Docket No. 2015-1588
LOURIE, DYK, HUGHES
March 18, 2016
Brief Summary: The FC panel found no error with the DC’s conclusion of obviousness (“pharmaceutically effective absorption would have been a logical and obtainable goal with bioavailability that is significantly affected by co-administration with food” and WC “failed to show the criticality of the claimed amount” of EDTA).
Summary: Warner Chilcott appealed DC decision that claim 16 of its US 7,645,459 and claim 20 of US 7,645,460, both relating to oral dosage forms of risedronate (a bisphosphonate) and the chelating agent EDTA and Altevia® for treating osteoporosis, invalid as obvious in view of a Brazilian patent. Both claims 16 and 20 are directed to “[a]n oral dosage form having pharmaceutically effective absorption…comprising….[about 35] mg of risedronate sodium…[about 100 mg] of disodium EDTA; and…an enteric coating [that is a methacrylic acid copolymer]”. Claim 16 required the coating to “provide for release…in the lower gastrointestinal tract of a mammal”, while claim 20 specified the small intestine. The DC found 35 mg to be the most commonly prescribed regimen, that the BR patent “contains all the limitations except ‘pharmaceutically effective absorption’”, and “the claimed 100 mg amount of EDTA was not critical within the range disclosed in the prior art”. It also concluded “one of skill would have recognized the food-effect problem with bisphosphonates and the solution of using chelators to block calcium ions” (a “solution… ‘well explored in the literature’”). It also rejected WC’s teaching away arguments by other prior art, “instead finding that the art was either irrelevant or the earlier concerns were addressed by later references like” the BR patent. WC’s evidence of objective considerations was found to be insufficient (“some long-felt need for improving patient compliance” but “no proof of improve compliance as an unexpected result of the claimed invention”, “simultaneous invention by a third party”, “insufficient evidence of skepticism by skilled artisans”, and “no nexus between the claimed invention and Teva’s alleged failures or copying”). The FC panel found the DC had not erred in its conclusion obviousness or its finding “that pharmaceutically effective absorption would have been a logical and obtainable goal with bioavailability that is significantly affected by co-administration with food.” It also found WC “failed to show the criticality of the claimed amount” of EDTA. The DC decision was therefore affirmed.