As we previously reported, Pfizer filed a petition for IPR of certain claims of Hoffman-La Roche’s U.S. Patent No. 8,314,225 (IPR2018-01219).  According to the petition, the challenged claims “purport to claim nucleic acid sequences that encode the C-terminal part of a human immunoglobulin heavy chain and a method for improving the expression of such an immunoglobulin by using the claimed sequences.”  On September 20, 2018, Hoffman-La Roche filed its Patent Owner Preliminary Response, which argues that the IPR should be denied institution because Hoffman-La Roche disclaimed all claims of the patent except claim 20.  Hoffman-La Roche also argues that institution should be denied because the patent is under ex parte reexamination (Control No. 90/014,063), where some of the same prior art is at issue, and where Hoffman-La Roche has presented amended claims.

Genentech is asserting this patent in three separate BPCIA suits: (1) against Pfizer, regarding its proposed biosimilar of Herceptin (trastuzumab) (17-cv-01672, D. Del.); (2) against Sandoz, regarding its proposed biosimilar of Rituxan (rituximab) (17-cv-13507, D.N.J.); and (3) against Amgen, regarding its proposed biosimilar of Herceptin (trastuzumab) (18-cv-00924, D. Del.).