Certain Pertuzumab Biosimilars, Including Those Made by Certain Methods of Manufacturing, the Active Ingredient Thereof, and Products Containing the Same; Inv. No. 337-TA-3890 (Violation)

Genentech, Inc. gives notice under 19 C.F.R. § 210.10(a)(5)(i) that it is withdrawing its February 27, 2026 complaint concerning pertuzumab biosimilars, relying on representations by proposed respondents Biocon Ltd., Biocon Biologics Ltd., Biocon Biologics UK PLC, and Biocon Biologics Inc. The withdrawal ends the Section 337 investigation over Biocon's pertuzumab biosimilar before any exclusion order could be considered. It rests on Biocon's representations that its importation falls within the 35 U.S.C. § 271(e)(1) safe harbor and that it has no U.S. commercial distribution arrangement. Genentech reserves the right to file a new complaint if those representations prove inaccurate. Complainant Genentech, Inc. withdraws its February 27, 2026 Complaint (EDIS Doc. ID 873837 public, 873842 confidential). Proposed respondents are Biocon Ltd., Biocon Biologics Ltd., Biocon Biologics UK PLC, and Biocon Biologics Inc. Biocon represented that its importation of BMAB 1500/PERT-IJS was solely for uses reasonably related to FDA submissions under the 35 U.S.C. § 271(e)(1) safe harbor. Biocon also represented that it has no agreement or communications with a U.S. distributor about commercial distribution of its pertuzumab biosimilar. Genentech may file a new complaint if it learns the representations are inaccurate or finds further evidence of importation or sale. The notice does not identify the asserted patents or the domestic industry allegations.