Digest of AstraZeneca LP v. Breath Limited (Fed. Cir. May 7, 2015) (non-precedential). On appeal from the District of New Jersey. Before Prost, Bryson, and Linn.

Procedural posture: Plaintiff appealed the finding of the district court, after a bench trial, that the claims were obvious. Previously, the CAFC reversed and remanded a finding of non-infringement. On remand, the district court found the claims infringed but invalid as obvious. CAFC affirmed.

  • Obviousness: Claims directed to sterile compositions of budesonide were obvious where (i) prior art disclosed compositions of budesonide, (ii) prior art disclosed sterile compositions of other corticosteroids, (iii) prior art disclosed five well-known sterilization techniques, and (iv) the parties agreed that a skilled artisan would have been motivated to produce a sterile budesonide composition. The district court determined that there would have been a reasonable expectation of success using four of the five methods. The district court did not err merely because no references disclosed processes actually yielding the claimed composition; only a reasonable expectation of success, not a guarantee, is required. The district court also did not err in discounting evidence of secondary considerations. The FDA requirement of sterility did not give rise to a long-felt need, nor did it provide a nexus between the claimed invention and the commercial success of the sterile product, even though there was a long-felt need for the drug itself, which was available elsewhere but could not legally be marketed in the United States unless it was sterile. Evidence of failures by others and by the plaintiff, and evidence of skepticism in the industry, was insufficient to overcome obviousness.