by Jake Meyer
A panel of Federal Circuit judges previously heard the case of Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 2007 WL 2712087 (Fed. Cir. 2009) and held that Ariad failed to provide adequate written description for its claims to methods of the regulation of the expression of certain genes. The Federal Circuit has granted a request to hear the case Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., en banc and in doing so will interpret a section of the Patent Act. The questions before the Federal Circuit en banc are now:
1. Whether 35 U.S.C. § 112, paragraph 1, contains a written description requirement separate from enablement?
2. If a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement?
35 U.S.C. § 112 provides:
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.
Enablement and written description have been treated as two separate requirements under 35 U.S.C. § 112. Enablement requires that a patent describe in clear terms how to make and use the invention in such a way that would allow a person skilled in the same field as the invention to make or use the invention. In Ariad, the Federal Circuit explained that the written description requirement served two purposes: 1) to satisfy the inventor’s obligation to disclose the knowledge that the patent was based on and 2) to demonstrate that the inventor was in possession of the invention that is claimed.
The requirements of enablement and written description, however, are not always addressed separately. Frequently a patent that describes how to make and use an invention clearly also satisfies the requirement of disclosing the knowledge the patent was based on and demonstrates that the inventor was in possession of the invention claimed. Further, it can be argued that the language of Section 112 only requires a "written description … to enable" i.e. enablement. From this standpoint, the merging of enablement and written description into one requirement wouldn't have much of an effect on patent law. However, written description has been treated as a separate requirement from enablement and has been used to serve another important role – to limit the scope of the invention claimed.
The Federal Circuit explained in Ariad that the purpose of the written description requirement is to ensure that the inventor doesn’t claim more than the inventor contributed to his or her field. "The purpose of [the written description requirement] is to ensure that the scope of the right to exclude . . . does not overreach the scope of the inventor's contribution to the field of the art as described in the patent specification." (addition in original). The Federal Circuit found that Ariad's claims were "broad far beyond the scope of the disclosure provided" in the patent, and were therefore invalid. It will be interesting to see if the Federal Circuit maintains the written description requirement as a separate requirement under section 112 and will continue to use it as a check on broadly written claims.