New BPCIA Complaint: Genentech Sues Samsung Bioepis Regarding Proposed Trastuzumab Biosimilar (UPDATED)

Yesterday, September 4, 2018, Genentech filed a complaint against Samsung Bioepis in the District of Delaware alleging infringement under the BPCIA of 21 patents based on Bioepis’s filing of an aBLA for SB3, a biosimilar candidate referencing Herceptin® (trastuzumab).  This is the fourth litigation regarding a biosimilar of Herceptin®, following Genentech’s suits against Pfizer, Celltrion and Teva, and Amgen, all of which are currently pending before Judge Sleet in the District of Delaware.  The patents that Genentech is now asserting against Bioepis have already been asserted in the other trastuzumab biosimilar litigations.

Although the complaint alleges that the parties engaged in steps of the patent dance, leading to the parties’ agreement that Genentech would assert the 21 patents-in-suit, the complaint also alleges that Bioepis failed to comply with its obligations under subsection (l)(2) to produce to Genentech a complete copy of the aBLA and additional manufacturing process information.  According to Genentech, Bioepis produced only select portions of its aBLA and refused to produce any additional aBLA subsections or information about its aBLA product.  Still, Genentech alleges that it provided Bioepis “a list of patents for which [Genentech] believed a claim of patent infringement could reasonably be asserted,” but “expressly reserved its rights to supplement or revise this list in light of any additional information provided by Bioepis,” noting “that Bioepis’s failure to comply with its disclosure obligations under § 262(l)(2) caused Bioepis to forfeit any rights under the BPCIA that were contingent upon its compliance with those obligations.”  Genentech further alleges that Bioepis’s non-compliance with subsection (l)(2) left Genentech “unable to evaluate many of Bioepis’s non-infringement arguments.”

In a joint status report filed last month in the Genentech v. Pfizer litigation regarding a scheduling dispute, Genentech had indicated that it expected to sue Bioepis in September 2018.

Stay tuned to Big Molecule Watch for further developments.

UPDATE (Sept. 5, 2018, 3:52 pm ET): The new Bioepis case has been docketed as Civil Action No. 18-1363 and assigned to Judge Sleet.

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