PTAB Grants Hospira's Request for Rehearing, Institutes IPR of Herceptin Patent

Hospira, Inc. v. Genentech, Inc., IPR2017-00731 (PTAB)

    by Aaron F. Barkoff

Apparently it is not impossible to change the PTAB's mind.  In a rare decision last week, the Board granted Hospira's request for rehearing of its earlier decision denying institution, and instituted review of U.S. Patent No. 7,846,441.  Genentech is expected to assert the '441 patent in BPCIA litigation over biosimilar versions of Herceptin (trastuzumab).

The '441 patent, entitled "Treatment with Anti-ErbB2 Antibodies," claims a method of treating a cancer "characterized by overexpression of ErbB2 receptor, comprising administering a combination of an intact antibody which binds to epitope 4D5 within the ErbB2 extracellular domain sequence and a taxoid, in the absence of an antracycline derivative."

In its Petition for IPR, Hospira argued that the prior art disclosed the claim limitation "in the absence of an antracycline derivative" because:

(1) the cardiotoxicity of anthracycline derivatives was well known in the prior art; (2) both preclinical and clinical
studies employed the combination of an anti-ErbB2 antibody "with paclitaxel or anthracycline, not together;" and (3) Baselga ʼ94 shows that the combination with paclitaxel was superior to the combination with doxorubicin, an anthracycline derivative.

Genentech countered that Hospira did not show that an ordinary artisan would have avoided anthracyclines when pursuing the combination therapy of antiErbB2 antibody with a taxoid."  The Board agreed, and therefore denied institution.

In its decision on Hospira's petition for rehearing last week, the Board reversed its earlier decision, explaining:

In its Request for Rehearing, Petitioner contends that we erred in interpreting the limitation "in the absence of an anthracycline derivative" as requiring "avoidance" of an anthracycline derivative.  According to Petitioner, this term "is a negative limitation that is satisfied by anti-ErbB2 antibody–paclitaxel combinations that do not include an [anthracycline] derivative."  After reconsidering the current record, we find Petitioner's argument persuasive.  In particular, because Baselga '94 suggests a therapeutic composition consisting of an anti-ErbB2 antibody and paclitaxel, and does not suggest that doxorubicin must necessarily be included as part of the same treatment regimen, we are persuaded that the reference satisfies the limitation "in the absence of an anthracycline derivative."

In support of its decision, the Board cited Upsher-Smith Labs., Inc. v. Pamlab, L.L.C., 412 F.3d 1319, 1322 (Fed. Cir. 2005) for its conclusion that a claim to a composition that is "essentially free of antioxidants" is anticipated when the prior art teaches "optional inclusion" of antioxidants, "despite no express teaching to exclude the antioxidants."

Although Hospira did not cite the Upsher-Smith case in its Petition (or propose a construction of the disputed claim limitation), it did so in its request for rehearing.

PTAB Grants Hospira's Request for Rehearing, Institutes IPR of Herceptin Patent