Warner Chilcott Company LLC et al. v. Teva Pharmaceuticals USA, Inc. et al.

Docket Nos. 2014-1439, -1441, -1444, -1445, -1446

November 18, 2014


Brief Summary: Grant of summary judgment that claims encompassing once monthly dosing of the osteoporosis bisphosphonate drug risedronate are invalid in view of prior art affirmed.

Summary: Warner Chilcott appealed from DC grant of SJ regarding claims 6, 8, 9 and 13-15 of US 7,192,938 and claims 9-10 of US 7,718,634 relating to the osteoporosis bisphosphonate drug risedronate (and Warner’s risedronate sodium ANDA for Actonel®) as invalid for obviousness. Representative ‘634 claim 9 claims a method for treating postmenopausal osteoporosis by administering a pharmaceutically acceptable salt of risedronic acid at the “equivalent to about 150 mg risedronic acid…once monthly on a single day”. The opinion referred to the earlier Hoffman-La Roche decision (DC NJ, affirmed and reh’g denied by FC 2014) in which SJ was granted on the grounds that claims 1-8 of the ‘634 patent relating to a different bisphosphonate oral drug, ibandronate (Boniva®), would have been obvious in view of several references. In this case, the DC considered that decision, “the record before it relating to risedronate, including the prior art, expert declarations, and proffered evidence of secondary considerations” and concluded that “the prior art, viewed as a whole, would have suggested the efficacy and safety of the claimed dosage regimen.” In this appeal, Warner Chilcott argued “there was a genuine dispute of material fact as to whether a person of ordinary skill in the art would have reasonably expected that dosing 150 mg risedronate once monthly would be safe and effective” because “researchers would not have been able to predict the bioavailability of risedronate or its retention in the bone over the month-long dose-free interval”, “there was a long felt need for and skepticism of others toward the claimed month regimen” and the earlier DC decision regarding ibandronate “does not control this case because ibandronate and risedronate are different compounds and the record here contains additional evidence of nonobviousness.” The FC panel disagreed regarding the prior art (including one not considered by the USPTO during prosecution), finding that the DC “correctly determined that the cited prior art references disclosed or suggested each of [the] limitations and provided an express motivation to pursue the claimed monthly regimen and a reasonable expectation of success in doing so” (including finding that the FDA’s approval of 5 mg daily dose and prior art disclosure of “an equivalent once weekly dose of 35 mg risderonate” provided a reasonable expectation of “success in administering a dose of 150 mg” and “obviousness does not require absolute certainty or guarantee of success” (In re O’Farrell, FC 1988)). Thus, the DC decision was affirmed.

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