U.S. Pat. No. 8,889,135B2
May 17, 2016
Decision instituting IPR
Update: See summary of May 16, 2017 FWD finding claims 1-5 unpatenable. See also July 6, 2017 FWD in IPR2016-00408 and IPR2016-00409 (both requested by Boehringer Ingelheim) finding claims 1-5 of the ‘135 patent unpatentable (408: obvious over van de Putte 2000 and Rau 2000; 409: obvious over Kempeni and van de Putte; Rau, Shattendkirchner and van de Putte). Also note IPR2016-00188 found claims 1-4 of US 9,017,680 obvious over van de Putte and Kempeni (June 9, 2017 FWD); and IPR2016-00189 found claims 1 and 2 US 9,073,987 obvious over Kempeni and van de Putte (June 9, 2017 FWD).
Brief Summary: Petition for IPR of Abbvie’s US 8,889,135B2 relating to Humira® granted on the basis of obviousness.
Summary: Coherus requested IPR of claims 1-5 of Abbvie’s US 8,889,135B2 relating to methods for treating rheumatoid arthritis (RA) using a human anti-TNF alpha antibody having particular complementarity determining regions (CDRs) (Humira® (adalimumab)). The claims require “administering subcutaneously…a total body does of 40 mg…once every 13-15 days for time period sufficient to treat” RA. The Petition alleged unpatentability for obviousness (§ 103) in view of the Kempeni (cited as anticipatory and for obviousness by the examiner during prosecution) and van de Putte (cited by the applicant during prosecution and by the examiner for anticipation and obviousness) references, and included 16 background technology references as well as three expert declarations (Drs. Baughman, O’Dell and Reisetter). It is noted here, not in the decision, that the Kempeni and van de Putte were cited in combination in an obviousness rejection during prosecution, but only with several other references. The decision first considered the broadest reasonable construction (BRC) of the claim terms “[a] method for treating” RA (RA) (preamble) and “for a time sufficient to treat the rheumatoid arthritis”. The Board determined the preamble phrase “do not appear to recite additional structure not included in the bodies of the claims” or “to be necessary to give life, meaning, and vitality to the claims” (Catalina Mktg., FC 2002) and “therefore, recites an intended use, i.e., treating RA” and is not limiting (Boehringer, FC 2003). The Board did not find a reason the “for a time sufficient” limitation should “require a specific level of efficacy as the Patent Owner proposes” (“to reduce significantly the signs and symptoms of” RA) because the claims “do not recite any particular level of efficacy”, the “plain and ordinary meaning of ‘treat’ or ‘treatment’ is the ‘management and care of a patient for the purpose of combating disease or disorder,’ and it does not require a particular level of efficacy”, and “the usage of ‘treat’ and related terms in the specification…does not indicate any deviation from its ordinary and customary meaning” (Seattle Box, FC 1984). The phrase was concluded to mean “for a time period sufficient to reduce the signs, symptoms, and/or progression of RA.” Kempeni was found to teach a fully human anti-TNF alpha antibody (D2E7) used in RA clinical trials, finding it to be “safe and effective”. van de Putte “compared three dose levels of D2E7 to placebo over three months in patients with long-standing active RA”, showing it to be “statistically significantly superior to placebo”. Coherus argued that the skilled artisan “would have been motivated from [those] disclosures to administer D2E7 subcutaneously biweekly, as recited in claims 1-5 of the ‘135 patent, and would have expected such a dose to be safe and effective in treating RA” (“no more that ‘a routine optimization of the therapy outlined in [the prior art]” (citing Biomarin, PTAB Feb. 23, 2015)). Abbvie argued the specific dosing parameters of the claims would not have been obvious, but the Board found the arguments “at best, create genuine issues of material fact…best resolved during trial when we are able to assess [the] evidence and arguments upon review of the entire record.” It therefore concluded Coherus “is reasonably likely to prevail” and granted the Petition. Regarding secondary considerations, the Board found “little indication that sales are due to the 40 mg dose amount recited in the claims” (“[A]t this stage of the proceeding, the arguments and information of record do not persuade us to decline to go forward with a trial.”)