On February 28, 2022, the Patent Trial and Appeal Board (“PTAB”) issued a decision on priority in an interference proceeding between the Broad Institute, Inc., Massachusetts Institute of Technology, and President and Fellows of Harvard College (collectively, “Broad”) and the Regents of the University of California, University of Vienna, and Emmanuelle Charpentier (collectively, “CVC”), and held that Broad’s inventors were the first to invent the subject matter of Count 1 of the interference,[1] a CRISPR-Cas9 system with a single guide RNA able to cleave or edit DNA to affect gene expression in ..read more

Under 35 U.S.C. § 315(e), inter partes review (IPR) estoppel applies to “any ground that the petitioner raised or reasonably could have raised during that inter partes review.” In 2018, the Federal Circuit held in Shaw Industries Group, Inc. v. Automated Creel Systems, Inc., 817 F.3d 1293 (Fed. Cir. 2016), that IPR estoppel does not apply to grounds where review was denied by the Patent Trial and Appeal Board (PTAB). Later that same year, the Supreme Court held in SAS that if the PTAB institutes review, it must review all challenged claims and asserted grounds, i.e., there cannot be parti ..read more

In a recent article, Real Parties In Interest Guidance On Who Is An RPI-And Who Is Not-In Post Grant Proceedings, linked here, Emily Greb and Maria Stubbing offer practical guidance and examine caselaw to clear some of the confusion and frustration practitioners encounter when real parties-in-interest in post-grant review proceedings before the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board ..read more

On November 2, Senator Thom Tillis—the ranking member of the Senate Judiciary Committee’s Subcommittee on Intellectual Property—sent a letter to acting PTO Director Andrew Hirshfeld expressing concern about the PTAB’s use of “unrealistic” trial schedules to guide institution denials under Apple v. Fintiv. We recently reported our own analysis concluding that approximately 94% of the trial dates the Board relied upon in Fintiv denials issued between May and October 2020 later proved to be inaccurate. Senator Tillis explained that he “support[s] the policies underlying Fintiv” but nonetheless be ..read more

In recent years, the Patent Trial and Appeal Board has frequently declined to institute IPRs for procedural reasons unrelated to a petition’s substantive strength. In particular, the Board has increasingly denied petitions in view of related, parallel litigation that it perceives as so far advanced that it would be most efficient to deny institution and leave patentability issues to be resolved in the other forum. Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (Precedential). Key among the factors guiding those Fintiv denials is whether and to what extent the oth ..read more

Last week, Magistrate Judge Jennifer Hall of the U.S. District Court for the District of Delaware recommended denial of two motions to dismiss and denied a motion to sever in a case involving a novel induced infringement claim against a health insurance provider. See Amarin Pharma, Inc. v. Hikma Pharm. USA Inc., No. 20-1630-RGA-JLH, 2021 WL 3396199 (D. Del. Aug. 3, 2021) (“Amarin R. & R.”) (docket version); Amarin Pharma, Inc. v. Hikma Pharm. USA Inc., No. 20-1630-RGA-JLH, 2021 WL 3363496 (D. Del. Aug. 3, 2021) (“Amarin Mem. Order”) (docket version). The dispute relates to Hikma Pharmaceut ..read more

In two recent decisions in Amgen Inc. v. Sanofi, Aventisub LLC, the Federal Circuit has made clear that broad functional patent claims must be fully enabled and underscored the high bar for enablement of broad biological compound claims including functional limitations.  Amgen v. Sanofi, Aventisub LLC, 987 F.3d 1080 (Fed. Cir. 2021).  On June 21, the Federal Circuit denied Amgen’s petition for rehearing en banc, and the original panel authored an opinion responding to Amgen and the amicis’ concerns that the court’s decision created a new enablement test or eviscerated genus clai ..read more

On June 21, 2021, the Supreme Court held that “35 U.S.C. § 6(c) is unenforceable as applied to the Director insofar as it prevents the Director from reviewing the decisions of the [Patent Trial and Appeal Board] PTAB on his own.”  United States v. Arthrex, Inc., No. 19-1434 slip op. at 22 (U.S. June 21, 2021).  The Court therefore stated that “[t]he Director may engage in such review and reach his own decision.”  Id.  The Court rejected Arthrex’s argument that the entire inter partes review proceeding was unconstitutional because it disagreed with Arthrex that the “goo ..read more

In an inter partes review proceeding, the petitioner first files a petition to challenge the validity of a patent. In response to the petition, the patent owner can file a POPR. Typically, the PTAB then decides whether to institute an IPR trial. In recent years, the rules have provided petitioners with an option to reply to the POPR. But such replies are not available as a matter of right—petitioners must request leave to file from the PTAB. The PTAB has discretion to either grant or deny the request, depending on whether the request satisfies “a showing of good cause” under 37 C.F.R. § 42.108 ..read more

We have previously written about the Patent Trial and Appeal Board’s (“PTAB”) precedential decision in Apple Inc. v. Fintiv, Inc., which set forth six factors the PTAB will consider when assessing whether to discretionarily deny an IPR petition in light of co-pending district court litigation.  Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (March 20, 2020).  The PTAB has been applying the Fintiv factors in subsequent IPRs, many of which involve a stayed district court litigation.  The PTAB has now designated as precedential a decision instituting IPR in Sotera Wireless, In ..read more