United States: Federal Circuit Issues En Banc Decision In Ariad v. Eli Lilly

The Holding: On March 22, 2010, the Federal Circuit ("CAFC") confirmed en banc that 35 U.S.C. § 112, ¶1 contains a written description requirement that is separate from the enablement requirement. Ariad Pharms., Inc. v. Eli Lilly & Co., No. 2008-1248 (Fed. Cir. March 22, 2010). The lengthy (72-page) decision is based on statutory interpretation, citation to U.S. Supreme Court precedent and previous CAFC decisions and attempts to provide guidance concerning what is needed to comply with the written description requirement. Importantly, although the case involved a biotechnology patent, its holding should not be viewed as in any way limited to the biotechnology area.

History of the Case: In 2009, Ariad petitioned for en banc rehearing of a prior panel decision of the CAFC that had reversed-in-part a jury verdict of no invalidity of four asserted claims from Ariad's U.S. Patent No. 6,410,516 (the '516 patent). The panel decision held that the claims were invalid for failing to satisfy the written description requirement. In its briefing to the en banc CAFC, Ariad conceded the statute contained two description requirements ("what the invention is" and "how to make and use it"), but argued that compliance was "judged by whether [the specification] enables one of skill in the art to make and use the claimed invention" and that the first step of identifying what the invention is applied only to priority determinations (i.e., amended claims or later-filed claims, since original claims "constitute their own description." (Opinion at 6-7.)

The Patent at Issue: At issue were broad claims directed to methods for reducing the activity of transcription factor "NF-& #312;B" by reducing its binding to certain gene recognition sites that encompassed the use of any substance that would achieve that claimed result.¹ The specification hypothesized three types of molecules had the potential to reduce NF-ĸB activity: decoy, dominantly interfering, and specific inhibitor molecules. Notably, although amended during prosecution, the claims used language that corresponded to language present in the originally-filed priority application.

The Standard: In a 9-2 decision, the CAFC held that all claims must be supported by an original disclosure that "reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter [as shown from its four corners] as of the filing date." (Opinion at 23-24.) Determination of compliance with the written description requirement was held to be a question of fact, and the level of detail required was explained as "var[ying] depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology." (Opinion at 24.) The Court further explained that the "written description. . .ensures that when a patent claims a genus by its function or result, the specification recites sufficient materials to accomplish that function." (Opinion at 27.) In other words, a patentee may not simply describe a problem to be solved and claim all later-created solutions to that problem. Similarly, the majority opinion noted that "[p]atents are not awarded for academic theories, no matter how groundbreaking . . . ." (Opinion at 28.)

Details: With respect to the claims at issue, the CAFC upheld the panel's 2009 decision invalidating the asserted claims for failure to meet the written description requirement, because the original disclosure failed to describe how to accomplish the claimed result of reducing NF-ĸB activity, instead simply suggesting three categories of molecules that prophetically may accomplish that result. (Opinion at 30-31.) The Court noted that the jury found—and the parties did not appeal—a relatively early priority date and that as of that date the field was "new and unpredictable" and "existing knowledge and prior art was scant," and, therefore, a more detailed description of the particular ways to accomplish the claimed result was required. (Opinion at 30-32.)

Other opinions: Judge Newman offered additional views, noting simply that, regardless of the majority's statutory interpretation, the language and policy of the patent statute requires both written description and enablement, and that in no case has an invention of basic science been patented without even a single embodiment demonstrating its application and illustrating its breadth, as in the case en banc. Judge Gajarsa—noting that he viewed the statute as a "model of legislative ambiguity"—concurred with the majority's decision solely to "provide some clarity to this otherwise conflicting area of our law" while stating that he viewed a written description requirement that is separate from the enablement requirement as "serv[ing] little practical purpose." In two spirited dissents, Judges Rader and Linn disputed both the majority's statutory interpretation and reading of prior case law. They argued that the statute was ambiguous, that prior case, including Regents of the Univ. of California v. Eli Lilly & Co., 119 F.3d 1559, 1568-69 (Fed. Cir. 1997), applied the written description requirement only to police "new matter" in amended or later-filed claims and that the case should have been remanded for resolution of enablement.

Impact of Ariad: The practical impact of Ariad to patentees is unclear, but the decision has the most potential impact on patentees who frequently file early during the research timeline—before sufficient research may have been completed to provide working examples of or detailed descriptions of making and using the claimed invention. Patent prosecutors have long been aware that the Patent Office and the CAFC have been more closely scrutinizing the original disclosure of a patent and requiring a sufficient disclosure to support broad claims, such as the claims at issue in Ariad. However, the decision may lead to an increased focus in the courts and in the Patent Office on the written description requirement. It remains to be seen in the coming months if the Patent Office will issue any revised guidelines directed to the Ariad case. While it seems probable that Ariad will file a petition for certiorarari, it seems improbable the petition will be granted. If the Supreme Court does not take up the case, the only way for the Ariad holding—that written description is separate from enablement—to be overturned is for Congress to amend the statute, and any call for such amendment may depend upon the decision's impact on institutions engaged in early and basic research, which the majority opinion acknowledged might suffer "some loss of incentive" to engage in such research. (Opinion at 28.)

Footnote

1. Representative claim 95 recites: "A method for modifying the effects of external influences on a eukaryotic cell, which external influences induce NF-& #312;B mediated intracellular signaling, the method comprising altering NF-?B activity in the cells such that NF-& #312;B mediated effects of external influences are modified, wherein NF-& #312;B activity in the cell is reduced] wherein reducing NF-& #312;B activity comprises reducing binding of NF-& #312;B to NF-& #312;B recognition sites on genes which are transcriptionally regulated by NF-& #312;B (emphasis added).

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.