AstraZeneca LP v. Breath Ltd. (Fed. Cir. May 7, 2015)

The U.S. Court of Appeals for the Federal Circuit recently affirmed the obviousness of claims directed to sterile, pharmaceutically effective budesonide compositions. AstraZeneca LP v. Breath Ltd., 2015 WL 2112951 (Fed. Cir. May 7, 2015). The court had previously reversed and remanded the U.S. District Court for the District of New Jersey’s non-infringement findings based on erroneous claim construction.

The asserted claims cover Pulmicort Respules®, a sterile, nebulized budesonide suspension used for treating asthma in children. Budesonide is a corticosteroid; non-sterile budesonide compositions, sterile compositions of other corticosteroids, and at least five sterilization techniques were known in the art. AstraZeneca conceded that a skilled artisan would have been motivated to prepare sterile budesonide compositions, thus the obviousness analysis focused on whether a skilled artisan had a reasonable expectation of success in using the known techniques to create sterile budesonide compositions. The district court concluded that there would have been a reasonable expectation of success and the Federal Circuit affirmed.

The Federal Circuit rejected AstraZeneca’s argument that none of the prior art references disclosed processes that would yield a sterile product of sufficient purity and pharmaceutical acceptability. The court re-iterated that, to meet the standard for obviousness, “only a reasonable expectation of success, not a guarantee, is needed,” and noted that the defendants, in fact, used two of the prior art methods to create sterile budesonide compositions.

With respect to secondary considerations, the district court found insufficient evidence of a nexus between the sterility of Pulmicort Respules and commercial success—the Federal Circuit affirmed. The court noted that sterility was an U.S. Food and Drug Administration (FDA) requirement; it did not drive demand for Pulmicort Respules. Further, the long-felt, yet unmet, need in the art was the nebulized delivery system—not the sterility of the product. The court also agreed with the district court’s discounting of the evidence on industry skepticism, failure of others, and AstraZeneca’s own failures during product development.