On March 22 the Federal Circuit issued its long anticipated en banc decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. More than 20 amicus briefs filed demonstrated the case's importance to the patent community (see "Brief on Briefs"). So, what was so important, what was decided, what does it mean, and where are we going?
The questions posed in the rehearing en banc order were potentially fundamental and far-reaching: (1) whether 35 U.S.C. Section112 contains a written description requirement separate from an "enablement requirement," and (2) if a separate written description requirement is set forth in the statute, what is the scope and purpose of that requirement .
The court answered "yes" to the first question. It therefore reaffirmed prior decisions that patents must satisfy two separate requirements: (a) a written description of the invention, and (b) a written description of the manner and process of making and using the invention (e.g. enablement).
In answering the second question, the court explained that the written description of the invention "must clearly allow persons of ordinary skill in the art to recognize that the inventor invented what is claimed." Stated differently, does the disclosure "reasonably convey to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date?"
Although the decision merely reaffirmed the Federal Circuit's recent positions, several points are still noteworthy. First and foremost, the decision, as intended in an en banc review, clarified that separate and distinct written description requirements exist. Second, many cases in the past suggested that the written description requirement was unique to the chemical or biotech fields. The Ariad decision expressly repudiates that position; it is not limited to any particular field. Third, while there had been some question in the past whether the written description requirement applied only to determining whether the patentee had in his or her possession as of the patent filing date what was claimed in later amendments, the Ariad decision clearly applied to determining whether the patentee had in his or her possession claims as originally filed.
In view of this decision, assuming it is not reviewed by the Supreme Court (and I doubt it will be), where are we going? In the prosecution area, counsel will need to carefully review when a case is filed--not too early in development to miss the chance to add examples and details showing possession of the invention, and not too late to open the door to additional prior art. In the litigation arena, I expect the use of the written description requirement to rise in addressing claim construction, as well as in attacking validity. Unquestionably, there will be a "reining in" of attempts to construe patent claims far beyond what the inventor ever had in mind.