IPR2017-01923 (US Pat. No. 7,976,838 B2)
April 4, 2018
Decision to Insitute IPR
Brief summary: Pfizer request for institution of IPR of Genentech’s ‘838 patent related to the TNFalpha inhibitor rituximab (Rituxan) on obviousness grounds granted.
Summary: Pfizer challenged claims 1-5 and 7-14 of the ‘838 patent related to Genentech’s rheumatoid arthritis (RA) treatment Rituxan (the TNFalpha inhibitor rituximab) as invalid on obviousness grounds. The introduction explains that the ‘838 patent has been challenged by Boehringer Ingelheim and Celltrion (terminated (IPR2015-00417 and -01733, or denied (IPR2016-01667)), and that litigation is ongoing with Sandoz (which also filed IPR2017-02036 and -02042). The ‘838 patent claims “methods for treating [RA] in a human patient who experiences an inadequate response to a TNFalpha-inhibitor, comprising administering to the patient an antibody that binds to CD20, wherein the antibody is administered as two intravenous [IV] doses of 1000 mg” (claim 1; independent claims 2, 8, 10 and 11 claim variations of the method). The Board explained that in an IPR, it “interprets the claims in an expired patent according to the broadest reasonable construction [BRC] in light of the specification” (§ 42.100(b); Cuozzo, US 2016; In re Translogic (FC 2007) (claim terms are given “their ordinary and customary meaning”); In re Paulsen, FC 1994 (“[a]ny special definitions for claim terms must be set forth with reasonable clarity, deliberateness, and precision”)). And it defined “the term ‘inadequate response to a TNFalpha-inhibitor’” as being “because of toxicity and/or inadequate efficacy” as “expressly define[d]” in the ‘838 specification. Pfizer cited seven references in its obviousness argument and several grounds based on combinations of those references, of which the Board considered two. The Board found that Pfizer showed a reasonable likelihood that it would prevail in showing the unpatentability of at least claim 1” since, e.g., the De Vita 2002 reference “discloses the administration of rituximab” to RA patients that “had been non-responsive to TNFalpha inhibitors” and that “anti-CD20 therapy proved clinical beneficial” to those patients (“we are not persuaded that De Vita 2002 sufficiently discredits” Pfizer’s arguments of an expectation that rituximab would “be effective to treat RA patients regardless of their TNFalpha levels”).
The Board also addressed Genentech’s “discretionary denial arguments” based on § 325(d) (“MULTIPLE PROCEEDINGS”) (Harmonic, FC 2016), explaining that its discretion “involves a balance amongst several competing interests” (Neil Ziegman, IPR2015-01860; Fox Factory, IPR2016-01876; Cultec, IPR2017-00777). Here, Genentech requested denial of institution “because ‘the Petition relies on substantially the same art and arguments previously presented in both prosecution and prior IPRs” (the Boehringer and Celltrion IPRs). The Board rejected the prosecution history-based arguments because, e.g., while one reference (“Edwards 2002”) was cited in an IDS, “at no point did the Examiner rejected any Challenged Claim in light of” the reference, “alone or in combination” and Pfizer’s arguments regarding others “differ substantially from arguments considered or positions taken by the Examiner during prosecution.” The Board also found Pfizer’s arguments to be different than those presented in the other IPRs. Genentech also requested denial under § 314(a)/General Plastic Ind. (IPR2016-01357) (regarding “seven nonexclusive factors” considered for “a follow-on petition on the same patent”), and the Board denied this ground as this reasoning is applicable only to “the same petitioner with respect to the same patent”.