On December 7, 2009, the Court of Appeals for the Federal Circuit, en banc, heard oral argument in Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 560 F.3d 1366 (Fed. Cir. 2009) ("Ariad"). The patent community now anxiously awaits the Court's ruling, which will decide whether the "written description requirement" of 35 U.S.C. § 112, ¶1 exists independently from the enablement requirement, and if so, what it means.
According to 35 U.S.C. § 112, ¶1, the specification of a patent "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...". The requirement to provide a "written description" has been applied independently from the "enablement" requirement since as early as 1853. O'Reilly v. Morse, 56 U.S. 62 (1853). Initially used to ban the introduction of new matter in claim amendments, the written description requirement later played a role in evaluating all claims, including original claims. Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997). As it stands, written description, along with 35 U.S.C. § 132 (prohibiting new matter), is used to police "possession of the invention." Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319 (Fed. Cir. 2003).
Applying this standard, the Federal Circuit held Ariad's biotechnology patent invalid for failing to provide substantial evidence establishing possession of the claimed biological process. Ariad, 560 F.3d at 1376. In reaching its conclusion, the Court explained that establishing "possession of the invention" is distinguishable from teaching how "to make and use [the invention]…" Id. at 1371-72; 35 U.S.C. § 112, ¶1.
In a concurring opinion, Judge Linn criticized the majority for deciding the case on a court-invented "separate written description requirement" rather than solely addressing whether Ariad complied with the enablement requirement. Ariad, 560 F.3d at 1380-81. Judge Linn stated that the "separate written description requirement has ‘create[d] confusion as to where the public and the courts should look to determine the scope of the patentee's right to exclude,' causing uncertainty ‘in how inventions are protected, in how the [United States Patent and Trademark Office] discharges its responsibilities, and in how business is conducted in emerging fields of law[.]'" Id. (quoting Univ. of Rochester v. G.D. Searle & Co., 375 F.3d 1303, 1326-27 (Fed. Cir. 2002)).
As a result, on August 21, 2009, the Federal Circuit granted Ariad's request for an en banc rehearing, vacated the previous decision, and requested briefing on two issues:
(1) Whether 35 U.S.C. § 112, ¶1 contains 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? Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 332 Fed.Appx. 636, 637 (Fed. Cir. 2009)
The oral argument shed light on the differing statutory interpretations, the fate of the existing case law and certain practical implications. Eli Lilly urged the Court to construe § 112, ¶1 as asking two "fundamentally different" questions: "whether the specification describes what an inventor has invented" and whether "a hypothetical person of ordinary skill…might without undue experimentation be able to do so." Ariad v. Eli Lilly: Oral Argument, December 9, 2009. The USPTO defended this position, arguing that "it has become increasingly popular to claim inventions by their functions or effect" and that the USPTO uses the written description requirement "to constrain these claims and to make the patentee make clear to the public what the scope of the invention is." Id. By contrast, Ariad argued that "full, clear, concise and exact terms as to enable…" is the only standard by which the written description should be judged. In apparent agreement with this proposition, Judge Prost stated that "that there is no way that you can enforce the written description requirement except by the enablement portion." Id.
A decision in Ariad is imminent. Based on the briefing, and the alignment of the panel, it is unlikely that the Court will entirely abolish the written description requirement, because this would have dramatic consequences. The USPTO would lose a valuable tool in its patent-screening process, particularly in the chemical and biotechnical arts. Patent litigators will lose a potent weapon for invalidating tenuous patent claims where an overbroad claim construction is being advanced. Finally, practitioners, their clients and the courts will lose the reliability of well-settled legal authority. Nevertheless, the Court may still take the opportunity to redefine the scope and purpose of § 112, ¶1, requiring the entire patent community to adapt to a new application of the statute.
Gregory L. Hillyer is a partner with the law firm of Feldman Gale, P.A. in its Bethesda, Maryland office. Javier Sobrado is an associate of Feldman Gale, P.A. Chelsea Severson is a third-year law student at the Catholic University of America, Columbus School of Law.