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.
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, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (Dec. 1, 2020). In this IPR, although the co-pending district court case was not stayed, Sotera Wireless (“Sotera”) filed a stipulation relinquishing all potentially duplicative arguments. The PTAB allowed the IPR to proceed, noting that the stipulation avoided duplication and prevented conflicting results, chief components of the Fintiv factors. More detail on this decision is below. Continue Reading One More Tool to Avoid Fintiv IPR Denial: File A Stipulation in District Court Relinquishing Potentially Duplicative Arguments
On January 5, 2021, the Orange Book Transparency Act of 2020, H.R. 1503, was signed into law. H.R. 1503 amends provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) related to patent information that new drug applicants must submit to the Food and Drug Administration (“FDA”) and FDA must publish in the “Orange Book.” See H.R. 1503, 116th Cong. § 2(a)–(d) (2021). The amendments require “manufacturers to share complete and timely patent information with the . . . (FDA), ensure that periods of exclusivity listed in the Orange Book are promptly updated, and clarify that patents found to be invalid through a court decision or a decision by the Patent Trial and Appeal Board would be required to be removed from the Orange Book promptly, but not before time for appeal has expired.” H.R. Rep. No. 116-47, at 3–4 (2019). The amendments also require FDA and the Comptroller General to submit reports to Congress about the types of patents that should and should not be listed in the Orange Book. See H.R. 1503 § 2(e)–(f). Continue Reading Orange Book Transparency Act of 2020 Signed Into Law
As part of the post-grant proceedings created in 2012 by the America Invents Act, a Patent Owner can choose to file a motion to amend its patent when that patent is challenged. See 35 U.S.C. § 316(d) (“Amendment of the patent.”); 37 CFR § 42.121 (“Amendment of the patent.”). For example, a Patent Owner may file a contingent motion to amend in lieu of filing a Patent Owner Response after institution of an inter partes review, cancelling the original, challenged claims. Or, the Patent Owner may file a noncontingent motion to amend with its Patent Owner Response, which allows the Patent Owner to argue that both the proposed and the original claims are patentable. However, the Petitioner in an instituted review can challenge the patentability of any proposed amended claims, arguing, for example, that the claims were anticipated by the prior art, or would have been obvious, or fail the requirements of 35 U.S.C. § 112. See Aqua Prods., Inc. v. Matal, 872 F.3d 1290, 1315 (Fed. Cir. 2017).
After several years of experience with post-grant proceedings involving motions to amend, the PTAB studied various aspects of the practice surrounding these motions. The PTAB then proposed two major changes to the motion to amend process, and implemented them in March 2019 in a Motion to Amend Pilot Program. The PTAB’s changes provided:
- A Patent Owner can request “preliminary guidance” from the PTAB regarding the patentability of proposed amended claims, when filing a motion to amend; and
- A Patent Owner can file a revised motion to amend regardless of whether the Patent Owner requests preliminary guidance.
Now, Tyler Bowen and Katherine Nesler, Ph.D., have published a short research paper entitled The Impact of the PTAB’s Motion to Amend Pilot Program [PDF], examining how the Pilot Program affected motion to amend practice. Tyler and Katherine’s research identified proceedings that involved a motion to amend, among the nearly 5,000 trials completed by March 31, 2020, and characterized and compared the outcomes of motions filed before versus after the Pilot Program began. In their paper, Tyler and Katherine identify trends in the data and provide practical tips, for both Patent Owners and Petitioners, regarding the motion to amend process.
We encourage you to download the paper, and hope you find the authors’ insights informative and helpful.
On December 4, 2020, the Board designated three cases from October as precedential. Together, the rulings help understand the Board’s approach to both serial challenges to issued patents and application of 35 U.S.C. § 315’s limitations on proceedings. Two of the newly precedential decisions address the real party in interest (“RPI”) requirement and the third concerns follow-on petitions and joinder motions. See RPX Corp. v. Applications in Internet Time, LLC, IPR2015-01750, Paper 128 (P.T.A.B. Oct. 2, 2020) (“RPX”); Apple Inc. v. Uniloc 2017 LLC, IPR2020-00854, Paper 9 (P.T.A.B. Oct. 28, 2020) (“Apple v. Uniloc”); SharkNinja Operating LLC v. iRobot Corp., IPR2020-00734, Paper 11 (P.T.A.B. Oct. 6, 2020) (“SharkNinja”).Read more about these decisions below. Continue Reading PTAB designates three precedential cases on Section 315’s time-bar and estoppel provisions