Earlier this month, in Regents of the University of Minnesota v. Gilead Sciences, Inc., (Fed. Cir. Mar. 6, 2023), a three-judge Federal Circuit panel found that an earlier Gilead patent publication, known as Sofia, anticipated the claims in the University of Minnesota’s U.S. Patent No. 8,815,830 (the “’830 patent”). This finding affirmed a May 2021 Patent Trial and Appeal Board (“PTAB”) holding that numerous claims in the ‘830 patent—­which covers the hepatitis C drug sofosbuvir—were unpatentable as anticipated by Sofia. "The board found that the challenged claims of the '830 patent were anticipated by Sofia," the Federal Circuit panel wrote. "We agree."

In order to satisfy the written description requirement of 35 U.S.C. § 112(a) of the U.S. patent act, “a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention.” For chemical compounds, as is the case here, written description of a broad genus requires description not only of the outer limits of the genus but also of either a representative number of members of the genus or structural features common to the members of the genus. The University of Minnesota (“UMN”) first filed a provisional patent application in 2004, followed by a PCT application in 2005, a non-provisional patent application in 2007, and finally another non-provisional patent application in 2013, which eventually granted as the ‘830 patent.

Prior to UMN’s non-provisional patent application filed in 2013, Gilead’s Sofia patent application (“Sofia”), which discloses every limitation of each challenged claim, was published in 2010. Thus, if UMN’s ‘830 patent properly claimed priority to at least one of its earlier applications filed before Sofia, then UMN could disregard Sofia entirely. However, if UMN is unable to prove its priority claim, then the ‘830 patent would be anticipated by Sofia.

UMN argued that its original provisional filing disclosed the claimed invention in ipsis verbis form by pointing to a combination of elements found in various provisional claims that collectively recited word-for-word claim 1 in the ‘830 patent. In response, the Federal Circuit panel declared that the claims of UMN’s provisional filing “recite a compendium of common organic chemical functional groups, yielding a laundry list disclosure of different moieties for every possible side chain or functional group.” Thus, on this basis alone, the provisional filing does not provide ipsis verbis support for the challenged ‘830 patent claims to entitle these claims to its earlier priority date because the list of possibilities are “so interwoven” that it is unclear how many compounds fall within the genera described. Therefore, the Court affirmed the PTAB’s decision holding that UMN’s earlier applications do not provide sufficient written description to support the ’830 patent claims, and that Sofia therefore anticipated these claims.

This Federal Circuit opinion has further established a standard requiring heightened disclosure in the context of supporting claims to chemical and biological inventions. In particular, the Court’s concern over a patentee receiving claims broader in scope than what has been adequately described in the specification is a recurring theme and one that will further solidify the description requirements for 35 U.S.C. § 112. This opinion is timely as the Supreme Court has granted certiorari in Amgen Inc. v. Sanofi (U.S. No. 21-757), where the Court is tasked with determining whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to "make and use" the invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art "to reach the full scope of claimed embodiments" without undue experimentation.  Oral argument for Amgen Inc. v. Sanofi has been scheduled for March 27, 2023.

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