Trastuzumab Biosimilar Litigation update (US): Genentech VS Tanvex Case Summary

Basic Information:

• Case Title: Genentech, Inc. v Tanvex BioPharma USA, Inc., Tanvex BioPharma, Inc., Tanvex Biologics, Inc., and Tanvex Biologics Corporation
• Case Number: 3:22-cv-0809-RBM-JLB
• Complaint Filing Date: Jun 02, 2022
• Court Name: The U.S. District Court for the Southern District of California
• Complaint filed for: Infringement of three patents under the BPCIA based on Tanvex’s submission of an aBLA (aBLA761266) for TX05, a proposed biosimilar of Herceptin (Trastuzumab).  Genentech asserts that Tanvex’s process for manufacturing TX05 infringes three patents.
• Patents in suit: US10662237B2, US10808037B1 & US8574869B2

Earlier in this Case: 

Exchanges under the BPCIA (Genentech's Complaint dated Jun 01, 2022):

• Oct 04, 2021: Tanvex announced that the FDA had accepted its aBLA No. 761266 for review.
• Oct 27, 2021: Tanvex provided Genentech with a copy of its aBLA. By providing its aBLA only, Tanvex did not provide all of manufacturing information for TX05 required by 42 U.S.C. § 262(l)(2)(A).
• On Nov 12, 2021: Genentech responded by identifying deficiencies in Tanvex’s production of manufacturing information and requesting specific information concerning the manufacturing of Tanvex’s biosimilar product. Genentech further explained that Tanvex’s production was deficient because it failed to provide all of the requested information in contravention of 42 U.S.C. § 262(l)(2).
• Dec 24, 2021: Genentech provided its operative list of seven patents pursuant to 42 U.S.C. § 262(l)(3)(A).
• Feb 22, 2022: Tanvex purported to provide its detailed statement concerning non-infringement and invalidity pursuant to 42 U.S.C. § 262(l)(3)(B) (“Tanvex’s 3B Statement”).
• Apr 21, 2022: Genentech provided its response pursuant to 42 U.S.C. § 262(l)(3)(C) (“Genentech’s 3C Statement”) and stated that Tanvex’s vague incorporation of indiscriminate arguments and legal concepts was insufficient under 42 U.S.C. § 262(l)(3)(B), and that it further thwarted Genentech’s ability to respond.
• May 03, 2022: Tanvex sent correspondence that it agreed that the Patents-in-Suit should be included in an infringement action.
• Jun 1, 2022: In light of the parties’ agreement, § 262(l)(6)(A) required Genentech to bring an action for patent infringement with respect to each of the three patents that were part of the parties’ agreement. This action is Genentech’s action pursuant to § 262(l)(6)(A), and is brought within 30 days of the parties’ Tanvex’s May 3, 2022 letter.

Tanvex’s Answer to complaint on Sep 01, 2022:

• Tanvex answered Genentech’s complaint, denying infringement of the three patents and asserting counterclaims for declaratory judgment of non-infringement and invalidity. 
• Tanvex asserts that the US10662237B2 patent claims are invalid as anticipated and/or obvious in view of “prior art disclosing processes for methods for the production and purification of recombinant proteins,” and that the “alleged invention of the US10662237B2 patent does no more than combine familiar elements according to known methods to yield predicable results.” 
• Tanvez also asserts that the US10808037B1 & US8574869B2 patent claims are invalid as anticipated and/or obvious in “view of prior art disclosing processes for methods of preventing the reduction of disulfide bonds via air sparging.”

Recent Update: Genentech and Tanvex reached on a settlement in principle to resolve all claims with respect to Genentech’s BCPIA complaint on January 6, 2023.  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.

Status of other biosimilar filers for Trastuzumab: Settled with Amgen, Centus, Samsung Bioepis, Pfizer, JHL Biotech, Mylan, Celltrion, and Teva.