On September 9, 2022, Biogen Inc. and Biogen MA Inc. (“Plaintiffs”) filed suit against Sandoz Inc., Sandoz International GMBH, Sandoz GMBH, and Polpharma Biologics S.A. (collectively, “Defendants”) in the District of Delaware concerning twenty-eight different patents. Although the complaint was filed under seal, the complaint appears to be related to Defendants’ natalizumab biosimilar (proprietary name of Tysabri®). Sandoz announced on July 25, 2022 that the FDA had accepted its aBLA for natalizumab. Biogen’s twenty-eight asserted patents have not yet been listed in the Purple Book. This suggests that either (1) Sandoz already provided its 180-day notice of commercial marketing under 42 USC § 262(l)(8)(A), or (2) Sandoz may have opted out of the patent dance by refusing to produce its aBLA and associated documents (see § 262(l)(9)). On September 12, Judge Connolly granted Plaintiffs motion to file the complaint under seal. The order requires Biogen to file a redacted version of the complaint by September 19, which will then provide more details on the BPCIA litigation. We will provide further updates as the case progresses.
Updated on September 20, 2022
The redacted, publicly available version of the complaint is now available. Based on the information in the complaint, Biogen claims that Defendants have provided some, but not all, of the information contemplated by 42 USC § 262(l) regarding the Defendants’ natalizumab aBLA product. Biogen asserts that Defendants have not provided all information requested under 42 USC § 262(l)(2)(A)-(B), and have not provided a complete response to Biogen’s list of asserted patents under 42 USC § 262(l)(3)(B)(ii). Because of these alleged failures to comply with the statute, Biogen has sought a declaratory judgment of patent infringement as permitted under 42 USC § 262(l)(9)(B).