On March 22, 2010, the Federal Circuit, sitting en banc, held that the first paragraph of Section 112 of the Patent Act (35 U.S.C. § 112, first paragraph) does contain a written description requirement separate from the enablement requirement. Ariad Pharms., Inc. v. Eli Lilly and Co., No. 08-1248, slip op. at 10. The court further held that this requirement applies to both original and amended claims. Id. at 23. In doing so, the Federal Circuit upheld recent Federal Circuit precedent.

Section 112, First Paragraph

Section 112, first paragraph of Title 35 of the United States Code states:

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.

Historically, courts have interpreted this paragraph to include three separate requirements: (1) a written description requirement; (2) an enablement requirement; and (3) a best mode requirement.

En Banc Decision

The Federal Circuit cited numerous reasons for its finding that the first paragraph of Section 112 contains an independent written description requirement. First, the court performed a grammatical analysis of the statute. Based on this analysis, the court determined that there is nothing grammatically improper in finding that a plain reading of the statute requires two separate requirements: “a written description [i] of the invention and [ii] of the manner and process of making and using [the invention].” Id. at 10. Turning to the legislative history, the court stated that since 1793, the Patent Act has “expressly stated that an applicant must provide a written description of the invention.” Id. at 11. Furthermore, the court explained that this language was recodified by Congress in 1952, at which time there was no indication that Congress intended to eliminate the written description requirement. Id. at 11-12. Finally, the court explained that Supreme Court case law and its own existing precedent supported the existence of a separate written description requirement. Id. at 23. From a policy standpoint, the court noted that the separate written description requirement serves the interests of the U.S. Patent Office, the courts, and the public. Id. at 12.

The en banc panel also explained that there was no support for Ariad’s argument that the written description requirement is limited to priority determinations. Id. at 23. Specifically, it determined that “neither the statute nor legal precedent limits the written description requirement to cases of priority.” Id. Further, the court explained that nothing in the statute or precedent distinguished the description requirements for original or amended claims. Id. More particularly, the appellate court explained that even though “many original claims will satisfy the written description requirement, certain claims will not.” Id. at 20. In the end, the court held that “generic language in the application as filed does not automatically satisfy the written description requirement.” Id. at 23.

The appellate court also rejected Ariad’s argument that this requirement imposes a heightened standard for disclosure for biotechnology and chemical inventions. Id. at 26. Rather, it explained that the written description requirement “ensures that when a patent claims a genus by its function or result, the specification recites sufficient materials to accomplish that function.” Id. at 27. The court reasoned that there is a fairly uniform standard for determining whether the disclosure is sufficient to satisfy the written description requirement. Id. at 23. In doing so, it reiterated that the test for whether there is sufficient written description requires a determination that the disclosure shows the inventor had possession of the full scope of the claimed subject matter. Id. At the same time, the court did acknowledge that the “possession of the invention” test “has never been very enlightening.” Id. at 24. It reasoned that a more accurate inquiry is whether or not “possession [is] shown in the disclosure.” Id. at 24. In the opinion, the “possession” requirement was clarified in that “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. Based on that inquiry, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.” Id.

The en banc panel acknowledged that the separate written description requirement may disadvantage organizations such as universities, who tend to file patent applications before the practical implications of the research are known. However, the court noted that this is the intention of the patent laws: “Patents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others.” Id. at 28.

Applying its statement of law to the case, the Federal Circuit reversed the district court and held that the written description requirement was not satisfied in this case by generic claims that “merely recite a description of the problem to be solved while claiming all solutions to it.” Id. at 27. Thus, it held Ariad’s asserted claims invalid for failing to comply with the written description requirement. Id. at 38.

Concurring and Dissenting Opinions

Judge Newman authored a concurring opinion to focus on the public policy concerns of whether “basic research” should be patentable. Ariad Pharms., Inc. v. Eli Lilly and Co., No. 08-1248 (Fed. Cir. Mar. 22, 2010) (Newman, J., concurring). Concurring with the majority, Judge Newman stated “[t]he role of the patent system is to encourage and enable the practical applications of scientific advances, through investment and commerce.” Id., slip op. at 3. Judge Newman thus argued from a public policy perspective that “the patentee is obliged to describe and to enable subject matter commensurate with the scope of the exclusionary right” claimed, including any practical applications. Id.

Judge Rader authored an opinion dissenting in part, in which Judge Linn joined. Ariad Pharms., Inc. v. Eli Lilly and Co., No. 08-1248 (Fed. Cir. Mar. 22, 2010) (Rader, J., dissenting). Judge Rader opined that there is no statutory or precedential support for the majority’s finding of a separate written description. Id., slip op. at 2 and 5. Judge Rader stated that separate written description requirement was a purely judicial creation and that the Federal Circuit’s “embarrassingly thin (perhaps even mistaken) justifications for the minting of this new description doctrine” dated back only to 1997. Id. at 2. Further, Judge Rader argued that the court’s definition of the written description requirement is unpredictable and contradictory because the test involves conflicting and unclear subjective and objective inquiries. Id. at 10-11. Judge Rader also argued that this separate written description requirement may also cause pioneering blocking patents to disappear because they will likely fail to meet what he argues are heightened requirements. Id. at 9.

This article was prepared by Tamsen Barrett (tbarrett@fulbright.com or 512 536 3123) from Fulbright’s Intellectual Property and Technology Practice Group. For additional information, please contact Tamsen Barrett or Gina Shishima (gshishima@fulbright.com or 512 536 3081).