Big Molecule Watch
January 6, 2023

Year in Review: Top Legal Developments of 2022

As we ring in the new year, we look back at the top legal developments of 2022 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district court, at the Federal Circuit, and at the PTAB. Below is our recap of the top five legal decisions and developments in the biosimilars space in 2023.

  1. Supreme Court Grants Cert to Address Enablement in Amgen Case

In November, the U.S. Supreme Court granted Amgen’s petition for writ of certiorari and agreed to review “whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to ‘make and use’ the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art ‘to reach the full scope of claimed embodiments’ without undue experimentation.” The case will be argued in early 2023 and will likely be decided by June 2023.

  1. Regeneron Files Antitrust Lawsuit

In June, Regeneron Pharmaceuticals, Inc. filed an antitrust complaint against Amgen Inc. in the U.S. District Court for the District of Delaware. In its complaint, Regeneron alleges that Amgen is engaged in an “unlawful, anticompetitive bundling scheme” that allegedly forces third-party payors to “jettison Regeneron’s Praluent® in favor of Amgen’s Repatha®.” Specifically, Regeneron alleges that Amgen is conditioning rebates on its Otezla® and Enbrel® drugs “on exclusivity or practical exclusivity” for Repatha® on drug formularies.  Regeneron claims that “Amgen’s bundled rebate scheme further excludes competition” by pricing Repatha® below its costs such that Regeneron “cannot make a financially viable case for Praluent®.” And, according to Regeneron, Amgen’s “scheme” is working: “As a result of Amgen’s anticompetitive practices, in 2022, Regeneron stands to lose money for the first time on the formerly profitable Praluent®.” Regeneron is seeking an injunction, actual damages, treble damages, costs, and attorneys fees, and a jury trial.  No trial date has been scheduled.

  1. Federal Circuit Reverses PTAB Decision in Amgen Biosimilar Related IPR Appeal

In April, The U.S. Court of Appeals for the Federal Circuit reversed the PTAB’s determination in IPR2016-01542 that certain claims of Amgen’s U.S. Patent No. 8,952,138 are obvious.  Amgen appealed the Board’s construction of “final thiol-pair ratio” and its obviousness determination based on the construction.  The Federal Circuit agreed with Amgen, and found the PTAB’s construction “inconsistent with the plain language of claim 1 and the specification.” Under the correct construction, the Federal Circuit found that claims 1-24 of the ’138 patent were not obvious over the prior art and reversed the PTAB’s decision.

  1. The Seventh Circuit Affirms Dismissal of the HUMIRA Antitrust Litigation

In August, the Seventh Circuit issued a long-awaited opinion in the HUMIRA antitrust litigation, UFCW Local 1500 Welfare Fund v. AbbVie Inc., Case No. 20-2402.  This case was an appeal from the Northern District of Illinois’s dismissal of a proposed class action alleging that AbbVie, Inc. created a “patent thicket” around HUMIRA to block biosimilars from entering the market and entered into “reverse payment” settlement agreements with biosimilar applicants to further delay entry. The Seventh Circuit affirmed the dismissal, agreeing that nothing alleged in the complaint stated an antitrust violation.

  1. PTAB Issues Final Written Decisions Finding Claims of Regeneron’s Aflibercpt Patents Invalid

In November, the PTAB issued final written decisions in IPR2021-00880 and IPR2021-00881, where Mylan was challenging two Regeneron patents related to aflibercept—U.S. Patent Nos. 9,254,338 and 9,669,069.  The PTAB ruled in Mylan’s favor in both IPRs, holding all challenged claims of both patents invalid as anticipated by the same prior art reference.  Mylan also filed three additional IPR petitions challenging claims of Regeneron patents directed to treating angiogenic eye disorders—IPR2022-01225, IPR2022-01226, and IPR2023-00099.  Institution decisions on IPR2022-01225 and IPR2022-01226 are expected in January 2023 and the institution decision on IPR2023-00099 is expected in April 2023.

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