The U.S. Court of Appeals for the Federal Circuit heard oral arguments on December 7 in its en banc rehearing of Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., Fed. Cir., No. 2008-1248. There has been great interest in the patent community in this rehearing with more than twenty amicus briefs filed, including an invited brief from the United States. None of the amici supported Ariad and its position that there is no separate written description requirement, and six of the amici support neither party. While not supporting Ariad, Novozymes A/S argued in its amici against the existence of a separate written description requirement, contending that a functional description of the claimed invention is sufficient to satisfy the disclosure requirements of 35 U.S.C. § 112. The amicus brief filed by the United States tracks Lilly’s position that there is indeed a separate requirement and has been for nearly 200 years, supported by Supreme Court precedent and legislative history. In this alert, we provide a brief summary of the oral arguments and offer background information for your reference in this alert.
Summary of Oral Arguments
The Federal Circuit, sitting en banc, queried:
- Whether 35 U.S.C. § 112, paragraph 1, contains a written description requirement separate from an enablement requirement?
- If a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement?
Lilly’s position: The written description requirement is, and has always been, a requirement separate from enablement. Lilly argues that, to meet the public notice function of Section 112, not only do the original and amended claims need to set forth the metes and bounds of the invention but also that inventor has actually invented what is claimed, i.e., was in “possession” of the invention. Lilly contends that any disruption to this requirement should be made by Congress, not this en banc Court.
Ariad’s position: The written description requirement is not a requirement separate from enablement. The test for an adequate written description is not possession but whether it provides enough written information for others to make and use the invention. Ariad contends that Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997) created a new disclosure requirement having no basis in the plain meaning of 35 U.S.C. § 112 or Supreme Court or CCPA precedent. From a policy perspective, a separate requirement disadvantages research universities and small biotech companies creating a technology-specific rule in a technology-neutral statute.
The initial peppering of Lilly’s counsel explored the question of whether a patent meets the written description is a question of law or fact and whether there were proper jury instructions. The main questioning eventually focused on whether there was any context outside of policing priority where the written description requirement was an appropriate inquiry. Lilly acknowledged that in the vast majority of the cases the issue arises with respect to priority and that the written description requirement is indeed co-extensive with the enablement requirement.
Nonetheless, Lilly urged that the inquiry regarding written description needs to be analyzed separately and independently of enablement to ensure that the inventor has actually invented what is claimed, even if the skilled artisans would otherwise be able to make and use the invention based on the description.
At several points during the arguments of all parties, the judges, grappling with the subtleties, solicited concrete examples when it would be possible for an applicant to meet the enablement requirement yet not meet the written description requirement. Lilly pointed out that the problem primarily arises in a genus-species context (e.g., are there sufficient species described to support a claimed genus, especially in amended claims). Lilly and the U.S. Government cautioned that the genus-species context is by no means limited to chemical compounds but arises in all technology areas in situations where support for broader claims is questioned. The U.S. Government further warned that the infrequency of cases reaching the Federal Circuit on written description alone is not indicative of how many applications would be impacted by disturbing stare decisis. The U.S. Government described written description as a "basic tool that the Patent Office has to constrain [the] claims and get ... the patentee to make clear to the public what the scope of [the] invention is."
Ariad's arguments primarily revolved around cannons of statutory construction. Ariad stressed that the single requirement of the first paragraph of Section 112 includes identifying the invention and instructing a skilled artisan how to mak and use that intervention. During Ariad’s presentation, some of the judges even suggested that Ariad’s seemingly circular argument was in agreement with its opponent’s position or, at most, draws the line in a different place.
While it is dangerous to make predictions based on questioning during oral arguments, especially those heard en banc in such a highly publicized case, the fact that the judges struggled with articulating how Ariad’s argument practically differed from the arguments urged by Lilly and the numerous amici seems to bode poorly for Ariad. It also did not appear to escape the judges that the novel statutory construction of Section 112 was only being urged by Ariad because it desired a different result at trial. As we await the Court's en banc decision to issue in the next several months, it goes without saying that patent practitioners should continue to provide as much support as possible to meet not only the enablement requirement but also the written description requirement.
The patent at issue is U.S. Patent US-B-6,410,516, which is assigned to the Massachusetts Institute of Technology, the Whitehead Institute for Biomedical Research, and the Presidents and Fellows of Harvard College and exclusively licensed to Ariad Pharmaceuticals, Inc. (collectively “Ariad”). The patent involves gene regulation, specifically the transcription factor NF-kappaB. The asserted claims require the single step of reducing or altering the activity of the transcription factor without indicating how the transcription factor is to be reduced or altered. The specification discloses three classes of hypothetical molecules as potentially being capable of reducing NF-kappaB activity – specific inhibitors, dominantly interfering molecules, and decoy molecules. There are no working or prophetic examples of methods that reduce NF-kappaB activity and no completed syntheses of any of the molecules in these three classes.
Trial Court Decision
Ariad filed suit against Lilly alleging infringement of US-B-6,410,516 by the Lilly’s drugs, Evista®, a small molecule for prevention and treatment of post-menopausal osteoporosis, and Xigris®, a recombinant human protein for treatment of adult patients with severe sepsis. A jury held that the asserted claims were not anticipated, that the specification was enabled and adequately described the claims, and that the use of Evista® and Xigris® infringed the claims and awarded Ariad $65 million in damages. Lilly moved for JMOL, which was denied. Ariad Pharms., Inc. v. Eli Lilly & Co., 1:02-cm-11280-RWZ (D. Mass. order filed Dec. 12, 2008). In a separate bench trial, the district court ruled that the claims were directed to patentable subject matter and that the patent was not unenforceable due to inequitable conduct or prosecution laches. Ariad Pharms., Inc. v. Eli Lilly & Co., 529 F. Supp. 2d 106 (D. Mass. 2007). Lilly appealed.
Federal Circuit Decision
A Federal Circuit panel of Circuit Judges Linn, Prost, and Moore held that the asserted claims of Ariad’s patent were invalid for an inadequate written description because the inventors were not in possession of the claimed invention at the time of filing the patent application:
Thus, to satisfy the written description requirement for the asserted claims, the specification must demonstrate that Ariad possessed the claimed methods by sufficiently disclosing molecules capable of reducing NF-kappaB activity so as to “satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed.”
Ariad Pharms., Inc. v. Eli Lilly & Co., 560 F.3d 1366, 1373 (Fed. Cir. 2009) (citing Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005)). The Court emphasized that there were no actual or prophetic examples of suitable compounds for reducing NF-kappaB activity, aside from a single specific inhibitor, and that what was disclosed was nothing more than a desired outcome, insufficient to otherwise show possession of the subject matter of the asserted claims. The Court found unavailing Ariad’s arguments that Rochester, Fiers, and Eli Lilly were distinguishable because, in those cases, the claims explicitly included the non-described compositions, whereas Ariad’s asserted claims did not.
Judge Linn, while joining the opinion of the Court written by Judge Moore, also provided a separate concurrence to express his belief that a separate written description requirement is misguided. He noted that, because the Court decided the validity issue solely on written description, the majority left unanswered the question of whether claims that are broad enough to cover any method to achieve a particular result can ever be valid, as the specification cannot enable unknown methods – a result that would not have happened if there was not a separate written description.
The en banc Court granted Ariad’s petition for a rehearing and vacated the panel opinion. Ariad Pharms., Inc. v. Eli Lilly & Co., 332 F. App’x 636 (Fed. Cir. 2009).