Today the Federal Circuit vacated the panel's decision in the case of Ariad Pharmaceuticals v Eli Lilly, and granted Ariad’s petition for rehearing en banc. The parties are requested to file new briefs addressing (1) whether 35 USC 112, paragraph 1, contains a written description requirements separate from enablement requirement; and (2) if a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement?
The order is available here.
The Ariad case was discussed in an earlier post, and has important implications for the biotechnology industry. Prior to Regents of the University of California v. Eli Lilly, decided by the Federal Circuit in 1997, the written description requirement was used solely to prevent patent applicants from amending or adding new claims encompassing subject matter not adequately disclosed in the patent application is filed. In UC v. Lilly, a panel of the Federal Circuit led by Judge Lourie established a new form of the written description requirement that applies to originally filed claims, and which functions very much like the enablement requirement. I have argued that this new form of the written description requirement, which I call Lilly written description (LWD), is essentially redundant with the enablement requirement, and should be abolished. Other academics, and some judges on the Federal Circuit, notably Judge Rader, have expressed a similar opinion.
This will be the first opportunity for the en banc court to address the viability and scope of LWD - it will be a case worth watching.