment contract claims, and obtaining a multimillion dollar jury verdict on counterclaims based on a technology licensing agreement in which the CEO (who was also the inventor of a heart valve) licensed the technology to the company.
TRICARE-Related Advocacy
We achieved a significant legislative victory for a major retail corporation when Congress passed the FY 2017 National Defense Authorization Act with new authorities to expand patients’ access to retail pharmacies. Our objective was to overcome the exclusion of chain and local pharmacies from providing brand maintenance drugs under TRICARE at the same rates available for prescriptions filled at military treatment facilities or through mail-order pharmacies, which caused significant losses to chain and local pharmacy businesses and limited beneficiaries’ access to retail pharmacies. Our efforts led to the inclusion of a pilot program allowing pharmacies to provide brand maintenance drugs to TRICARE beneficiaries. The bill passed with overwhelming support in both the House (375-34) and the Senate (92-7).
Bayh-Dole Advice Across Sectors
We have advised clients in various sectors regarding the substantial manufacturing requirement under the Bayh-Dole Act, including securing waivers of the requirement and helping clients structure manufacturing obligations to maximize business efficiencies within the requirements of the Bayh-Dole Act. We also routinely advise clients regarding the Bayh-Dole Act’s requirements for perfecting title in intellectual property and avoiding potential march-in actions under the Act.
Half-billion Dollar Trade Secrets Trial Victory for McKesson
After being retained months prior to trial following nearly a decade of litigation, Covington obtained a complete defense verdict for a subsidiary of McKesson Corporation in a bench trial in New York Supreme Court. The plaintiff had alleged breach of a non-disclosure agreement and trade secret misappropriation related to a drug discount program. Plaintiff sought the assignment of certain McKesson patents and half a billion dollars: nearly $250 million in damages and 11.5 years’-worth of prejudgment interest. PSKW, LLC v. McKesson Specialty Arizona, Inc. (S. Ct. NY).
Pharmaceutical Manufacturing Project Development
Represented Novartis Vaccines and Diagnostics, Inc. (successor to Chiron Corporation) in its plans to locate, construct and operate a cell culture-derived influenza vaccines manufacturing facility in Holly Springs, North Carolina.
Share Repurchase Programs
We routinely represented Fortune 500 companies in the pharmaceuticals, consumer goods, and health insurance industries with respect to multibillion dollar share repurchase programs.
Securities Counsel to Numerous Fortune 500 companies
Represent numerous Fortune 500 companies in the pharmaceuticals, consumer goods, health insurance, home equipment, advertising, motor vehicles, network communications, and technology industries with respect to the resolution of shareholder proposals concerning executive compensation, majority voting, proxy access, the right to call special meetings, political spending and lobbying disclosures, and a host of other topics.
Sanofi in Series C Funding of Therapeutic Vaccine Product Development Company
Advised Sanofi-Genzyme Bioventures in a Series C round for Immune Design Corp., a company developing innovative technologies to strengthen patient-specific immune responses to potentially fight cancer and other chronic diseases.
Salix Pharmaceuticals, Ltd. Notes Offering
Represented Salix Pharmaceuticals, Ltd. in its $750 million offering of 6.00% senior notes due 2021.
Salix Acquisition of Specialty Pharma Developer
Represented Salix Pharmaceuticals, Ltd. in its $2.6 billion acquisition of Santarus, Inc.
Salix Acquisition Financing and Credit Facility
Represented Salix Pharmaceuticals in its $1.95 billion acquisition financing and an additional $150 million revolving credit facility in connection with its acquisition of Santarus, Inc.
Salix $2.6 billion Tender offer Acquisition
Represented Salix Pharmaceuticals Ltd. in its $2.6 billion tender offer acquisition of Santarus Inc.
Sale of Specialty Pharma Company Omthera Pharmaceuticals
Represented Omthera Pharmaceuticals in its $443 million merger with AstraZeneca.
Shareholder Proposals in Proxy Materials
Represented a global life sciences company with respect to selected securities disclosure and governance matters, including obtaining no-action relief allowing the exclusion of several shareholder proposals from its proxy materials. We also successfully defended and achieved favorable outcomes for this client in related litigation.
Successfully protested $2 billion+ biodefense award
When the federal government awarded a contract worth more than $2 billion for the development and delivery of a medical countermeasure, we protested at the U.S. Government Accountability Office (GAO). After many rounds of briefing, and a hearing before GAO, the agency agreed to cancel and re-compete the majority of the contract.
Procter & Gamble Sale of Pharma Business
Represented Procter & Gamble in the $3.1 billion sale of its global pharmaceuticals business to Warner Chilcott.
Post-acquisition Compliance Review for Pharmaceutical Company
Conducted a post-acquisition trade compliance review for a global pharmaceutical company that included a voluntary disclosure to the U.S. Commerce Department. We also provided related Iran sanctions advice.
Pharmaceutical Company in its Series C Funding of Biopharma Company
Advised AstraZeneca as lead investor in a $20 million Series C funding round of PhaseBio Pharmaceuticals, a clinical-stage biopharmaceutical company.
Personal care product classification
Advised a Fortune 50 company with respect to the proper classification of personal care products.
Perseus in Convertible Debt Investment
Represented Perseus LLC in connection with its convertible debt investment in PhotoMedex, Inc., a publicly traded medical devices company, to finance the acquisition of the operations of Photo Therapeutics Ltd.
Pepco on $6.6 billion in securities offerings
Represented Pepco Holdings, Inc. and its subsidiaries as corporate and securities counsel for over 25 years, including representation in over $6.6 billion of securities offerings since 2002.
Protection of IP rights for pharmaceutical companies
For pharmaceutical companies entering into R&D contracts, grants, and cooperative agreements with BARDA, NIH, and DTRA, we have successfully developed and implemented strategies for protecting our clients’ intellectual property. We have helped our clients limit or avoid government IP rights through the use of alternative contracting vehicles, specially negotiated contract clauses, properly drafted statements of work, and other means. We have also obtained waivers of U.S. manufacturing requirements under the Bayh-Dole Act.
Rules of Origin
Provided foreign-origin and “Made in USA” marking advice to manufacturers in the life sciences, automotive, machine tooling, and consumer electronic industries.
Reviewing and amending Binding Corporate Rules
Reviewing and amending BCRs for a Swiss-based pharmaceutical company with the French data protection authority acting as the lead authority.
Representing global pharmaceutical company in “test” case involving BCR and CBPR interoperability
Representing Merck in one of the first “test” cases involving interoperability between BCRs and APEC’s Cross-border Privacy Rules (CBPR). The case will establish a precedent for cross-border transfers of personal data for both the EU and Asia-Pacific Region.
Renegotiated government IP agreements
On behalf of a major pharmaceutical manufacturer, we renegotiated agreements with the National Institutes of Health (NIH) concerning IP rights arising out of the development, manufacture, and use of experimental vaccine supplies for international clinical trials, and negotiated contract terms placing on the government the risk of the client’s use of contested IP developed by another contractor.
Recruiting and Employee Training Outsourcing
Represented a pharmaceutical company in outsourcing its recruitment and employee training functions.
Multiple successes for independent contractors
Successfully defended Capital Cities/ABC, GE, the NFL, Verizon, and the Pharmaceutical Research and Manufacturers of America in separate suits against claims that independent contractors were entitled to benefits under company plans.
Trusted Advisor to Fortune 100 Companies
Represent Fortune 100 companies in the consumer goods, health insurance, and technology industries with respect to sensitive, ongoing securities disclosure, and compliance matters.
Trinity Equity Investment and Life Sciences Recapitalization
Represented Trinity Equity Investments I, LLC in its investment in, and recapitalization of, Ricerca Biosciences, LLC, which was completed in connection with Ricerca’s acquisition of the Discovery and Preclinical business of MDS Pharma Services.
Transmission and Compliance Monitoring of UK Patient Health Information
Represented a major global biopharmaceutical company on information governance requirements of the UK’s National Health Service with respect to the use and transmission of patient information collected using internet-enabled compliance monitoring tools.
Telehealth IT System Development
Represented a major global pharmaceutical company on negotiating arrangements with multiple suppliers for the development and operation of a complex state-of-the-art telehealth IT system.
Abbott Laboratories de-merger
We represented Abbott Laboratories in connection with its global spin-off of its pharmaceutical research business, and creation of a new global enterprise, AbbVie.
AA Pharma
Represented bidder in connection with Section 363 sale of substantially all of the assets of this Chapter 11 debtor.
State of Louisiana
We assisted the State of Louisiana in securing amendment in the Patient Protection and Affordable Care Act to modify federal matching funds to reflect impact of Katrina on the State’s per capita income.
Congressional action on organic product marking
We helped a trade association obtain congressional reversal of a crippling federal court decision that would have compelled removal of the USDA seal from approximately 90 percent of organic products and that would have likely resulted in a market loss of nearly $1 billion in the first year after the ruling.
ChemGen Corp. Merger with Eli Lilly
Advise ChemGen in its merger agreement with Eli Lilly. The client became a wholly-owned subsidiary of Eli Lilly and an operating unit of Elanco, the animal health division of Eli Lilly.
Children's Medicine Recall Class Actions
Represented Johnson & Johnson and McNeil Consumer Healthcare in consumer class actions arising out of recall of children’s medicines.
China Regulatory and Compliance
Conducting internal investigation on behalf of a multinational pharmaceutical company into whistleblower allegations of corruption at its Chinese subsidiary.
China pharma bribery investigation
Representation of a major pharmaceutical company in its response to a Chinese government commercial bribery investigation in China.
China life sciences transactional
Advising a leading multinational pharmaceutical company on the acquisition of diabetes drug assets in China and the transfer of related employees from a multinational drug company.
China life sciences transactional
Representing a leading U.S. pharmaceutical company to set up a joint venture in China with a Chinese biotech company to research, develop and commercialize a late-stage clinical product for the Asia market.
China licensing and joint venture
Advising a U.S. biotech company on its sino-foreign joint venture with a Chinese life sciences company to focus on RNAi-based drug discovery, and related license agreement.
China licensing and collaboration
Advising a leading multinational pharmaceutical company on its agreement with a Nasdaq-listed drug manufacturer to develop and market its linaclotide capsule in China.
August 17, 2018
LONDON—Covington has advised Sensyne Health on medical device regulatory and data protection matters in connection with its £60 million IPO on London’s AIM market. The firm also represented Sensyne Health in negotiating strategic research and data processing agreements with the Chelsea and Westminster Hospital NHS Foundation Trust, the Oxford University ...
August 9, 2018
WASHINGTON—Covington advised Emergent BioSolutions in its $270 million acquisition of PaxVax. PaxVax is majority owned by an affiliate of Cerberus Capital Management. Emergent is a global life sciences company focusing on providing specialty products for civilian and military populations that address public health threats. PaxVax is a company focused on ...
July 31, 2018, Medtech Insight
Wade Ackerman is quoted in Medtech Insight regarding the FDA’s software pre-certification program and what that means for device and digital health firms interested in getting new products to the market. Mr. Ackerman says, "The agency has been transparent in that it is considering various legal mechanisms available to the agency to establish the program – ...
July 27, 2018, Covington Alert
On July 11, 2018, the U.S. Food and Drug Administration (FDA or the Agency) made available a suite of six scientific draft guidance documents on human gene therapy (GT) products.
Sarah Crowder Named to GIR's "Women in Investigations"
July 17, 2018
LONDON—Global Investigations Review has named Covington’s Sarah Crowder to the second edition of “Women in Investigations,” highlighting 100 female practitioners from across the globe. Nancy Kestenbaum and Mythili Raman were selected to the list’s first edition in 2015. The survey highlights a variety of women not previously recognized by the magazine—from ...
July 13, 2018
WASHINGTON—Covington's patent litigators secured a significant win on behalf of Indivior, obtaining a preliminary injunction preventing Dr. Reddy's Laboratories from launching a generic version of Indivior's SUBOXONE® Sublingual Film used in treatment of opioid addiction. The court's decision recognizes that Indivior had shown a likelihood of success on the ...
June 20, 2018
NEW YORK—Covington advised Boston Children's Hospital in its monetization of a portion of its royalties relating to Vonvendi, a recombinant drug used to treat a common bleeding disorder called von Willebrand disease. The purchaser, Barings Alternative Investments, part of Barings LLC, on behalf of institutional investors, paid $51.5 million. Boston Children’s ...
June 4, 2018, Inside EU Life Sciences
This article was originally posted on our sister blog Global Policy Watch Introduction Health technology assessment (“HTA”) is a multidisciplinary assessment process that seeks to evaluate the added therapeutic value of health technologies (i.e., drugs, certain medical devices, medical treatments including surgical procedures, and measures for disease prevention ...
June 1, 2018, Silicon Valley Business Journal
Emily Leonard was recognized among Silicon Valley Business Journal's "2018 Women of Influence." In discussing her career at Covington, Leonard says, "I have had the privilege of partnering with a large number of industry clients on challenging transactions that involve innovative technologies—some of which turn out to be life-changing therapies."
May 25, 2018, Inside EU Life Sciences
The “Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity” is an international agreement which aims at sharing the benefits arising from the utilization of genetic resources in a fair and equitable way. It entered into force on 12...… Continue Reading
May 22, 2018, The American Lawyer
Michael Labson is quoted by The American Lawyer in an article regarding Covington's presence in Ireland. "We were focused on whether it’s a strategic fit with the firm’s overall strengths,” says Labson. “With Brexit, we saw the Irish office would be of growing importance. A lot of large pharmaceutical companies have significant operations in Ireland and large ...
May 9, 2018
FRANKFURT—Covington advised Adiuva Fund II GmbH & Co. KG, a private equity fund advised by Adiuva Capital GmbH, on the acquisition of nt-trading from private equity investor INVICTO Invest GmbH and various co-investors. Adiuva Capital is a Hamburg-based independent investment firm focused on investing in mid-sized enterprises. nt-trading is headquartered in ...
May 9, 2018
LOS ANGELES—Covington partners Carolyn Kubota, Robyn Polashuk, and Sonya Winner have been named to the Daily Journal’s 2018 “Top 100 Women Lawyers” list, recognizing the “top women lawyers in California.” Based in the firm’s Los Angeles office, Ms. Kubota is a member of the American College of Trial Lawyers and has served as lead counsel on high-profile ...
April 20, 2018
LONDON—Covington advised BenevolentAI on an £80 million equity investment by new and existing investors, including Woodford Investment Management, at a pre-money valuation of £1.4 billion. The firm also recently advised BenevolentAI on its acquisition of Proximagen Limited, a Cambridge, UK-based drug discovery and development company, for an undisclosed ...
April 2018, Digital Health Legal
Brian Kelly and Raj Gathani are quoted in a Digital Health Legal article regarding a report published by the UK’s Care Quality Commission on "The state of care in independent online primary health services." According to Kelly and Gathani, “The report illustrates some of the teething problems in the inspection system, particularly when applied to online ...
March 22, 2018, Covington Alert
European General Court confirms that a new medicinal product containing the same active substance as a company’s existing medicinal product may be entitled to its own period of orphan exclusivity.
March 13, 2018, Covington Alert
On October 12, 2017, President Trump issued an executive order, entitled “Promoting Healthcare Choice and Competition Across the United States”, that, among other things, instructed the Secretaries of Health and Human Services (HHS), Labor, and Treasury to “consider proposing regulations or revising guidance, consistent with law, to expand the availability of ...
March 8, 2018, Biotech and Money
James Gubbins, Lucinda Osborne, and Brian Kelly are quoted in a Biotech and Money article providing an overview of Covington's Life Sciences practice and discussing the legal implications of issues facing the sector. “Having an international practice, having a team in London, on [the U.S.] East Coast and West Coast, and in Asia, who encompass that regulatory ...
February 9, 2018, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
February 6, 2018
LOS ANGELES—The Los Angeles Business Journal recognized Wade Ackerman and Aaron Lewis in its second annual list of the most influential diverse lawyers in Los Angeles. The list recognizes 50 "stellar diverse lawyers in the LA region." In Mr. Ackerman’s profile, the Business Journal emphasized his work in the FDA regulatory space. The profile noted that “with a ...
January 31, 2018, Covington Alert
In the EU, a sponsor can obtain an “orphan designation” for a medicinal product pursuant to Regulation 141/2000. Adopted in December 1999, the regime aims to encourage investment in R&D for treatments for rare diseases. The most important incentive is the 10-year market exclusivity for designated products. Other incentives include protocol assistance and fee ...
FDA Releases FSVP and Supply Chain Program Draft Guidances and Announces FSVP Enforcement Discretion
January 30, 2018, Covington Alert
Last week (January 24, 2018), FDA issued a series of guidance documents and an enforcement discretion policy intended to help the food industry comply with the requirements of the Food Safety Modernization Act (FSMA). The documents further FDA’s goal to ensure that all food under its jurisdiction is produced under procedures that comply with its risk-based food ...
January 29, 2018, Inside EU Life Sciences
By Dr. Dr. Adem Koyuncu, Covington & Burling LLP In the EU, drug companies are not allowed to publicly promote prescription-only medicines. As courts also apply a broad interpretation of the term “promotional”, nearly all public statements that mention a prescription drug are likely to be qualified as illegal advertising. In certain circumstances, this may...… ...
FDA Announces “Nutrition Action Plan” while Stakeholders await Final Guidance on Nutrition Labeling
January 16, 2018, Covington Alert
As we near the two year mark since FDA issued the new Nutrition Facts Label (NFL), stakeholders anxiously await FDA’s final NFL guidance, particularly FDA’s conclusions on the pending fiber petitions and other fiber ingredients. Although FDA proposed last fall to extend the July 26, 2018 compliance date until January 1, 2020 (for large companies and January 1, ...
January 9, 2018, Inside EU Life Sciences
On 4 January 2018, the European Commission published a draft implementing regulation laying down rules for the application of Article 26(3) of Regulation (EU) N° 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers (“FIC”), as regards the rules for indicating the country of origin or place...… Continue Reading
Covington Represents Autifony Therapeutics in Collaboration and Option Deal with Boehringer Ingelheim
December 21, 2017
LONDON—Covington represented Autifony Therapeutics Limited in connection with an option and asset purchase agreement with Boehringer Ingelheim (BI), with respect to Autifony's Kv3.1/3.2 positive modulator platform. This agreement provides BI with an exclusive option to acquire Autifony’s Kv3.1/3.2 positive modulator platform, including Autifony's lead compound ...
December 12, 2017, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
Covington Lures Back FDA Drug Quality Leader
December 7, 2017, Law360
Tom Cosgrove is quoted in a Law360 article regarding his return to Covington's Food, Drug and Device Practice Group. “I think companies are looking hard at their supply chain risks and wondering how much they can trust other companies that make up the links in that chain,” Cosgrove says. “These challenges, brought about by increased globalization, will only ...
December 6, 2017
WASHINGTON—Tom Cosgrove, who until last month was a senior official at FDA charged with ensuring the quality of drugs and therapeutic biologics marketed to U.S. patients, has rejoined Covington as a partner in its Food, Drug, and Device practice, resident in Washington. Mr. Cosgrove held senior leadership positions within FDA’s Office of Compliance in the Center ...
November 21, 2017, Covington Alert
In a July 7, 2017 post to the FDA Voice blog, FDA Commissioner Scott Gottlieb announced that FDA would be releasing a “comprehensive regulatory framework” for regenerative medicine products. On November 16, 2017, FDA issued four guidance documents outlining certain aspects of that framework. This alert summarizes each of the guidance documents and highlights ...
November 8, 2017, Covington Alert
On November 1 and 2, 2017, the Centers for Medicare & Medicaid Services (“CMS”) released two final rules addressing changes to Medicare Part B reimbursement policies for biosimilars. These final rules—for the Medicare Physician Fee Schedule (“PFS”) and the Hospital Outpatient Prospective Payment System (“OPPS”)—announced new directions for both the coding and ...
Covington Advises Financial Advisor to Advanced Accelerator Applications in $3.9 Billion Sale
November 3, 2017
NEW YORK—Covington represented Jefferies LLC as exclusive financial advisor to Advanced Accelerator Applications S.A. (AAAP) in its $3.9 billion all cash sale to Novartis AG. Based in Saint-Genis-Pouilly, France, AAAP is a radiopharmaceutical company developing, producing, and commercializing molecular nuclear medicine theragnostics. AAA’s theragnostic platform ...
November 2, 2017, BioWorld MedTech
John Balzano is quoted in a BioWorld MedTech article regarding the decision by Chinese regulators to accept data from clinical trials conducted outside China for approvals of new drugs and medical devices. “In general, this statement is part of a long-term effort by the government and the China Food and Drug Administration that has been ongoing since 2015 to ...
European approvals face delay from agency move
October 25, 2017, EP Vantage
Grant Castle is quoted in an EP Vantage article examining how the move of the European Medicines Agency from London will impact European drug approvals. According to Castle, the main consequence of lower staff numbers could be longer waiting times to file drugs. “Because of the regulatory timetable there isn’t a huge amount of scope for delaying reviews, but ...
October 11, 2017, Covington Alert
On Monday, October 9, 2017, California Governor Jerry Brown signed into law Senate Bill 17 (SB 17), establishing substantial new reporting and notification requirements in California for prescription drug manufacturers related to drug pricing. California is the latest of several states to enact legislation related to drug pricing. This alert, prepared by ...
October 10, 2017, EurActiv
Peter Bogaert is quoted in a EurActiv article regarding EU Commissioner for Health and Food Safety Vytenis Andruikaitis' remarks in support of drug innovation. "The incentives which are built in the pharmaceutical regime and especially the SPCs and the regulatory exclusivity aim to work as a stimulus to develop new products in order to basically continue the ...
October 10, 2017, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
October 6, 2017
NEW YORK, October 5, 2017—Covington advised Zoetis Inc. in an underwritten public offering of its investment grade notes in an aggregate principal amount of $1.25 billion. Zoetis is a global leader in the discovery, development, manufacture, and commercialization of animal health medicines and vaccines, with a focus on both livestock and companion animals. This ...
October 4, 2017
SAN FRANCISCO—The Recorder has named Covington partner Ingrid Rechtin to its list of “2017 Women Leaders in Tech Law.” This annual recognition commemorates “recent outstanding work by California-based lawyers whose practices focus on technology companies and issues.” In its profile of Ms. Rechtin, the publication highlights her representation of Sanofi in ...
October 3, 2017
BEIJING—China Law & Practice has named Covington as the international winner for “Trade Firm of the Year” at its annual awards ceremony in Beijing. The leading Chinese legal publication also recognized the firm for its role in the Technology, Media, and Telecom “Deal of the Year,” Tencent’s $8.6 billion acquisition of Supercell. The awards focus on “innovation ...
October 2, 2017, The Recorder
The Recorder named Ingrid Rechtin one of its "2017 Women Leaders in Tech Law." In her profile, Ms. Rechtin provides advice to young lawyers in tech. She says, "Be flexible and open to new opportunities. The tech space evolves quickly and as a lawyer you can provide more value to your clients if you have a broader view—across industries, companies of all sizes, ...
September 26, 2017, The Pink Sheet
A blog post by Jennifer Boudet and Miranda Cole is referenced in a Pink Sheet article regarding the Advocate General's Opinion in Hoffmann-La Roche vs Autorità Garante della Concurrenza e del Mercato. Boudet and Cole write, if the opinion was followed by the full court it could have "significant implications for market definition in relation to pharmaceutical ...
AG’s Opinion – Licensed and Unlicensed Medicines May Fall Within the Same Relevant Product Market
September 22, 2017, Inside EU Life Sciences
Yesterday’s Opinion from Advocate General Saugmandsgaard Øe (AG) in Hoffmann-La Roche vs Autorità Garante della Concurrenza e del Mercato takes the position that licensed and unlicensed pharmaceutical products used for the same indication may fall within the same relevant product market. The Italian Council of State (ICS) referred a number of questions to the ...
September 20, 2017, Covington Alert
This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.
Regulatory and Legislative Blockbuster: Where Are We Headed Under the Trump Administration?
September 14, 2017, ABA Life Sciences Legal Summit
D.C.'s Rising Stars: Shankar Duraiswamy, 37
September 1, 2017, The National Law Journal
Shankar Duraiswamy was named a "D.C. Rising Star" by The National Law Journal, recognizing him as one of the “region’s 40 most promising lawyers age 40 and under.” Commenting on his biggest accomplishment, Duraiswamy says, "I am proudest of the results I have secured for my pro bono clients. A highlight was a landmark settlement in 2013 that we secured for deaf ...
Shankar Duraiswamy Named "D.C. Rising Star"
August 30, 2017
WASHINGTON—The National Law Journal has named Covington partner Shankar Duraiswamy a “D.C. Rising Star,” recognizing him as one of the “region’s 40 most promising lawyers age 40 and under.” In his profile, Mr. Duraiswamy highlights a number of experiences and lessons learned in his career. When asked about a key to his success, he credited one of his early ...
August 10, 2017
NEW YORK—Covington is representing IFM Therapeutics in its sale to Bristol Myers Squibb for $300 million in cash and the right to receive contingent payments upon achievement of specified milestones that could total in excess of $1 billion for each of its two oncology programs. Prior to closing, IFM will spin off its inflammation program to a newly-formed ...
August 10, 2017
NEW YORK—Covington advised the underwriters in a $138 million follow-on public offering of common stock by Repligen Corporation. Covington previously represented the underwriters in Repligen's $115 million convertible note offering in May 2016. Repligen is a bioprocessing company focused on the manufacture of Protein A ligands, cell culture growth factors, and ...
Covington Represents Australian Medical Research Institute in Landmark Royalty Monetization
July 27, 2017
NEW YORK—Covington advised The Walter and Eliza Hall Institute of Medical Research (WEHI), Australia's oldest medical research institute, in its landmark monetization of a portion of its royalties relating to the cancer drug Venetoclax. The purchaser, a wholly owned subsidiary of Canada Pension Plan Investment Board, paid US$250 million upfront, and agreed to ...
Rising Star: Covington's Shankar Duraiswamy
July 19, 2017, Law360
Shankar Duraiswamy was named a "Rising Star" by Law360, recognizing him as a top attorney under 40 in Product Liability law. In its profile of Duraiswamy, Law360 highlights his defense of Takata Corp. in the wake of the largest public safety recall in U.S. history and his dedication to pro bono work.
July 6, 2017, Daily Journal
John Hall and Carolyn Kubota are quoted in a Daily Journal article regarding Kubota's recent arrival to Covington's Los Angeles office. According to Hall, "Carolyn is a world-class litigator with an exceptional track record of trial success, and her tenacity and depth of experience will be highly valuable to our clients," adding that her track record of handling ...
Covington's LA Office Makes Another Lateral Addition
July 6, 2017, The Recorder
Carolyn Kubota and John Hall are quoted by The Recorder in an article regarding Kubota's recent arrival to Covington's Litigation and White Collar Defense and Investigations practices in Los Angeles. “I hope I’ll be able to expand the work I’m doing for pharma companies to other companies and broaden, rather than change, [my practice],” Kubota says. According to ...
Covington Snags Undefeated Litigator From O'Melveny
July 6, 2017, Law360
Carolyn Kubota and John Hall are quoted in a Law360 article regarding Kubota's arrival to Covington's Los Angeles office as a partner in the firm's Litigation and White Collar Defense and Investigations practices. “A friend of mine once said, [trials] are the most fun you can have wearing a suit, and I’m a strong believer in that,” Kubota says. “I find [that], ...
Leading Trial Lawyer Joins Covington
July 5, 2017
LOS ANGELES—Carolyn Kubota, a nationally acclaimed trial and white collar defense lawyer and former federal prosecutor, has joined Covington’s Litigation and White Collar Defense and Investigations practices in Los Angeles. Ms. Kubota has served as lead counsel on high-profile investigations, criminal trials, and high-stakes commercial litigation matters, ...
June 29, 2017, Inside EU Life Sciences
This article was originally posted on our sister blog Inside Medical Devices The EU Regulatory Committee on Medical Devices recently voted in favor of the European Commission’s draft decision on the classification of cranberry products (the “Cranberry Decision”). In essence, the Cranberry Decision provides that cranberry products intended to prevent or treat ...
June 16, 2017
LONDON—Euromoney Legal Media Group has selected three Covington lawyers for its annual “Europe Women in Business Law Awards.” The awards honor women in the legal sector across Europe. The Covington lawyers recognized are: Louise Nash, Best in Mergers & Acquisitions. Ms. Nash focuses on M&A and other transactional matters for clients in the consumer brands, ...
June 1, 2017, MLex
Robin Blaney is quoted in an MLex article regarding pleas from the EMA urging UK drugmakers to relicense their products in another EU country before Brexit. According to Blaney, the transfer of authorizations is "primarily an administrative exercise," and there is no legal obstacle to using a shell company in the European Economic Area to hold marketing ...
May 19, 2017, Bloomberg Law
Shaoyu "Andrew" Chen is quoted in a Bloomberg Law article regarding the latest series of announcements from China's Food and Drug Administration on accelerating drug and medical device approvals. According to Chen, “The four documents proposed many critical policies that will bring China much closer to Western countries in the regulatory oversight of drugs and ...
May 18, 2017, Covington Alert
On May 18, 2017, newly confirmed U.S. Trade Representative Robert Lighthizer formally notified Congress that President Trump intends to renegotiate the North American Free Trade Agreement (NAFTA). The Trump Administration has indicated that it will request public input on the “direction, focus, and content” of these negotiations, and will publish notice in the ...
May 11, 2017, PaRR
Bart Van Vooren is quoted in PaRR's "Brexit Club" column regarding the two-part approach to the Brexit negotiation process, following the publication of draft negotiating directives for “phase one” of the talks. According to Van Vooren, there are real legal problems with this two-part approach, regardless of the parties' up-front negotiating positions. One ...
May 10, 2017, Silicon Valley Business Journal
Emily Henn was profiled by Silicon Valley Business Journal as a part of the publication's "Women of Influence" feature, honoring 100 of the most influential business women in Silicon Valley.
May 9, 2017, MedTech Insight
Wade Ackerman is quoted by MedTech Insight in an article covering the May 5 Food, Drug and Law Institute's annual meeting in Washington. Ackerman provided his insights on the hiring trajectory for those individuals tasked to implement the 21st Century Cures Act, and noted that the funds can be viewed as having broad applications for hiring. Ackerman stated, ...
May 5, 2017
LOS ANGELES—The California Life Sciences Association (CLSA) has named Covington partner Wade Ackerman to its board of directors. Founded in 2015, CLSA works closely with industry, government, academia and other stakeholders to shape public policy, drive business solutions, and grow California’s life sciences innovation ecosystem. CLSA serves biotechnology, ...
April 26, 2017, Inside EU Life Sciences
The EU pharmaceutical industry landscape is in significant flux. There are many pressures to provide new therapies and to make them available more early and for as many qualifying patients as possible. In that context, the industry model and the role of exclusivity rights as a tool to stimulate innovation are being discussed. At the...… Continue Reading
April 26, 2017
SILICON VALLEY—Silicon Valley Business Journal has named Covington partner Emily Henn to its annual “Women of Influence” list, honoring “100 of the most influential business women in Silicon Valley.” Ms. Henn serves as co-chair of the firm’s Class Action Litigation Practice, specializing in defending antitrust, consumer, and other types of class actions. Ms. ...
April 21, 2017, Covington Alert
On April 20, 2017, President Trump issued a memorandum announcing that the Secretary of Commerce had initiated an investigation to determine the effects of imported steel on national security. The investigation was initiated under Section 232 of the Trade Expansion Act of 1962, as amended. While it remains to be seen what actions the Administration might ...
April 20, 2017, Medtech Insight
A post by Charlotte Ryckman on Covington's Inside Medical Device blog is quoted extensively in a Medtech Insight article regarding the impact of the new EU regulatory structure on the classification of borderline and combination products. According to the post, there is not enough clarity in the new medtech regulations around the definitions of the physical ...
April 17, 2017, Covington Alert
On April 7, 2017, the SEC’s Division of Corporation Finance (the “Division”) issued a statement indicating that it will not recommend enforcement action to the SEC if companies subject to the SEC’s conflict minerals reporting rule only file disclosure under the provisions of paragraphs (a) and (b) of Item 1.01 of Form SD, and not under paragraph (c) of Item ...
April 16, 2017, The Litigation Daily
The Litigation Daily highlights Covington’s representation of Roche in the ongoing Accutane litigation, which recently saw a momentous defense ruling, likely leading to the dismissal of the nearly 3,000 remaining cases. Covington’s Product Liability team is led by Paul Schmidt and Michael Imbroscio.
Covington & Burling Adds Ex-Tyco Counsel In M&A Practice
April 13, 2017, Law360
Thomas Repke is quoted in a Law360 article regarding his arrival to the firm’s Mergers and Acquisitions practice. “This is an opportunity to share best practices, put the best teams together, which the firm is really conducive to,” Repke says. “Providing excellence in client service and that’s really the goal. Having been in-house for the past seven years, ...
April 12, 2017, Covington Alert
On April 11, 2017, the Cyberspace Administration of China (“CAC”) released a draft of the Measures on Security Assessment of Cross-border Data Transfer of Personal Information and Important Data (“the Draft Measures”) for public comment (official Chinese version available here; Covington’s translation of the Draft Measures is appended at the end of this alert).
April 7, 2017, Inside EU Life Sciences
This article was originally posted on our sister blog Inside Medical Devices Earlier this week, in a plenary vote, the EU Parliament endorsed the texts of the Regulation on Medical Devices (the “Regulation”—latest version available here) and the parallel Regulation on In-Vitro Diagnostic Medical Devices (the “IVD Regulation”—latest version available here). This ...
Covington Adds Senior M&A Partner
April 4, 2017
WASHINGTON—Thomas Repke, who has extensive M&A private practice and in-house experience, has joined Covington as a partner in its Mergers and Acquisitions practice in Washington. Most recently, Mr. Repke served as lead counsel for Tyco on all M&A, divestiture, joint venture, and investment transactions across all business units. While at Tyco, he helped ...
March 30, 2017
SILICON VALLEY—Former Patent Trial and Appeal Board (PTAB) judges Peter Chen and Scott Kamholz have joined Covington’s Patent Office Trials Practice. Mr. Chen and Dr. Kamholz are the only former PTAB judges to enter private practice who have overseen Leahy-Smith America Invents Act of 2011 (AIA) trial proceedings from institution through final decision. Peter ...
GDPR Planning and Preparation Conference for Employers
March 30, 2017, Business Forums International Ltd.
March 17, 2017
LONDON—Covington advised AstraZeneca on its strategic collaboration with Circassia Pharmaceuticals plc, a respiratory biopharmaceutical company, for the development and commercialisation of Tudorza and Duaklir* in the U.S. Tudorza and Duaklir are inhaled respiratory medicines for the treatment of chronic obstructive pulmonary disease (COPD). Tudorza was ...
Shrunken Chickens, Neck Flanges, Pill Mills & Bacteria: New Twists on Perennially Difficult Issues in Products-Related Coverage
March 4, 2017, ABA Insurance Coverage Litigation Committee CLE Seminar
President Issues New Executive Order, Requires Agencies to Establish Regulatory Reform Task Forces
February 28, 2017, Covington Alert
On February 24, 2017, President Donald Trump signed an executive order entitled “Enforcing the Regulatory Reform Agenda” (the “Executive Order” or the “Order”). The Order is one of several actions the Trump Administration has taken concerning regulatory reform since inauguration.
February 27, 2017
WASHINGTON—Law360 has named four Covington practice groups among its “Practice Groups of the Year.” The practice groups recognized by Law360 are as follows: International Trade Life Sciences Product Liability Sports
Life Sciences Group Of The Year: Covington & Burling
February 10, 2017, Law360
Law360 selected Covington’s Life Sciences practice as a “Practice Group of the Year,” highlighting the firm’s involvement in billion-dollar transactions, success in contentious litigation, and regulatory advice on cutting-edge technology. According to Michael Labson, “What we offer and bring to complicated, complex issues is a mixture of deep subject-matter ...
Covington Adds Ex-Deputy Assistant AG To Appellate Group
February 6, 2017, Law360
Beth Brinkmann is quoted in a Law360 article regarding her recent arrival to Covington’s Appellate and Supreme Court Practice Group. According to Brinkmann, “The teamwork and collaboration at Covington is incredible and the strength of its appellate practice attracted me to the firm.”
February 3, 2017, Global Investigations Review
Ian Hargreaves and David Lorello are quoted in a Global Investigations Review article regarding Hargreaves’ recent arrival to Covington. According to Hargreaves, the firm’s “pre-eminence in dispute resolution, and its immense strength and global recognition as a market-leader in white-collar crime matters and investigations” fueled his decision. Lorello says, ...
January sees US law firms seek lateral talent
February 2, 2017, Commercial Dispute Resolution
Beth Brinkmann and Robert Long are quoted in a Commercial Dispute Resolution article regarding Brinkmann’s arrival to Covington’s Appellate and Supreme Court Practice Group. Citing “Covington’s long history litigating important cases in the Supreme Court,” Brinkmann says she looks forward to the opportunity to help expand the appellate practice. According to ...
Regenerative Medicine and Combination Products
February 1, 2017, 21st Century Cures Act Webinar Series
January 31, 2017
LONDON—Ian Hargreaves has joined Covington as a partner in the firm’s European Dispute Resolution practice resident in London. Mr. Hargreaves’ arrival follows that of litigation partners Craig Pollack, Greg Lascelles, Elaine Whiteford, and Louise Freeman over the past six months. Mr. Hargreaves advises on major European white collar and related civil and ...
Deputy Assistant Attorney General Joins Covington
January 31, 2017
WASHINGTON—Beth Brinkmann has joined Covington as a partner in the firm’s Appellate and Supreme Court Practice Group in Washington. Ms. Brinkmann served as Deputy Assistant Attorney General in the Civil Division of the U.S. Department of Justice from 2009 to 2016. She has argued 24 cases before the Supreme Court of the United States. Ms. Brinkmann is an ...
Covington Bags Brinkmann to Bolster Appellate Expertise
January 31, 2017, The National Law Journal
Beth Brinkmann is quoted by The National Law Journal in an article regarding her arrival to Covington’s Appellate and Supreme Court Practice Group. "Covington turned out to be just a really unique opportunity," Brinkmann says. The firm is "a longstanding presence in the legal community," she adds, praising the "culture of teamwork."
January 30, 2017
WASHINGTON—Covington represented India-based Piramal Enterprises and its wholly owned Critical Care subsidiary in the UK in its agreement to acquire a portfolio of intrathecal spasticity and pain management drugs from Mallinckrodt LLC. The purchase price was $171 million, plus an earn-out of up to an additional $32 million. This is the third acquisition that ...
Device and Health Software Provisions
January 25, 2017, 21st Century Cures Act Webinar Series
January 24, 2017, Inside EU Life Sciences
Recently, the Council of State (i.e., the Italian supreme administrative court and consultative body) adopted an important advisory opinion, which allows for improved access to investigational medicines by patients in Italy. In particular, the Council of State found that patients may be enrolled in compassionate use programmes or supplied with a medicine listed ...
January 19, 2017, The Pink Sheet
Michael Labson is quoted by The Pink Sheet in an article regarding FDA’s draft guidance on payor communications. According to Labson, the draft guidance is consistent with changes from the 21st Century Cures Act and evolving case law on the First Amendment, and "provides additional important flexibility for manufacturers to communicate science-based information ...
Drugs and Biological Product Provisions
January 18, 2017, 21st Century Cures Act Webinar Series
Product Liability Group Of The Year: Covington & Burling
January 17, 2017, Law360
Law360 selected Covington’s Product Liability practice as a “Practice Group of the Year,” profiling the team’s defense of Takata in litigation over potentially explosive airbags and Bayer Healthcare in multidistrict litigation (MDL) over Mirena IUDs, among other matters. According to Paul Schmidt, the firm’s range of work showcases its diversity of ...
January 13, 2017, Medtech Insight
Wade Ackerman participated at the Medtech Showcase and is quoted in a Medtech Insight article regarding the launch of AdvaMed Digital and the increased focus on medtech and digital health. According to Ackerman, having the dedicated sector within AdvaMed will be a positive for future digital-health policy development.
January 11, 2017, The Pink Sheet
Denise Esposito is quoted by The Pink Sheet in an article regarding the difficulty of accelerating pandemic vaccine development. According to Esposito, further complicating the development is the frequent lack of a good human model, as it is typically unethical to expose humans to a disease to test the vaccine's efficacy. She adds that this issue has been a far ...
J.P. Morgan Notebook Day 1: PCSK9 Face-Off, Teva's Slowed Growth, Merck's Keytruda Wins, Lilly's CDK4/6 Hopes And More
January 10, 2017, The Pink Sheet
Wade Ackerman participated at the Biotech Showcase and is quoted by The Pink Sheet in an article regarding the increased use of real-world evidence by FDA following the passage of the 21st Century Cures Act. According to Ackerman, FDA will be running a pilot program to evaluate the potential of real-world evidence to support supplemental indications and satisfy ...
January 6, 2017, Inside EU Life Sciences
This article was originally posted on our sister blog Inside Medical Devices The term “industrial scale” appears twice in the draft EU Medical Devices Regulation (“MD Regulation”) in relation to so-called “in-house devices.” The term equally appears in the draft in-vitro diagnostic medical devices (“IVD”) Regulation. To provide perspective on the meaning of ...
3 Questions Shaping 2017 JPMorgan Health Care Conference
January 6, 2017, Law360
Eric Blanchard is quoted in a Law360 article providing a roundup of top-of-mind questions at this year’s JPMorgan health care conference. According to Blanchard, “I think the real question is: Are people going to buy this year?” He adds, “Is there going to be investor demand?” Commenting on mergers and acquisitions, Blanchard says, “By and large, if there is a ...
An Overview of Key FDA Provisions
January 5, 2017, 21st Century Cures Act Webinar Series
Six Covington Lawyers Named Law360 MVPs
January 3, 2017
WASHINGTON—Law360 has named six Covington lawyers as MVPs in their respective practice areas. The awards single out lawyers from across various practice areas based on their “success in high-stakes litigation, complex global matters, and record-breaking deals.” The Covington lawyers recognized as Law360 MVPs are: Shara Aranoff, International Trade. Ms. ...
December 21, 2016
SHANGHAI—China Business Law Journal has named Covington partner Weishi Li to its “A-List” of the top 100 private practice lawyers in China. Ms. Li is one of two life sciences lawyers recognized by the magazine. China Business Law Journal’s inaugural A-list is based on interviews of in-house counsel in China and around the world, as well as partners at Chinese ...
Food & Beverage MVP: Covington's Jessica O'Connell
December 20, 2016, Law360
Law360 selected Jessica O’Connell as a 2016 Food & Beverage MVP and profiled her involvement in FDA’s decision to review its “healthy” labeling regulations after convincing the agency to refrain from taking legal action against Kind LLC over allegedly misleading labeling of snack bars. According to O’Connell, her intimate understanding of the FDA was helpful as ...
Legislative Initiatives: Hot Topics in Health Care
December 13, 2016, PLI's Health Care Law Institute 2016
December 7, 2016, Covington Alert
In October 2014, the Nagoya Protocol entered into force. It created a new international regulatory system affecting all life science companies that conduct R&D on biological material such as animals, seeds, flowers, viruses, fragrances, flavonoids, essential oils, enzymes, yeasts, and so on. So far, compliance by companies is progressing slowly due to ...
December 6, 2016, Covington Alert
On November 8, 2016, the U.S. Food and Drug Administration (FDA) published a final guidance titled Medical Device Reporting for Manufacturers (“Final Guidance”). The guidance explains and clarifies FDA’s interpretations of its regulations under 21 C.F.R. Part 803 for adverse event and malfunction reporting and recordkeeping for manufacturers. On November 30, ...
November 23, 2016
NEW YORK—Covington is advising Cantor Fitzgerald as financial advisor to Signal Genetics in connection with Signal’s merger transaction with miRagen Therapeutics. Signal is a commercial stage, molecular diagnostic company that provides innovative diagnostic services that help physicians make better-informed decisions concerning the care of cancer patients. ...
Positions Staked out on Impact of First Amendment on Manufacturer Communication on Off-label Uses
November 16, 2016, Health Law News and Commentary
Michael Labson spoke at an FDA public hearing on behalf of the Pharmaceutical Research and Manufacturers of America and is quoted in a Health Law News and Commentary article regarding constitutional concerns surrounding manufacturer communication of information on off-label uses. According to Labson, the FDA should proceed in "a step-wise fashion that balances ...
Overview of EMA Approval Processes For Drugs and Devices
November 16, 2016, European Healthcare Industry Training: Compliance Certification Program, Seton Hall and Sciences Po, Barcelona
November 14, 2016, Regulatory Affairs Professionals Society
Michael Labson spoke at an FDA public hearing on behalf of the Pharmaceutical Research and Manufacturers of America and is quoted in a Regulatory Affairs Professionals Society article regarding regulations on off-label promotions for drugs and devices. According to Labson, safe harbors are needed for communicating certain types of information outside a drug's ...
November 11, 2016, FDA Week
Michael Labson spoke at an FDA public hearing on behalf of the Pharmaceutical Research and Manufacturers of America where he laid out a stepwise approach PhRMA believes FDA should take regarding off-label communication, and is quoted in an FDA Week article. According to Labson, FDA should create three safe harbors for different types of communication: first, ...
November 11, 2016, Drug Industry Daily
Michael Labson spoke at an FDA public hearing on behalf of the Pharmaceutical Research and Manufacturers of America and is quoted in a Drug Industry Daily article providing key points from the meeting on off-label communication. According to Labson, communication should be rooted in scientifically-sound findings.
November 4, 2016, FDA Week
Michael Labson spoke at the FDLI Annual Advertising Conference and is quoted in an FDA Week article regarding communication between drug makers and payers under a section of the FDA Modernization Act. According to Labson, first amendment jurisprudence may make concerns over FDAMA 114 a non-issue. "If the first amendment idea that you have a constitutional right ...
POLITICO Pro Morning Health Care, presented by Lilly: Brexit wobble — WHO DG candidates compete
November 4, 2016, Politico Pro
Brian Kelly and Grant Castle are quoted in a Politico Pro “Morning Health Care” article regarding the High Court ruling that the UK government does not have the legal power to invoke Article 50 without Parliamentary approval. According to Kelly, “This presents an opportunity for individual companies and the industry to engage with members of Parliament to ensure ...
November 4, 2016, EU Food Law
Brian Kelly is quoted in an EU Food Law article regarding the UK High Court ruling requiring its government to have Parliamentary approval before triggering Article 50. According to Kelly, the decision added uncertainty around Brexit, although it did also present a lobbying opportunity for the industry as well. “The immediate impact of the judgment is that, as ...
November 4, 2016, FDAnews
John Balzano participated in an FDAnews webinar and is quoted in an article regarding China FDA’s proposed expanded requirements for medical device recalls and higher fines for manufacturers that fail to issue recalls. According to Balzano, to be eligible for the accelerated pathway for breakthrough medical devices, the intellectual property for the device needs ...
Spanner In Works For UK Gov’t’s Brexit Plans; Industry Looks To Ongoing Talks With Ministers
November 3, 2016, The Pink Sheet
Brian Kelly is quoted by The Pink Sheet in an article regarding the UK High Court’s ruling that its government does not have the right to trigger Article 50 without Parliamentary approval. According to Kelly, the judgment presented "an opportunity for individual companies and the [life sciences] industry to engage with members of Parliament to ensure that their ...
Postmarking Issues
November 3, 2016, FDLI Introduction to Medical Device Law and Regulation Course
October 28, 2016, FDA Week
Wade Ackerman spoke at a DIA conference on October 24 and is quoted in an FDA Week article regarding combination product reform. According to Mr. Ackerman, there has been strong bipartisan support for 21st Century Cures and Medical Innovation bills. However, if combination product language does not get passed in this Congress, Ackerman also pointed to the FDA ...
October 21, 2016
WASHINGTON—Covington represented India-based Piramal Enterprises and its wholly owned Critical Care subsidiary in the UK in the acquisition of five anesthesia and pain management injectable products from Janssen Pharmaceutica NV, in an all cash deal for an upfront consideration of US$155 million, and up to an additional US$20 million. The products to be acquired ...
New Post-Market Surveillance Measures
October 17, 2016, 6th Semi-Annual European Device and Diagnostic Regulation Conference, Q1 Productions, Brussels
October 7, 2016
LONDON—Covington advised AstraZeneca on its agreement with Cilag GmbH International, an affiliate of Johnson & Johnson, for the divestment of the rights to Rhinocort Aqua outside the U.S. Rhinocort Aqua is a nasal spray indicated for allergic and non-allergic rhinitis (inflammation of the inside of the nose), and for the treatment of nasal polyps (swelling of ...
October 6, 2016, EP Vantage
Grant Castle is quoted in an EP Vantage article regarding the effect of Brexit on life science funding and strategy. According to Castle, “Particularly if the UK heads for a ‘hard Brexit,’ the UK will be a less attractive venue for investment by pharma. It’s one of the sad side effects of all this.”
October 2016, Digital Health Legal
September 29, 2016, Inspection Insider
John Balzano participated in an FDAnews webinar and is quoted in an Inspection Insider article regarding China FDA’s proposed rules that increase penalties for devicemakers that fail to issue recalls. Commenting on the agency’s “accelerated pathway” for breakthrough medical devices, Balzano says that in order to be eligible for the pathway, the devices’ ...
Prominent Medical Device Lawyer Joins Covington
September 22, 2016
WASHINGTON—Pamela Forrest has joined Covington in its Food, Drug, and Device practice, resident in Washington. Ms. Forrest has more than 20 years of experience advising clients on a broad range of FDA regulatory issues. Her practice focuses on FDA medical device matters, including premarket review, product recalls, medical device reporting (MDR), Quality System ...
September 13, 2016, The Recorder
Tom DeFilipps and Doug Gibson are quoted by The Recorder in an article regarding DeFilipps’ recent move to Covington, where he will serve as chair of the West Coast corporate practice. According to DeFilipps, “Covington presented to me an opportunity to do something that sounded very interesting at this point in my career.” He continues, "I felt as though it was ...
Silicon Valley Dealmaker Joins Covington
September 13, 2016, ABF Journal
Timothy Hester and Tom DeFilipps are quoted in an ABF Journal article regarding the arrival of DeFilipps to Covington. According to Hester, “Adding Tom to our Silicon Valley office is a major step forward in our plan for continued growth in California.” DeFilipps says, “I am very pleased to join Covington’s growing California practice.” He continues, “I am ...
September 13, 2016, Daily Journal
Tom DeFilipps and Doug Gibson are quoted in a Daily Journal article regarding DeFilipps’ move to Covington’s Silicon Valley office. Commenting on the draw to Covington DeFilipps says, “One of the more compelling aspects of the Covington platforms is the way it allows you to meld the strength of its regulatory practice in D.C. and non-U.S. jurisdictions, like ...
Leading Silicon Valley Dealmaker Joins Covington
September 12, 2016
SILICON VALLEY—Tom DeFilipps has joined Covington as a partner in the Silicon Valley office and will serve as chair of the West Coast Corporate practice. “Adding Tom to our Silicon Valley office is a major step forward in our plan for continued growth in California,” said Timothy Hester, Covington’s chair. “Tom has built a successful Northern California ...
September 12, 2016, International Devices & Diagnostics Monitor
John Balzano participated in an FDAnews webinar and is quoted in an International Devices & Diagnostics Monitor article regarding China’s changing device regulations. According to Balzano, "Overall, they're going to want to make sure that they have a regulatory structure in place that facilitates the most innovative applications and the applications for devices ...
September 12, 2016, Law360
Timothy Hester and Tom DeFilipps are quoted in a Law360 article regarding DeFilipps’ recent arrival. According to Hester, “Adding Tom to our Silicon Valley office is a major step forward in our plan for continued growth in California.” He continues, “Tom has built a successful Northern California corporate practice over many years and has a demonstrated track ...
Health Hires: Government Attorneys Join Covington, Foley
September 9, 2016, Law360
Wade Ackerman and Denise Esposito are quoted in a Law360 article regarding Ackerman’s recent arrival as a partner in the firm’s Food, Drug, and Device practice. According to Ackerman, he’d like to serve as bridge between Washington, D.C., and Los Angeles for the firm. For a food and drug attorney, Covington is the place to go, given its “long history of having a ...
August 31, 2016
LOS ANGELES—Wade Ackerman has joined Covington as a partner in its Food, Drug, and Device practice, resident in Los Angeles. Until June 2016, Mr. Ackerman served as Senior FDA Counsel to the U.S. Senate Health, Education, Labor & Pensions Committee. In this role, he has been intimately involved in legislative initiatives, oversight hearings, and other Senate ...
August 25, 2016
Earlier this week, FDA released five chapters of a multi-chapter draft guidance on hazard analysis and risk-based preventive controls for human food. The long-awaited draft guidance is intended to help industry comply with certain requirements of the agency’s final rule for preventive controls for human food (PC rule) under the Food Safety Modernization Act ...
Kurt Calia Named One of California's Top IP Lawyers
August 22, 2016
SILICON VALLEY—The Daily Journal has named Covington partner Kurt Calia to its list of the “Top Intellectual Property Attorneys in California for 2016.” The list recognizes California lawyers who have “pushed technological progress forward.” The Daily Journal highlighted Mr. Calia’s successful representation of Elbit Systems in a patent litigation involving the ...
Covington Represents Dana-Farber in Royalty Monetization
August 5, 2016
NEW YORK—Covington advised Dana-Farber Cancer Institute in its monetization of a portion of its interest in royalties related to its Programmed Death Ligand-1 (PD-L1) intellectual property. PD-L1 inhibitors are immuno-oncology drugs used for the treatment of various types of metastatic cancer. CPPIB Credit Europe S.à r.l., a wholly owned subsidiary of Canada ...
July 28, 2016, Food Dive
Jessica O’Connell spoke at the IFT expo and is quoted in a Food Dive article regarding medical food products. O’Connell, commenting on how companies have tried to develop medical food, said the most common warning letters sent out by the FDA since 2006 use the words no “distinctive nutritional requirement” for the disease or condition. She added that since 2009, ...
Covington Represents MRCT in Royalty Monetization Deal
July 15, 2016
NEW YORK—Covington advised Medical Research Council Technology, a UK-based independent life science medical research charity, in its sale of a portion of the royalty stream associated with its cancer drug Keytruda® for $150 million (£115.6 million). Keytruda® (pembrolizumab), is a new generation treatment which stimulates the body’s immune system to fight ...
2018
Our Brexit Task Force is staffed by senior lawyers and advisors across London, Brussels, and Washington to monitor events and to keep clients apprised of legal, regulatory, and policy developments. We are advising clients across a wide range of businesses and industries on the impact and implications of Brexit, including on strategic policy and regulatory ...
Health Hires: Greenberg, Covington Add IP, Deals Pros
July 1, 2016, Law360
Van Ellis and John Hurvitz are quoted in a Law360 article regarding Ellis’ arrival as a partner in the firm’s life sciences transactions practice. According to Ellis, who says he is drawn to how Covington deals with some of the largest and most complex transactions in the industry, “Every deal is different than the other deals. There are innovative aspects of ...
UK science brains seek truce after Brexit
June 30, 2016, Politico
Grant Castle is quoted in a Politico article regarding Britain’s desire to continue its dominance in health research. Commenting on the possibility of having Britain stay in the single market, Castle says, “I don’t think that’s a practicality now.” He continues, “I would think that access to the country would be tightened…given the strength of feeling on ...
June 28, 2016, Bloomberg
Grant Castle is quoted in a Bloomberg article regarding the implications of Brexit on the future of the pharmaceutical industry and the drug approval process. According to Castle, the best that the UK regulator could hope for would be an observer status on European Medicines Agency committees. That loss of influence could make the UK less appealing, because it ...
June 27, 2016, The Legal Intelligencer
Grant Castle is quoted in a Legal Intelligencer article regarding the regulatory impact of Brexit. Commenting on the Food and Drug sector, Castle says, “The UK will inevitably diminish in significance when it comes to the regulation of pharmaceuticals and a venue where drug companies are going to want to be based. Historically, U.S. companies wanted to operate ...
June 27, 2016, Covington Alert
Last week, the UK voted in an advisory referendum to leave the European Union. The next steps are not yet clear, but the referendum may have significant implications for the pharmaceutical industry in the UK and for international companies operating in the UK. Its impact will very much depend on the form a post-Brexit UK will take, the relationship that the UK ...
June 24, 2016, Politico
Grant Castle is quoted in a Politico article regarding the effect of Brexit on the future location of the European Medicines Agency. Castle predicts that the EMA is inevitably going to leave the UK. “Given the strength of feeling on immigration,” it looked unlikely the country would opt for a European Economic Area relationship, since that would mean continuing ...
UK Votes to Leave the EU
June 24, 2016, Covington Alert
The UK has voted to leave the European Union in an advisory referendum. 52% leave - 48% remain. Were the UK to leave the EU, this would have significant implications for the UK and for international businesses operating in the UK. The longer term impact of the decision on the regulatory framework for the UK will depend, in part, on the relationship that the UK ...
Leading Life Sciences Lawyer Joins Covington
June 20, 2016
WASHINGTON—Van Ellis has joined Covington as a partner in its life sciences transactions practice, resident in Washington. Mr. Ellis has extensive experience in a wide variety of technology-based transactions and corporate matters in the life sciences field, from billion-dollar global collaborations to daily commercial and operational matters. He also counsels ...
Dealing with Adverse Events/Product Problems
June 13-14, 2016, FDLI/CDRH In-House Training: Introduction to Medical Device Law and Regulation Workshop
Covington Receives Top Rankings from Chambers USA
June 7, 2016
WASHINGTON—Covington has again received top rankings from Chambers USA, with 60 practice rankings and 120 individual rankings for lawyers in the publication’s 2016 edition. The legal guide identifies leading lawyers and law firm practices based on interviews conducted by Chambers’ researchers with thousands of lawyers and their clients. The firm was ranked in ...
June 3, 2016
NEW YORK—Covington advised the underwriters in connection with Repligen’s $115 million debt offering. The senior convertible notes due in 2021 were placed at 2.125 percent. Repligen is a bioprocessing company focused on the manufacture of Protein A ligands used by life science companies to purify biologic drugs such as monoclonal antibodies, recombinant ...
May 16, 2016, Covington Alert
Last week, FDA finalized its guidance for industry about medical foods, which it issued in draft form in August 2013. This guidance incorporates most of the principles that FDA articulated in the 2013 draft guidance regarding the agency’s position on the definition of medical foods, the scope of lawful uses of medical foods, and other labeling and safety ...
EU Law and Life Sciences - Cosmetics: Managing Online Sales to Protect Your Brand
May 12, 2016, Webinar
May 11, 2016, This article was published in Scrip Regulatory Affairs
May 8, 2016, Financial Times
Peter Bogaert and Grant Castle are quoted in a Financial Times article regarding the effect Brexit would have on the UK pharma industry. According to Bogaert, commenting on the important relationship between the European Medicines Agency and the UK’s Medicines and Healthcare Products Regulatory Agency, “Brexit would be a loss for both sides.” Castle adds that ...
April 20, 2016
LOS ANGELES — Covington partners Emily Henn, Robyn Polashuk and Sonya Winner have been named to the Daily Journal’s annual list of “Top Women Lawyers” in California. The list recognizes 100 lawyers who “try complex commercial disputes and put together industry-transforming deals.” Ms. Henn, based in the firm’s Silicon Valley office, co-chairs the firm’s Class ...
Postmarket Issues And Strategies
March 31, 2016, FDLI Hot Topics in Medical Device Law Conference
Covington Represents Underwriters in Senseonics' IPO
March 24, 2016
NEW YORK - Covington advised the underwriters in the $45 million initial public offering of common stock of Senseonics Holdings, Inc. The offering closed on March 23, 2016. Shares of Senseonics trade on the NYSE MKT under the ticker “SENS.” Senseonics develops continuous glucose monitoring systems for patients with diabetes. Its Eversense product consists of ...
A Less Verbose SEC Means IPOs Are Cleared More Quickly
March 18, 2016, Law360
Donald Murray is quoted in this Law360 article regarding the SEC’s new streamlined review process. Murray says, “If you pick up a prospectus for an early-stage life sciences company, the piece that would get the bulk of staff comments in other industries, the financials, they’re very basic, not much to comment on.”
March 1, 2016
LONDON — Covington advised AstraZeneca on an agreement with ProStrakan Group, a subsidiary of Kyowa Hakko Kirin Co. Ltd., for the rights to Moventig (naloxegol) in the European Union (EU), Iceland, Norway, Switzerland and Liechtenstein. Moventig is the first once-daily, oral peripherally-acting mu-opioid receptor antagonist (PAMORA) approved in Europe for the ...
Downer? Could the UK Psychoactive Substances Act spell disaster for the food & supplements industry?
February 26, 2016, Nutra Ingredients
Brian Kelly is quoted extensively in this Nutra Ingredients article discussing the UK Psychoactive Substances Act and its possible effect on the food supplements industry. According to Kelly, “Despite criticism and proposed amendments about unintended targets the law has been pushed through. It’s a poorly drafted law when it comes to food.” He continues, “You ...
Fate of EU drugs agency hangs in Brexit balance
February 17, 2016, Politico
Grant Castle and Robin Blaney are quoted in this Politico article discussing the potential impact of “Brexit” on the pharmaceutical sector in the UK and Europe. According to Castle, the “only rational alternative” to EU membership is for the U.K. to become a member of the European Economic Area, as this arrangement would make it so the practical and operational ...
February 8, 2016
BRUSSELS — Erika Mann, a former Member of the European Parliament and policymaker with over 20 years of experience, has joined Covington in its Brussels office as a senior European policy advisor in the firm’s global Public Policy and Government Affairs practice. Most recently, Ms. Mann served as Managing Director of Public Policy for Facebook in Brussels from ...
January 28, 2016
WASHINGTON, DC - Law360 has named six Covington practice groups among its “Practice Groups of the Year.” The practice groups recognized by Law360 are as follows: Government Contracts Insurance International Trade Life Sciences Product Liability Sports
Covington Advises AstraZeneca on mRNA Collaboration
January 13, 2016
LONDON — Covington advised AstraZeneca, along with its global biologics research and development arm, MedImmune, on a new collaboration with Moderna Therapeutics to discover, co-develop and co-commercialize messenger RNA (mRNA) therapeutic candidates for the treatment of a range of cancers. The collaboration is in addition to the agreement announced by the ...
January 2016, Covington Alert
This e-alert is part of a series of alerts summarizing publicly-available FDA enforcement letters relating to the advertising and promotion of prescription drugs, medical devices, and biologics. This alert reviews warning and untitled letters issued in 2015. In 2015, FDA’s Office of Prescription Drug Promotion (OPDP) posted the following letters on FDA’s ...
The American Lawyer Names Covington “Litigation Department of the Year: Product Liability”
December 22, 2015
WASHINGTON, DC, December 22, 2015 - The American Lawyer has named Covington its “Litigation Department of the Year: Product Liability.” The magazine recognizes the firm for its “string of big victories in trial and appellate courts, major settlements, plus a creative strategic edge that sets it apart.” In its profile of the firm in its January 2016 issue, The ...
Catherine Dargan Named a “Most Influential Woman” in M&A
December 17, 2015
WASHINGTON, DC, December 17, 2015 - Mergers & Acquisitions magazine has named Catherine Dargan as one of “The Most Influential Women in Mid-Market M&A.” The inaugural special report celebrates 25 of “the best and the brightest female dealmakers.” Among a group of corporate executives and investment bankers, Ms. Dargan is the only outside counsel recognized. Ms. ...
December 17, 2015
LONDON, 17 December, 2015 — Covington advised AstraZeneca on its acquisition of Takeda’s respiratory business. Under the terms of the agreement, AstraZeneca will make a payment of $575 million, and approximately 200 staff will transfer to AstraZeneca upon completion. The deal will include the expansion of rights to roflumilast (marketed as Daliresp in the ...
Legislative Initiatives: Hot Topics in Health Care
December 2015, PLI's Health Care Law Institute 2015
Covington Advises Allergy Therapeutics on £11.5 Million Placement and License Agreement
November 23, 2015
LONDON, November 23, 2015 — Covington represented Allergy Therapeutics, the AIM-listed specialty pharmaceutical company specializing in allergy vaccines, in the placement of ordinary shares raising approximately £11.5 million. The placement was conducted through an accelerated bookbuilding process with Panmure Gordon & Co acting as financial adviser, nominated ...
November 2, 2015
Paul Schmidt is featured in The National Law Journal’s special report on Top Litigators, where he shares some of his winning strategies. "The keys are to humanize the company and explain the science in a clear, understandable way," he says.
September 30, 2015
NEW YORK - Covington advised the underwriters in the $106.1 million initial public offering by Austrian-based Nabriva Therapeutics AG of 10,350,000 million American Depositary Shares, representing 1,035,000 shares of Nabriva’s common stock. This was the first U.S. initial public offering by an Austrian company. The ADSs are now listed on the NASDAQ Global Market ...
September 17, 2015
SHANGHAI, September 17, 2015—China Law & Practice named Covington "International Firm of the Year - Life Sciences" at its annual awards ceremony. The leading Chinese legal publication also named Hui Xu a "Rising Star" in regulatory and compliance law and recognized the firm for its role in its "Deal of the Year," Lenovo’s acquisition of IBM's server ...
Premarket Approvals (PMAs)
September 16, 2015, FDLI/CDRH In-House Training: Introduction to Medical Device Law and Regulation Workshop
September 14, 2015
WASHINGTON, DC, September 14, 2015 - The National Law Journal has named Phyllis Jones and Daniel Suleiman among its “D.C. Rising Stars.” The list recognizes Washington, D.C.’s “40 most promising lawyers age 40 and under.” Ms. Jones focuses on complex legal issues facing clients in the pharmaceutical and healthcare industries. Her wide-ranging litigation ...
September 14, 2015, Covington Alert
September 8, 2015, Covington Alert
September 3, 2015
NEW YORK, September 3, 2015 — UCB and Lannett Company, Inc. announced they have entered into a definitive agreement providing for the acquisition of UCB’s U.S. specialty generics subsidiary, Kremers Urban Pharmaceuticals Inc., by Lannett. UCB will receive upfront cash proceeds of US $1.23 billion upon closing, which is subject to regulatory approval and other ...
August 11, 2015, Covington Alert
Gefährliche Mixtur
August 2015, JUVE
Quoting Adem Koyuncu on anti-corruption issues in the pharma sector.
European Union: Pharmaceuticals
August 2015, An Extract from The European Antitrust Review 2016
July 29, 2015
WASHINGTON, DC, July 29, 2015 – Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) have entered into a new global collaboration to discover, develop and commercialize new antibody cancer treatments in the field of immuno-oncology. Sanofi has committed to an initial investment of up to $2.17 billion in the exclusive collaboration, including $640 million in ...
7/27/2015, Covington Alert
July 15, 2015, Covington Alert
Covington Advises Allergy Therapeutics on Alerpharma Acquisition and £20 Million Placing
June 24, 2015
LONDON, June 24, 2015 — Covington advised Allergy Therapeutics plc, the AIM-listed specialty pharmaceutical company, on its recently announced acquisition of Alerpharma, S.A. a Spanish-based allergy immunotherapy company which previously spun out from Spanish biopharmaceutical company, Zeltia S.A. Alerpharma’s principal operating subsidiary, Inmunal, markets ...
June 17, 2015, The New York Times
The firm is mentioned in this article regarding it's representation of Allergan in its $2.1 billion acquisition of Kythera Biopharmaceuticals.
Life Sciences Congressional Investigations: Trends, Traps and Tips
June 17, 2015, Life Sciences Essentials Webinar Series
6/15/2015, Covington Alert
May 4, 2015, Covington E-Alert
Tax Invades the C-Suite: What is Happening and What You Can Do About It
April 21, 2015, Life Sciences Essentials Webinar Series
Covington Represents Underwriters in Cidara IPO
April 20, 2015
NEW YORK — Covington advised the underwriters in the $76.8 million initial public offering of common stock of Cidara Therapeutics, Inc. Shares of Cidara trade on the NASDAQ Global Market under the ticker “CDTX.” Cidara is a biopharmaceutical company focused on the discovery, development and commercialization of anti-infectives for treatment of diseases ...
April 10, 2015, Am Law's The Litigation Daily
Covington's Paul Schmidt and Michael Imbroscio were named "Litigators of the Week" by AmLaw for their successful representation of Hoffmann-La Roche Inc.: "Not so long ago, Hoffmann-La Roche Inc. faced a grim reality in sprawling litigation over the acne medication Accutane." "In 2007, New Jersey judge Carol Higbee handed an edge to plaintiffs lawyers at ...
March 9, 2015, United Nations Development Programme
This report proposes four overlapping principles that should guide the integrated global accountability framework for the post-2015 process: transparency, inclusiveness, deliberation and responsiveness.
February 27, 2015
LONDON, February 27, 2015 — Covington advised Heptares Therapeutics Limited on its announced sale to Sosei Group, a Tokyo-listed Japanese biopharmaceutical company with operations in Japan and the UK. Consideration consisted of $180 million cash at closing and up to an additional $220 million contingent upon the successful progression of Heptares’ pipeline and ...
Regulation of eHealth Products and Mobile Apps
February 25, 2015, Covington’s Life Sciences Essentials Webinar Series
February 13, 2015, Covington E-Alert
Covington Advises AstraZeneca on Acquisition of Rights to Actavis' Branded Respiratory Portfolio
February 5, 2015
LONDON, 5 February, 2014 — Covington advised AstraZeneca on its acquisition of the rights to Actavis' branded respiratory business in the US and Canada for an initial consideration of $600 million on completion and low single-digit royalties above a certain revenue threshold. Upon completion of the transaction, AstraZeneca will own the development and ...
Covington Advises Horizon Discovery Group plc on its Acquisition of Haplogen Genomics GmbH
January 26, 2015
LONDON, January 26, 2015 — Covington has advised Horizon Discovery Group plc on the acquisition of Haplogen Genomics GmbH for an initial consideration of £6 million in cash and the issue of new ordinary shares, with potential earn-out payments based on future performance to be satisfied by the issue of further new ordinary shares having an aggregate value of up ...
Covington Advises Esteve on Global Collaboration
January 15, 2015
LONDON, January 15, 2015 — Covington & Burling advised Laboratorios Esteve, S.A. (Esteve) in a global multi-programme discovery and development collaboration with Mundipharma Laboratories GmbH and its independent associated company, Purdue Pharmaceuticals LP, to bring to market important next generation products for the management of pain. Under the agreements, ...
January 13, 2015
WASHINGTON, DC, January 13, 2015 — For the third consecutive year, Law360 named Covington’s life sciences practice one of the top “Life Sciences Practice Groups of the Year.” Law360 recognized Covington for its “significant litigation wins and helping clinch big deals between pharmaceutical companies.” Among the matters highlighted were Covington’s handling of ...
Life Sciences Group Of The Year: Covington & Burling
January 9, 2015, Law360
Covington's life sciences group is featured in this article regarding their being named a "Practice Group of the Year." "The firm's life sciences group, which includes some 250 attorneys with deep knowledge of the industry, has been a cornerstone of Covington since its early days, according to John Hurvitz, co-chairman of the group. The group has been ...
January 6, 2015, Covington E-Alert
Relationship between pharmaceutical companies and wholesalers/distributors: Assessing the competition law aspects
2015, Webinar, 24th Annual EU Pharmaceutical Forum
November 17, 2014
LONDON, 17 November, 2014 — Covington is advising Indivior, formerly RB Pharmaceuticals, in the demerger transaction announced today from Reckitt Benckiser, a global consumer products company. The demerger is subject to the approval of RB shareholders. Indivior PLC will be a specialty pharmaceutical company focused on the treatment of addiction and closely ...
November 13, 2014
Shanghai, November 13, 2014 — Covington & Burling has been named “Compliance / Regulatory Firm of the Year” by Asian-MENA Counsel magazine. Asian-MENA Counsel bases the award on a survey sent to over 21,000 in-house counsel and company directors across Asia Pacific and the Middle East. Covington partner Eric Carlson, who leads the firm’s compliance practice in ...
November 3, 2014
Shanghai, October 29, 2014 — Asia Legal Business has named Shaoyu Chen, a partner based in Covington & Burling’s Beijing and Shanghai offices, as one of the “Client Choice Top 20 Lawyers in China.” The award is given to 20 China-based lawyers who demonstrate strong client connections and recognition in the market. In-house counsel and business professionals are ...
October 27, 2014, Covington E-Alert
The Importance of Creating a Coordinated Multi-Jurisdictional Compliance Program
October 16, 2014, Life Sciences Essentials Series Webinar
October 7, 2014
LONDON, 7 October, 2014 — Covington & Burling advised Horizon Discovery Group plc, an AIM listed international life science company supplying research tools and services to organizations engaged in genomics research and the development of personalized medicines, on the acquisition of Sage Labs Inc. for a total of approximately $48 million (£29 million), ...
October 6, 2014, Covington E-Alert
September 2, 2014, Covington E-Alert
August 5, 2014
LONDON, 5 August, 2014 — Covington & Burling advised Illumina on its partnership with Genomics England to provide infrastructure and expertise for a four-year project that aims to make the UK the world leader in genetic research into cancer and rare diseases, through funding research to decode 100,000 human genomes - a patient's personal DNA code. The deal is ...
August 5, 2014, Covington E-Alert
Covington Advises AstraZeneca on Strategic Transaction with Almirall in Respiratory Disease
July 30, 2014
LONDON, 30 July, 2014 — Covington & Burling advised AstraZeneca on its agreement to transfer to the company the rights to Almirall’s respiratory franchise for an initial consideration of $875 million on completion, and up to $1.22 billion in development, launch, and sales-related milestones. AstraZeneca has also agreed to make various sales-related payments. ...
July 30, 2014, Legal Business
Lucinda Osborne, Gregor Frizzell, Christopher Walter and Miranda Cole are mentioned regarding their representation of AstraZeneca on its £1.2bn acquisition of Spanish healthcare group Almirall’s respiratory unit.
July 29, 2014, Forbes
Covington's John Balzano writes on the safety issues with meat production in his blog for Forbes Asia. "Safety issues with the meat and meat products in China are causing controversy again. Last year a group of diseased pig carcasses came floating into rivers near Shanghai, causing concern about black markets for meat spreading foodborne illnesses. This time ...
Covington Receives Top Tier Nods in Legal 500 U.S.
June 26, 2014
WASHINGTON, DC, June 26, 2014 — The Legal 500 U.S. has ranked Covington & Burling in its top tier in eight practice areas and recognized 23 individual attorneys as “Leading Lawyers” in the directory’s 2014 edition. Additionally, Legal 500 “recommended” 42 Covington practice areas and 153 Covington lawyers. The eight Covington practices given the top tier ranking ...
China's Elusive Pet Food Regulation
June 25, 2014, Forbes
Covington's John Balzano writes on Chinese pet food regulation for Forbes. "Long-term, all-too-frequent, and severe safety issues with pet treats and pet food coming from China have led to serious questions about the state of China’s pet food regulations. The answer to those questions may be fairly simple: China does not have a significant body of pet food ...
June 4, 2014, Covington E-Alert
April 30, 2014, Covington E-Alert
April 30, 2014, Covington E-Alert
April 28, 2014, Covington E-Alert
April 25, 2014, Covington E-Alert
The Food Police: China Proposes a Plan for a Special Unit for Food and Drug Safety Violations
April 20, 2014, Forbes
Covington's John Balzano writes about a recent announcement by the China FDA and the Ministry of Public Security that China is creating a special police unit for food and drug law violations.
April 9, 2014, Covington E-Alert
April 7, 2014, The Lawyer
Covington's Paul Claydon, Guy Dingley, and Sarah Hoult are mentioned regarding their representation of Horizon Discovery on their IPO.
April 1, 2014, Covington E-Alert
March 3, 2014, Covington E-Alert
February 28, 2014, Covington E-Alert
Covington Secures Jury Verdict for Salix Pharmaceuticals
February 25, 2014
WASHINGTON, DC, February 25, 2014 —Covington & Burling secured a defense verdict for Salix Pharmaceuticals today after a jury rejected all of Napo Pharmaceuticals’ breach of contract claims related to Fulyzaq (Crofelemer). Following a two-week trial before New York Supreme Court Justice O. Peter Sherwood, a jury rejected all of Napo’s claims against Salix, ...
February 5, 2014, Covington E-Alert
January 29, 2014, Covington E-Alert
January 22, 2014, Covington E-Alert
January 16, 2014, Covington E-Alert
FDA Issues Guidance Documents Relating to Liquid Dietary Supplements and Substances Added to Foods
January 16, 2014, Covington E-Alert
January 13, 2014
LONDON, 13 January, 2014 — Covington & Burling advised Isarna Therapeutics GmbH on an agreement with Santaris Pharma A/S whereby Isarna gains access to Santaris' Locked Nucleic Acid (LNA) technology to further develop its next generation oligonucleotide product candidates. Under the terms of the agreement, Isarna obtains rights to utilize Santaris Pharma's ...
January 13, 2014
WASHINGTON, DC, January 13, 2014 — For the second consecutive year, Law360 has named Covington & Burling’s life sciences practice as one of the top five “Life Sciences Practice Groups of the Year.” In a profile of the firm, Law360 noted that Covington “delivered for drugmakers on three continents in 2013, spearheading a momentous investment by U.K.-based ...
January 10, 2014, Covington E-Alert
January 9, 2014
LONDON, 9 January, 2014 — Covington & Burling advised Innovacell Biotechnologie AG on a collaboration and exclusive licensing agreement with Norgine BV. Under the terms of the agreement Innovacell and Norgine will co-develop, and Norgine will commercialise, ICEF15 - an innovative personalised cell therapy to treat faecal incontinence. The agreement territory ...
December 31, 2013, Covington E-Alert
December 24, 2013, Covington E-Alert
Covington Advises Natrogen on Agreements with Takeda
December 20, 2013
WASHINGTON, DC, December 20, 2013 — Covington & Burling advised Natrogen Therapeutics International in its agreement with Takeda Pharmaceuticals for the exclusive license for worldwide development of Natura-alpha, a synthetic small molecule oral compound that is believed to inhibit pro-inflammatory cytokine expression, as well as an option to acquire Natrogen. ...
December 19, 2013
NEW YORK, December 19, 2013 — Covington & Burling advised AstraZeneca in its acquisition of Bristol-Myers Squibb's interests in the companies’ diabetes alliance for an initial consideration of $2.7 billion on completion and up to $1.4 billion in regulatory, launch and sales-related payments. AstraZeneca has also agreed to pay various sales-related royalty ...
Covington Boosts European Life Sciences Group
December 19, 2013
Brussels, 19 December, 2013 — Covington & Burling is pleased to announce that Adem Koyuncu is joining its life sciences practice as a partner, along with associate Sabine Stute. Dr. Koyuncu and Ms. Stute will be resident in the firm’s Brussels office, and will focus on issues involving the law of the European Union and, in particular, of Germany. Dr. Koyuncu, ...
December 2, 2013, Covington E-Alert
December 2, 2013, Covington E-Alert
November 20, 2013, Covington E-Alert
November 12, 2013, Covington E-Alert
November 8, 2013, Covington E-Alert
November 8, 2013, Covington E-Alert
October 31, 2013, Covington E-Alert
Covington Advises AstraZeneca/ MedImmune on Acquisition of Spirogen and Investment in and Collaboration with ADC Therapeutics
October 18, 2013
LONDON, 18 October, 2013 — AstraZeneca announced that MedImmune, its global biologics research and development arm, has acquired Spirogen, a privately-held biotech company focused on antibody-drug conjugate technology for use in oncology. Covington & Burling advised AstraZeneca on the transaction working alongside AstraZeneca’s in-house legal team. MedImmune has ...
October 1, 2013, Covington E-Alert
Covington Wins Six LMG Life Sciences Awards
9/27/2013
NEW YORK, September 27, 2013 — Covington & Burling received six awards at the inaugural LMG Life Sciences awards on September 25, including “FDA Pharmaceutical Firm of the Year” and Richard Kingham’s induction to the Hall of Fame. The awards, which are selected based on a survey of peers and leading companies in the life sciences industry, “recognize and honor ...
September 24, 2013, Covington E-Alert
August 28, 2013, Covington E-Alert
August 12, 2013, Covington E-Alert
August 8, 2013, Covington E-Alert
July 31, 2013, Covington E-Alert
July 30, 2013, Covington E-Alert
July 26, 2013, Covington E-Alert
July 22, 2013
LONDON, 22 July, 2013 — Covington & Burling acted for AIM listed stem cell therapy company, ReNeuron Group plc, on its £33 million fund raising. ReNeuron today announced that £25.35 million (before expenses) will be raised through an oversubscribed placing of new shares to fund the company’s therapeutic programmes through Phase II trials, together with a £7.8 ...
June 27, 2013, Covington E-Alert
June 26, 2013
LONDON, 26 June, 2013 — The UK Information Commissioner's Office has authorised GlaxoSmithKline’s 'Binding Corporate Rules' (BCRs) – a set of internal policies and procedures used to protect personal data across GSK’s operations globally. The privacy and data security team at Covington & Burling was instrumental in the development, implementation and ...
June 25, 2013, Covington E-Alert
Covington’s Peets and Prescott, Named “Best in Copyright” and “Best in Investment Funds”
June 21, 2013
LONDON, 21 June, 2013 — Euromoney LMG awarded Covington partners Lisa Peets and Hilary Prescott the "Best in Copyright" and "Best in Investment Funds" awards at its Europe Women in Business Law Awards 2013 ceremony in London. The awards honour firms that set “the standard in terms of female-friendly work practices, and women leading the field in the legal sector ...
May 30, 2013, Covington E-Alert
May 17, 2013, Covington E-Alert
Robert Trainor Joins Covington’s Life Sciences Practice
May 13, 2013
WASHINGTON, DC, May 13, 2013 — Robert J. Trainor, former executive vice president and general counsel of Brussels-based UCB S.A., joins Covington & Burling today as senior of counsel in the firm’s New York City office. He will advise clients on a broad range of corporate, policy, and litigation matters affecting the pharmaceutical industry and other corporate ...
Toro and Winner Named Top Women Lawyers in California
5/9/2013
SAN FRANCISCO, May 9, 2013 — Covington & Burling partners Amy Toro and Sonya Winner have been named to the Daily Journal’s annual list of “Top Women Lawyers” in California. The list, which includes 75 litigators and 25 corporate practitioners, recognizes “excellent lawyering and leadership skills among women attorneys.” Ms. Toro was recognized for her work ...
D.C. District Court Rules FDA Has Inherent Authority to Rescind 510(k) Clearance in "Rare Situation"
April 26, 2013, Covington E-Alert
April 15, 2013, Covington E-Alert
March 28, 2013, Covington E-Alert
March 25, 2013
LONDON, 25 March, 2013 — AstraZeneca and Moderna Therapeutics announced an agreement to develop and commercialise pioneering messenger RNA therapeutics™ for the treatment of serious cardiovascular, metabolic and renal diseases as well as cancer. Covington & Burling advised AstraZeneca on the deal, working alongside AstraZeneca’s in-house legal team. Under the ...
March 18, 2013, Covington E-Alert
February 27, 2013, Covington E-Alert
January 28, 2013, Covington E-Alert
Covington Named ‘Life Sciences Group of the Year’
1/22/2013
WASHINGTON, DC, January 22, 2013 — Law360 named Covington’s life sciences practice as of one of the top five “Life Sciences Practice Groups of the Year.” In a profile highlighting Covington’s life sciences practice, Law360 noted that the group has “grown to develop an increasingly global reach that has made it a go-to for complex transactions, high stakes ...
January 10, 2013, Covington E-Alert
January 7, 2013
NEW YORK, January 7, 2013 — Covington & Burling advised Illumina, Inc. on its announced acquisition of Verinata Health, Inc. for cash consideration of $350 million plus up to $100 million in milestone payments through 2015. Upon completion of the acquisition, Illumina will have access to the Verinata’s verifi® prenatal test, the broadest non-invasive prenatal ...
December 28, 2012, Covington E-Alert
December 10, 2012, Covington E-Alert
December 7, 2012, Covington E-Alert
Five Covington Lawyers Named Law360 MVPs
December 3, 2012
WASHINGTON, DC, December 3, 2012 — Law360 named five Covington & Burling lawyers today as “Most Valuable Players” in their respective practice areas. The award singles out lawyers from across 22 practice areas whose achievements in major litigation or transactional matters have “raised the bar” over the past year. The Covington lawyers recognized as Law360 MVPs ...
December 3, 2012, Covington E-Alert
11/7/2012
WASHINGTON, DC, November 7, 2012 — Covington & Burling received 97 first-tier practice rankings in the 2013 “Best Law Firms” survey by U.S. News-Best Lawyers, placing Covington among the top 10 firms nationwide. Covington was also named “Law Firm of the Year” in both FDA Law and Corporate Compliance Law. The honor is presented to one law firm in each of the ...
November 2012, Regulatory Focus
October 31, 2012, Covington E-Alert
10/23/2012
WASHINGTON, DC, October 23, 2012 — AstraZeneca and Ironwood Pharmaceuticals, Inc. announced today an agreement to develop and market Ironwood’s linaclotide in China. Covington & Burling advised AstraZeneca on the deal. The U.S. Food and Drug Administration approved linaclotide last August, making it the first of its class of drugs approved in the United States. ...
Lynn Neils Joins Covington’s White Collar Practice
10/2/12
NEW YORK, October 2, 2012 — Former federal prosecutor Lynn Neils joins Covington & Burling’s litigation group as a partner, strengthening the firm’s highly regarded white collar practice. She will be resident in Covington’s New York office. A prosecutor in the U.S. Attorney’s Offices for the Southern District of New York and the District of New Jersey for more ...
September 28, 2012, Covington E-Alert
Biennial Registration for Food Facilities to Begin Soon, Despite Uncertainties About Requirements
September 27, 2012, Covington E-Alert
September 17, 2012, Covington Advisory
Covington Advises Meda on Acquisition of Jazz Pharmaceuticals’ Women’s Health Products
September 6, 2012
LONDON, 06 September, 2012 — Covington & Burling LLP acted as legal advisers to Meda in an agreement with Jazz Pharmaceuticals to acquire a portfolio of six pharmaceutical products for women for $95 million in cash. The largest and most important product in the portfolio is Elestrin, a patented product with sales of almost 100 MSEK, that doctors prescribe for ...
September 5, 2012
WASHINGTON, DC, September 5, 2012 — Covington & Burling is pleased to announce the addition of Weishi Li as a partner to its corporate team, further bolstering the firm’s global transactional and IP capabilities in the life sciences and technology sectors. Ms. Li will be based in Shanghai when that office opens. Ms. Li’s practice covers a wide range of ...
September 2012, Scrip Regulatory Affairs
SFDA Issues Proposed Regulations for the Administration of Inspections of Foreign Drug Manufacturers
September 2012, Covington E-Alert
August 31, 2012, Covington E-Alert
August 27, 2012
WASHINGTON, DC, August 27, 2012 — Covington & Burling LLP lawyers received 196 individual mentions in 57 areas of law in the 2013 edition of The Best Lawyers in America. This annual compilation of top U.S. lawyers is based on peer-review surveys and is used as a referral guide in the legal profession. The Covington lawyers recognized are as ...
August 16, 2012, Covington E-Alert
August 14, 2012
WASHINGTON, DC, August 14, 2012 — Covington & Burling advised AstraZeneca in its agreement with Pfizer for over-the-counter rights to sell a nonprescription version of Nexium, a medication prescribed to treat the symptoms of gastroesophageal reflux disease. The agreement gives Pfizer rights to sell a 20mg nonprescription version of AstraZeneca's Nexium ...
Covington Receives Top Tier Nods in Legal 500 US
August 14, 2012
WASHINGTON, DC, August 14, 2012 — Covington & Burling LLP has received a top tier ranking in six practice areas and 18 individual attorneys are named “Leading Lawyers” in the recently released Legal 500 US 2012 edition. Additionally, Legal 500 US also “recommended” 36 Covington practice areas and 123 Covington lawyers. The six Covington practices given the top ...
August 10, 2012, Covington E-Alert
July 26, 2012, Covington E-Alert
FDA Issues Proposed Rule to Establish a Unique Device Identification System for Medical Devices
July 16, 2012, Covington Advisory
June 28, 2012, Covington E-Alert
June 14, 2012, Covington E-Alert
June 11, 2012, Covington E-Alert
June 7, 2012, Covington Advisory
June 2012, Scrip Regulatory Affairs
May 29, 2012, Covington E-Alert
May 24, 2012
BRUSSELS, 24 May, 2012 — Best Lawyers in Belgium has named Covington & Burling partner Peter Bogaert as the 2012 Brussels “Lawyer of the Year” in the regulatory category for his “abilities, professionalism and integrity.” Best Lawyers recognises one lawyer in each practice area and region. Mr. Bogaert has a broad European life sciences practice. He has detailed ...
May 8, 2012, Covington E-Alert
April 30, 2012, Covington E-Alert
April 23, 2012
WASHINGTON, DC, April 23, 2012 — Covington & Burling represented AstraZeneca in its $1.26 billion acquisition of Ardea Biosciences. Under the agreement, AstraZeneca will pay $32 per share for all of the outstanding shares of Ardea. AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and ...
Covington Announces Six New Counsel
April 16, 2012
WASHINGTON, DC, April 16, 2012 — Covington & Burling is pleased to announce the promotion of one lawyer to of counsel and five lawyers to special counsel, effective April 1, 2012. Wendy Feng (San Francisco), the new of counsel, represents policyholders in insurance coverage cases in state and federal courts. She provides strategic claims-related advice and has ...
March 23, 2012, Covington E-Alert
March 22, 2012, Covington E-Alert
March 19, 2012
LONDON, 19 March, 2012 — Covington & Burling LLP received 46 individual mentions and 20 practice mentions in the Chambers Global 2012 edition. The guidebook, which ranks lawyers globally by pan-regional and country practice area, is designed to identify the most skilled legal practitioners based on the qualities most valued by clients. The Covington lawyers ...
February 29, 2012, Covington E-Alert
Covington Adds Five in Silicon Valley and China
February 8, 2012
SAN FRANCISCO, February 8, 2012 — Covington & Burling is adding a highly regarded corporate team to its Beijing and Silicon Valley offices, bolstering Covington’s global transactional capabilities in the technology and life sciences sectors. The firm is pleased to announce that Michelle Edwards, Eva Wang and Scott Anthony have joined the firm as partners; ...
January 27, 2012
WASHINGTON, DC, January 27, 2012 — Law360 named Covington’s life sciences practice as of one of the top five “Health Practice Groups of the Year,” recognizing its substantial strengths across multiple practices in Asia, Europe and the United States. Covington’s life sciences practice history dates back to the founding of the firm nearly a century ago. The ...
1/17/2012
BRUSSELS, 17 January, 2012 — Covington & Burling LLP is pleased to announce that Jean De Ruyt has joined the firm’s government affairs group as a senior European policy advisor in Brussels. Ambassador Jean De Ruyt is among the most experienced diplomats in Europe. Most recently, he served as the Permanent Representative of Belgium to the European Union and was ...
2012, PLC Life Sciences Handbook 2012
December 8, 2011
LONDON, 8 December, 2011 — Covington & Burling LLP is pleased to announce that Kristian Wiggert has joined the firm’s European corporate group as a partner in London. Mr. Wiggert is a US-qualified lawyer with extensive experience in cross-border financings, mergers and acquisitions, private equity and securities. His practice covers a wide range of industries, ...
November 18, 2011, Covington E-Alert
U.S. News-Best Lawyers Awards Covington ‘Law Firm of the Year’ in FDA Law and 82 First-Tier Practice Rankings
November 1, 2011
WASHINGTON, DC, November 1, 2011 — For the second consecutive year, U.S. News-Best Lawyers awarded Covington & Burling the most first-tier practice rankings for Washington, DC in the “Best Law Firms” survey. The 2011-12 survey also awarded the firm 82 first-tier practice rankings, placing Covington among the top 20 firms nationwide. Additionally, U.S. ...
November 2011, Journal of Medical Device Regulation
10/21/2011
LONDON, 21 October, 2011 — Covington & Burling LLP is advising Axis-Shield plc on the recommended £235 million all cash public takeover offer from Alere, Inc., a US company listed on the New York Stock Exchange. Axis-Shield is a Scottish-Norwegian company, listed on the London and Oslo Stock Exchanges, that develops and manufactures in vitro diagnostic tests for ...
Eight Covington Lawyers Named ‘2012 Lawyer of the Year’
October 5, 2011
WASHINGTON, DC, October 5, 2011 — Best Lawyers named eight Covington & Burling lawyers as the “2012 Lawyer of the Year” in their respective practice areas and cities. According to Best Lawyers, the selected lawyers have received particularly strong ratings in the Best Lawyers' survey by earning a high level of respect among their peers for their “abilities, ...
September 7, 2011
WASHINGTON, DC, September 7, 2011 — Covington & Burling LLP lawyers received 184 individual mentions in 56 areas of law in the 2012 edition of The Best Lawyers in America. This annual compilation of top US lawyers is based on peer-review surveys and is used as a referral guide in the legal profession. The Covington lawyers recognized are as follows: ...
June 15, 2011, Covington E-Alert
June 10, 2011
WASHINGTON, DC, June 10, 2011 — Covington & Burling LLP received 123 individual mentions and 45 practice mentions in Chambers USA 2011. The guidebook, which ranks lawyers by state and national practice area, is designed to identify the most skilled legal practitioners based on the qualities most valued by clients. Here are the Covington lawyers and practices ...
Covington Adds Four Partner Life Sciences Corporate Team
5/16/2011
LONDON, May 16, 2011 — Covington & Burling LLP adds a top life sciences corporate team to its London office, further enhancing its comprehensive global life sciences practice. Covington is pleased to announce that Paul Claydon, Natalie Diep, James Gubbins and James Halstead are joining Covington & Burling LLP as partners. They complement Covington’s highly ...
May 11, 2011, Covington E-Alert
May 9, 2011, Covington E-Alert
Covington Lands Leading China Life Sciences Lawyer
May 5, 2011
BEIJING, May 5, 2011 — Covington & Burling LLP is pleased to announce that Shaoyu Chen has joined the firm as managing director of the firm’s China food and drug practice. Mr. Chen’s experience in food and drug law includes serving as assistant chief counsel in the U.S. Food and Drug Administration’s Office of Chief Counsel, as senior counsel at ...
February 22, 2011
NEW YORK, February 22, 2011 — Forest Laboratories, Inc. (NYSE: FRX) and Clinical Data, Inc. (NASDAQ: CLDA) announced today that they have entered into a merger agreement pursuant to which Forest will acquire Clinical Data, a specialty pharmaceutical company focused on the development of first-in-class and best-in-category therapeutics. Covington & Burling LLP ...
February 15, 2011
WASHINGTON, DC, February 15, 2011 — For the seventh time, Practical Law Company has awarded Covington & Burling LLP its worldwide first place ranking in the Life Sciences Regulatory Super League category. PLC also singled out Covington’s Antitrust/Competition, Corporate, and Insurance practices, along with lawyers from each group, in its practice-specific ...
2011, Life Sciences Handbook 2011
November 30, 2010, EuroWatch
November 10, 2010, Covington E-Alert
November 2010, Regulatory Affairs Pharma
October 25, 2010
NEW YORK, October 25, 2010 — Kadmon Pharmaceuticals announced today that it has acquired Three Rivers Pharmaceuticals, a privately held specialty pharmaceuticals company based in Warrendale, Pennsylvania. Three Rivers will serve as the commercial and operational cornerstone for Kadmon, a privately held biopharmaceutical company based in New York City. Terms of ...
October 25, 2010
SAN FRANCISCO, October 25, 2010 — Omeros Corporation today announced that it has received $20 million from Vulcan Capital as well as a grant award for $5 million from Washington State's Life Sciences Discovery Fund (LSDF) to support the advancement of the Company's G protein-coupled receptor (GPCR) program. In return, Vulcan Capital and LSDF have a right to ...
October 12, 2010
NEW YORK, October 12, 2010 — King Pharmaceuticals and Pfizer announced today that they have entered into an agreement for Pfizer to acquire all of the outstanding stock and stock equivalents of King for $14.25 in cash per share, or aggregate consideration of $3.6 billion. Covington & Burling LLP advised King on the transaction. King is a vertically integrated ...
October 12, 2010
REDWOOD SHORES, CA, October 12, 2010 — Covington & Burling LLP partner Kurt Calia received the Boston University School of Law Victor J. Garo Public Service Award. Mr. Calia, a partner in Covington’s intellectual property litigation, technology, and life sciences practices, was honored for his representation of a death-row inmate in Alabama, a political asylum ...
October 6, 2010
LONDON, 6 October, 2010 — Covington & Burling LLP is pleased to announce the appointment of Christopher Walter as a partner in the European employment practice. He will be joined by special counsel Chris Bracebridge and associate Helena Laughrin. They will significantly enhance Covington's capabilities to meet the needs of the firm's growing European corporate ...
October 2010, Regulatory Affairs Journal
August 9, 2010
REDWOOD SHORES, CA, August 9, 2010 — Covington & Burling LLP is pleased to announce that three partners from its Washington, D.C. office, Kurt Calia, Emily Henn, and Emily Leonard, have relocated to the Silicon Valley office. Their move will strengthen the link to the firm’s deep regulatory roots as well as further enhance the firm’s transactional and litigation ...
August 6, 2010
WASHINGTON, DC, August 6, 2010 — Covington & Burling LLP received 138 individual mentions in 40 areas of law in the 2011 edition of The Best Lawyers in America. This annual compilation of top US lawyers is based on peer-review surveys and is used as a referral guide in the legal profession. The Covington lawyers recognized are as follows: Administrative: ...
August 2010, Journal of Medical Device Regulation
June 25, 2010
NEW YORK, June 25, 2010 — Gilead Sciences, Inc. and CGI Pharmaceuticals, Inc. today announced the signing of a definitive agreement pursuant to which Gilead will acquire CGI. Under the terms of the agreement, Gilead will acquire CGI for up to $120 million, the majority as an upfront payment and the remaining based on clinical development progress. Covington & ...
June 16, 2010
WASHINGTON, DC, June 16, 2010 — Covington & Burling LLP received 112 individual mentions and 44 practice mentions in Chambers USA 2010. The guidebook, which ranks lawyers by state and national practice area, is designed to identify the most skilled legal practitioners based on the qualities most valued by clients. Here are the Covington lawyers and practices ...
5/6/2010
LONDON, 6 May, 2010 — Intercell AG today announced that it has signed an agreement with Cytos Biotechnology Ltd. to acquire Cytos’ platform technology for monoclonal antibody discovery. The technology is based on expression cloning of monoclonal antibodies from human B-cells and enables the identification of anti-infective antibodies to prevent and treat ...
Covington Announces Three New Of Counsel
April 30, 2010
<?xml:namespace prefix="o"?><o:p>WASHINGTON, DC, April 30, 2010 — Covington & Burling LLP is pleased to announce the promotion of three lawyers to of counsel.</o:p> <o:p>The new of counsels are as follows:</o:p> <o:p>Natalie Derzko (Washington) practices in the areas of intellectual property, strategic counseling, due diligence, patent prosecution, patent ...
February 24, 2010
LONDON, February 24, 2010 — Vernalis plc, the London main market listed pharmaceutical company, announced on 11 February the completion of a fully underwritten placing and open offer raising £30 million before expenses. Vernalis proposes to apply most of the proceeds of the fundraising to regain the right to the royalties from Menarini’s sales of frovatriptan by ...
February 9, 2010
LONDON, February 9, 2010 — BioPharm Insight has ranked Covington & Burling LLP as the top legal advisor for biotech and pharma licensing agreements by value. Along with leading the 2009 league tables by value globally and in North America, Covington was ranked first by volume and second by value in Europe, and in Asia, the firm topped both the value and volume ...
Covington Advises Minster Pharmaceuticals in Recommended Takeover by Proximagen Neuroscience
January 15, 2010
LONDON, January 15, 2010 — Covington & Burling LLP advised Minster Pharmaceuticals plc, the AIM-quoted drug development company specialising in compounds for the treatment of neurological and psychiatric conditions, in its recommended takeover by Proximagen Neuroscience plc. The terms of the all cash offer value Minster at £4.3 million. The Covington team ...
2009/10, PLC Life Sciences Handbook 2009/10
2009/10, PLC Life Sciences Handbook 2009/10
Covington Advises HealthpointCapital on Sale of Scient’x Groupe SAS to Alphatec Holdings
December 18, 2009
LONDON, December 18, 2009 — Alphatec Holdings, Inc. has entered into an agreement to acquire Scient’x Groupe SAS, a spinal implant company based in France. Alphatec Holdings, Inc., the parent company of Alphatec Spine, Inc., is a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders. ...
October 9, 2009, Covington E-Alert
Covington Advises Boehringer Ingelheim on Acquisition of Animal Health Assets from Pfizer and Wyeth
9/24/2009
NEW YORK, September 24, 2009 — Boehringer Ingelheim, and its US animal health business Boehringer Ingelheim Vetmedica, Inc., has entered into an agreement with Pfizer to acquire certain assets of Wyeth’s Fort Dodge Animal Health business upon the closing of the global Pfizer-Wyeth merger. Covington & Burling LLP represented Boehringer Ingelheim on the ...
Covington Expands Antitrust Group With DOJ’s O’Connell
9/10/2009
WASHINGTON, DC, September 10, 2009 — Covington & Burling LLP is pleased to announce that James O’Connell, who most recently served as Deputy Assistant Attorney General in charge of International, Policy, and Appellate matters in the Justice Department’s Antitrust Division, has joined the firm as a partner. He will be resident in the firm’s Washington office and ...
September/October 2009, RAJ Devices
Covington Advises Procter & Gamble on $3.1B Sale of Global Pharmaceuticals Business to Warner Chilcott
8/24/2009
NEW YORK, NY, August 24, 2009 — Procter & Gamble today announced the sale of its global pharmaceuticals business to Warner Chilcott Ltd. Covington & Burling LLP advised Procter & Gamble on the transaction. Procter & Gamble is a leading global branded products company, with one of the strongest portfolios of quality, leadership brands in consumer health and ...
August 7, 2009
WASHINGTON, DC, August 7, 2009 — Covington & Burling LLP received 131 individual mentions in 38 areas of law in the 2010 edition of The Best Lawyers in America. This annual compilation of top US lawyers is based on peer-review surveys and is used as a referral guide in the legal profession. The Covington lawyers recognized are as follows: Administrative: ...
June 12, 2009
WASHINGTON, DC, June 12, 2009 — Covington & Burling LLP received 100 individual mentions and 40 practice mentions in Chambers USA 2009. The guidebook, which ranks lawyers by state and national practice area, is designed to identify the most skilled legal practitioners based on the qualities most valued by clients. Here are the Covington lawyers and practices ...
Federal Preemption in the Non-Drug Context After Wyeth v. Levine
June 2009, Drug Litigation Conference: Pharmaceutical Law and Preemption in a Post-Levine World
Covington Advises Merrill Lynch on Johnson & Johnson’s Acquisition of Cougar Biotechnology
5/22/2009
NEW YORK, NY, May 22, 2009 — Johnson & Johnson and Cougar Biotechnology, Inc. announced a definitive agreement whereby Cougar Biotechnology will be acquired for approximately $970 million in a cash tender offer. Covington & Burling LLP advised Merrill Lynch, financial advisor to Cougar Biotechnology, on the transaction. Johnson & Johnson engages in the research ...
5/19/2009
LONDON, May 19, 2009 — Vernalis plc, the London main market listed pharmaceutical company which is developing a pipeline of clinical and early stage programmes, today announced the completion of a placing and open offer raising £24 million before expenses. It proposes to apply the proceeds of the fundraising to fund its clinical development and discovery ...
5/14/2009
LONDON, May 14, 2009 — Covington & Burling LLP is pleased to announce the arrival of Daniel Pavin, who joins the firm’s leading European life sciences practice as a partner in London. Mr. Pavin is recognized as a leading life sciences transactional lawyer in the UK and Europe and brings extensive experience in the life sciences and healthcare sectors. He ...
Covington Advises Biotech HepaHope on IPO
5/1/2009
WASHINGTON, DC, May 1, 2009 — Covington & Burling LLP advised California-based biotech HepaHope, Inc. on its initial public offering in Germany and Luxembourg and its listing on the Frankfurt Stock Exchange. HepaHope raised a total of $12.6 million from funding activities in connection with the IPO. The offering had to be carefully structured and managed to ...
4/13/2009
WASHINGTON, DC, April 13, 2009 — For the fourth consecutive year, Covington & Burling LLP has been awarded worldwide first place firm rankings by the Practical Law Company in both the Life Sciences Industry and Life Sciences Regulatory Super League categories. The rankings are published in PLC’s Cross-border Quarterly for April-June 2009. In honoring Covington, ...
3/17/2009
SAN FRANCISCO, CA, March 17, 2009 — Sanofi-aventis U.S. and Æterna Zentaris GmbH have signed an agreement for the development, registration and marketing for cetrorelix for the treatment of benign prostatic hyperplasia (BPH) for the US market. Under the terms of the agreement sanofi-aventis will make upfront and future milestone payments, and Æterna Zentaris ...
12/11/2008
WASHINGTON, DC, December 11, 2008 — Salix Pharmaceuticals, Ltd. announced that it has acquired rights to crofelemer from Napo Pharmaceuticals, Inc. Covington & Burling LLP represented Salix in the deal. Crofelemer currently is being investigated in a Phase 3 study as an anti-diarrheal agent for the treatment of chronic diarrhea in people living with HIV. Salix ...
Covington Advises Gilead Sciences in Agreement to Distribute HIV Medication in 12 Countries
8/5/2008
SAN FRANCISCO, CA, August 5, 2008 — Gilead Sciences and Merck & Co., Inc. have entered into an agreement through which Gilead will assume the lead role for the distribution of the HIV medication Atripla(R) in 12 countries located primarily in Latin America and the Asia-Pacific region. Covington & Burling LLP advised Gilead in the agreement. Atripla is the first ...
7/11/2008
WASHINGTON, DC, July 11, 2008 — Cubist Pharmaceuticals, Inc. announced that it has signed an exclusive agreement with AstraZeneca to promote and provide support in the United States for MERREM® I.V. Covington & Burling LLP advised AstraZeneca on the deal. AstraZeneca, a major international healthcare business, is engaged in the research, development, ...
Covington Again Ranked World’s Top Life Sciences Firm
4/9/2008
WASHINGTON, DC, April 9, 2008 — For the third consecutive year, Covington & Burling LLP has been awarded worldwide first place firm rankings by the Practical Law Company in both the Life Sciences Industry and Life Sciences Regulatory Super League categories. In honoring Covington, PLC states: “Known for its outstanding regulatory practice in Washington DC, the ...
Covington Advises Pfizer on Acquisition of Serenex
3/3/2008
NEW YORK, NY, March 3, 2008 — Pfizer Inc. announced today that it has entered into an agreement to acquire Serenex Inc., a privately held biotechnology company. Covington & Burling LLP advised Pfizer on the transaction. Pfizer, the world’s largest research-based biomedical and pharmaceutical company, discovers and develops innovative medicines to treat and help ...
March 2008, EURALex
Covington Advises Encysive on Pfizer Deal
2/21/2008
WASHINGTON, DC, February 21, 2008 — Encysive Pharmaceuticals Inc. announced yesterday that it has entered into an agreement to be acquired by Pfizer Inc. Under the terms of the agreement, Pfizer will make a cash tender offer for all issued and outstanding shares of Encysive for $2.35 per share, representing an equity value of approximately $195 million. ...
1/2/2008
NEW YORK, NY, January 2, 2008 — Pfizer announced on December 31 that it has completed the cash tender offer for the outstanding shares of common stock of Coley Pharmaceutical Group, Inc., a publicly-held biopharmaceutical company specializing in vaccine adjuvant technology and a new class of immunomodulatory drug candidates designed to fight cancers, allergy and ...
2008, PLC Cross-border Life Sciences Handbook
12/28/2007
LONDON, December 28, 2007 - The latest edition of Chambers Global has ranked Covington & Burling LLP’s expertise in 12 categories globally. “Sound knowledge of the industry” and “sheer breadth of experience“ are just some of the comments gathered by the research team from the firm’s clients. The firm has also achieved 10 individual rankings and a further 16 ...
December 18, 2007
NEW YORK, NY, December 18, 2007 — BUPA today announced that it has entered into an agreement to acquire Health Dialog. Covington and Burling LLP represented BUPA, Health Dialog’s largest shareholder, in the $775M transaction, which is expected to close in January. BUPA is a global provider of healthcare services and is the largest private health insurer in the ...
Covington Advises Pfizer on Acquisition of CovX
12/18/2007
NEW YORK, NY, December 18, 2007 — Pfizer Inc. announced today that it has entered into an agreement to acquire CovX, a privately-held biotherapeutics company. Covington & Burling LLP advised Pfizer on the transaction. Pfizer, the world’s largest research-based biomedical and pharmaceutical company, discovers and develops innovative medicines to treat and help ...
Covington Advises the Venture Capital Arm of GSK on an Investment in Breakthrough Drugs
November 26, 2007
LONDON, November 26, 2007 - Covington & Burling LLP has advised SR One, the venture capital arm of GSK, on a Series B investment in Syntaxin Ltd, a biopharmaceutical company developing novel biologic drugs that control cell secretion. The round, which was co-led by SR One and Life Science Partners (LSP) with additional funds from one of Syntaxin’s existing ...
November 20, 2007
LONDON, November 21, 2007 - This autumn Chambers and Legal 500 UK have recognised the London office of Covington & Burling in a combined 20 categories, praising the firm’s experts for “creative and commercial thinking” and “outstanding expertise” as well as “diversity of skills.” The firm’s London office has also achieved seven individual rankings and a further ...
Covington Secures Arbitration Victory for GPC Biotech
November 6, 2007
WASHINGTON, DC, November 6, 2007 — Covington & Burling LLP has won a favorable arbitration ruling for GPC Biotech AG in its dispute with Spectrum Pharmaceuticals, Inc. Yesterday, a three-arbitrator panel of the American Arbitration Association unanimously rejected all of Spectrum’s claims against GPC Biotech under their co-development and license agreement for ...
Covington Elects Six New Partners
10/1/2007
WASHINGTON, DC, October 1, 2007 — Covington & Burling LLP announced that six of its associates have been elected to the firm’s partnership, effective today. Stuart Stock, chair of the firm’s management committee, commented, “These six outstanding men and women are representative of Covington’s depth and excellence. We are pleased to welcome them to our ...
September 6, 2007
WASHINGTON, DC, September 6, 2007 — Covington & Burling LLP received 115 individual mentions in 38 areas of law in the 2008 edition of The Best Lawyers in America. This annual compilation of top US lawyers is based on peer-review surveys and is used as a referral guide in the legal profession. The recipients are as follows: Administrative: E. Edward Bruce and ...
September 5, 2007, Covington E-Alert
8/7/2007
LONDON, 7 August, 2007 — Covington & Burling LLP announces its role in advising US biotechnology company Northwest Biotherapeutics, Inc. on its admission to AIM and £15 million placing, which valued the company at approximately £68 million on a fully-diluted basis. The transaction was particularly complex due to Northwest's quotation on the OTC Bulletin Board in ...
Covington Boosts European Life Sciences and TMC Groups
8/6/2007
LONDON, 6 August, 2007 — Covington & Burling LLP is pleased to announce the appointment of two associates in the London office: Janet Kidd joins the European Life Sciences Group and Mark Young joins the European TMC Practice. Before qualifying as a solicitor, Janet spent 15 years in the pharmaceutical industry where she worked for household names such as Pfizer, ...
June 18, 2007
WASHINGTON, DC, June 18, 2007 — Covington & Burling LLP received 44 practice mentions and 74 individual mentions in the newly released 2007 Chambers USA guidebook. The 2007 edition of Chambers USA attempts to identify the most skilled legal practitioners throughout the country based on the qualities most valued by clients. Covington attorneys have been ...
Chambers Europe and Legal 500 EMEA Recognize Achievements of Covington Experts in 9 Categories
May 18, 2007
LONDON, 18 May, 2007 — This year’s editions of Chambers Europe and Legal 500 EMEA recognize the firm’s expertise in the following nine areas: CHAMBERS EUROPE • Regulatory and Public Affairs - Europe-wide • Regulatory: Pharma/Life sciences - Europe-wide • WTO/International Trade - Europe-wide In addition, Georg Berrisch was also ranked as a leading individual in ...
Covington Advises Procter & Gamble in Consumer Diagnostic Products Joint Venture with Inverness
May 18, 2007
NEW YORK, NY, May 18, 2007 — The Procter & Gamble Company and Inverness Medical Innovations, Inc. announced that they have completed their previously announced deal to form a 50/50 joint venture for the development, manufacturing, marketing and sale of existing and to-be-developed consumer diagnostic products. Inverness contributed its related consumer ...
May 3, 2007, Covington E-Alert
May 2, 2007, Covington E-Alert
April 26, 2007
SAN FRANCISCO, CA, April 26, 2007 — Bristol-Myers Squibb Company and Pfizer Inc. today announced a worldwide collaboration to develop and commercialize apixaban, an anticoagulant discovered by Bristol-Myers Squibb being studied for the prevention and treatment of a broad range of venous and arterial thrombotic conditions. In a separate agreement, the companies ...
2007, Delivered as part of Transactions in the Life Sciences Sector, London, England
April 17, 2007, Covington E-Alert
Covington Ranked World’s Top Life Sciences Firm
April 5, 2007
WASHINGTON, DC, April 5, 2007 — Covington & Burling LLP announced today it was awarded worldwide first place firm rankings by the Practical Law Company in both the Life Sciences Industry and Life Sciences Regulatory categories for the second consecutive year. The Life Sciences Industry Super League and Life Sciences Regulatory Super League law rankings, ...
March 29, 2007, Covington E-Alert
January 29, 2007, Covington E-Alert
January 26, 2007, Covington E-Alert
January 19, 2007, Covington E-Alert
January 12, 2007, Covington E-Alert
Leading European Affairs Expert Joins Covington
January 10, 2007
BRUSSELS, January 10, 2007 — International law firm Covington & Burling LLP is pleased to announce the appointment of Wim G. van Velzen as Senior European Policy Advisor in the firm’s Brussels office. Mr. van Velzen, a leading expert on European affairs, served with distinction as a Member of the European Parliament from 1994 to 2004, where he was vice president ...
December 18, 2006, Covington E-Alert
December 14, 2006, Covington E-Alert
December 14, 2006, Covington E-Alert
December 7, 2006, Covington E-Alert
November 10, 2006, Covington E-alert
Covington Advises Abbott Laboratories in $3.7 Billion Acquisition of Kos Pharmaceuticals, Inc.
11/06/2006
NEW YORK, NY, November 6, 2006 — Abbott Laboratories (NYSE: ABT) announced the acquisition of Kos Pharmaceuticals (NASDAQ: KOSP) through a cash tender offer of $78.00 per common share, or $3.7 billion. Covington & Burling LLP represented Abbott in the transaction. Abbott is a global, broad-based health care company devoted to the discovery, development, ...
Proposed Rule Regarding Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
October 13, 2006, Covington E-Alert
October 9, 2006, Covington E-Alert
September 27, 2006, Covington E-Alert
Covington Represents Eisai In $205 Million Acquisition of Four Oncology-Related Products
9/13/2006
WASHINGTON, D.C., September 13, 2006 — Covington represented both Eisai Co., Ltd. and Eisai Inc. in the recent $205 million product acquisition agreement with Ligand Pharmaceuticals. Eisai obtained exclusive global rights to four products, including ONTAK®, Targretin® capsules, Targretin® 1% gel and Panretin® 0.1% gel. This acquisition will help to ...
August 24, 2006, Covington E-Alert
July 25, 2006
WASHINGTON, D.C., July 25, 2006 - Covington advised Novartis Vaccines and Diagnostics, Inc. (successor to Chiron Corporation) in its plans to locate, construct and operate a cell culture-derived influenza vaccines manufacturing facility in Holly Springs, North Carolina. The facility, slated to be the first of its kind in the United States, should ...
July 20, 2006
SAN FRANCISCO, July 20, 2006 - The San Francisco office of Covington & Burling LLP advised Procter & Gamble Pharmaceuticals, Inc., a division of The Procter & Gamble Company, in its strategic alliance with ARYx Therapeutics, a private drug discovery and development company based in Fremont, CA. Under the terms of the agreement, P&G will develop and ...
Covington Advises Emergent BioSolutions on Major R&D Collaboration Agreement with sanofi pasteur
June 6, 2006
LONDON, June 6, 2006 - Emergent BioSolutions, a privately-held biopharmaceutical company, has signed an agreement with sanofi pasteur, the vaccines business of the sanofi-aventis Group, to develop a critically-needed vaccine to prevent one of the world's deadliest childhood diseases, serogroup B meningitis. The Covington team that advised Emergent BioSolutions ...
June 5, 2006, Covington E-Alert
April 6, 2006
SAN FRANCISCO, CA, April 6, 2006 - Covington & Burling announced today that Simon J. Frankel will join the firm's intellectual property litigation group as a partner. Mr. Frankel will be resident in the firm's San Francisco office. Mr. Frankel's extensive IP litigation experience includes handling trademark, copyright, patent, anti-counterfeiting, and trade ...
March 3, 2006, Covington E-Alert
February 10, 2006, Covington E-Alert
January 27, 2006, Covington E-Alert
January 19, 2006
WASHINGTON, D.C., January 19, 2006 - Covington & Burling represented AstraZeneca AB in its recent global licensing and research collaboration agreement with Targacept Inc. Under the terms of the agreement, which is subject to the expiration or termination of the HSR (Hart Scott Rodino) clearance period in the US, AstraZeneca will obtain the global rights for ...
Covington Ranked World's Top Life Sciences Firm
January 11, 2006
WASHINGTON, D.C., January 11, 2006 - Covington & Burling announced today it was awarded worldwide first place firm rankings in the Life Sciences Industry and Life Sciences Regulatory categories. The Life Sciences Industry Super League and Life Sciences Regulatory Super League law firm rankings, published in the Practical Law Company's Cross-border Quarterly ...
December 19, 2005, Covington E-Alert
October 14, 2005
LONDON, UK, October 14, 2005 - Covington & Burling assisted Medarex, the biopharmaceutical company focused on human antibody-based therapeutics to treat life-threatening and debilitating diseases, on the acquisition by its subsidiary Celldex Therapeutics Limited of privately held biotechnology company, Lorantis Ltd. Celldex will acquire Lorantis for 6.8 ...
September 22, 2005
WASHINGTON, D.C., September 22, 2005 - Covington & Burling lawyers Peter Barton Hutt and Peter Safir were featured as two of Washington's top eleven Leading Food & Drug Lawyers in this week's edition of Legal Times. Covington was the only firm to have two lawyers recognized. In describing Mr. Hutt's reputation as a standout in the field, the Legal Times ...
July 21, 2005
NEW YORK, NY, July 21, 2005 - Covington & Burling advised Emory University in the sale of its emtricitabine royalty interest to Gilead Sciences and Royalty Pharma for $540 million. The royalty interest was sold through means of an auction run by Citigroup Global Markets, financial advisor to Emory University, and is the largest known sale of a royalty stream ...
Covington and mergermarket Publish Life Sciences Survey
June 27, 2005
LONDON, UK, June 27, 2005 - Covington & Burling, in association with financial intelligence company mergermarket, released the Covington Life Sciences Monitor. The report, the result of a survey of senior life sciences corporate executives and investment bankers in the U.S. and Europe, gauges perceptions and expectations for the sector. The Monitor focuses on ...
June 2005, Covington E-Alert
Leading Patent Litigators, George Pappas, Jeffrey Elikan, and Kevin Collins, Join Covington
April 22, 2005
WASHINGTON, D.C., April 22, 2005 - Covington & Burling announced today that George Pappas, and Jeffrey Elikan have joined the firm as partners, and Kevin Collins has joined as of counsel. All three will be resident in the Washington, D.C., office. Messrs. Pappas, Elikan, and Collins, previously at Venable LLP, will join Covington's national patent and ...
Leading Trial Lawyer Geoffrey E. Hobart Joins Covington
April 15, 2005
WASHINGTON, D.C., April 15, 2005 - Covington & Burling announced today that Geoffrey E. Hobart has joined the firm as a partner. Mr. Hobart will join Covington's Trial, White Collar, and Pharmaceutical Litigation and Investigations practice groups and will be resident in the firm's Washington, D.C. office. His private practice focus over the past several ...
Covington Advises Pfizer in Acquisition of Idun
February 25, 2005
NEW YORK, NY, February 25, 2005 - Covington & Burling represented Pfizer, Inc. in its agreement to acquire Idun Pharmaceuticals, Inc. The acquisition of Idun, a biopharmaceutical company focused on the discovery and development of therapies to control apoptosis, is expected to close during the second quarter of the year. "The acquisition of Idun is a further ...
Leading IP Litigator Roderick McKelvie Joins Covington
January 4, 2005
WASHINGTON, D.C., January 4, 2005 - Covington & Burling announced today that Roderick R. McKelvie, a former federal district court judge whose litigation practice focuses on patent and other intellectual property matters, has joined the firm as a partner. Judge McKelvie will be resident in the firm's Washington, D.C. office. From 1992 to 2002, Judge McKelvie ...
December 2004/January 2005, Life Sciences Law & Business, Vol. 1, Issue 5
November 12, 2004
WASHINGTON, D.C., November 12, 2004 - Covington & Burling announced today it has been ranked as the number one life sciences regulatory law firm worldwide and the best U.S. law firm overall that advises the life sciences sector. The Life Sciences Super League law firm rankings, published in Global Counsel magazine's November 2004 issue, are based on an ...
November 11, 2004
WASHINGTON, D.C., November 11, 2004 - Covington & Burling recently assisted Medarex, Inc.(Nasdaq: MEDX) in its worldwide collaboration with Bristol-Myers Squibb (NYSE: BMY). The agreement allows the two companies to jointly develop and commercialize MDX-010, an antibody product that is currently in a Phase III clinical trial for the treatment of metastatic ...
Covington Advises Medarex in Collaboration with Pfizer
September 28, 2004
WASHINGTON, D.C., September 28, 2004 - Covington & Burling recently assisted Medarex, Inc. (Nasdaq: MEDX) in its global collaboration with Pfizer, Inc. (NYSE: PFE). The agreement allows the two companies to develop as many as 50 antibody products over the next ten years and cross-licenses particular patents for Medarex's anti-CTLA-4 antibody programs. ...
2004/2005, Global Counsel Life Sciences Handbook
August 2004, Covington E-Alert
April 14, 2004, Covington E-Alert
April 2004, Law & Business, Volume 1, Issues 1&2
December 11, 2003, Covington E-Alert
Drug Import Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003
December 8, 2003, Covington Report
Hatch-Waxman Provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003
December 8, 2003, Covington Report
November 26, 2003, Covington E-Alert
March 1, 2003, Global Counsel Life Sciences Industry Report
Covington & Burling Announces Eight New Partners
October 3, 2002
October 3, 2002 - WASHINGTON, D.C. - Covington & Burling announced that eight attorneys have been elected to the partnership, effective October 1, 2002. New partners in Covington's Litigation Practice include Georgia Kazakis and Edward H. Rippey. Michael S. Labson is a new partner in the firm's Food and Drug and Life Sciences Practices. Erin M. Egan and Jennifer ...
Peter O. Safir, Leading Food & Drug Regulatory Lawyer, Joins Covington & Burling as a Partner
October 1, 2002
October 1, 2002 - WASHINGTON, D.C. - International law firm Covington & Burling is pleased to announce that Peter O. Safir has joined as a partner. Mr. Safir has been practicing in the food and drug field for nearly 30 years. He is widely recognized in the pharmaceutical industry as one of the leading food and drug regulatory lawyers in the country. In recent ...
Former General Counsel of GlaxoSmithKline Joins Covington & Burling as Senior Of Counsel
March 6, 2002
March 6, 2002 - LONDON, U.K.- International law firm Covington & Burling is pleased to announce that James Beery, who recently retired as Senior Vice President and General Counsel of GlaxoSmithKline (GSK), one of the largest pharmaceutical companies in the world and the UK’s second largest company, will join the firm as Senior Of Counsel from 18 March. Mr. ...
March 2003, Global Counsel Life Sciences Industry Report
October 12, 1998, Legal Times
- The only firm recognized by Chambers as a “Band 1” firm for Life Sciences across their US, UK, Europe, China and Global surveys
- Awarded “Life Sciences Practice Group of the Year” by Law360 in 2012, 2013, 2014, 2015, and 2016.
- Recognized as a leading life sciences law firm by Chambers, Legal 500, Law360 and LMG Life Sciences
- More than 30 individual attorneys – across a range of practice areas, including corporate/commercial, regulatory/compliance, intellectual property and litigation – recognized for excellence in life sciences by the leading legal industry surveys
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