Today in Ariad Pharmaceuticals v. Eli Lilly and Co., the Federal Circuit, sitting en banc, reaffirmed that § 112, first paragraph, contains a written description requirement separate from the enablement requirement, and that a patent application meets this requirement only if the application, as filed, contains disclosure showing that the inventor had "possession" of what is defined by each claim.1 Judge Lourie, writing for the majority, stated that “a separate requirement to describe one’s invention is basic to patent law.”
In 2009, the Federal Circuit reversed a trial court and held invalid a patent claim to a method of reducing the level of expression in a cell of a gene whose expression is regulated by transcription factor NF-κB. Even though the claim recited only one step - reducing the level of expression of the gene by reducing activity of the transcription factor such that the desired reduction in gene expression is obtained - the basis for the ruling was not lack of enablement, or that the claim was invalid in the same way that a single-means claim would be. Rather, the court held that the patent failed to meet the written description requirement for the claim. The patentees petitioned for rehearing, and oral argument before the en banc court was held in December.
The Federal Circuit held that both the plain language of the statute and Supreme Court precedent recognize written description and enablement as separate requirements. The court also held that even originally-filed claims, although part of the original disclosure, may nonetheless violate the written description requirement, and do not necessarily provide their own written description. Whether the claim at issue is originally-filed or later-added, the specification must establish that the inventor was in possession of what is claimed, and a claim that is too broad for its disclosure will not pass muster.
The court clarified the commonly-cited “possession” standard, emphasizing that the key is that the disclosure shows possession of the invention. It is a question of fact whether the specification describes the invention in such a way that a person having ordinary skill in the art would recognize that the inventor actually invented what is claimed, with the requisite level of detail varying depending upon the complexity and predictability of the relevant technology. The court rejected the suggestion that written description operates as a sort of “super enablement” standard for chemical and biotechnology inventions. It stated that the “doctrine never created a heightened requirement to provide a nucleotideby- nucleotide recitation of the entire genus of claimed genetic material; it has always expressly permitted the disclosure of structural features common to the members of the genus.”
The court acknowledged the concern that universities are potentially disadvantaged in that “basic research” cannot be patented, but it affirmed that patents are for the useful arts, not for “academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others.”
Judges Rader and Linn dissented, arguing that the separate written description requirement is a creation of “judicial imagination” lacking proper justification.
Ariad, of course, may still seek review by the Supreme Court if it wishes.