IP News

On Aug. 21, 2009, the Federal Circuit vacated its prior decision in Ariad Pharms., Inc. v. Eli Lilly & Co., 2008-1248, reinstated defendant-appellant Eli-Lilly's appeal and granted rehearing en banc on the issue of whether 35 U.S.C. ' 112 contains a written description requirement separate from an enablement requirement.

On April 3, 2009, a panel of the Federal Circuit reversed a ruling by the U.S. District Court for the District of Massachusetts denying Eli-Lilly's post-trial motion for judgment as a matter of law that U.S. Patent 6,410,516 (“the '516 patent”) was invalid for, inter alia, failure to meet the written description requirement of 35 U.S.C. ' 112. Ariad Pharms., Inc. v. Eli Lilly & Co., 560 F.3d 1366 (Fed. Cir. 2009). The asserted claims of the '516 patent relate to reducing activity of a transcription factor referred to as NF-KB. Transcription factors are molecules found in cells that regulate the extent to which genes are expressed. Eli-Lilly argued that the '516 patent specification was invalid under ' 112 for failing to describe how to achieve the claimed reduction of NF-KB activity. The Federal Circuit panel agreed, holding that the '516 patent specification hypothesized three classes of molecules potentially capable of reducing NF-KB activity, but that such disclosures failed to meet the ' 112 written description requirement because they were described only as a “wish, or arguably a plan” for “future research” without any descriptive link to the actual reduction of NF-KB activity.