The Court of Appeals for the Federal Circuit Declares: Scientists Are Bad at Explaining Themselves
In a recent decision, the Court of Appeals for the Federal Circuit (CAFC) affirmed a decision from the District Court of Delaware, holding Johnson & Johnson’s patents invalid under 35 U.S.C. §112 for lack of written description and enablement. In general, to satisfy the requirements of §112, a patent’s specification must disclose sufficient information to demonstrate to a person having ordinary skill in the art (PHOSITA) that the applicant was in possession of the invention at the time of the application (written description), and to instruct the PHOSITA in how to practice the invention without undue experimentation (enablement).
The patent at issue claimed “drug-eluting stents containing either rapamycin or a macrocyclic trien analog of rapamycin. The claims were construed by the court as “genus-species” claims. The analysis of a genus-species claim was laid out in Ariad, where the court determined that: “a sufficient description of a genus requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” (Ariad) Here, the applicant had disclosed species from the genus of rapamycin analogs. However, the patent’s specification did not include disclosure of any representative species from the sub-genus of macrocyclic trien analogs. Therefore, the CAFC ruled that the §112 written description requirement was not met.
The most interesting part of this opinion is not the majority’s opinion, but the concurrence in part authored by Judge Gajarsa. Judge Gajarsa argues that the majority opinion inappropriately blurs the line between written description and enablement, and advocates for a two prong approach to §112 cases, whereby the court would dispose of all cases that lack enablement without reaching the more challenging issue of written description. However, Judge Gajarsa’s opinion fails to specifically address where he sees the majority’s opinion as crossing the line between written description and enablement. Instead he simply highlights the critical issues addressed in the case: “[m]uch of the confusion in this case is due to the difficulty of determining what constitutes a genus or subgenus, the relationship between the structure and the function of compounds, and how the written description requirement applies to novel compounds as opposed to novel combinations of known elements.”
While Judge Gajarsa’s characterization of the challenges presented by the case is accurate, the conclusions that he arrives at are not. It is certainly true that the field of biotechnology presents unique challenges to the application of §112’s written description requirement. However, it is precisely because of these challenges that the CAFC must address these issues directly. In Ariad, the CAFC held that “the hallmark of written description is disclosure.” While biotechnology may frequently challenge the courts to adequately describe what constitutes sufficient written description, Judge Gajarsa’s proposal to utilize enablement to dispose of such cases wherever possible would push these challenges down the road. By addressing these issues head on and attempting to provide clear guidance as to what constitutes written description, the court provides tools for patent examiners to use to ensure that such issues are addressed during the prosecution phase of a patent application. If the CAFC were to avoid issuing such decisions, patent examiners would not have clear guidance as to which claims could properly be rejected, and more patents with questionable disclosures would have to be challenged in the courts.