On March 22, 2010, the Federal Court issued its en banc decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Company [2010 U.S. App. LEXIS 5966], reaffirming that 35 U.S.C. § 112, ¶ 1 contains a written description requirement separate from the enablement requirement. An earlier panel had concluded that Ariad's claims did not meet the written description requirement. The court agreed to rehear the case en banc, seeking briefing on whether a written description requirement existed separately from the enablement requirement, and if so, what the scope and purpose of the separate written description requirement was.
A Separate Written Description Requirement Does Exist
The Federal Circuit observed that principles of statutory construction, controlling Supreme Court authority and stare decisis supported its conclusion that a separate written description requirement exists. Notably, the court observed that "to change course now would disrupt the settled expectations of the inventing community." Slip Op. at 16. As such, any change "would rest with Congress." Slip Op. at 16.
Concurring separately, Judge Gajarsa offered that the statutory text was "a model of legislative ambiguity," but also agreed that it could be read as setting forth an independent requirement. Gajarsa Concurrence at 1-2.
The Majority Reaffirmed The Written Description Requirement's Scope And Application
The court noted that its previous rulings had set forth a "'fairly uniform standard'" that it again affirmed. Slip Op. at 23. It emphasized that "the hallmark of written description is disclosure," judged by "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." Slip Op. at 24.
Any inconsistencies that might have been observed in earlier jurisprudence arose because satisfaction of the written description requirement is a question of fact, resting on the different facts and arguments presented to the courts in each case. While acknowledging that such a question did not lend itself to bright-line rules, the court reiterated "a few broad principles that hold true across all cases":
Slip Op. at 25.
While acknowledging that, as applied, the written description and enablement requirements often stand or fall together in some fields, the court stressed the vital purpose of the separate written description requirement as ensuring "that when a patent claims a genus by its function or result, the specification recites sufficient materials to accomplish that function - a problem that is particularly acute in the biological arts." Slip Op. at 26-27. Claims that merely recite a description of the problem to be solved while purporting to encompass all solutions to it do not meet the written description requirement. Slip Op. at 27. In a similar vein, Judge Newman's separate concurrence emphasized that "basic scientific principles are not the subject matter of patents . . . ." Newman Concurrence at 3. Because the majority did not alter its prior written description law, it adopted the panel's reasoning and concluded that Ariad's claims did not satisfy the written description requirement.
Judges Rader And Linn Dissented
In a strongly worded dissent, Judge Rader, joined by Judge Linn, criticized the majority's conclusion. Observing that "[t]he frailties of the court's 'written description' doctrine have been exhaustively documented in previous opinions," the dissenting judges found no support for the existence of a separate written description requirement in the statute or in controlling Supreme Court precedent. Rader Dissent at 2. In fact, the dissent observed that the majority's reasoning would conflict with settled principles of claim construction and the concept of blocking patents.
Practical Implications of Ariad
The Ariad opinion did not purport to announce a vast change in written description law. However, it contains several warnings for those working with technologies at early stages of basic research and development. For example, although not required, specific practical examples within the specification can always help an applicant seeking a broad functional claim or genus claim to satisfy the written description requirement. Conversely, Ariad provides patent challengers with potentially stronger arguments against claims that simply describe a problem and then attempt to cover all possible solutions.
If you have any questions or wish to discuss how this decision may impact your company, please contact your attorney at Brinks Hofer Gilson & Lione.
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