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Abelman, Frayne, &Schwab

Possession is Everything in the En Banc Review of Ariad v. Eli Lilly
By Jeffrey A. Schwab, Partner, and Charles S. Stein, Associate, both of Abelman, Frayne, &Schwab

There has been a long-standing debate about the required content of a U.S. patent specification, namely, whether the requirement of an adequate written description was a separate requirement from that of an "enabling disclosure." Prior precedent suggested they were two separate requirements.

On March 22, 2010, in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., the Federal Circuit, sitting en banc, confirmed that the first paragraph of 35 U.S.C. § 112 indeed has two distinct requirements: a written description requirement and a separate enablement requirement. The first paragraph of the statute reads as follows:

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.

The written description’s purpose, according to the Federal Circuit, is to ensure that the claims are not overbroad when compared to the description presented in the specification. The description needs to establish that an "inventor had possession of the claimed subject matter as of the filing date."

The import of the holding will be felt most dramatically by those engaged in basic research, particularly in identifying potentially beneficial substances and which later workers establish have the hypothesized end benefit. These basic researchers may achieve fame in their discoveries but find it difficult to obtain broad patent protection for them.

Claims of Ariad's patent were directed to a method of using a protein called Nuclear Factor kappaB ("NF-kB"), which mediates certain intracellular signaling, to reduce the symptoms of certain diseases. The specification hypothesized three classes of molecules potentially capable of reducing NF-kB activity: specific inhibitors, dominantly interfering molecules and decoy molecules. This turned out to be prophetic, as later researchers established that all three techniques were viable. However, the applicants had not taken the final step in identifying any of these molecules on their own.

Perhaps suspecting that the specification was insufficient to demonstrate that they were in "possession" of the claimed subject matter, Ariad asked the Federal Circuit to judge the patent solely on the question of whether it had "provide[d] enough information to enable a person skilled in the art to make and use the invention." The position was rejected.

Ariad had argued the fact that a separate written description requirement prevents research universities from patenting basic scientific research. The court agreed, noting however that the Constitution directs that patents are to be granted for "useful Arts," and not for basic research or "academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others."

It is too early to predict whether the Supreme Court will grant certiorari. As it stands, the case law leaves many unanswered questions. For example, in his dissent, Judge Rader noted tension between the case law of blocking patents and the written description requirement. He posed the case of an applicant disclosing a sufficient number of species within a genus to obtain a claim for the entire genus. If a second party later claims a new species within that genus, the Federal Circuit has held that the earlier patent is not anticipatory, though the second party needs to license the earlier patent. Yet a conflict exists because of the court's position on written description: if the first party did not possess the later-developed species, why should it have received the earlier patent for the entire genus?

For now, the en banc Ariad opinion serves as a cautionary tale that it is not enough for an applicant to disclose a "desired outcome" based upon original research, but rather the applicant must go the final mile and demonstrate actual possession of the invention.