Federal Circuit En Banc Decision Confirms Written Description is Separate from Enablement

In Ariad Pharmaceuticals, Inc., et a. v. Eli Lilly and Co., 598 F3d 1336, 94 USPQ2d 1161 (Fed. Cir. 2010) (en banc), the Federal Circuit reversed the district court’s denial of a JMOL and held that the asserted claims of U.S. Patent No. 6,410,516 are invalid as failing to meet the statutory written description requirement.   As background, the plaintiffs (herein, collectively referred to as “Ariad”) are the owners of U.S. Patent 6,410,516 (“the ’516 patent”). The patented technology relates to a method of reducing the activity of NF-κB, a transcription factor, in eukaryotic cells. Briefly, NF-κB is a substance that normally exists in cells as an inactive complex with a protein inhibitor, IκB. When a cell encounters extracellular stimuli, such as lipopolysaccharides from a bacterial invader, NF-κB is released from its inhibitor and travels to the cell nucleus, where it binds to NF-κB recognition sites to crank up the production of cytokines that stimulate the immune system to fight the invaders. However, the production of too many cytokines is also harmful to an organism.  The inventors of the ’516 patent were the first to identify NF-κB and discovered its mechanism of activating gene expression. The inventors also came up with the idea that it would be useful under certain circumstances to reduce NF-κB activity in cells. Continue reading