The Federal Circuit recently agreed to rehear Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. en banc to resolve an intra-court split over whether 35 USC § 112 imposes a written-description requirement that is separate from the enablement requirement. The outcome of this case could have a significant impact on biotechnology patents, which often are vulnerable to written-description challenges.
The first paragraph of §112 is the basis for the written-description, enablement, and best-mode requirements: “The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.”
The panel decision in Ariad determined that claims that effectively claimed “the single step of reducing NF-kB activity” were invalid for failing to satisfy the written-description requirement. The Ariad patent grew out of the discovery of the transcription factor NF-kB, its role in different diseases, and the realization that inhibiting its activity could “ameliorate the harmful symptoms of diseases.”
The priority document, however, did not describe any specific molecules that could be used to reduce NF-kB activity. The court reasoned that §112 required the patent to “adequately describe the claimed methods...including adequate description of the molecules necessary to perform the methods.” Without that information, the patent did not satisfy the written-description requirement, and so was invalid.
Judge Linn wrote a concurring opinion that emphasized his belief that §112 does not, in fact, impose a written-description requirement separate from the enablement requirement. Judge Linn would have preferred that the panel decide the case on the enablement issue, to answer the “important” question whether a claim “written broadly enough to cover any method for achieving a particular result” ever could satisfy the enablement requirement.
Ariad filed a petition for rehearing en banc of the panel decision. While granting rehearing en banc is unusual, the court did so in this case to specifically address the following questions: Whether 35 USC § 112, paragraph 1, contains a written-description requirement separate from an enablement requirement? and If a separate written-description requirement is set forth in the statute, what is the scope and purpose of the requirement?
The Patent Office interprets §112 as imposing a separate written-description requirement. Indeed, the Manual of Patent Examining Practices (MPEP) § 2161 interprets §112 as imposing three separate requirements: “(A) A written description of the invention; (B) The manner and process of making and using the invention (the enablement requirement); and (C) The best mode contemplated by the inventor of carrying out his invention.”
According to the MPEP, policy considerations behind these requirements include ensuring “that the public receives something in return for the exclusionary rights that are granted to the inventor by a patent,” and that the application “disclose[s]...sufficient information to put the public in possession of the invention and to enable those skilled in the art to make and use the invention.”
Prior to 1997, the written-description requirement primarily was used to invalidate claims directed to subject matter added to an application (or to a continuation-in-part application) after the original filing date. The Federal Circuit applied the requirement more broadly in its 1997 decision in Regents of the University of California v. Eli Lilly & Co.