Case IPR2017-00731 (U.S. Pat. No. 7,846,441 B1)
Decision Granting Request for Rehearing
October 26, 2017
Brief summary: Petition for Rehearing granted as prior decision lacked of construction of the limitation “in the absence of an anthracycline derivative” which the Board accepted as “a negative limitation…satisfied by anti-ErbB2 antibody-paclitaxel combinations that do not include an [anthracycline] derivative”.
Summary: Hospira’s initial Petition for IPR of the ‘441 patent directed to treating cancer that overexpresses the ErbB2 receptor with “a combination of an intact antibody which binds to epitope 4D5” (Herceptin®) “and a taxoid…in the absence of an anthracycline derivative” was initially denied but reconsidered and granted as described herein. This decision explains that it prior decisions are reviewed for an abuse of discretion (37 CFR § 42.71(c), PPG Indus., FC 1998). This decision explains that Celltrion’s Petition for IPR of the ‘441 patent was granted on Oct. 4, 2017 (IPR2017-01121). Hospira and Celltrion also petitioned for IPR of family member US 7,892,549; trial was instituted on one of Hospira’s two Petitions (IPR2017-00739 denied, IPR2017-00737 instituted), and Celltrion’s was instituted (IPR2017-01122). The ‘441 claims were challenged as obvious in view of two combinations of references (Baselga ’97 and Baselga ’94, or Baselga ’96 and Baselga ’94). Since “the applicant successfully antedated Baselga ’97 [during prosecution]”, the Board declined institution based on that combination. This decision is therefore focused on Baselga ’96 and Baselga ’94. Under the broadest reasonable construction (BRC), the Board accepted Genentech’s proposed construction of “‘administering a combination’ as requiring ‘a single treatment in which the patient receives all drugs that are part of the claimed combination.’” The Board also construed the limitation that the claimed methods “extend the time to disease progression in said human patient, without increase in overall severe adverse events”, “a relative term” for which the claims do not “identify the comparator.” The Board noted that “[t]he facial ambiguity of this phrase was expressly addressed during prosecution” by the applicant in response to an indefiniteness rejection as being “relative to an untreated patient”, which the Board accepted (Microsoft, FC 2015; Trivascular, FC 2016; construed the same way in the other IPRs listed above). The Board found that Baselga ’96’ disclosure “does not amount to” the claimed “combination” but concluded Hospira “pointed to other” persuasive evidence “that an ordinary artisan would have had a reason to treat HER2-positive breast cancer patients with a combination of rhuMAb HER2 and a taxoid.” It was not convinced by Genentech’s contrary arguments since, e.g., “a multitude of effective combinations does not render any particular formulation less obvious” (Merck, FC 1989), after “weighing all evidence of record” and the “prior art as a whole” (“Each of Baselga ’94 and Baselga ’96 specifically teaches the claimed combination and suggests clinical trials to test the effectiveness. Nothing more is required to satisfy the combination limitation.”) The Board also explained that “[o]bviousness does not require absolutely predictability of success” and “all that is required is a reasonable expectation of success” (O’Farrell, FC 1988; Hoffman-La Roche, FC 2014). And the failure of other combinations was not found to “negate the reasonable expectation of success” since the “extend the time” limitation was construed as being relative to no treatment. In its discussion of the Petition for Rehearing, the Board explained that basis for granting the same as being due to the previous lack of construction of the limitation “in the absence of an anthracycline derivative”. Here, it was convinced by Hospira’s argument that it does not require “ “‘avoidance’ of an anthracycline derivative” but “is a negative limitation…satisfied by anti-ErbB2 antibody-paclitaxel combinations that do not include an [anthracycline] derivative” (Cf. Upsher-Smith Labs., FC 2005 (concluding the prior art anticipates a claim requiring a composition “essentially free of antioxidants,” because the prior art teaches “optional inclusion” of antioxidants, “despite no express teaching to exclude the antioxidants.”)) The Board acknowledged the proposed evidence of secondary considerations but decided that the best “course of action is to permit the parties to fully develop the record during trial before further weighing” that evidence.