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, a CRISPR-Cas9 system with a single guide RNA able to cleave or edit DNA to affect gene expression in a eukaryotic cell. The Regents of the University of California v. The Broad Institute, Inc., Interference No. 106,115, Decision on Priority at 2, 4 (PTAB Feb. 28, 2022). Continue Reading PTAB Declares that Broad Institute, MIT, and Harvard Inventors Were First to Invent a CRISPR-Cas Gene Editing System to Alter Gene Expression in Eukaryotic Cells
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 partial institution. SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348 (2018). In the latest line of these cases, the Federal Circuit held in California Institute of Technology v. Broadcom Ltd., Nos. 2020-2222, 2021-1527, 2022 WL 333669 (Fed. Cir. Feb. 4, 2022) (original opinion) (errata), that IPR estoppel applies to all grounds that reasonably could have been asserted against the challenged claims, including grounds that were not stated in the petition. Continue Reading Federal Circuit Confirms the Broad Reach of IPR Estoppel
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.
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. Continue Reading Senator Tillis Asks the PTO to Reconsider Fintiv Factor Two
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 other proceeding’s trial date is scheduled to precede the Board’s deadline for issuing a final written decision, i.e., Fintiv factor two. Id. at 9.
But how reliable are those trial dates?
Section 325(d) gives the Patent Trial and Appeal Board (“PTAB”) discretion to deny a post-grant petition when “the same or substantially the same prior art or arguments previously were presented to the Office.” 35 U.S.C. § 325(d). Both the PTAB and the Federal Circuit have opined on the discretionary denial provisions in 35 U.S.C. § 325(d) in the context of serial inter partes review (“IPR”) petitions. The Federal Circuit has now held that § 325(d) applies to requests for ex parte reexamination. This decision did not involve biotechnological subject matter, but the holdings are nevertheless applicable. Continue Reading Federal Circuit Applies § 325(d) to Reexamination Requests
The Federal Circuit’s August 5, 2021 ruling in GlaxoSmithKline LLC v. Teva Pharm. USA, Inc. (link to issued opinion), is an important development in the law of “skinny” generic pharmaceutical labels and induced infringement claims. See GlaxoSmithKline LLC v. Teva Pharm. USA, Inc., 7 F.4th 1320 (Fed. Cir. 2021) (“GSK II”) (Google Scholar link). Read on for important aspects of the majority’s opinion and Judge Prost’s dissent. Continue Reading Federal Circuit Issues Second GSK v. Teva Opinion On “Skinny” Label-Based Inducement
On June 21, 2021, the Supreme Court held the Director of the USPTO “may review final PTAB decisions and, upon review, may issue decisions himself on behalf of the Board.” United States v. Arthrex, Inc., 141 S. Ct. 1970, 1987 (2021) (holding that 35 U.S.C. § 6(c)—“Only the Patent Trial and Appeal Board may grant rehearings”—cannot be constitutionally enforced against the Director for inter partes review proceedings). In this way, the agency’s decisions now have the imprimatur of the President-appointed and Senate-confirmed Director, otherwise eliminating a constitutional infirmity under the Appointments Clause. U.S. Constitution, Art. II, § 2, cl. 2; see Arthrex, 141 S. Ct. at 1985–86. Of note, presently, Drew Hirshfeld, Commissioner for Patents, is performing the functions and duties of the Director and does not intend to defer Director review until a political appointee is confirmed. PTAB Boardside Chat (July 1, 2021) at 28:00–50.
To facilitate the Director’s review, the USPTO has outlined an interim procedure that the agency expects to evolve over time. See Arthrex Q&As, https://www.uspto.gov/patents/patent-trial-and-appeal-board/procedures/arthrex-qas (July 20, 2021); USPTO Implementation of an Interim Director Review Process Following Arthrex, https://www.uspto.gov/patents/patent-trial-and-appeal-board/procedures/uspto-implementation-interim-director-review. Presently, the interim procedures apply only to final written decisions in inter partes review, post-grant review, and covered business method review proceedings, not institution decisions. PTAB Boardside Chat (July 1, 2021) at 31:44–32:38, 52:53–53:15. Continue Reading Post-Arthrex Interim Procedure for Director Review of PTAB Decisions
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 Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC’s (collectively, “Hikma”) generic version of the plaintiffs’ VASCEPA® product (icosapent ethyl). Hikma’s generic product has been on the market since November 2020. See Amarin R. & R., 2021 WL 3396199, at *3. The plaintiffs asserted three patents against Hikma and a health insurance company, Health Net, LLC (“Health Net”). Hikma and Health Net both moved to dismiss for failure to state a claim, and Health Net also moved to sever the claims against it from those against Hikma. Magistrate Judge Hall recommended that the motions to dismiss be denied, and she denied the motion to sever. Id. at *1; Amarin Mem. Order, 2021 WL 3363496, at *1. Continue Reading Delaware Magistrate Judge: Novel Induced-Infringement Claim Against Health Insurance Provider Survives Dismissal
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 claims. Amgen Inc. v. Sanofi, Aventisub LLC, No. 20-1074, 2021 WL 2525530 (Fed. Cir. June 21, 2021). Patentees claiming biological materials should be aware that “[e]nablement is required, even for generic claims to biological materials[,]” and “as with genus claims to chemical compounds, if they encompass more subject matter than just a few species, they need to be enabled accordingly.” Id. at *1. Further, “[b]iological compositions not actually prepared need to be described constructively, if required to enable the full scope of the claims, with procedures and names of resultant compositions, as with chemical compositions.” Id. Continue Reading Federal Circuit emphasizes high bar for enablement of functional claims