35 U.S.C. § 112, ¶ 1 states:
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.
There has been disagreement for some time as to whether the “written description” requirement is simply a part of the enablement requirement, or whether there is a separate statutory “written description” requirement. Several Federal Circuit panels have suggested that the written description requirement is separate from the enablement requirement: the inventor must show that he was “in possession” of the invention at the time of application. See Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956 (Fed.Cir.2002)(Lourie, J.); and Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed.Cir.2004)(Lourie, J.)).
The entire Federal Circuit will now review the “written description” requirement in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. Specifically, the court granted a petition for rehearing en banc based on two questions:
a. Whether 35 U.S.C. § 112, paragraph 1, contains a written description requirement separate from an enablement requirement?
b. If a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement?
The original panel in Ariad had found the patent at issue invalid for failure to comply with the written description requirement, citing Enzo and Rochester, but there has always been considerable disagreement as to whether these cases are good law.
Cases interpreting the statute as having a separate written description requirement were both written by Judge Lourie. Several other Federal Circuit cases have followed these as binding precedent, but did not always seem to agree with the reasoning. Judge Linn wrote a separate concurrence in the Ariad panel opinion where he argued as much. The panel was bound by Enzo and Rochester, but he did not read the statute as requiring a separate written description beyond the enablement requirement. He had also dissented from the denial to rehear Rochester. There may be a real fight among the judges on the court on this issue.
The Federal Circuit seems to be taking a lot more issues en banc than it has historically. Earlier this week, in the court’s most recent en banc opinion, the court noted its appreciation of the amicus briefs filed in that case. Perhaps the court is giving them more weight in these decisions. There is sure to be a flurry in the Ariad case.