Hospira Finds Mixed Results in Instituting IPRs Against Genentech Patents for Herceptin®

Written by Casey D. Donahoe, Ph.D. and Kerry S. Taylor, Ph.D.

Hospira (owned by Pfizer) filed five IPR petitions against Genentech patents that Genentech asserted were directed to Herpceptin® (trastuzumab). The PTAB has now instituted IPRs in three of the five petitions and denied the other two.  See Hospira, Inc. v. Genentech, Inc., IPR2017-00804, Paper 13 (P.T.A.B. July 27, 2017) (instituting trial); IPR2017-00805, Paper 13 (P.T.A.B. July 27, 2017) (instituting trial); IPR2017-00737, Paper 19 (P.T.A.B. July 27, 2017) (instituting trial); IPR2017-00731, Paper 19 (P.T.A.B. July 27, 2017) (denying trial); IPR2017-00739, Paper 16 (P.T.A.B. July 27, 2017) (denying trial).

Hospira’s petition in IPR2017-00804 challenged U.S. Patent No. 6,627,196, which claims “a method for the treatment of a human patient diagnosed with cancer.” The PTAB was persuaded that Hospira had a reasonable likelihood of success in demonstrating the claimed methods would have been obvious in view of a Herceptin® label, phase II clinical trial reports, and ordinary skill in the art. The PTAB acknowledged that similar prior art was presented during examination, but declined to exercise its discretion under 35 U.S.C. § 325(d) to deny institution based on Hospira’s newly presented expert declarations asserting the modification would have been “a matter of routine calculation.” The PTAB instituted Hospira’s petition in IPR2017-00805 against U.S. Patent No. 7,371,379, which is a related family member of the ‘196 patent, for the same reasons.

The PTAB also instituted Hospira’s petition in IPR2017-00737 challenging U.S. Patent No. 7,892,549, which claims “a method for the treatment of a human patient with breast cancer ….” The PTAB stated that it relied on the broadest reasonable interpretation of a claim limitation that recites “an amount effective to extend the time to disease progression …” as encompassing “an amount sufficient to extend the time … compared to [a patient] receiving no treatment.”  Based on this interpretation, the PTAB agreed with Hospira’s expert’s testimony that there is a reasonable likelihood that the claimed method would have been obvious over the cited prior art references.

Hospira filed a second petition against the ‘549 patent.  See IPR2017-00739.  The PTAB discretionarily denied institution of this second petition under § 325(d) based on the applicants having previously antedated the reference relied upon during prosecution. 

Hospira filed a petition challenging U.S. Patent No. 7,846,441 in IPR2017-00731.  The PTAB discretionarily denied institution of this petition under § 325(d) also based on the applicants having previously antedated the asserted reference.

The PTAB’s decisions to institute the three IPRs are preliminary holdings that Hospira has a reasonable likelihood of successfully demonstrating that the claims are unpatentable. These instituted proceedings will now proceed into the trial phase and, absent a settlement, will result in a final decision on the patentability of the instituted claims.