Ken Burchfiel has been a partner at Sughrue Mion for over 20 years, counseling and representing clients in litigation in federal district courts, the USPTO, and in appeals in the Federal Circuit, regional circuits, and the Supreme Court. He has extensive experience conducting complex litigation and interference proceedings, and has represented individual corporations, industry consortia, and US government agencies. His current principal focus as a member of Sughrue's Pharma Litigation Group is Hatch-Waxman Act ANDA litigation involving such blockbuster drugs as Lipitor®, Cymbalta®, Lyrica®, and Zithromax®.
Ken has frequently testified as a patent law expert in federal court litigation on topics including patent infringement, the doctrine of equivalents, validity, double patenting, inventorship, interference procedure, prior invention, inequitable conduct, numerous aspects of patent office procedure, patent valuation, and legal malpractice, in cases involving biotechnology inventions (monoclonal antibodies, humanized antibodies, bovine growth hormone, human growth hormone, RNA interference), pharmaceuticals, and business methods and systems. He has also served as a consulting expert in mediation involving malpractice issues.
Since 1982 Ken has closely followed patent law developments in the Federal Circuit, and has analyzed over 3000 cases in preparing his treatise on Biotechnology and the Federal Circuit, now in its second edition (BNA 2010). This 1100-page volume presents a detailed review and critique of all significant Federal Circuit and Supreme Court precedent affecting biotechnology and pharmaceutical inventions, including developments under the Hatch-Waxman Act. His publications have been cited by the Federal Circuit and the Supreme Court.
Ken lectures on topics including US patent protection for biosimilars, litigation strategies for generic drug manufacturers in Hatch-Waxman litigation, biotechnology and interference law, and developments including proposed patent opposition provisions. He is a member of the faculty of the Japanese Intellectual Property Association, and has taught CLE courses on patent law developments including the 2009 Biologics Price Competition and Innovation Act, the 1994 Uruguay Round Agreements Act, patent term extension, and the Japanese patent system.
Ken opened the firm’s office in Tokyo in 1989, as the first US patent attorney admitted to practice in Japan, where he lived for five years.