AstraZeneca LP v. Breath Ltd.

Case Name: AstraZeneca LP v. Breath Ltd., 2015-1335, 2015 U.S. App. LEXIS 7525 (Fed. Cir. May 7, 2015) 

Drug Product and Patent(s)-in-Suit: Pulmicort Respules^® (budesonide inhalation suspension); U.S. Patent No. 7,524,834 ("the '834 patent") 

Nature of the Case and Issue(s) Presented: In a prior decision by the Federal Circuit, the court reversed and remanded the district court’s non-infringement findings concerning the ’834 patent based on the district court’s erroneous claim construction. On remand, and following a thirteen-day bench trial, the district court found the asserted claims of the ’834 patent infringed but invalid as obvious. In particular, the district court concluded that a person of ordinary skill in the art, whom the parties agree was motivated to prepare a sterile budesonide composition, would have had a reasonable expectation of successfully doing so with four of five well-known sterilization techniques. AstraZeneca appealed and the Federal Circuit found that the district court correctly determined that the asserted claims of the ’834 patent were invalid for obviousness, and affirmed.

Why Defendant Prevailed: The prior art presented at trial included non-sterile budesonide compositions, sterile compositions of corticosteroids other than budesonide, and five well-known sterilization techniques: sterile filtration followed by aseptic crystallization; moist heat; ethylene oxide; irradiation; and dry heat. Thus, the question before the district court was whether the claimed sterile budesonide compositions were obvious in light of the sterilization methods known in the prior art. The district court found that although each sterilization method had known disadvantages, a skilled artisan “had within her toolbox several methods to address them.” On appeal, AstraZeneca challenged the district court’s decision on grounds that the prior art did not disclose “actual success” using the known sterilization methods. The Federal Circuit held that AstraZeneca mistook the test for obviousness. Obviousness requires a showing that “a skilled artisan would have perceived a reasonable expectation of success in making the invention in light of the prior art.” Thus, “only a reasonable expectation of success, not a guarantee, is needed.”

AstraZeneca also challenged the district court’s analysis of the objective indicia of nonobviousness, including the lack of commercial success, no long-felt but unmet need, no industry skepticism, and any perceived failure of AstraZeneca and others. The Federal Circuit affirmed the district court’s finding that the need was really the nebulized budesonide and that, “had the FDA determined that Pulmicort Respules could be sold in the United States without being sterile, unmet need would have been met.” Similarly, the district court found, and the Federal Circuit likewise affirmed, that the evidence did not demonstrate a connection between the sales of Pulmicort Respules and its characteristic of being sterile. While recognizing that Pulmicort Respules has been very profitable for AstraZeneca in the United States, the district court found that the success was due to factors other than that claimed in the ’834 patent—namely, efficacy, safety of the budesonide molecule, and nebulized delivery. Finally, the Federal Circuit credited the district court’s findings of insufficiency concerning AstraZeneca’s evidence of others’ failures and further discounted AstraZeneca’s evidence of its own failures as relating only to potential disadvantages and commercial feasibility.