AstraZeneca LP v. Breath Ltd.

Case Name: AstraZeneca LP v. Breath Ltd., Civ. No. 08-1512 (RMB/AMD), 2013 U.S. Dist. LEXIS 49375 (D.N.J. Apr. 1, 2013) (Bumb, J.)

Drug Product and Patent(s)-in-Suit: Pulmicort Respules^® (budesonide suspension); U.S. Patent Nos. 6,598,603 (“the ’603 patent”) and 7,524,834 (“the ‘834 patent”)

Nature of the Case and Issue(s) Presented: The court conducted a 19-day bench trial from Nov. 7, 2012 to Dec. 18, 2012. The issues addressed were whether the defendants’ dosing regimen infringed the claims of the plaintiffs’ method of use patent, and whether claims directed toward the dosing regimen were invalid. Additionally at issue was whether the defendants’ sterilization procedure infringed the asserted claims of the plaintiffs’ patent.

The court held that (i) Breath, Apotex, and Sandoz infringed the asserted claims of the ’603 patent; (ii) the asserted claims of the ’603 patent were invalid on separate grounds of obviousness and anticipation; and (iii) the defendants did not infringe any of the asserted claims of the ’834 patent.

Why Breath Limited Prevailed:  The court first addressed whether the labels proposed by each of the defendants would result in induced infringement of the ’603 patent. That patent is directed to the once-daily use of nebulized budesonide. The court determined that the language of the Sandoz and Breath labels clearly infringed the “once daily” claim limitation of the ’603 patent. Accordingly, Sandoz and Breath/Watson would induce infringement of the asserted claims with their 1.0 mg labels. The court further found that Breath and Apotex would induce infringement of the claims of the ’603 patent with their 0.25 mg and 0.5 mg labels. The court concluded that the Breath and Apotex defendants possessed the specific intent to encourage direct infringement by end users.

The court next addressed the issue of obviousness. At trial, defendants established that the prior art would have motivated a person having skill in the art at the time of invention to apply a once-daily technique to the application of nebulized budesonide. Such a combination would have resulted in greater compliance and convenience among patients. Defendants definitively established that once-daily doses of budesonide were available already in at least two other delivery systems, and that one of those delivery systems was very similar to the claimed nebulizer delivery system. In addition to being obvious, the court found the asserted claims of the ’603 patent anticipated. A piece of prior art published by the defendants’ expert witness anticipated each of the asserted claims.

The ’834 patent claimed a method for producing sterile powders and formulations that were incorporated into Pulmicort Respules. AstraZeneca pursued different claims against the defendants. Specifically, AstraZeneca alleged that Apotex and Sandoz literally infringed claims 50 and 51 of the ’834 patent, while Breath infringed claims 1, 2, 50, and 51 under the doctrine of equivalents. Sandoz and Apotex argued that they did not literally infringe the asserted claims because their generic formulations did not include heat-sterilized, finely-divided dry particles, which were required under the court’s construction of the term “micronized powder composition.” The district court agreed.

Concerning its doctrine of equivalents argument, AstraZeneca introduced expert testimony indicating that a technical comparison between Pulmicort Respules and the defendants’ generic version showed that the products were insubstantially different. But the court did not find the expert’s testimony persuasive. It determined that he failed to identify elements in the defendants’ respective manufacturing processes that were similar to the heat sterilized element in the claimed “micronized powder composition” in accordance with its claim construction. AstraZeneca’s expert testimony instead established a greater likelihood of noninfringement, because the generic drugs underwent various physical and chemical changes during the manufacturing process, as opposed to the “heat sterilized” products that were claimed in the patent. Further, the court found that prosecution history estoppel barred AstraZeneca from relying on the doctrine of equivalents. During the prosecution of the ’834 patent, the inventors disclaimed budesonide solutions that were not heat sterilized.