Amgen has filed its answer in response to AbbVie’s complaint alleging infringement of 10 patents that allegedly cover Amgen’s recently-approved adalimumab biosimilar, Amjevita (formerly known as ABP501).
Amgen asserts that AbbVie’s responses to its aBLA and required disclosures were deficient. Specifically, Amgen asserts that AbbVie did not provide an adequate “(3)(c) statement,” or detailed statement of validity, enforceability, and infringement for each of the 61 patents AbbVie originally identified. Amgen also indicated that it “intends to fully comply with its obligations under 42 U.S.C. § 262(l)(8)(A),” which provision states that the biosimilar applicant “shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).”
Amgen asserts a number of affirmative defenses, including invalidity, non-infringement, and inability to maintain a cause of action due to alleged failure to comply with the BPCIA. Amgen also lodged counterclaims of invalidity and noninfringement for each of the patents-in-suit.
Stay tuned to Big Molecule Watch for further updates.