Event Title
Developments in Hatch-Waxman Litigation
Panel
Panel 11: Recent Developments in Patent Law
Moderator
Dan Wadhwani, Professor of Management and Fletcher Jones Chair in Entrepreneurship, University of the Pacific, Eberhardt School of Business
Description
Despite wide-spread fear amongst Hatch-Waxman litigators that the “patent cliff” would dramatically curtail litigation, we have seen no sign of that yet. As in other areas of patent law, and specifically with regard to drug patents, the law of obviousness continues to be a focal point of Hatch- Waxman litigation. Recent decisions from the Federal Circuit have reaffirmed the application and strength of Section 103, which have provided brand-side pharma clients with some much needed assurance that their patent portfolios have vitality against generic challengers. For the most part, the implications of these developments is that generics will have to delay and/or wait on the sidelines to launch competing generic products.
Location
Pacific McGeorge School of Law, Lecture Hall, 3200 Fifth Ave., Sacramento, CA
Developments in Hatch-Waxman Litigation
Pacific McGeorge School of Law, Lecture Hall, 3200 Fifth Ave., Sacramento, CA
Despite wide-spread fear amongst Hatch-Waxman litigators that the “patent cliff” would dramatically curtail litigation, we have seen no sign of that yet. As in other areas of patent law, and specifically with regard to drug patents, the law of obviousness continues to be a focal point of Hatch- Waxman litigation. Recent decisions from the Federal Circuit have reaffirmed the application and strength of Section 103, which have provided brand-side pharma clients with some much needed assurance that their patent portfolios have vitality against generic challengers. For the most part, the implications of these developments is that generics will have to delay and/or wait on the sidelines to launch competing generic products.
Speaker Bio
Michael Sitzman is a partner in the firm’s Intellectual Property and Life Science Practice Groups. Mr. Sitzman has extensive litigation experience in the pharmaceutical and biotechnology fields; he has handled many high-profile cases for Allergan, Alza, Depomed, Genentech, Gilead, Janssen Pharm., Medicis, Merck Serono, Novo Nordisk and Ultragenyx. Mr. Sitzman represents brand-name pharmaceutical companies in biologic and drug patent litigation, including ANDA litigation. Mr. Sitzman was one of the chief architects of the strategy for Novo Nordisk that culminated in the Supreme Court’s first substantive review of the Hatch-Waxman Act. Mr. Sitzman also represents a broad array of biotechnology companies in high stakes patent litigation involving recombinant DNA, CAR-T technology, antisense technology, protein synthesis and regulation and immunological markers.
Mr. Sitzman received a Bachelor of Science degree from the University of California at Davis in the field of molecular genetics. Before becoming an attorney, he worked at the U.C. Davis Plant Growth Laboratory and Biogenex Labs, combining the fields of immunology, histology and general chemistry. Mr. Sitzman earned his Juris Doctor, with distinction, from the University of the Pacific in 1991, where he was elected Order of the Coif.
Mr. Sitzman is a member of the State Bar of California and is registered to practice before the United States Patent and Trademark Office. He is admitted to all Federal and State courts in California, the United States Court of Appeals for the Federal Circuit and the United States Supreme Court. Mr. Sitzman regularly appears pro hac vice in the District Courts of New Jersey, Delaware, Maryland and the Southern District of New York. Mr. Sitzman is a Global Fellow of the Federal Circuit Bar Association and speaks regularly at PLI and ACI conferences on issues of biotechnology and pharmaceutical patent law.