Year in Review: Top Legal Developments of 2021 Impacting Biosimilars

As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars.  There were many interesting decisions and other developments in district court, at the Federal Circuit, at the PTAB, and even at the ITC.  Biosimilars also saw some attention from Congress, as new legislative proposals were considered and passed.  Below is our recap of the top five legal decisions and developments that will likely impact legal strategy in the biosimilars space in 2022 and moving forward.

  1. Antitrust Litigation Continues: The industry has been watching as litigation continues on antitrust claims against AbbVie and J&J regarding their patenting and contracting practices.  In July, Pfizer and J&J settled and agreed to dismiss Pfizer’s claims that J&J violated the Sherman Act and Clayton Act by entering into de facto exclusivity agreements with insurers and providers of Remicade that excluded competitors.  Meanwhile, an appeal remains pending that could revive claims that AbbVie’s so-called “patent thicket” on its Humira product harmed competition.
  2. Written Description and Enablement Take Center Stage: Litigation over the requirements of the patent statute that a patent be adequately described and enabled were prevalent throughout 2021.  In February, the Federal Circuit affirmed a decision invalidating two Amgen patents that were alleged to cover Amgen’s cholesterol-lowering drug Repatha® (evolocumab) and Sanofi’s Praluent® (alirocumab).  Amgen petitioned for rehearing, which Sanofi opposed; the Federal Circuit denied Amgen’s petition over the summer.  In another case, the Federal Circuit invalidated a patent related to a nucleic acid polymer encoding a three-part CAR for a T cell for lack of written description, undoing a prior $1.2 billion jury verdict in favor of the patent owner.  We expect written description and enablement issues to remain at the forefront of biologics litigation in 2022.
  3. PTAB Remains Important Venue for Biologics Patent Challenges: As followers of our PTAB Tracker know, PTAB challenges continued in 2022.  Fresenius is pursuing challenges to Chugai, Roche, and Genentech patents related to treatment of rheumatoid arthritis.  Mylan was successful in its IPR on a patent covering the mechanics of a drug delivery pen device for dispensing dosed drug from a cartridge related to Sanofi’s Lantus product.  Meanwhile, all eyes were on the Supreme Court as it considered the constitutionality of inter partes review proceedings in the Arthrex case.  In June, the Supreme Court held that the PTAB is unconstitutionally structured, and that the remedy is to implement an opportunity for PTO Director review in order to allow him or her to decide whether to reconsider a panel decision in an IPR or similar proceeding.
  4. Biosimilars and Generics Get Congress’s Attention: Laws governing generic and biosimilar pharmaceutical products saw legislative activity in 2021.  In January, the President signed the Orange Book Transparency Act, which, among other things, clarified information related to patent listing and the types of patents that should be listed in the Orange Book.  In March, the Senate passed a bill to promote education for health care providers and the public on biosimilar products; the legislation then passed the House and was signed into law in April.  Other legislation has been proposed, including a Senate bill that would prohibit biological product manufacturers from compensating biosimilar and interchangeable biological companies in exchange for delaying entry of those biosimilar and interchangeable biological products.  We will be watching to see if there’s action on any other pending bills in the second half of the 117th Congress.
  5. ITC Investigation Is a New Front in Battle over Adalimumab Biosimilar: Alvotech is the latest biosimilar manufacturer to spar with AbbVie over its Humira patent portfolio.  Earlier this year, an Illinois district court dismissed AbbVie’s complaint against Alvotech hf. alleging theft of trade secrets relating to adalimumab.  Just last week, AbbVie fired back by filing a complaint at the U.S. International Trade Commission against proposed respondents Alvotech, Teva, and others, requesting that the ITC investigate alleged theft of trade secrets relating to adalimumab and seeking to exclude importation of adalimumab by Proposed Respondents.  Although investigations involving intellectual property infringement allegations at the ITC have been on the rise in recent years, the ITC remains a relatively uncommon venue for matters involving pharmaceutical and biotech products.  The industry will be watching as AbbVie pursues its claims in this new venue in 2022.