Impact Of Nautilus On Biotech And Pharmaceutical Patents

In Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120 (2014), the Supreme Court rejected the Federal Circuit's "insolubly ambiguous" standard for determining whether a patent claim meets the definiteness requirement under 35 U.S.C. §112, ¶ 2, and held that "a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention." In the ensuing one and a half years, the Federal Circuit and several trial courts have applied the Nautilus standard in the biotechnology and pharmaceutical contexts. We discuss three notable decisions.

In Teva Pharms. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335 (Fed. Cir. 2015), the Federal Circuit, on remand from the Supreme Court decision in Teva Pharms. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831 (2015), found a disputed patent claim indefinite in part based on conflicting representations made by the patentee during the prosecution of two related applications. The term was "molecular weight," or average molecular weight in the context of a synthetic copolymer. The concept of average molecular weight is also relevant to technologies concerning other macromolecules, such as proteins and DNA. Specifically, the Federal Circuit found that while average molecular weight can be ascertained by any of three possible measures, the claims do not indicate which measure to use, and the specification does not define molecular weight or mention any of the three measures. Additionally, the patentee argued conflicting positions during prosecution of two related patents containing identical disclosure, stating that one measure applies in one application and another applies in the other application. In light of the specification and the prosecution history of the related applications, the Federal Circuit held that the patentee failed to meet the reasonable certainty standard under Nautilus.

In Regeneron Pharms., Inc v. Merus B.V., 2014 U.S. Dist. LEXIS 163350 (S.D.N.Y. Nov. 21, 2014), the district court held a term in a patent related to genetic technologies indefinite because its metes and bounds cannot be determined with reasonable certainty. The patent relates to a mouse genetically modified to include human DNA at specific locations of a mouse chromosome. The disputed term was "endogenous mouse immunoglobulin locus." The court found it significant that...