Covington’s Patent Litigation Practice draws on the firm’s traditional strengths as one of the world’s leading law firms, including its Litigation, Antitrust, Food and Drug, Communications, and Life Sciences Practices. From compliance with FDA regulations and the vagaries of Orange book listings to the complexities of patent litigation and avoiding antitrust liabilities, the breadth of our legal practice enables us to deliver exceptional service to companies in the pharmaceutical industry. This practice starts with seasoned, experienced trial lawyers who know how to prepare a case for trial and who have tried patent infringement and other important commercial cases to verdicts before judges and juries. Our ranks are filled with many former clerks of the United States Court of Appeals for the Federal Circuit. This breadth of experience allows us to solve our clients’ hardest litigation problems by winning at trial and by winning before trial through dispositive motions and alternative dispute resolution.
Our lawyers have a wealth of experience in handling all aspects of Hatch-Waxman matters. We regularly provide counseling and pre-litigation strategy advice to clients, beginning even before a certification is received from an ANDA filer. We have litigated a number of significant ANDA cases in district court, and at the Federal Circuit. Our lawyers have handled ANDA cases for products including antibiotics, oral contraceptives, ivermectin, and PAXIL. As an example, George Pappas was lead trial lawyer for Ortho-McNeil, which prevailed in the district court in an ANDA case relating to LEVAQUIN, an antibiotic. George handled the appeal, and the Federal Circuit affirmed. We are also involved in litigation that shapes the contours of Hatch-Waxman cases. We represented Merck and Schering Plough to secure a ruling by the Federal Circuit that the life of existing pharmaceutical patents could be extended by combining the benefits of both the patent term extension provisions of the Hatch Waxman Act and the twenty-year patent life established through the Uruguay Round of GATT.
We have an extensive human drug regulatory practice. We regularly advise the Pharmaceutical Research and Manufacturers of America (PhRMA), the National Pharmaceutical Council, and many of the largest research-intensive pharmaceutical companies. Our work for pharmaceutical clients spans the full range of regulatory matters, such as product approvals, labeling and advertising, recordkeeping and reporting, factory inspection, and enforcement. Our product approval work includes advice with respect to new drug applications and supplements, Rx-OTC switch applications, and the effect of market exclusivity and patent protections on the timing of market entry by follow-on companies. We also advise clients in connection with product liability issues related to clinical trials and marketing of drug products.
We have extensive experience in counseling, government investigations, and litigation concerning the application of antitrust and international competition laws to the acquisition, licensing, enforcement and sale of intellectual property rights. The firm represents clients before the Federal Trade Commission (FTC) and the U.S. Department of Justice (DOJ) and has handled many complex civil and criminal antitrust matters, including major treble-damage actions, nationwide class actions, consolidated multidistrict litigation, internal investigations, short fuse preliminary injunction proceedings, and appeals up through the US Supreme Court. We have extensive experience handling state law antitrust, consumer protection and unfair competition claims, and matters involving regulated industries. Our experience encompasses jury and bench trials in state and federal courts and before administrative agencies. Chambers USA noted that Covington’s antitrust team won "marks across the board" for its "sophistication" in general advisory, regulatory, and litigation matters. Included among the firm’s antitrust and consumer law attorneys are several alumni of the DOJ, the FTC, and the Office of the Solicitor General, including a former general counsel of the FTC.
We have been actively involved in all of the major legislative initiatives that have affected pharmaceutical regulation, including the 1997 enactment of the Food and Drug Administration Modernization Act, as well as the Orphan Drug Act, the Drug Price Competition and Patent Term Restoration Act, the FDA Export Reform and Enhancement Act of 1996, the Drug Export Amendments of 1986, and the Prescription Drug User Fee Act. Our work on these and other statutes has included drafting and representation as bills moved through Congress and advice on compliance after they became law. We are currently working with PhRMA on implementation issues associated with the 1997 FDA Modernization Act.
Representative Matters
- Representation of GlaxoSmithKline in the District of Maryland in patent litigation brought by Classen Immunotherapies involving immunization methods and schedules. In late July 2005, the US District Court issued a ruling granting GSK's motion to dismiss three of the four counts of Dr. Classen's complaint against GSK and Biogen based on the safe harbor of 35 U.S.C. § 271(e)(1). The fourth count was subsequently dismissed by the plaintiff, with prejudice. Proceedings continue in the district court. An appeal to the Federal Circuit is expected.
- Representation of Ortho-McNeil in the Northern District of West Virginia and the Court of Appeals for the Federal Circuit in an ANDA case brought by Mylan Laboratories relating to a patent covering LEVAQUIN, an antibiotic. Ortho-McNeil prevailed in the US District Court. The Federal Circuit affirmed the US District Court decision in a per curium decision. Mylan has filed a petition for rehearing en banc. (Ortho-McNeil Pharmaceuticals, Inc. v. Mylan Laboratories, Inc., 348 F. Supp. 2d 713 (N.D. W. Va. 2004)).
- Represented Johnson & Johnson subsidiary Ethicon in a patent infringement action brought by Arthrocare in the Northern District of California relating to electrosurgical devices used for arthroscopic and gynecological applications.
- Represented Pfizer in a successful defense of FDA's decision granting Pfizer a period of pediatric exclusivity under the food and drug statutes following expiration of Pfizer's patent for fluconazole (Diflucan). (Ranbaxy Laboratories Ltd. v. FDA, 307 F.Supp.2d 15 (D.D.C. 2004), aff'd 96 Fed. App. 1 (D.C. Circ. 2004).).
- Represented of Merck and Schering-Plough in securing a ruling by the Federal Circuit that the companies were entitled to extend the life of existing pharmaceutical patents by combining the benefits of both the patent life extension provisions of the Hatch Waxman Act and the 20 year patent life established through the Uruguay Round of GATT.
Accolades
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