Federal Circuit Confirms That Written Description and Enablement Are Separate Requirements under Section 112

On March 22, the Court of Appeals for the Federal Circuit, sitting en banc, confirmed that the "written description" requirement is separate from the "enablement" requirement under 35 U.S.C. § 112. Relying on principles of statutory construction, the Court held that § 112, first paragraph, contains two separate description requirements: a "written description [i] of the invention, and [ii] of the manner and process of making and using [the invention]." Ariad Pharms., Inc. v. Eli Lilly & Co., No. 08-1248, Slip op. at 10 (Fed. Cir. 2010) (en banc).

The patent at issue related to the regulation of gene expression by the transcription factor NF-κB. The inventors discovered that NF-κB normally exists in cells as an inactive complex with a protein inhibitor, and is activated by extracellular stimuli such as bacterial-produced lipopolysaccharides, which, through a series of biochemical reactions, free NF-κB, enabling it to enter the cell nucleus and help the body