Federal Circuit Reaffirms Separate Written Description and Enablement Requirements for Patents
By Tyler Lacey – Edited by Jad Mills
Ariad Pharm., Inc. v. Eli Lilly & Co., Appeal 2008-1248 (Fed. Cir., Mar. 22, 2010)
The U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”), in a 9-2 en banc decision, affirmed a panel decision holding Ariad’s patent claims invalid for lack of written description. In so holding, the Federal Circuit reaffirmed that the first paragraph of 35 U.S.C. § 112 (“§ 112”) contains two separate requirements: written description and enablement.
The patent, which related to “the regulation of gene expression by the transcription factor NF-κB,” encompassed a genus of substances. In holding the patent invalid for lack of written description, the court agreed that the ”doctrine disadvantages universities to the extent that basic research cannot be patented,” because of the difficulty of providing a written description for a complete invention embodying basic research, but noted that this is the law’s “intention”.
Patently-O provides an overview of the case. Inventive Step argues that § 112 is “not a model of clarity” and that the court errs when it “seems to argue that the statute is not ambiguous and that its interpretation is clear from the language.” Chris Holman, a law professor at the University of Missouri-Kansas City who filed an amicus brief arguing against separate requirements, criticized the decision by noting that “any positive policy aspects of [written description] can be better accomplished using the enablement requirement, and that the courts have failed to articulate any coherent standard for compliance with [written description] beyond the requirements of enablement.” Holman believes that the court retained the separate written description requirement because “it has developed into a useful tool for invalidating clearly objectionable patent claims precisely because it lacks any coherent standard.” (more…)