Howard W. Levine

Partner

Howard Levine's practice concentrates on patent litigation before the federal district courts and the U.S. Court of Appeals for the Federal Circuit, primarily in the areas of biotechnology and pharmaceuticals. Mr. Levine has extensive experience in cases arising from the filing of Abbreviated New Drug Applications (ANDA).

Over the last 18 years, Mr. Levine has represented both pharmaceutical and biotechnology companies in technologies ranging from the inhibition of NF-κB to genetically engineered corn. Mr. Levine was involved in litigations between Eli Lilly, Genentech, and the Regents of the University of California regarding human insulin, the first biotechnology product to be marketed. Some of the products involved in the litigations Mr. Levine served as counsel include Humulin^®, Humatrope^®, Zantac^®, Paxil^®, Evista^®, Xigris^®, Cymbalta^®, Gemzar^®, and Differin^®.

Mr. Levine has conducted all aspects of pre-trial, trial, and post-trial proceedings, including appeals to the U.S. Court of Appeals for the Federal Circuit and the U.S. Supreme Court. Mr. Levine lectures on the subject matter of patent law, including such topics as the written description and the patentability of different crystalline forms of drug substances.

Highlights

• Served as head of the firm's biotechnology and pharmaceutical practice group, 2006-2010.
• Eli Lilly and Co. v. Wockhardt Ltd. (S.D. Ind.). Successfully defended Lilly's patent covering its Cymbalta^® drug product in litigation against nine generic defendants.
• Ariad Pharmaceuticals v. Eli Lilly (D. Mass., Fed. Cir.). Principal drafter of appellate briefs in panel and en banc rehearing involving the written description requirement under 35 U.S.C. §112.
• Eli Lilly and Company v. Teva Pharmaceuticals USA (Fed. Cir.). Principal drafter of appellate brief regarding extension of thirty month regulatory stage.
• Regents of the Univ. of California v. Eli Lilly & Co. (S.D. Ind., Fed. Cir.). Member of trial and appellate teams that successfully litigated case relating to recombinant DNA used to make human insulin.
• Monsanto Company v. Syngenta Seeds Inc. (D. Del., Fed. Cir.). Successfully obtained summary judgment, which was later affirmed by the Federal Circuit, on Syngenta's behalf in case relating to genetically engineered corn.
• Accuscan Inc. v. Xerox Corp. (Fed. Cir.). Member of appellate team that successfully obtained the reversal of a multi-million dollar verdict against Xerox.

Professional Activities

• American Intellectual Property Law Association
• New York Intellectual Property Law Association
• District of Columbia Bar (Intellectual Property Section)

Select Publications

• Discussed the Ariad v. Eli Lilly and Company case and the written description requirement in a Legally Brief Video for the Washington Legal Foundation, 2010.
• "United States Patent Law and Polymorphs," Lecture Notes, International School of Crystallography, 2004.
• "The Written-Description Requirement in UC v. Lilly: A Rat Is a Rat Is a Rat…," Nature Biotechnology, Jan. 1998.
• "Fences Make Good Neighbors If You Can Find the Fence: An Analysis of the Supreme Court's Decision in Hilton Davis," Nature Biotechnology, April 1997.
• Coauthor. "Impact of Hilton Davis on Biotech Is Unclear," The National Law Journal, June 16, 1997.