C.A. No. 09-11340-FDS, 2013 WL 952380 (D. Mass. March 8, 2013) (Saylor, D.J.) [Post-Trial Motions]

Following an eleven day trial in the Fall of 2012, Plaintiffs AbbVie Deutschland GmbH & Co., AbbVie Biosearch Center, Inc., and AbbVie Biotechnology Ltd. (collectively, “Abbott”) filed a renewed motion for judgment as a matter of law seeking to overturn the jury’s verdict with respect to its invalidity findings. The Court (Saylor, D.J.) denied Abbott’s motion.

In 2009, Abbott initiated suit against Janssen Biotech, Inc. and Centocor Biologics, Inc. (collectively, “Centocor”),1 alleging that Centocor’s product, Stelara, infringed U.S. Patent Nos. 6,914,128 (the “‘128 patent”) and 7,504,485 (the “‘485 patent”). The patents are directed to a set of antibodies for interleukin-12 (IL-12), a naturally-occurring human protein that assists the immune system by binding to receptors on the surface of certain cells in response to infection. Overproduction of IL-12 can lead to immune diseases, such as psoriasis, and, therefore, the antibodies at issue in this case seek to block the effects of IL-12. At trial, Centocor did not contest infringement. It did, however, assert that the patent claims were invalid under 35 U.S.C. §§ 102, 103, and 112. The jury agreed, finding invalidity on three separate grounds: written description, enablement, and obviousness. This summary focuses on the first two of those three grounds.

Written Description

Abbott challenged the jury’s finding that the patent-in-suits’ claims failed to meet the written description requirement. To meet that requirement, where a patent claims a genus, the specification must adequately describe species that are “representative of the entire genus.” “When there is a substantial variation within the genus, one must describe a ‘sufficient variety of species to reflect the variation within the genus.’” Abbott argued post-trial that the evidence proffered by Centocor regarding whether the disclosed antibodies were representative of other members of the genus was irrelevant because it was based only on structural differences between the disclosed and non-disclosed species. It also argued that differences between the disclosed antibodies and the allegedly infringing product, Stelara, were irrelevant.

First, Judge Saylor found that, based on the evidence elicited at trial—including testimony from Abbott’s expert—the jury was free to credit Centocor’s claim that structure is relevant to the functional claims and that the disclosed species were not representative. Indeed, Abbott’s own expert testified that he had “no idea how many antibodies would meet the scope of the claims.” At bottom, Abbott’s evidence “was not so overwhelming as to require a conclusion of representativeness.”

Second, the Court found that it was not unreasonable for the jury to infer that, if the claimed genus included an antibody that was fundamentally different from the disclosed antibodies, that the disclosed antibodies were not representative. Because Stelara indisputably fell within the claimed genus, Centocor used differences between Stelara and the disclosed antibodies to illustrate the variety within the genus. The Court held that it was not unreasonable for the jury to be persuaded by this illustration.

Judge Saylor also rejected Abbott’s various other legal and policy arguments. Although accepting the general principle that there is “no universal requirement that a patent disclose every species,” the Court held that the failure to disclose one species could render the patent invalid if that species calls into question the representativeness of the disclosed species. Moreover, the Court emphasized that representativeness, a question of fact, is not the same as numerosity. Next, the Court analyzed the Federal Circuit’s language in Ariad Pharmaceutials, Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010) (en banc). That case set forth two tests for the written description requirement: (1) a representative species test and (2) a structural features test. Abbott contended that in applying the first of these two tests, one need not determine whether one of skill in the art can “visualize or recognize” the members of the genus based on the representative number of species. This contention, however, was found to be unsupportable. Finally, the Court disagreed with Abbott’s concern that Centocor’s structural arguments, when taken to their logical extreme, would allow future defendants to argue invalidity based on arbitrary distinctions, such as molecular weight. Focusing only on the issue before him, Judge Saylor concluded that “there was sufficient testimony about the relevance of structure to the claim limitations to establish a clear link between structure and function.”

Enablement

As with written description, the law requires, when a patent claims a genus, that the specification enable a representative number of species falling within its scope. Although the patent indisputably enabled the disclosed species, the central question was whether it enabled enough species so as to be representative of the genus. The jury found, in part on the basis that Stelara was not enabled, that the patent did not enable the full scope of the claimed invention. The Court upheld this verdict for the same reasons that it upheld the verdict with respect to written description.