IPR2017-01168 (US Pat. No. 8,821,873 B2)
Final Written Decision
October 31, 2018
Brief summary: Board concluded that Pfizer showed by a preponderance of the evidence that Biogen’s ‘873 claims regarding a method for treating DLCL using rituximab are unpatentable for obviousness.
Summary: Pfizer’s challenged Biogen’s ‘873 patent related to methods for treating diffuse large cell lymphoma (DLCL, “an aggressive form of non-Hodgkin’s lymphoma” (NHL)) patients older than 60 by administering a chimeric anti-CD20 antibody (RITUXAN® rituximab), a combination of cyclophosphamide, hydroxdaunorubicin/doxorubicin, vincristine, and prednisone/prednisolone (referred to as “CHOP”), and stem cell transplantation (SCT) for obviousness in view of five prior art references. The Board reviewed the ‘873 claims under the broadest reasonable construction (Cuozzo, US 2016; the standard under Nov. 13 when it will be replaced by the Phillips (FC 2005) standard) which “absent any special definitions…give[s] claim terms their ordinary and customary meaning” (In re Translogic, FC 2007; Trivascular, FC 2016). The Board determined that the claim phrase “in combination with” SCT means that the anti-CD20 antibody can be administered “at the induction of CHOP chemotherapy but before the actual collecting or translplanting of stem cells” (among other stages of treatment, but this definition was suggested by Pfizer). The Board also concluded a person having ordinary skill in the art “would have at least an M.D. degree” and experience treating patients with NHL. The Board also explained that under KSR (US 2007) “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results”. Here, the Board wrote, Biogen did “not dispute that Moreau taught all the elements of claims 1 and 5” (CHOP therapy and stem cell transplantation” in patients over 60 years old) “except for the addition of rituximab”. And the Board found that based on its “review of the record as a whole,” Pfizer “provide[d] sound reasoning, supported by a preponderance of the evidence, for combining” the treatments and “demonstrated persuasively that the modification of Moreau amounts to no more than ‘the predictable use of prior art elements according to their established functions’” (KSR, US 2007; In re Rosselete, CCPA 1965 (“what the references taken collectively would suggest to those of ordinary skill in the art”)). The other claims (2-4) were similarly concluded to have been shown by a preponderance of the evidence to be invalid for obviousness for similar reasons. Pfizer moved to dismiss certain exhibits but the Board explained that it did not rely on those exhibits and therefore dismissed the motion. Biogen attempted to exclude the Rituxan label for “lacking authentication under Federal Rules of Evidence (FRE 901) but the Board explained that this issue “should have been raised in the briefing and not a motion to exclude” (Groupon, CBM2013-00033, PTAB 2013) and that Biogen, e.g., “has not explained its contention adequately”. The Board therefore concluded that Pfizer had shown by a preponderance of the evidence that the ‘873 claims are unpatentable.