Posts Tagged: "Method of Treatment Claims"

On Monday, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in Biogen MA, Inc. v. EMD Serono, Inc., reversing the U.S. District Court for the District of New Jersey’s judgment as a matter of law (JMOL) for Biogen. The New Jersey court had found no anticipation of Biogen’s patent claims, overturning a jury’s finding that the claims were anticipated by the prior art. The Federal Circuit’s decision, which turned on the issue of applying a product-by-process novelty analysis to certain nested claim limitations, said that a reasonable jury could find the claims anticipated and remanded with instructions to reinstate the jury verdict.

Earlier this month, Mallinckrodt succeeded in its inter partes review (IPR) challenge against patent owner Biovie, Inc. (Biovie). The Patent Trial and Appeal Board’s (PTAB’s) final determination held that all claims of Biovie’s U.S. Patent No. 9,655,945 (the ‘945 patent) were unpatentable. The claims of Biovie’s ‘945 patent, directed to administering terlipressin to ascites (abnormal buildup of fluid in the abdomen) patients, were deemed anticipated and/or obvious over the prior art. During the IPR, Biovie attempted to use the recent Federal Circuit decision from OSI Pharmaceuticals v. Apotex (OSI) as a shield to patentability, but the shield was unsuccessful. As such, OSI is unlikely to be a cure-all for pharmaceutical method of treatment claims, in IPR proceedings or otherwise.

This article examines Federal Circuit case law analyzing validity challenges to method of treatment patent claims where the claims at issue are alleged to recite an inherent property of a method or molecule taught in the prior art. While Federal Circuit case law challenging method of treatment claims on inherent anticipation grounds is generally globally consistent and reasonably straightforward, the court’s inherent obviousness case law is less so.