As we previously reported, on June 3, 2022, Genentech filed a complaint against Tanvex in the U.S. District Court for the Southern District of Florida, alleging infringement of three patents under the BPCIA based on Tanvex’s submission of an aBLA for TX05, a proposed biosimilar of HERCEPTIN (trastuzumab).  The three asserted patents are generally directed to methods for virus filtration (U.S. Patent No. 10,662,237) and methods for producing an antibody involving “sparging the pre-harvest cell culture fluid” (U.S. Patent Nos. 10,808,037 and 8,574,869).

On September 1, 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 ’237 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 ’237 patent does no more than combine familiar elements according to known methods to yield predicable results.”  Tanvez also asserts that the ’037 and ’869 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.”

Stay tuned to Big Molecule Watch for developments on this BPCIA case.

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