Ariad Pharm., Inc. v. Eli Lilly & Co.: 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.”
The Federal Circuit 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].” In so holding, the court noted that “[i]f Congress had intended enablement to be the sole description requirement of § 112, first paragraph, the statute would have been written differently.” The court gave weight to the fact that Congress had reenacted the first paragraph of § 112 without “significant amendment” despite courts having previously interpreted its language to mandate both an enablement and a written description requirement.
The court further cited Supreme Court precedent demanding separate requirements dating back to 1822, and noted that stare decisis compels upholding this standard because “[changing] course now would disrupt the settled expectations of the inventing community, which has relied on it in drafting and prosecuting patents, concluding licensing agreements, and rendering validity and infringement opinions.”
Judge Rader, who was joined by Judge Linn, dissented-in-part and concurred-in-part. The dissent would have held that there is no separate written description requirement in the first paragraph of § 112 because it “has no statutory support,” calling the court’s reading “strained.” The dissent further argues that the court has “simply sidestep[ped] the conflict between its position and the language of the statute by suggesting that Supreme Court precedent has settled this issue.” The dissent also argues that the court’s decision is “in tension with other areas of long-established law: claim construction and blocking patents.”
This case is significant because it resolves a fundamental question about the basic requirements for a valid patent and reaffirms a doctrine that, according to the court, is designed to ensure that “[p]atents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others.” The court stated that this policy “is part of the quid pro quo of the patent grant and ensures that the public receives a meaningful disclosure in exchange for being excluded from practicing an invention for a period of time.” By separating written description from enablement, the court has yet another tool to ensure that the public gets the full benefit of its bargain.