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?

Continue Reading How reliable are trial dates relied on by the PTAB in the Fintiv analysis?

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

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 “good cannot be separated from the bad.”  Id. at 20.  Instead, the Court found that the constitutional violation was the lack of review by the Director.  By providing the Director authority to take control, the Administrative Patent Judges (APJs) properly function as “inferior officers” who are not appointed by the President.  Id. at 21.

Also of note, the Court limited its holding to the Director’s supervision of APJs in the inter partes review context, and specified that its holding did not look at other adjudications by the PTAB.  Id. at 22.

As applied to the facts in Arthrex, the Court stated that “appropriate remedy is remand to the Acting Director for him to decide whether to rehear the petition filed by Smith & Nephew.” Id. at 22.  The Court stated that this “provides an adequate opportunity for review by a principal officer.”  Id. at 22-23.

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(c). If the PTAB grants the request, then typically, the petitioner and patent owner both receive authorization to file another brief paper, usually around five pages, before the PTAB issues an institution decision.

To date, it has not been clear what qualifies as “good cause” when a petitioner decides to reply to the POPR. Is the filing of a reply a strong predictor of the institution decision? We analyzed the role of petitioners’ replies to POPRs in recent PTAB proceedings, and our research provides a fresh view on the replies’ impact on corresponding institution decisions. In addition, our findings include updated practice tips for IPR practitioners.

Continue Reading What Qualifies as a Good “Good Cause” When Responding to a Patent Owner’s Preliminary Response?