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Tanvex Answers Genentech’s Trastuzumab Complaint – Patent

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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.”

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