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

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 October 13, 2020, the Supreme Court granted petitions for certiorari filed by the United States (in No. 19-1434), Smith & Nephew, Inc. (in No. 19-1452), and Arthrex, Inc. (in No. 19-1458) regarding the appointments of the administrative patent judges of the Patent Trial and Appeal Board.  No date has been set to argue the cases, but the Court consolidated them and allotted one hour for argument time.  Because the Court consolidated the cases for briefing and oral argument, it noted that “future filings and activity in the cases will now be reflected on the docket of No. 19-1434.”  On December 31, 2020, the Court set oral argument for March 1, 2021.

The various petitions were granted only to the extent of “Questions 1 and 2 as set forth in the July 22, 2020 Memorandum for the United States.”  See Orders List at 2.

Question 1 asks “[w]hether, for purposes of the Appointments Clause, U.S. Const. Art. II, § 2, Cl. 2, administrative patent judges of the U.S. Patent and Trademark Office are principal officers who must be appointed by the President with the Senate’s advice and consent, or ‘inferior Officers’ whose appointment Congress has permissibly vested in a department head.”

Question 2 asks “[w]hether, if administrative patent judges are principal officers, the court of appeals properly cured any Appointments Clause defect in the current statutory scheme prospectively by severing the application of 5 U.S.C. § 7513(a) to those judges.”

Links to the briefs, and details of the briefing schedule, are below. [Updated 1/8/2021, to reflect most current filings, and argument date]
Continue Reading Supreme Court grants certiorari in PTAB Appointments Clause cases

In Uniloc 2017 LLC v. Hulu, LLC, No. 2019-1686 (Fed. Cir. July 22, 2020), the Federal Circuit considered whether the AIA permits the PTAB to reject substitute claims proposed during an IPR for patent ineligibility under § 101.
Continue Reading Federal Circuit confirms that the PTAB can consider the patent eligibility of substitute claims proposed during an IPR

Last week, we wrote about Arthrex, Inc. v. Smith & Nephew, Inc. and described recent developments that suggested the Federal Circuit was leaning toward holding that all current PTAB judges had been unconstitutionally appointed in violation of the Appointments Clause of Article II. The Federal Circuit has now done just that
Continue Reading Federal Circuit Holds that PTAB Judges Were Unconstitutionally Appointed

An order from the Federal Circuit on October 15 suggests the court may be close to holding that the PTAB has been operating in violation of the Appointments Clause, which could significantly disrupt PTO operations.  The case presents important questions: whether the PTAB’s judges have been lawfully appointed, and if not, what happens to decisions that have been issued by panels of those judges?
Continue Reading Constitutional Challenge under the Appointments Clause May Upend PTAB Proceedings

On July 30, the Federal Circuit issued a decision in Celgene Corporation v. Peter (Nos. 2018-1167, -1168, -1169, and -1171), where the patent owner argued that the PTAB’s authority to cancel claims through IPR amounted to an unconstitutional taking as applied to pre-AIA patents. Numerous patent owners have raised similar challenges since the Supreme Court expressly reserved judgment on the issue in Oil States Energy Services, LLC v. Greene’s Energy Group, LLC, 138 S. Ct. 1365, 1379 (2018). The Federal Circuit’s decision puts that issue to rest (at least for now) and confirms that all issued patents remain subject to IPR.

Background

The Celgene appeal arose
Continue Reading Federal Circuit Rejects Latest Constitutional Challenge to Inter Partes Review

In Amerigen Pharmaceuticals v. UCB Pharmaceuticals, the Federal Circuit held that a generic Abbreviated New Drug Application (“ANDA”) filer with a Paragraph III certification to an Orange Book-listed patent has standing to appeal decisions from the Patent Trial and Appeal Board (“the Board”). Case No. 17-2529, Doc. 54, January 11, 2019 (the “Decision”). In this case, Amerigen was a Petitioner in inter partes review proceedings involving U.S. Patent No. 6,858,650 (“the ’650 patent”). The Board found the challenged claims not unpatentable, and Amerigen appealed. On appeal, UCB argued that Amerigen lacked standing to appeal because Amerigen had filed a Paragraph III certification with its ANDA. The Federal Circuit disagreed.
Continue Reading ANDA Filers with Paragraph III certifications = standing to appeal Inter Partes Review decisions according to Federal Circuit

In the chemical and biological arts, it is common for patent challengers to allege obviousness based upon prior art disclosures of ranges combined with “routine optimization” by one skilled in the art.  In E.I. du Pont de Nemours & Co. v. Synvina C.V., No. 17-1977 (Fed. Cir. Sept. 17, 2018), the Federal Circuit reversed the PTAB’s (“Board”) final written decision upholding Synvina’s U.S. Patent No. 8,865,921 (“’921 patent”) as non-obvious, in response to du Pont’s inter partes review (“IPR”) challenge on such grounds.  In particular, in E.I. du Pont, the Court found that the patentee failed to demonstrate that 1) the claimed range produced a new and unexpected result, different in kind and not merely in degree from the prior art, 2) the optimized parameter was not recognized as a result-effective variable, 3) the disclosure of broad ranges did not invite more than routine optimization, or 4) that the prior art taught away from the range.
Continue Reading Obviousness of Overlapping Ranges – The Burden-Shifting Framework Applies to Inter Partes Review: E.I. du Pont de Nemours & Co. v. Synvina C.V.

The Federal Circuit recently held that a product catalog distributed at a trade show was “publicly accessible,” and therefore qualified as prior art. In Nobel Biocare Services AG, v. Instradent USA, Inc., decided on September 13, 2018, the Federal Circuit affirmed the Patent Trial and Appeal Board’s (“PTAB”) finding that a catalog distributed at the International Dental Show (“IDS”) Conference in Cologne, Germany was publicly accessible. The court’s decision in Nobel hinged largely on the testimony of two declarants, one who went to the conference (Zvi Chakir), and another who Chakir gave the catalog to upon his return (Yechiam Hantman).
Continue Reading Federal Circuit again finds product catalog distributed at trade show to be “publicly accessible”