Takeaway: A petitioner must provide evidence showing why each and every element of the claims would have been obvious when presenting a ground of unpatentability based on obviousness. Merely stating that a feature would have been obviously taught by the combination of references is insufficient.

In its Decision, the Board denied institution of inter partes review, finding that Petitioner did not establish a reasonable likelihood of prevailing with respect to any challenged claim. The ’748 patent relates to “methods of treating cancer using ErbB receptor-directed cancer therapies.”

The Board first addressed the question of claim construction, noting that unexpired patent claims are given their “broadest reasonable construction in light of the specification of the patent.” Neither party offered construction of any claim terms. The Board considers the preamble phrase “method for the treatment of a tumor” to be limiting “when read in combination with the ‘whereby’ clause reciting that ‘said tumor’ is ‘characterized by overexpression of an ErbB2 receptor’ and ‘does not respond, or responds poorly, to treatment with an anti-ErbB antibody, is treated.’”

The Board then turned to the five asserted grounds of unpatentability based on obviousness with a non-patent literature article authored by Chari as the primary reference in each. Petitioner argues that Chari teaches the elements of the conjugate recited in the challenged claims, but fails to disclose the particular huMADB4D5-8. Petitioner further argues that “the HERCEPTIN® label describes the use of huMADB4D5-8 for the treatment of human patients with metastatic breast cancer, and specifically tumors characterized by overexpression of an ErbB2 receptor.” Patent Owner does not dispute these contentions. However, Patent Owner argues that Chari and the label fail to teach the limitations in the claims of “identifying and treating a tumor that ‘does not respond, or responds poorly, to treatment with an anti-ErbB antibody.’” Petitioner contends that the label discloses the “identifying” such a tumor, and that an ordinary artisan would have been motivated to treat such a tumor with the HERCEPTIN®.

The Board agreed with Patent Owner. Specifically, the Board was “persuaded by Patent Owner’s position that the neither the Petition nor Dr. Rosenblum’s Declaration adequately explains how, or provides sufficient evidence indicating that, the teaching in HERCEPTIN® Label that certain patients failed to respond to HERCEPTIN® would have motivated n ordinary artisan to treat such patients using a HERCEPTIN® (huMab 4D5-8) conjugate.” The Board was also “persuaded by evidence offered by Patent Owner indicating that ordinary artisans would have thought it likely that HERCEPTIN® resistance occurred in patients because obstacles prevented the antibody from binding its ErbB2 receptor target, or due to other events that prevented HERCEPTIN® from working as expected.”

The Board then turned to the ground of unpatentability based on obviousness over Chari, HERCEPTIN®, and an article authored by Baselga. Petitioner argued that Baselga provides additional motivation for a method comprising “identifying” a tumor “characterized by overexpression of an ErbB2 receptor and as being a tumor that does not respond, or responds poorly, to treatment with an anti-ErbB antibody.” Baselga also taught “identifying” relevant tumors. However, in this ground, the Board also found that Petitioner relied on the argument that an ordinary artisan would have been motivated to treat such a patient population without any evidence supporting this argument.

The Board then turned to the remaining grounds of unpatentability based on obviousness over combinations of other references with Chari and the HERCEPTIN® Label. The Board found that in these grounds, Petitioner relied on the other references to show that an ordinary artisan would have been motivated to make the recited conjugate and use it in a method for treating tumors that overexpress an ErbB2 receptor generally. However, the Board found that none of the additional references cured the deficiencies of Chari, the HERCEPTIN® Label, and/or Baselga.

Finally, the Board turned to the final ground of unpatentablity, which was based on obviousness over Cohen, the HERCEPTIN® Label, and Morgan. The Board found this ground insufficient as well, because the Petitioner relied on the same disclosure in the HERCEPTIN® Label to support its contention that the label discloses the “identifying” step and “provides a motivation for treating tumors that do not respond, or respond poorly, to treatment with an anti-ErbB antibody.”

Phigenix, Inc. v. Genentech, Inc. and Immunogen, Inc., IPR2014-00842
Paper 11: Decision Denying Institution of Inter Partes Review
Dated: December 9, 2014
Patent: 7,575,748 B1
Before: Francisco C. Prats, Jacqueline Wright Bonilla, and Zhenyu Yang
Written by: Bonilla
Related Proceedings: IPR2014-00676 (U.S. Pat. No. 8,337,856)