On March 22, 2010, the U.S. Court of Appeals for the Federal Circuit issued its en banc decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., Case No. 08-1248 (Fed. Cir. Mar. 22, 2010) (en banc) (Lourie, J.)—a 9–2 decision confirming that 35 U.S.C. § 112, ¶1 includes a written description requirement separate from the enablement requirement. The court explained that "[i]f Congress had intended enablement to be the sole description requirement of § 112, first paragraph, the statute would have been written differently."
Ariad asserted claims from its patent that relates to the regulation of gene expression by the transcription factor NF-κB. The asserted claims recite methods encompassing a genus of materials comprising the single step of reducing NF-κB binding to NF-κB recognition sites in response to external influences. Lilly argued that the asserted claims are not supported by a written description because the patent specification fails to adequately disclose how the claimed reduction of NF-κB activity is achieved. Lilly argued that Ariad’s disclosures amounted to little more than a research plan and do not satisfy the patentee’s quid pro quo of disclosure as described in the 2004 Federal Circuit decision in University of Rochester v. G.D. Searle & Co., Inc. (IP Update, Vol. 7, No. 7).
In its April 2009 panel decision (IP Update, Vol. 12, No. 5), the Federal Circuit rejected Ariad’s claims as invalid for lack of written description but granted an en banc rehearing in August to resolve an issue that has been brewing for more than a decade. The en banc questions were:
(1) Whether the first paragraph of 35 U.S.C. § 112 contains a written description requirement separate from the enablement requirement, and
(2) if a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement.
Over vigorous dissents from Judges Linn and (soon to be chief judge) Rader, the en banc court held that § 112, first paragraph, includes two separate description requirements: a written description of the invention and a written description of how to make and use the invention (i.e., a description requirement separate from the enablement requirement). Applying that holding to the claims in issue, the court held that the claimed methods for dominantly interfering molecules “just represent a wish, or arguably a plan” for future research and that the specification “at best describes [ ] molecule structures and hypothesizes with no accompanying description that they could be used to reduce NF-κB activity.”
The court rejected Ariad’s argument that the written description requirement was satisfied by the originally presented claims that form a part of the specification. In doing so, the court cited the Supreme Court of the United States decision in Festo (IP Update, Vol. 5, No. 5), characterized itself as a “subordinate federal court” and insisted it could not dismiss, as dicta, the statement in Festo that “[T]he patent application must describe, enable and set for the best mode of carrying out the invention.” (emphasis in the original)
The Federal Circuit thus concluded that a patentee could not rely on its claims to satisfy the written description requirement, noting that the “principal” function of claims
is to provide notice of the boundaries of the right to exclude and to define limits; it is not to describe the invention . . . Claims define and circumscribe, the written description discloses and teaches.
As the court explained, this is not to say that the original claims do not contribute to the description and in certain cases even satisfy the written description requirement. Rather, citing its landmark decision in Ruching, the court explained that in terms of the written description requirement, whether a person of skill in the art is enabled to make the claimed invention is “besides the point”; the question is whether the specification discloses the claimed invention as “something [the inventors] actually invented.”
Citing its 1997 decision in Regents of University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), the court explained that the written description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. Here, the court found “Ariad’s specification describes only a generic invention that it purports to claim and that the asserted claims of the . . . patent are [therefore] invalid for lack of written description.”
The court explained that although some original claims may satisfy the written description requirement, certain very broad or generic claims may not. The court reasoned that while “a generic claim may define the boundaries of a vast genus of chemical compounds . . . the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus.” This problem is especially manifest with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and must do so by showing that the applicant has invented species sufficient to support a claim to the functionally defined genus.
To do so, the written description should provide “a precise definition, such as by structure, formula, chemical name, physical properties, or other properties of species falling within the genus sufficient to distinguish the genus from other materials.” Functional claim language can meet the written description requirement “when the art has established a correlation between structure and function.” However, merely “drawing a fence around the outer limits of a purported genus” is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
Responding to a concern voiced by basic researchers (such as Ariad’s university scientists), the court paused to acknowledge that "[r]equiring a written description of the invention limits patent protection to those who actually perform the difficult work of 'invention'" and makes it more difficult to patent "basic research" that has not yet been fully reduced to a practical implementation. However, the court did not view this as inimical to the underlying purpose of the patent system, noting "that research hypotheses do not qualify for patent protection possibly results in some loss of incentive,” but there is “no evidence of any discernable impact on the pace of innovation or the number of patents obtained by universities.” Further, the court stated that “claims to research plans also impose costs on downstream research, discouraging later invention. The goal is to get the right balance, and the written description doctrine does so by giving the incentive to actual invention and not ‘attempt[s] to preempt the future before it has arrived.’”
Actual Reduction to Practice Not Required
The court did make it clear that "the written description requirement does not demand either examples or an actual reduction to practice” and that “a constructive reduction that identifies the claimed invention can satisfy the written description requirement.” Indeed, the court noted that even “actual ‘possession’ or reduction to practice outside of the specification” has nothing to do with written description. Rather “the hallmark of written description is disclosure,” and the test for adequate disclosure 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.
Judge Newman, in a separate concurring opinion, took on the “basic research” issue squarely, sympathetically noting that the patentees made a “basic discovery” relating to a “previously unknown protein,” and they even postulated that their discovery could “reduce the symptoms of certain diseases.” However, as Judge Newman explained, “the overriding policy of the patent system[s] requires both written description and enablement” and that “basic scientific principles are not the subject matter of patents.” Rather, the “role of the patent system is to encourage and enable the practical application of scientific advances . . . .”
Judges Linn and Rader filed separate dissents, finding scant support either in the statute, the Supreme Court case law or the Federal Circuit’s own jurisprudence for the en banc ruling—a ruling that Judge Rader posited lay with a sequence of rulings that started with the court’s “erroneous” 1997 decision in Eli Lilly where the Federal Circuit “ultra vires impos[ed] a new written description requirement for original claims.”