On January 6, 2023, Genentech and Tanvex reached a settlement in principle to resolve all claims with respect to Genentech's BCPIA complaint. As we previously reported, Genentech filed a complaint against Tanvex in June 2022, alleging infringement of three patents under the BPCIA based on Tanvex's submission of an aBLA for TX05, a proposed biosimilar of HERCEPTIN (trastuzumab). Tanvex responded in September 2022, denying infringement of the three patents and asserting counterclaims for declaratory judgment of non-infringement and invalidity. According to the Joint Notice of Settlement, "[t]he Parties are in the process of finalizing the settlement documents and expect that the final executed Joint Stipulation of Dismissal of all claims will be filed within 30 days." The court has also vacated all case deadlines.
Genentech has previously settled with Samsung Bioepis, Centus, Amgen, Pfizer, JHL Biotech, Mylan, Celltrion, and Teva in relation to their respective trastuzumab biosimilars.
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