On March 22, in Ariad Pharmaceuticals v. Eli Lilly & Co., No. 2008-1248, an en banc panel of the U.S. Court of Appeals for the Federal Circuit reaffirmed that § 112, ¶ 1 contains a written description requirement that is separate and distinct from the enablement requirement. The court ruled that the asserted claims of U.S. Patent No. 6,410,516 (the ‘516 patent) are invalid for failure to meet the statutory written description requirement.
The case originally came to the Federal Circuit following a fourteen-day jury trial on the issues of infringement and validity where the jury found the asserted ‘516 patent claims valid and infringed. A panel of the Federal Circuit reversed, holding that the asserted claims were invalid for lack of adequate written description as required by § 112, ¶ 1. The Federal Circuit granted Ariad’s petition, vacated the prior panel opinion and directed the parties to address two questions:
- Whether 35 U.S.C. § 112, ¶ 1, contains a written description requirement?
- If a separate written description requirement is set forth in the statute, what is the scope and purpose of that requirement?
As to the first question, the court held that § 112, ¶ 1 “contains two separate description requirements: a ‘written description [i] of the invention, and [ii] of the manner and process of making and using [the invention].’” In addition, and contrary to Ariad’s assertion, the court, based on statutory interpretation, Supreme Court precedent and stare decisis, held that the written description requirement is separate and distinct from the enablement requirement.
As to the second question, the court confirmed that the written description requirement applies to all claims, including claims in the original specification, and requires that the specification objectively demonstrate that the applicant actually invented –was in possession of- the claimed subject matter. Specifically, the description must “clearly allow persons of ordinary skill in the art to recognize that the [the inventor] invented what is claimed. In other words, the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys those skilled in the art that the inventor has possession of the claimed subject matter as of the filing date.”
The court, however, acknowledged that the term “possession” has never been very enlightening. Rather, “the hallmark of written description is disclosure” and “the test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art.” The court noted that the inquiry is a “question of fact” and that “determining whether a patent complies with the written description requirement will necessarily vary depending on the context.”
Generally, however, the court noted “a few broad principles that hold true across all cases.” Specifically, “the written description requirement does not demand either examples or an actual reduction to practice; a constructive reduction to practice that in a definite way identifies the claimed invention can satisfy the written description requirement. Conversely, … actual ‘possession’ or reduction to practice outside of the specification is not enough. Rather … it is the specification itself that must demonstrate possession … [and] a description that merely renders the invention obvious does not satisfy the requirement.”
Although the Federal Circuit’s opinion largely reaffirms previous decisions, the practical effect of the court’s decision remains to be seen and may require interpretation in subsequent decisions.