Samsung Bioepis and Genentech Settle Trastuzumab Biosimilar Patent Disputes

On June 28, 2019, Samsung Bioepis and Genentech filed a joint stipulation of dismissal of their BPCIA patent litigation concerning ONTRUZANT (trastuzumab-dttb), Samsung Bioepis’s biosimilar of HERCEPTIN that received FDA-approval earlier this year.  According to the stipulation, the parties “have entered into a settlement agreement, and mutually agree to voluntarily dismiss all claims and counterclaims asserted in the above-captioned consolidated case without prejudice.”

In view of the parties’ Settlement and License Agreement, the parties also jointly moved to voluntarily dismiss Samsung Bioepis’s appeal of the PTAB’s final written decisions upholding the patentability of the challenged claims of U.S. Patent Nos. 6,627,196 and 7,371,379, directed to cancer treatment methods.  The Federal Circuit has since granted the motion and dismissed the appeal.

In a similar vein, Samsung Bioepis moved to withdraw from a pending Federal Circuit appeal in which Genentech is seeking to overturn a final written decision of unpatentability in an IPR of U.S. Patent No. 7,892,549, also directed to cancer treatment methods.  The court has granted this motion and invited the USPTO to intervene in the appeal. The USPTO has already intervened in related IPR appeals concerning the ‘549 and a related patent, after Pfizer and Celltrion reached settlements with Genentech and similarly withdrew from the appeals.

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