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FEDERAL CIRCUIT CONFIRMS SEPERATE REQUIREMENTS FOR WRITTEN DESCRIPTION AND ENABLEMENT

by Jeffrey To and John Osha

On March 22, 2010, the U.S. Court of Appeals for the Federal Circuit confirmed in an en banc decision that 35 U.S.C. § 112, first paragraph, includes separate requirements for written description and enablement.

Background: Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co.

Ariad brought suit against Lilly in the U.S. District Court of Massachusetts, alleging infringement of U.S. Patent No. 6,410,516 ("the ‘516 patent"). The ‘516 patent pertains to pharmaceuticals, and the asserted claims recite methods to achieve a desired result (reducing NF-κB activity and binding of NF-κB to NF-κB recognition sites). The specification of the ‘516 patent recites the goal of achieving the desired result and also hypothesizes three types of molecules with the potential to achieve the desired result.

Lilly argued that the asserted claims were not supported by adequate written description because the specification of the ‘516 patent fails to adequately disclose how the desired result is achieved.

The jury rendered a special verdict finding infringement of the asserted claims and that the asserted claims were not invalid for anticipation, lack of enablement, or lack of written description. Further, the court ruled in favor of Ariad regarding Lilly's additional defenses of unpatentable subject matter, inequitable conduct, and prosecution laches.

Lilly appealed to the U.S. Court of Appeals for the Federal Circuit, and a panel upheld the district court's finding of no inequitable conduct, but reversed the jury's verdict on written description, holding the asserted claims invalid for lack of an adequate written description as required by 35 U.S.C. § 112, first paragraph.

Ariad petitioned for rehearing en banc, challenging the existence of a written description requirement in 35 U.S.C. § 112, first paragraph, separate from the enablement requirement.

The Federal Circuit's ruling addressed two questions:

(1) Does 35 U.S.C. § 112, first paragraph, contain a written description requirement separate from an enablement requirement?
(2) If a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement?

The Federal Circuit held that the language of the statute contains two separate requirements: a written description of the invention and a written description of the manner and process of making and using the invention.

The Federal Circuit decided that "possession as shown in the disclosure" of the invention demonstrates meeting the requirement for written description. 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. As such, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the claimed invention.

According to the Federal Circuit, the purpose of the separate requirement of written description is to allow the United States Patent and Trademark Office to examine applications effectively; courts to understand the invention, determine compliance with the statute, and to construe the claims; and the public to understand and improve upon the invention and avoid the claimed boundaries of the patentee's exclusive rights.

Lilly asserted that the written description requirement applies to all claims – both original and amended – to ensure that inventors have actually invented the subject matter claimed. The court confirmed that originally-filed claims can violate the written description requirement.

Further, the court recognized that the written description requirement is a disadvantage to universities to the extent that it makes it more difficult to patent basic research that has not been fully reduced to practice.

That is no failure of the law's interpretation, but its intention. Patents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable invention of others. "[A] patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion." Id. at 930 n. 10 (quoting Brenner, 383 U.S. at 536).

The court concluded that the written description requirement limits patent protection to those who "actually perform the difficult work of ‘invention' – that is, conceive the complete and final invention with all of its claimed limitations – and disclose the fruits of that effort to the public" and that the purpose of the written description requirement is to "ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art described in the patent specification." Rochester, 358 F.3d at 920 (quoting from Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345 (Fed. Cir. 2000)).

Implications of the Decision

Though enabling an invention may, sometimes, show possession of the invention, this is not always true, particularly with inventions in the unpredictable arts, as shown with the ‘516 patent.

After this decision by the Federal Circuit, all claims – including both original claims and amended claims – should be considered in light of a written description requirement that is separate from the enablement requirement when determining validity under 35 U.S.C. § 112, first paragraph.
 

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