Sandoz Stipulates to Infringement of Certain Asserted Claims Prior to Etanercept Biosimilar Trial

As we have previously reported, the Immunex v. Sandoz patent litigation under the BPCIA concerning Sandoz’s Erelzi™ (etanercept-szzs) biosimilar is scheduled to begin trial today before New Jersey District Judge Claire C. Cecchi.

Yesterday, prior to the start of trial, the Court entered a stipulation wherein Sandoz stipulated to infringement of certain asserted claims of two of the five patents-in-suit: U.S. Patent No. 8,063,182 (“the ‘182 patent”) and U.S. Patent No. 8,163,522 (“the ‘522 patent”).  Sandoz stipulated that:

  1. Sandoz Inc.’s submission of abbreviated Biologics License Application (“aBLA”) No. 761042 for Defendants’ etanercept biosimilar, infringed claims 11-12 and 35-36 of U.S. Patent No. 8,063,182 under 35 U.S.C. § 271(e)(2)(C);
  2. Sandoz Inc.’s submission of aBLA No. 761042 for Defendants’ etanercept biosimilar infringed claims 3, 8, and 10 of U.S. Patent No. 8,163,522 under 35 U.S.C. § 271 (e)(2)(C);
  3. Defendants’ making, using, offering to sell, or selling of Defendants’ etanercept biosirnilar within the United States, or Defendants’ importation of Defendants’ etanercept biosirnilar into the United States, will infringe claims 11-12 and 35-3 6 of U.S. Patent No. 8,063,182 under 35 U.S.C. § 271(a); and
  4. Defendants’ making, using, offering to sell, or selling of Defendants’ etanercept biosimilar within the United States, or Defendants’ importation of Defendants’ etanercept biosimilar into the United States, will infringe claims 3, 8, and 10 of U.S. Patent No. 8,163,522 under 35 U.S.C. § 271(g).

 

Sandoz further stated that its stipulation of infringement to the claims of the ‘522 patent were “made under the Court’s August 20, 2018 claim construction ruling, without prejudice to Defendants’ right to appeal that ruling.”  The Court’s August 20, 2018 claim construction ruling construed the term “wherein the polynucleotide encodes a protein consisting of” to mean “wherein the polynucleotide contains the genetic information for a protein consisting of.”

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