Docket No. 2015-1335
NEWMAN (D), DYK, HUGHES
May 7, 2015
Brief Summary: DC findings of obviousness affirmed since analysis only requires that the “skilled artisan would have perceived a reasonable expectation of success in making the invention in light of the prior art..not a guarantee” and evidence of secondary considerations was unconvincing.
Summary: AZ appealed DC finding of obviousness of its US 7,524,834 encompassing sterile, pharmaceutically effective budesonide compositions (exemplary claim 1: “pharmaceutically acceptable, micronized powder composition of at least 98.5% by weight of which is pure budenoside…wherein the composition meets the criteria of sterility according to US Pharmacopoeia…”; claim 50 similar but to “pharmaceutically acceptable suspension”). AZ markets the product as Pulmicort Respules®, a nebulized suspension for treating asthma in children; the defendants filed ANDAs for generic versions. A previous appeal remanded the case due to erroneous claim construction by the DC (AstraZeneca, FC 2013). The FC opinion noted that, in a 166 page opinion, the DC made “extensive fact-findings on the prior art” (over 90 pages) and “thoroughly analyzed and rejected AstraZeneca’s arguments for nonobviousness based on objective indicia.” It explained that the DC’s ultimate legal conclusion of obviousness de novo and the underlying findings of fact for clear error (Novo Nordisk, FC 2013). The question before the DC was “whether the claimed sterile budenoside compositions were obvious in light of the sterilization methods known in the art” (“[b]oth parties agreed that a skilled artisan would have been motivated to prepared sterile budenoside compositions”). AZ argued that none of the prior art disclosed “actual success” in creating the sterilized compositions. But the FC explained that AZ “mistakes the test for obviousness” which only a requires that the “skilled artisan would have perceived a reasonable expectation of success in making the invention in light of the prior art” (Amgen, FC 2009; Pfizer, FC 2007 (“only a reasonable expectation of success, not a guarantee, is needed”)). The FC concluded AZ could not show any clear error in the DC’s analysis. The DC also rejected AZ’s arguments regarding secondary considerations (commercial success, long-felt but unmet need, industry skepticism, and the failure of AZ and others). The FC rejected AZ’s arguments that its evidence was ignored, finding the DC “thoroughly reviewed the evidence and concluded, simply, that sterility was not the underlying need for, or the crux for success of” the product (“no connection between the sales of Pulmicort Respules®and its characteristic of being sterile…the [DC] found that success was due to factors other than that claimed in the ‘834 patent-namely, efficacy, safety of the budenoside molecule, and nebulized delivery”). AZ’s “attempt to equate regulatory compliance with evidence of nonobviousness” was also rejected, as was its evidence of others and its failures and the argument “that the FDA believed sterilization to be impossible.” The DC decision was therefore affirmed.