Life Sciences

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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.

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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.

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.

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.

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.

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.

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. The PTAB 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

Advice to Numerous Life Sciences Companies on Regulatory Compliance and Infrastructure

Advice to numerous pharmaceutical and medical technology companies on compliance with with pharmaceutical and medical device regulations. For pharmaceutical companies, this has included compliance with manufacturing and supply chain rules, pharmacovigilance, and other “GxP” requirements. We have advised device manufacturers on borderline, classification, conformity assessment and other quality system requirements, including in the digital health space. In both industries, we have advised extensively on the impact of, and preparations for Brexit.

$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.

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.

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.

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.

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).

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.

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).

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.

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.

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.

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.

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.

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).

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.

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.”

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.

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.

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.

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.

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.

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).

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.

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.

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.

Illumina in $1.2 Billion Deal with Pacific Biosciences

Represented Illumina, Inc. in its announced $1.2 billion acquisition of Pacific Biosciences and its novel Single Molecule, Real Time (SMRT®) technology, which provides high accuracy, ultra-long reads for full genome sequencing. The acquisition complements Illumina sequencing solutions with accurate long read sequencing capabilities to answer a set of complex genomic questions.

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.

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.

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.

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.

Advised UK-based Clinical AI Company Sensyne Health

Advised Sensyne Health, a UK-based clinical AI company, on: a collaboration with Bayer to analyze patient data from the UK National Health Service using Sensyne’s clinical artificial intelligence platform and apply the findings to Bayer’s cardiovascular disease pipeline; Jefferson Health to evaluate the clinical and commercial potential of its GDm-Health™ system in the United States; novel strategic research and data processing; and agreements with the Chelsea and Westminster Hospital National Health Service (NHS) Foundation Trust, the Oxford University Hospitals NHS Foundation Trust, and the South Warwickshire NHS Foundation Trust.

Advising Client Efforts in Analysis of Patient Information

Advising clients in the life sciences, healthcare and technology sectors on collaborations with hospitals and hospital systems in respect of the analysis of patient information, including: advising on laws and regulations governing the collection and use of patient information; structuring, negotiating and drafting collaboration agreements between life sciences and technology companies; advising on data-driven revenue models; drafting and negotiating data processing agreements under GDPR and business associate agreements under HIPAA; advising on the regulation of the provision of healthcare services.

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European Commission publishes Strategic Forum’s recommendations on Smart Health

On November 5, 2019, the European Commission published a report entitled “Strengthening Strategic Value Chains for a future-ready EU Industry”, which was prepared by the Strategic Forum on Important Projects of Common European Interest (“Forum”). The Forum assists the European Commission in identifying key strategic value chains that can contribute to Europe’s ...

Covington Advises BenevolentAI on $90M Investment from Temasek

LONDON—Covington has advised BenevolentAI on its $90 million investment from Temasek, a Singapore-headquartered investment company. BenevolentAI aims to improve the lives of patients suffering from diseases with no effective treatment. The Benevolent Platform® is used by scientists and technologists to find new ways to treat disease, improve the efficacy, and ...

The Nagoya Protocol at Its 5th Anniversary: Legal Lessons Learned in the Pharmaceutical, Food and Cosmetics Sectors

📄 Download PDF of Client Alert The Nagoya Protocol on Access and Benefit Sharing is the main global mechanism to regulate the access and utilization of biological resources. The agreement entered into force nearly five years ago, on October 12, 2014, as a supplement to the 1992 Convention on Biological Diversity Today, 118 countries are a contracting party ...

Clinical Trial Data Are Presumptively Confidential, Opines EU Advocate General

In a long-running legal case challenging the European Medicines Agency’s approach to disclosure of clinical trial data, Advocate General Hogan has recommended that the Court of Justice find that such data are presumptively confidential when handling disclosure requests under the Transparency Regulation 1049/2001. PTC Therapeutics International Limited (“PTC”) ...

China confirms drug reforms to spur innovation, ensure drug quality, ease restrictions

John Balzano is quoted in BioWorld regarding recent updates to China’s drug administration law and the establishment of marketing authorization holders (MAH). Mr. Balzano says, “This creates much-needed flexibility for research-based companies to develop products and bring them to market.” Another advantage of the MAH system is that licenses can officially be ...

Eli Lilly defeats billion-dollar claim over trade secrets

Marney Cheek is quoted in Global Arbitration Review regarding Eli Lilly & Company’s victory over a French biotech company that alleged it had misused trade secrets and confidential information. Ms. Cheek says, “We are very pleased that the tribunal acknowledged the innovative and independent work of Lilly scientists. We are delighted with the outcome.”

Shout-Out: Covington Beats Back $1.4 Billion Trade Secret Claim Against Lilly

Marney Cheek is quoted in Litigation Daily regarding the firm’s win for Eli Lilly & Company against a French biotech company regarding alleged misappropriation of trade secrets. Ms. Cheek says, “We are very pleased that the tribunal acknowledged the innovative and independent work of Lilly scientists. We are delighted with the outcome.”

Covington Successfully Defends Lilly in $1+ Billion Trade Secret Arbitration

WASHINGTON—Covington has secured a complete victory for our client Eli Lilly & Company against French biotech company Adocia S.A., defeating Adocia’s claims of $1.39 billion for alleged misappropriation of trade secrets in an arbitration before a three-member panel at the American Arbitration Association (AAA). After extensive written submissions and a lengthy ...

Former FDA lawyer: DSHEA largely 'a success'

Peter Hutt spoke with the Natural Products Insider podcast in the second part of a discussion about the FDA’s role over the decades in regulating dietary supplements and efforts to impose restrictions that were stymied time and again. Mr. Hutt says, “FDA has not done adequate enforcement against [companies that put prescription drug ingredients in dietary ...

Regulatory Watch: How has recent Law No 2019-774 of 24 July 2019 on the organization and transformation of the health system changed the anti-gift rules?

French “anti-gift” rules strictly regulate the relationship between the life sciences industry and healthcare professionals (“HCP”) and the possibility for companies active in the health sector to offer benefits, in cash or in kind to healthcare professionals, medical students or associations representing them. This includes a general prohibition against ...

French medicines regulator produces first in Europe medical devices cybersecurity guidelines

France’s medicines regulator, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), has released draft guidelines, currently subject to a public consultation, setting out recommendations for manufacturers designed to help prevent cybersecurity attacks to medical devices. Notably, the draft guidelines are the first instance of ...

The CJEU Rules that Companies Can Seek Orphan Status for a New Product Containing the Same Active Substance as an Existing Orphan Product

On July 29, 2019, the Court of Justice of the European Union (“CJEU”) issued its judgment in Case C-359/18 P, Shire Pharmaceuticals Ireland v. EMA, dismissing the European Medicines Agency’s (“EMA”) appeal and reconfirming the position set by the General Court. Covington represented Shire Pharmaceuticals Ireland (“Shire”), which was recently acquired by Takeda.

Key Takeaways from China's Regulation on the Administration of Human Genetic Resources

On June 10, 2019, the State Council (China’s chief executive agency) promulgated the long-awaited Regulation on the Administration of Human Genetic Resources (the “Regulation”), which will become effective on July 1, 2019. The Regulation supersedes the currently effective regulations and guidance on human genetic resources (“HGR”).

FDA kicks off review of CBD with 140 people scheduled to testify at first public hearing Friday

Miriam Guggenheim spoke with CNBC about the increasing interest around CBD. Ms. Guggenheim says, “Interest continues to skyrocket. It is mainstream, interest is mainstream. It is not fringe anymore, which doesn’t mean mainstream companies are ready to jump in. But they want to be prepared to do so once the legal landscape is clarified.”

Covington Represents Merck in $1.05B Acquisition of Peloton Therapeutics

WASHINGTON—Covington advised Merck & Co., Inc., in its definitive agreement under which Merck, through a subsidiary, will acquire privately held Peloton Therapeutics, Inc. in exchange for an upfront payment of $1.05 billion in cash. In addition, Peloton shareholders will be eligible to receive a further $1.15 billion contingent upon successful achievement of ...

Covington Represents LifeArc in Landmark $1.297B Royalty Monetization

NEW YORK—Covington advised LifeArc, a UK-based medical research charity, on its monetization of a portion of its royalties relating to Keytruda® for $1.297 billion (approximately £1 billion). This royalty monetization is the largest single-product royalty monetization ever done by a non-profit. The transaction closed on May 10, 2019, the culmination of efforts ...

Covington Represents Bayer in $550M Sale of Coppertone™

NEW YORK—Covington advised Bayer in a definitive agreement to sell its Coppertone™ business to Beiersdorf AG, a provider of skin care products, for $550 million. Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome ...

States Could Take Bloom Off Growth Of CBD Supplement, Food Market

Miriam Guggenheim is quoted in HBW Insight regarding Congressional action to exclude hemp from the definition of “marijuana” in the Controlled Substances Act. Ms. Guggenheim says the change does not have a preemptive effect with states and creates confusion, even for some municipal governments. She adds, "The states have their own controlled substances laws and ...

Compliance Corner: When Is An Action Exempt From FDA's Recall Reporting Requirements?

Medtech Insight included Pamela Forrest's comments from FDAnews' 16th Annual Medical Device Quality Congress about medical device recalls from a product enhancement. Ms. Forrest said the key question companies should ask themselves is whether their action makes a safe device better or improves existing safety concerns. If the action improves a device's safety, ...

Covington Represents Biopharmaceutical Startup IFM Tre in $1.575B Sale to Novartis

NEW YORK—Covington represented IFM Tre, Inc. in its sale to Novartis for a $310 million upfront cash payment and up to $1.265 billion in milestone payments (for a total of $1.575 billion). IFM Tre develops chemically distinct systemic, gut-directed, and CNS-penetrant drug candidates to address several indications triggered by NLRP3, including metabolic, ...

Former FDA Official Joins Covington

WASHINGTON—Julie Dohm has joined Covington's Food, Drug, and Device practice in Washington. Dr. Dohm focuses on regulatory matters for pharmaceutical and biotechnology clients. She has handled cases on a wide range of regulatory topics such as preemption, drug promotion, drug shortage, import-export, exclusivity, and generic drug approval standards. Prior to ...

The Brexit Headaches Keeping Partners Awake At Night

Bart Van Vooren is quoted in Legal Week regarding the potential decrease in work for law firms in the UK following Brexit. He says, “A general impression is that small and medium-sized enterprises don’t have enough resources to prepare, while our clients – large worldwide pharmaceutical companies – have invested millions into this. Many have done their homework, ...

UK regulator provides further ‘no deal’ Brexit guidance for medical devices regulation

On 26 February, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published further guidance (available here) setting out the anticipated regulation of medical devices in the UK, should the UK leave the EU without a deal (Guidance). This Guidance will apply from ‘exit day’ (expected to be 11 p.m. 29 March 2019) subject to...… Continue Reading

European Commission publishes Letter on Exemption allowing for UK Batch Testing post-Brexit

On 21 February 2019, the European Commission wrote to the European Medicines Agency (“EMA”) and the Heads of Medicines Agencies of the EU-27 Member States concerning the acceptability of UK batch testing after Brexit (see the letter here). The letter seeks to address concerns that a number of pharmaceutical companies will not have been able...… Continue Reading

Reconciling Personalized Nutrition with the GDPR

As with anything personalized, be it advertising, medicines or training schedules, also personalized nutrition — using information on individual characteristics to develop targeted nutritional advice, products, or services — risks being affected by the feared GDPR. Kristof Van Quathem discusses the topic in Vitafoods’ Insights magazine of January 2019, ...

Covington adds to M&A tech practice

Denny Kwon and Tom DeFilipps spoke with Global Data Review on Mr. Kwon’s move to Covington. Mr. Kwon told GDR that for him, Covington was a natural fit in light of the increased prominence of regulatory issues in M&A transactions and the firm’s “incredibly broad” array of practices. He said that data usage and privacy issues are becoming increasingly ...

Covington Snags Ex-Wilson Sonsini Tech M&A Pro In Calif.

Denny Kwon and Tom DeFilipps spoke with Law360 about Mr. Kwon’s move to Covington. Mr. DeFilipps says, “Denny will greatly enhance our Northern California corporate offering and our ability to further develop M&A and broader corporate relationships with West Coast-based technology and life sciences clients.” Mr. Kwon told Law360 that his favorite part of ...

European Data Protection Board releases Guidance on Intersection of the GDPR and the Clinical Trials Regulation

The European Data Protection Board (“Board”) released an opinion on January 23, 2019, on the intersection between the EU General Data Protection Regulation (“GDPR”) and the Clinical Trials Regulation (“CTR”). The opinion considers a Q&A on this topic prepared by the European Commission’s Directorate General for Health. The Directorate General decided to create ...

Proposed Changes to UK Allergen Labelling Law

Introduction The Department for Environment, Food & Rural Affairs (“DEFRA”) has announced a consultation regarding proposed changes to allergen labelling laws for food prepacked for direct sale in the UK. This follows the death of Natasha Ednan-Laperouse in July 2016, which was the result of an allergic reaction after consuming a baguette from Pret a...… ...

Latinvex Names Four Covington Partners Among "Top 100 Lawyers"

NEW YORK—Latinvex has named Covington partners Nicole Duclos, Rubén Kraiem, Miguel López Forastier, and Gabriel Mesa among “Latin America’s Top 100 Lawyers” in 2019. Ms. Duclos represents clients in international commercial and investment arbitration, as well as transnational litigation. Clients interviewed by Latinvex praised Ms. Duclos’ extensive arbitration ...

Covington Advises Sensyne Health on Collaboration with Jefferson Health

NEW YORK—Covington has advised Sensyne Health, the British clinical AI technology company, on its agreement with Jefferson Health to evaluate the clinical and commercial potential of its GDm-Health™ system in the United States. GDm-Health is a direct patient-to-clinician blood glucose monitoring management system specifically designed for the management of ...

Covington Advised SK Holdings in $100M Investment

PALO ALTO—Covington advised South Korea-based SK Holdings in its $100 million investment in Kinestral Technologies, Inc. The Series D funding round was led by SK Holdings and included existing Kinestral investors like 5AM Ventures, Alexandria Real Estate, Capricorn Investment Group, and Versant Ventures. Headquartered in the San Francisco Bay Area, Kinestral ...

EPA’s Final Hazardous Waste Pharmaceuticals Rule Has Significant Implications for Pharmaceuticals and Product Recalls

Under the Resource Conservation and Recovery Act (“RCRA”), waste deemed “hazardous waste” is subject to onerous regulatory requirements, including: a 90-day storage limitation, shipment to a RCRA-permitted facility for disposal, and tracking from generation to disposal via a manifest system.

Covington Advises Merck on €2.1 Billion Acquisition of Animal Health Company

WASHINGTON—Covington advised Merck & Co., Inc. on its acquisition of Antelliq Group for approximately €2.1 billion ($2.4 billion) plus the assumption of €1.15 billion of debt. Antelliq will be wholly owned and separately operated subsidiary within the Merck Animal Health Division. Antelliq is an animal intelligence group focused on animal identification, ...

Federal Circuit Delivers Two Important Decisions on Obviousness-Type Double Patenting

On December 7, 2018, the Federal Circuit issued two highly-anticipated decisions clarifying the application of the obviousness-type double patenting doctrine: Novartis AG v. Ezra Ventures LLC (patent term extension ("PTE")), and Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc. (pre-Uruguay Round Agreements Act ("URAA") versus post-URAA ...

Covington Represents Illumina in $1.2 Billion Deal with Pacific Biosciences

NEW YORK—Covington advised Illumina, Inc. in its announced $1.2 billion acquisition of Pacific Biosciences. Illumina is a leading developer, manufacturer, and marketer of life science tools and integrated systems for large-scale analysis of genetic variation and function, and the company’s products are used for applications in life sciences, oncology, ...

New Laws Expand Requirements for Pharmaceutical Companies to File Agreements With FTC and DOJ

President Trump on October 24 signed the SUPPORT for Patients and Communities Act (H.R. 6), which together with the Patient Right to Know Drug Prices Act (S. 2554), signed October 10, expands the scope of pharmaceutical product-related agreements subject to filing requirements under subtitle B of Title XI of the Medicare Prescription Drug, Improvement, and ...

The Implications of the GDPR on Clinical Trials in Europe

On October 22, 2018, the European Federation of Pharmaceutical Industries in cooperation with the Future of Privacy Forum and the Center for Information Policy Leadership organized a workshop entitled “Can GDPR Work for Health Research.” In the first session, the workshop discussed the implications of the General Data Protection Regulation (“GDPR”) on clinical ...

Covington Advises Sensyne Health on IPO and Pioneering Strategic Agreements

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 ...

Covington Represents Emergent BioSolutions in $270M Acquisition

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 ...

US FDA's Software Pre-Cert Program: Is The Authority On The Books?

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 – ...

Sarah Crowder Named to GIR's "Women in Investigations"

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 ...

Covington Secures Key Preliminary Injunction for Indivior

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 ...

Covington Represents Boston Children's Hospital in Royalty Monetization

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 ...

Covington & Burling's Emily Leonard | Women of Influence 2018

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."

US, Global Law Firms Look to Ireland for 'Brexit Insurance Policy'

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 ...

Covington Advises German Private Equity Fund on Medical Device Acquisition

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 ...

Three Covington Partners Among Top 100 Women Lawyers in California

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 ...

Covington Advises BenevolentAI on £80m Funding and Acquisition

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 ...

CQC report on online primary health services shows progress

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 ...

Trump Administration Proposes Rules to Expand Access to Short-term Health Plans

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 ...

Covington: Drawing on Life Science Sector Depth to Tackle Complexity

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 ...

Wade Ackerman and Aaron Lewis Named Among LA's Most Influential Diverse Lawyers

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 ...

Increasing Pressure on Orphan Medicinal Product Designations in the EU

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

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 ...

FDA Announces “Nutrition Action Plan” while Stakeholders await Final Guidance on Nutrition Labeling

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, ...

Covington Represents Autifony Therapeutics in Collaboration and Option Deal with Boehringer Ingelheim

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 ...

Covington Lures Back FDA Drug Quality Leader

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 ...

Former FDA Official Rejoins Covington's Life Sciences Practice

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 ...

FDA Releases Comprehensive Regulatory Framework for Regenerative Medicine

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 ...

CMS Revises Medicare Part B Biosimilar Coding and Payment Policies

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

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 ...

China moves to accept overseas data, approval times could speed up

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

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 ...

California SB 17: New Requirements for Drug Manufacturers

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 ...

Andriukaitis: Supporting drug innovation is 'the only way'

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 ...

Covington Advises Zoetis in $1.25 Billion Debt Securities Offering

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 ...

Ingrid Rechtin Among The Recorder's "Women Leaders in Tech Law"

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 ...

Covington Named International Firm of the Year for Trade by China Law & Practice

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 ...

Women Leaders in Tech Law: Ingrid Rechtin, Covington & Burling

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, ...

EU Legal Opinion In Roche/Novartis Case Has Competition And Licensing Implications

A blog post by 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. Cole write, if the opinion was followed by the full court it could have "significant implications for market definition in relation to pharmaceutical products, and potentially for ...

D.C.'s Rising Stars: Shankar Duraiswamy, 37

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"

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 ...

Covington Represents IFM Therapeutics in $300 Million Sale of Assets to BMS

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 ...

Covington Advises Underwriters in $138 Million Stock Offering by Repligen

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

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

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.

Covington Snags Undefeated Litigator From O'Melveny

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], ...

Covington Hires Kubota from O'Melveny After 17-Year Long Stay

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

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 ...

Leading Trial Lawyer Joins Covington

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, ...

Covington Lawyers Win Three “Europe Women in Business Law Awards"

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, ...

Comment: Licensing drugs post-Brexit amounts to surmountable administrative task

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 ...

Administration Submits Notice of NAFTA Renegotiation

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 ...

The Brexit Club featuring Barclays, Cambria Automobiles and Gear4music

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 ...

FDA 'Cures' Fund Breakdown: Breakthrough Devices, HDEs, IRB Flexibility And More

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, ...

Wade Ackerman Named to California Life Sciences Association's Board of Directors

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, ...

Emily Henn Named One of Silicon Valley’s Most Influential Women

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. ...

Trump Moves on Steel Under Section 232

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 ...

SEC Signals Some Relief on Conflict Minerals Rule

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 ...

The Massive Accutane Litigation Just Fell Apart After Judge Boots Expert ‘Hired Guns’

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

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, ...

China Seeks Public Comments on Draft Regulation of Cross-Border Data Transfer

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).

Covington Adds Senior M&A Partner

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 ...

Two Former PTAB Judges Join Covington's Patent Office Trials Practice

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 ...

Covington Advises AstraZeneca on Strategic Collaboration with Circassia

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 ...

President Issues New Executive Order, Requires Agencies to Establish Regulatory Reform Task Forces

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.

Life Sciences Group Of The Year: Covington & Burling

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

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.”

KWM London's former head of fraud and investigations joins Covington

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

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 ...

White Collar and Fraud Specialist Joins Covington’s European Practice

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

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 Represents India-Based Healthcare Company In Drug Portfolio Acquisition

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 ...

Industry Communications With Payors: US FDA Okays Info On Investigational Drugs

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 ...

Product Liability Group Of The Year: Covington & Burling

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 ...

IBM Digs Deeper Roots In Medtech, As AdvaMed Builds Digital Footprint

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.

Pandemic Vaccines Probably Can't Use Accelerated Approval - US FDA Chief Scientist

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

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 ...

3 Questions Shaping 2017 JPMorgan Health Care Conference

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 ...

Six Covington Lawyers Named Law360 MVPs

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. ...

China Business Law Journal Names Weishi Li Among Top Lawyers

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

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 ...

Global Enforcement of the Nagoya Protocol in Life Sciences Industries

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 ...

Medical Device Reporting for Manufacturers; Final Guidance

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, ...

Covington Advises Cantor Fitzgerald in Signal Genetics Merger

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

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 ...

FDA Questions Need for Looser Off-Label Promotion Restrictions

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 ...

Industry, Patient Advocates at Odds as FDA Revisits Off-Label Communication

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, ...

FDA Asks Industry Where to Draw the Line on Off-Label Communication

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.

PhRMA To FDA: Weigh Payer Communication Before 1st Amendment Issue

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

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 ...

China Proposes Expanded Criteria, Increased Penalties for Device Recalls

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 ...

Brexit ruling “only adds to uncertainty” in the UK food industry

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 ...

Spanner In Works For UK Gov’t’s Brexit Plans; Industry Looks To Ongoing Talks With Ministers

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 ...

Combo Product Reforms May Appear in User Fees if Not Passed in Lame Duck

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 ...

Covington Represents India-Based Healthcare Company in Acquisition

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 ...

Covington Advises AstraZeneca on Divestment of Rights to Rhinocort Aqua

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 ...

Vantage point – What Brexit means for life science funding and strategy

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.”

China's Proposed Rules Expand Penalties for Medical Device Recalls

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

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 ...

Silicon Valley Dealmaker Joins Covington

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 ...

Covington Continues Calif. Growth With Sidley Palo Alto Leader

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 ...

Covington grabs partner from Sidley to grow NorCal offices

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

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 ...

China's Changing Device Regulations: What You Need to Know

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 ...

Covington Nabs Sidley NorCal Vet To Lead West Coast Deals

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

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 ...

Leading FDA Lawyer Joins Covington's Life Sciences Practice

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 ...

FDA Releases Long-Awaited Draft Guidance on Hazard Analysis and Risk-Based Preventive Controls for Human Food

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

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

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 ...

The medical foods category has an uncertain bill of health

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

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 ...

Covington's Brexit Task Force Provides Insights on Latest Developments

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

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

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 ...

Drugmakers Ensnared in Brexit Seek Sway Over Medicine Cabinets

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 ...

Brexit Leaves U.S. Regulatory Attorneys With Many Questions

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 ...

Impact of Brexit on Pharmaceutical Regulations and Structures

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 ...

‘Painful…power vacuum’ coming for European Medicines Agency

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

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

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 ...

Covington Receives Top Rankings from Chambers USA

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 ...

Covington Advises Underwriters in Life Sciences Debt Offering

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 ...

FDA Finalizes Guidance for Industry about Medical Foods

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 ...

UK would lose two pharma bodies in event of Brexit, lawyers warn

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 ...

Three Covington Partners Among Top 100 Female Lawyers in California

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 ...

Covington Represents Underwriters in Senseonics' IPO

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

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.”

Covington Advises AstraZeneca on European Rights to Moventig

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?

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

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 ...

Covington Boosts European Public Affairs Practice with Erika Mann

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 ...

Covington Earns Six Law360 “Practice Group of the Year” Awards

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

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 ...

Summary of FDA Advertising and Promotion Enforcement Activity in 2015

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”

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

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. ...

Covington Advises AstraZeneca on Acquisition of Takeda’s Respiratory Business

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 ...

Covington Advises Allergy Therapeutics on £11.5 Million Placement and License Agreement

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 ...

Covington Represents Underwriters in Nabriva Therapeutics IPO

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 ...

Covington Multiple Winner at 2015 China Law & Practice Awards

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 ...

National Law Journal Names Phyllis Jones and Daniel Suleiman “D.C. Rising Stars”

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 ...

Covington Advises UCB on Sale of Kremers Urban Pharmaceuticals to Lannett

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 ...

Covington Advises Regeneron on New Immuno-Oncology Collaboration

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 ...

Covington Advises Allergy Therapeutics on Alerpharma Acquisition and £20 Million Placing

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 ...

Covington Represents Underwriters in Cidara IPO

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 ...

Litigators of the Week: Paul Schmidt and Michael Imbroscio of Covington & Burling

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 ...

Covington Advises Heptares Therapeutics on its Sale to Sosei Group

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 ...

Covington Advises AstraZeneca on Acquisition of Rights to Actavis' Branded Respiratory Portfolio

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

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

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, ...

Law360 Names Covington’s Life Sciences Practice One of Year’s Best

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

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 ...

Covington's Competition Law Practice Named to GCR Global Elite

WASHINGTON, December 22, 2014 — The Global Competition Review (GCR) has named Covington & Burling to its Global Elite, a list of the top 20 competition practices worldwide, ranking it among the top practices in both Brussels and Washington, D.C. Each year, GCR undertakes extensive analysis of competition law groups in 50 jurisdictions around the world. In ...

Covington Advises Indivior on Demerger from Reckitt Benckiser

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 ...

Covington Named Compliance / Regulatory Firm of the Year 2014 by Asian-MENA Counsel

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 ...

Covington Advises Horizon Discovery on Sage Labs Acquisition

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), ...

Covington Advises Illumina on Partnership with Genomics England

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 ...

Covington Advises AstraZeneca on Strategic Transaction with Almirall in Respiratory Disease

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. ...

China Looks Closer At Enforcement Of Meat Product Regulations

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.

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

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 ...

Covington Secures Jury Verdict for Salix Pharmaceuticals

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, ...

Covington Advises Isarna Therapeutics on License Agreement with Santaris Pharma

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 ...

Law360 Names Covington’s Life Sciences Practice One of Year’s Best

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 ...

Covington Advises Innovacell on a Collaboration and License Agreement with Norgine

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 ...

Covington Advises Natrogen on Agreements with Takeda

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. ...

Covington Advises AstraZeneca on Acquisition of Diabetes Alliance Assets

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

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, ...

Covington Advises AstraZeneca/ MedImmune on Acquisition of Spirogen and Investment in and Collaboration with ADC Therapeutics

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 ...

Covington Wins Six LMG Life Sciences Awards

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 ...

Covington Advises ReNeuron Group on £33 million Financing Package

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 ...

Covington Helps Secure Approval for GlaxoSmithKline's BCRs

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 ...

Covington’s Peets and Prescott, Named “Best in Copyright” and “Best in Investment Funds”

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 ...

Robert Trainor Joins Covington’s Life Sciences Practice

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

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 ...

Covington Advises AstraZeneca on Moderna Therapeutics Deal

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 ...

Covington Named ‘Life Sciences Group of the Year’

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 ...

Covington Advises Illumina in Acquisition of Verinata Health

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 ...

Five Covington Lawyers Named Law360 MVPs

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 ...

U.S. News-Best Lawyers Again Ranks Covington Among Nation's Top Law Firms

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 ...

Covington Advises AstraZeneca on Ironwood Pharmaceuticals Deal

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

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 ...

Covington Advises Meda on Acquisition of Jazz Pharmaceuticals’ Women’s Health Products

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 ...

Covington Expands Life Sciences Practice in China with Addition of Weishi Li

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 ...

Covington Receives 196 Individual Mentions in 2013 Edition of Best Lawyers

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 ...

Covington Advises AstraZeneca in Agreement with Pfizer for OTC Nexium

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

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 ...

Covington’s Peter Bogaert Named ‘2012 Lawyer of the Year’

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 ...

Covington Advises AstraZeneca in $1.26 Billion Acquisition of Ardea Biosciences

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

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 ...

Covington Receives 46 Lawyer, 20 Practice Accolades in Chambers Global

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 ...

Covington Adds Five in Silicon Valley and China

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; ...

Law360 Names Covington ‘Health Practice Group of the Year’

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 ...

Covington Boosts Cross-Atlantic Government Affairs with Jean De Ruyt

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 ...

Covington Bolsters Cross-Border M&A and Capital Markets with Kristian Wiggert

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, ...

U.S. News-Best Lawyers Awards Covington ‘Law Firm of the Year’ in FDA Law and 82 First-Tier Practice Rankings

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. ...

Covington Advises Axis-Shield plc on £235M Takeover Offer from Alere, Inc.

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’

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, ...

Covington Receives 184 Individual Mentions in 2012 Edition of Best Lawyers

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: ...

Chambers USA Recognizes Covington with 123 Individual, 45 Practice Nods

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

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 ...

Covington Advises Forest on Acquisition of Clinical Data, Inc.

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 ...

Covington Practice Groups and Lawyers Named to PLC Rankings

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 ...

Covington Advises Colbeck Capital Management on Kadmon Pharmaceuticals Acquisition

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 ...

Covington Advises Omeros Corporation in Deal to Advance GPCR Program

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 ...

Covington Advises King Pharmaceuticals on $3.6B Merger with Pfizer

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 ...

Covington’s Calia Receives Victor J. Garo Public Service Award

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 ...

Covington Boosts International Employment Capabilities with London Team Hire

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 ...

Covington Expands Silicon Valley Presence with Three Partners from DC

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 ...

Covington Receives 138 Individual Mentions in 2011 Edition of Best Lawyers

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: ...

Covington Advises Gilead Sciences on Acquisition of CGI Pharmaceuticals

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 & ...

Chambers USA Recognizes Covington with 112 Individual, 44 Practice Nods

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 ...

Covington Advises Intercell on Acquisition of Antibody Technology Platform

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

<?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 ...

Covington Acts for Piper Jaffray in a £30M Fundraising by Vernalis

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 ...

Covington Tops BioPharm Insight Global Licensing Agreements

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

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 ...

Covington Advises HealthpointCapital on Sale of Scient’x Groupe SAS to Alphatec Holdings

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. ...

Covington Advises Boehringer Ingelheim on Acquisition of Animal Health Assets from Pfizer and Wyeth

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

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 ...

Covington Advises Procter & Gamble on $3.1B Sale of Global Pharmaceuticals Business to Warner Chilcott

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 ...

Covington Receives 131 Individual Mentions in 2010 Edition of Best Lawyers

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: ...

Chambers USA Recognizes Covington With 100 Individual, 40 Practice Nods

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 ...

Covington Advises Merrill Lynch on Johnson & Johnson’s Acquisition of Cougar Biotechnology

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 ...

Covington Acts for Piper Jaffray in a £24m Fundraising by Vernalis

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 ...

Covington Expands European Life Sciences Transactions Practice with Daniel Pavin

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

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 ...

Covington Ranked World’s Top Life Sciences Firm for Fourth Year

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, ...

Covington Advises Sanofi-aventis on Agreement with Æterna Zentaris

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 ...

Covington Advises Salix Pharmaceuticals in In-License from Napo Pharmaceuticals

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

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 ...

Covington Advises AstraZeneca on Agreement With Cubist Pharmaceuticals

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

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

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 ...

Covington Advises Encysive on Pfizer Deal

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. ...

Covington Advises Pfizer in Completion of Coley Pharmaceutical Tender Offer

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 ...

Chambers Global Recommends Covington in a Dozen Categories

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 ...

Covington Advises Global Healthcare Provider BUPA in $775M Acquisition

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

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

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 ...

Chambers and Legal 500 UK Recommend Covington in 20 Categories

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

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

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 ...

Covington Receives 115 Individual Mentions in 2008 Edition of Best Lawyers

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 ...

AIM High: Covington Advises US Biotech Northwest Biotherapeutics on its AIM IPO

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

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, ...

Covington Receives 44 Practice, 74 Individual Mentions in 2007 Chambers USA Guide

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

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

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 ...

Covington Represents Pfizer in Collaboration with Bristol-Myers Squibb

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 ...

Covington Ranked World’s Top Life Sciences Firm

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, ...

Covington Advises Abbott Laboratories in $3.7 Billion Acquisition of Kos Pharmaceuticals, Inc.

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, ...

Covington Represents Eisai In $205 Million Acquisition of Four Oncology-Related Products

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 ...

Covington advises Novartis Vaccines on New Flu Cell Culture Facility Intended to Produce Vaccine for Influenza Including Avian or "Bird" Flu

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 ...

Covington Advises Procter & Gamble in Alliance with ARYx Therapeutics

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

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 ...

Leading Intellectual Property Litigator, Simon J. Frankel, Joins Covington as Partner

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 ...

Covington Represented AstraZeneca in Collaboration Agreement with Targacept

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

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 ...

Covington & Burling Advises Medarex on Biotechnology Acquisition

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 ...

Peter Hutt & Peter Safir Recognized in Legal Times Profile of Top Food & Drug Lawyers

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 ...

Covington Advises Emory University in $540 Million Pharmaceutical Royalty Sale

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

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 ...

Leading Patent Litigators, George Pappas, Jeffrey Elikan, and Kevin Collins, Join Covington

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

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

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

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 ...

Covington Ranked by Industry as Best U.S. Life Sciences Firm

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 ...

Covington Advises Medarex in Collaboration with Bristol-Myers Squibb

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

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. ...

Covington & Burling Announces Eight New Partners

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 - 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 - 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. ...

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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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Life Sciences

Representative Matters

Legislative Victory in a 2016 FDA Nutrition Facts Panel Rule

Pharmaceutical Manufacturing Project Development

GammaDelta Therapeutics on Strategic Collaboration with Takeda

Pharmaceutical manufacturer

Pharmaceutical marketing programs

Pharmaceutical public policy and government affairs

Pharmaceutical Regulations as Hazardous Waste

Pohlad Family’s Acquisition of PaR Systems

Policy advice in South Africa

Canadian IP trade dispute

Children's Medicine Recall Class Actions

Case Challenging a Negative Reimbursement Decision before the Irish High Court

ChemGen Corp. Merger with Eli Lilly

Bayh-Dole Advice Across Sectors

Bristol-Myers Squibb €1.15 billion Eurobond Offering

Bellicum Pharmaceuticals IPO and Follow-On Offering

Binding Corporate Rules for global pharmaceutical company

Bradley Pharmaceuticals in Trademark Litigation

Dana Farber Cancer Institute Royalty Monetization

Covington Avoids IPR Trial for AstraZeneca SYMBICORT® Patent

Cymbalta trials

Colbeck Capital in Secured Debt Financing

Comprehensive privacy policies

Clinical Stage Cellular Therapeutics Company in Series B Funding

Clinical trial defense

“Co-Generators” Listing for RCRA Purposes

Congressional action on organic product marking

Coordinated monitoring and advocacy at the multinational, international and national levels

Position Paper Concerning Potential Amendments

Post-acquisition Compliance Review for Pharmaceutical Company

Obtained Dismissal with Prejudice of Two Cases Against Pharmaceutical Companies

Off-label promotion and reporting investigations

OrbiMed Advisors Debt Financings

Orange Book Listed Patents in Reexamination Proceedings

Lombard Medical IPO and Re-Domiciliation

Medical device company legislative support

Magellan’s Acquisition of AFSC

McCarrell v. Hoffmann-LaRoche Inc. and Roche Laboratories Inc.

Northwestern University Royalty Monetization

Numerous Clients in Managing U.S. and Global Trademark Portfolios

Nidek ITC Section 337 Investigation

Leading role in OxyContin suits

LifeArc Royalty Monetization

Kit Check Pharmacy Automation System Distribution

Life Sciences Investors in Series C Funding of Development Stage Biotech Company

Kite Pharma IPO and Follow-On Offering

Large commercial award for Merck

Medical student placement litigation

Medicare Part D coverage for pharma product

Merck class action claims

MedImmune in Series A Funding of Clinical-Stage Pharmaceutical Company

Meretek Diagnostics ITC Section 337 Investigation

Mitigating the impact of the Ebola crisis on operations in Africa

More than $1 billion in recoveries for Dow Corning

Merck on €2.1 Billion Acquisition of Animal Health Company

Merck ITC and District Court Litigation

Merck Merger with Schering-Plough

Navigation of Organizational Conflicts of Interest

Negotiated cooperative research and development agreements (CRADAs)

Negotiation and vetting of state contracts for healthcare exchanges and MMIS

NICE Challenge for Irish Biopharmaceutical Company

King Pharmaceuticals Acquisition by Pfizer

Janssen Pharmaceuticals Hatch-Waxman Litigation

Johnson & Johnson $2 billion Investment Grade Debt Offering

Kennedy Trust Royalty Monetization

Multiple successes for independent contractors

Navigation of issues specific to CMS Recovery Audit Contracting

Navigation of multiple issues related to healthcare.gov

MStar Semiconductor ITC Section 337 Investigation

Multimillion Dollar Jury Verdict in Trade Secret Dispute for Former CEO of a Medical Device Company

Iran Sanctions Investigation for Pharmaceutical Company

FCPA investigation for Fortune 500 life sciences company

FDCA, FTC Act, and Lanham Act Compliance for life sciences companies

Foreign Pharmaceutical Company Internal Compliance Review

Food and Cosmetics Labeling Class Actions

Genentech cancer medication product liability claims

Data breach notification requirements