Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co.
The Federal Circuit on August 21 granted rehearing en banc in Ariad v. Eli Lilly, in which the panel held claims relating the transcription factor NF-kB invalid for lack of written description, under §112, first paragraph.
Sughrue Mion, PLLC filed a brief in support of rehearing en banc on behalf of Novozymes A/S.
The patent included claims to various methods “for modifying effects of external influences on a eukaryotic cell” which induce NF-kB-mediated intracellular signaling, by reducing binding of NF-kB to NF-kB recognition sites on genes which are transcriptionally regulated by NF-kB. The panel considered that Ariad claimed “methods comprising the single step of reducing NF-kB activity” and concluded that the claims were not adequately supported by three “hypothezise[d]” classes of molecules potentially capable of reducing NF-kB activity.
Applying University of Rochester v. Searle, the panel stated that regardless of whether the claims recited a compound, Ariad was still required to provide an adequate description of the molecules that are necessary to perform the claimed methods. Of the three general classes of molecules discussed in the patent, only one was described by a specific example—“decoy” molecules were described by specific sequences of DNA nucleotides, and the court acknowledged that there was “little doublt that the specification adequately described the actual molecules to one of ordinary skill in the art.” In the absence of working or even prophetic examples of methods that reduce NF-kB activity, or the completed synthesis of any of the molecules “prophesized” to be capable of reducing NF-kB activity, the panel concluded that “the vast scope of these generic claims” was not adequately supported. The panel thus applied a “free-standing” written description requirement, independent of the statutory enablement requirement, in finding the claims invalid.
The issue of whether §112, first paragraph imposes a distinct “written description” requirement, in addition to enablement, has sharply divided the Federal Circuit since its 1997 decision in University of California v. Eli Lilly, and arguably dates back to In re Ruschig’s interpretation of §112, first paragraph by the C.C.P.A. in 1967.
In its order granting rehearing en banc, the court requested new briefs from the parties on two broad issues:
a. Whether §112, first paragraph contains a written description requirement separate from an enablement requirement, and
b. If a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement?
Resolution of these questions, and clarification of the scope of any separate written description requirement, will provide much-needed guidance to biotechnology patent applicants. The question of whether working and prophetic examples are sufficient (or required) to support generic claims relating to recombinant technology has been unclear since Eli Lilly.