Press Release
New York, October 21, 2009 - Kenyon & Kenyon partner Charles A. Weiss has submitted an amicus (friend of the court) brief on behalf of the New York Intellectual Property Law Association (NYIPLA) in a closely-watched case regarding the written description requirement for patents that is before the full United States Court of Appeals for the Federal Circuit. Weiss is co-chair of the amicus committee of the NYIPLA.
The case, on appeal from the U.S. District Court for the District of Massachusetts, involves plaintiffs Ariad Pharmaceuticals, Inc., Massachusetts Institute of Technology, The Whitehead Institute for Biomedical Research, and the President and Fellows of Harvard College vs. Eli Lilly & Company.
The Federal Circuit in August 2009 granted a petition to rehear the appeal in a case filed by Ariad that alleged Eli Lilly's Evista and Xigris drugs infringed on the plaintiffs' work on NF-kB, a protein complex that controls the transcription of DNA and ameliorates the effects of certain diseases.
Earlier this year, the Federal Circuit reversed a judgment in favor of Ariad (and its licensors MIT, the Whitehead Institute, and Harvard) and held Ariad's patent invalid for lack of written description. The decision was originally seen as applying existing precedent concerning written description in biotechnology and pharmaceuticals, relying on the well-known 2004 Federal Circuit case, University of Rochester vs. G.D. Searle. But a concurring opinion questioned the existence of a written description requirement separate from enablement in determining patentability, showing that the court’s existing precedent in this area was not without controversy among its members.
Ariad sought a review of this decision by the full court, which granted the request. In an Order dated August 21, 2009, the Federal Circuit vacated the previous decision and directed the parties to submit new briefs addressing the following questions:
a. Whether 35 U.S.C. § 112, paragraph 1, contains a written description requirement separate from the enablement requirement?
b. If a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement?
Ariad’s patent—which issued in June 2002 as U.S. Patent 6,410,516—was based on the discovery of transcription factor NF-kB and the realization that reduction of NF-kB activity could ameliorate the effects of certain diseases, such as those that are associated with production of cytokines. After a 14-day trial, the jury found two claims of the patent infringed by Evista and two claims infringed by Xigris.
IPLaw360 recently interviewed Mr. Weiss on the brief. Click here to read the full article.