Ariad v. Lilly: Written Description Requirement Separate from Enablement Requirement

Authored by Thomas L. Irving and Ningling Wang

In March of this year, the U.S. Court of Appeals for the Federal Circuit issued a very important en banc (full court) decision on the issue of meeting the requirements set forth in 35 U.S.C. § 112. The citation of the case is Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1341 (Fed. Cir. 2010) (en banc.) Specifically, the Federal Circuit held that § 112 contains both a written description requirement and an enablement requirement. In other words, a patent specification must describe the invention sufficiently so that one of ordinary skill in the art would understand that the inventor possessed the subject matter claimed and, separately, must teach one of ordinary skill in the art how to make and use the invention.

Ariad’s patent contained broad genus claims covering “the use of all substances that achieve the desired result of” inhibiting NF-κB activity. Id. at 1341. Although the specification recited the desired goal of reducing NF-κB activity, Ariad’s patent did not disclose any “working or even prophetic examples of methods that reduce NF-κB activity, and no completed syntheses of any of the molecules prophesized to be capable of reducing NF-κB activity.” Id. at 1357-58.

The jury held that Ariad’s claims were valid and infringed. Id. at 1340. On appeal, the Federal Circuit reversed the jury verdict, and held the asserted claims invalid for lack of written description. Id. Ariad petitioned for en banc rehearing on the question of whether there is a separate written description requirement set forth in 35 U.S.C. § 112, ¶1. According to Ariad, there is no separate written description requirement, the description is just to identify what needs to be enabled: Id. at 1342.  Lilly, on the other hand, argued that “two hundred years of precedent support the existence of a statutory written description requirement separate from enablement.” Id.

The Federal Circuit granted Ariad’s petition, and, sitting en banc, held that the language of § 112 supported a separate written description requirement, and that a contrary interpretation would actually read words out of the statue: “If Congress had intended enablement to be the sole description requirement of § 112, first paragraph, the statute would have been written differently.” Id. at 1344.

In addition, the Federal Circuit found that Supreme Court precedent recognized a written description requirement separate from an enablement requirement, and found that there was not a conflict between the existence of a separate written description requirement and the function of claims (“Claims define and circumscribe, the written description discloses and teaches”). Id. at 1347.

Finally, the Federal Circuit found that stare decisis supported the position that the written description requirement is separate and distinct from enablement:

In addition to the statutory language and Supreme Court precedent supporting the existence of a written description requirement separate from enablement, stare decisis impels us to uphold it now. Ariad acknowledges that this has been the law for over forty years, . . . and to change course now would disrupt the settled expectations of the inventing community, which has relied on it in drafting and prosecuting patents, concluding licensing agreements, and rendering validity and infringement opinions. …If the law of written description is to be changed, contrary to sound policy and the uniform holdings of this court, the settled expectations of the inventing and investing communities, and PTO practice, such a decision would require good reason and would rest with Congress. (emphasis added)

Id.

In affirming the existence of the written description requirement, the Federal Circuit found long-standing support for the position that the written description requirement applies to both original and amended claims. The panel agreed with Lilly’s argument that the requirement “applies to all claims and requires that the specification objectively demonstrate that the applicant actually invented—was in possession of—the claimed subject matter.” Id. at 1349. The Federal Circuit went on to note that fulfilling the written description requirement means more than merely repeating claim language in the specification:

generic claim language appearing in ipsis verbis in the original specification does not satisfy the written description requirement if it fails to support the scope of the genus claimed.

Id. at 1350.

As for what must be shown to satisfy the description requirement, the court explained:

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 . . . show that the inventor actually invented the invention claimed.”

Id. at 1351. This inquiry is a question of fact and “the level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.” Id.

The Federal Circuit held that Ariad’s broad claims were invalid for lack of written description; although the claims covered all methods of inhibiting NF-κB regulation, the specification only used broad functional language to disclose only hypothetical methods. In other words, Ariad’s patent described a problem—not a solution. Specifically:

In the context of this invention, a vague functional description and an invitation for further research does not constitute written disclosure of a specific inhibitor. …[t]his disclosure is not so much an ”example” as it is a mere mention of a desired outcome.

Id. at 1356-57.

The decision in Ariad v. Lilly encourages practitioners to carefully consider the support for broad genus claims when drafting the specification. Depending on the technology involved and the breadth of the claims sought, more detail may be necessary to show sufficient possession to satisfy the written description requirement.

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