Samsung Bioepis (“Bioepis”) has joined a growing list of challengers to Genentech’s U.S. Patent No. 6,407,213 (“the ʼ213 patent”) issued to Carter, et al. by filing two new petitions for inter partes review (“IPR”). The ʼ213 patent, entitled “Method for Making Humanized Antibodies,” is generally directed to antibodies with humanized variable domains comprising non-human complementarity determining region sequences for antigen binding and specified substitutions within the framework regions. The company has previously stated that the ‘213 patent covers technology used in the development of Herceptin® (trastuzumab).

On September 29, 2017, Bioepis filed IPR2017-02139 and IPR2017-02140 challenging Genentech’s ʼ213 patent. In the petitions, Bioepis is listed as the real party-in-interest. Bioepis asserts that a skilled artisan would understand that none of the claims are directed to a specific antibody, including claim 30 of theʼ213 patent, which recites “an antibody which binds p185HER2”. Bioepis challenges the patent on the basis that “humanization” and “reshaping” of antibodies was known in the prior art. Bioepis filed concurrent motions for joinder of its petitions with pending petitions filed by Pfizer (reported here), contending that the petitions are practical copies of those filed by Pfizer.

As noted in the above table, previous challenges to the ʼ213 patent have come from Mylan, Celltrion, Pfizer, and Boehringer Ingleheim. An early challenge to the ʼ213 patent from two petitions filed by Mylan was dropped (previously reported here) following a settlement agreement that was brokered between Roche and Genentech to provide Mylan with global licenses for trastuzumab. However, the petitions filed by Celltrion (IPR2017-01373 and IPR2017-01374), Boehringer Ingelheim (IPR2017-02032 and IPR2017-02031), and Pfizer (IPR2017-01488 and IPR2017-01489) are awaiting an institutional decision by the PTAB.

We will provide updates as decisions come to light.