The Federal Circuit reaffirms separate written description and enablement requirements under the patent statute
In Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2010), the Federal Circuit in a 9-2 en banc decision reaffirmed its position that 35 USC § 112, ¶ 1 includes a separate written description requirement distinct from the enablement requirement. http://www.cafc.uscourts.gov/opinions/08-1248.pdf.
While it had been anticipated by some that the Federal Circuit would shift its approach when it agreed to consider en banc whether a separate written description requirement exists under 35 USC § 112, ¶ 1, the majority decision formally changes little—the Federal Circuit has applied a very similar interpretation at least since 1997’s Regents of the University of California v. Eli Lilly & Co. decision (119 F.3d 1559). Although there is little change in the law, from a psychological position, this strengthens the written description requirement. For example, from a patent prosecution standpoint, the en banc nature of this decision will likely strengthen the resolve of an examiner with regard to whether a specification does or does not satisfy the written description requirement.
The question of written description arises frequently in the context of claims to a genus—while the disclosure may well teach one of skill in the art how to make and use the invention with respect to species within the genus, the separate written description requirement requires that valid claims broadly encompassing the genus must be supported by description showing that the applicant had “possession” of the full scope of the genus as claimed.
In upholding the written description requirement, the majority acknowledged that “the term ‘possession’ has never been very enlightening.” The decision elaborated: “But the hallmark of written description is disclosure. Thus, ‘possession as shown in the disclosure’ is a more complete formulation.”
This emphasizes that in order to satisfy the written description requirement for claims to a genus, it is what is in the patent specification that is paramount. The specification must include details showing a sufficient variety of species within the scope of the genus, the number of species depending upon the facts of the case. Thus, relying upon one or two species for support of the written description of a genus will be more risky. The majority decision notes that the problem of written description “is especially acute with genus claims that use functional language to define the boundaries of a claimed genus,” indicating that to satisfy the requirement, again, the specification must show that “the applicant has invented species sufficient to support a claim to the functionally defined genus.” In short, function must be correlated with structure to support a genus defined functionally.
The court acknowledged that the written description problem is “particularly acute in the biological arts,” but expressly rejected the appellant’s contention that the written description doctrine constitutes a “super enablement” standard for chemical and biotechnology inventions, noting that the court “has always expressly permitted the disclosure of structural features common to members of the genus.” The court stated that Ariad’s claims “cover any compound later actually invented and determined to fall within the claim’s functional boundaries—leaving it to the pharmaceutical industry to complete an unfinished invention” (emphasis added). That is, one must describe the structure of a range of species falling under the claims in order to be entitled to genus claims.
Finally, the court addressed Ariad’s complaint that the written description doctrine disadvantages universities to the extent that basic research cannot be patented. The majority decision emphasized that “patent law has always been directed to the ‘useful Arts,’” and that the intention of the law is to reward “those who actually perform the difficult work of ‘invention’—that is, conceive of the complete and final invention with all its claimed limitations—and disclose the fruits of that effort to the public.”
What this means to all applicants, and particularly to those engaged in more basic research, is that patent applications, including provisional patent applications to the extent one hopes to rely upon them for priority, must include as much detail as possible with regard to the structure of those species falling within a genus one wishes to claim. For example, where one recites a claim encompassing an inhibitor of a given function, the specification must set out the common structural attributes of species falling within the genus: What do members of the genus look like? What structural aspect is it that permits a member of the genus to inhibit the recited function? A specification that sets out the answers to these questions, preferably in successive layers of detail, will be more likely to be viewed as satisfying the written description requirement upheld by the majority in this decision than one that does not.