AstraZeneca LP v. Breath Ltd.

Case Name: AstraZeneca LP v. Breath Ltd., Civ. No. 08-1512 (RMB/AMD), 2015 U.S. Dist. LEXIS 17687 (D.N.J. Feb. 13, 2015) (Bumb, J.) 

Drug Product and Patent(s)-in-Suit: Pulmicort Respules^® (budesonide inhalation suspension); U.S. Pats. Nos. 6,899,099 (“the ’099 patent”), 6,598,603 (“the ’603 patent”), and 7,524,834 (“the ’834 patent”) 

Nature of the Case and Issue(s) Presented: During the parties’ first stint at the district court, the court ultimately found no likelihood of success on the merits that the asserted claims of the ’099 and ’603 patents were infringed because those claims were likely invalid as a matter of law. The court held that those claims did not functionally alter a known product so as to create a new patentable product. The Federal Circuit affirmed. Concerning certain other asserted claims of the ’603 patent, the district court found that those claims were invalid as obvious in view of the prior art. The Federal Circuit also affirmed this finding.

The sole issue that remained after appeal was whether the asserted claims of the ’834 patent were valid in light of the Federal Circuit’s revised claim construction. The district court initially construed the term “micronized powder composition” as a product-by-process claim, to mean “heat-sterilized finely divided dry particles.” On appeal, the Federal Circuit rejected the district court’s construction; instead, defining that term to mean “finely divided dry particles” without requiring any specific process for sterilizing the particles. The Federal Circuit remanded the case, instructing the district court to apply its claim construction to the remaining claims of the ’834 patent. Additionally, AstraZeneca moved for a preliminary injunction against the defendants, which was consolidated with the proceedings. After a 13-day bench trial, the court found invalid the asserted claims of the ’834 patent, and denied AstraZeneca’s motion for a preliminary injunction.

Why Breath Prevailed:  Breath alleged that the ’834 patent was invalid as obvious, anticipated, and that it did not meet the requirements of having an adequate written description and enablement.

With respect to obviousness, the court noted that prior to the date of invention of the ‘834 patent, AstraZeneca was selling pharmaceutically acceptable, aqueous suspensions consisting of highly pure, micronized budesonide powder. This formulation met each of the claim limitations of the ’834 patent, except for the limitation requiring that the powder be sterile. Thus, the issue to be decided was whether it would have been obvious to a skilled artisan to create a sterilized budesonide composition. The motivation to create such a combination would have come from an FDA-proposed rule requiring that all aqueous-based inhalation solutions for nebulization be manufactured as sterile. The court then proceeded to review the sterilization techniques that existed in the prior art.  This was due to the breadth of the Federal Circuit’s new claim construction, which did not specify a particular sterilization technique. The court determined that there were five sterilization methods that would have been known by a skilled artisan at the time of invention: (i) sterile filtration followed by aseptic crystallization; (ii) moist heat; (iii) dry heat; (iv) ethylene oxide (“EO”); and (v) irradiation. After providing a detailed analysis of each sterilization methods, the court concluded that a skilled artisan would have had a reasonable expectation of success in combining four of the five sterilization methods with the drug-composition claim element (dry-heat sterilization’s being the lone exception where this was not the case). Accordingly, the asserted claims of the ’834 patent were invalid as obvious.

The court next considered AstraZeneca’s evidence of objective indicia of non-obviousness. AstraZeneca argued that its sterile budesonide composition faced industry skepticism.  But, the court noted, that skepticism came from its own scientists. The proper analysis was whether there was skepticism by others in the industry. Regardless, there was not any universal skepticism, even among AstraZeneca’s own scientists, regarding sterilization of budesonide compounds. The court also disregarded AstraZeneca’s argument that the FDA had expressed skepticism about the sterilization technique and had actually changed its Final Rule in response to the ’834 patent.  The court referred to AstraZeneca’s claim as “hype and speculation” and found that this factor did not demonstrate non-obviousness. The court also found AstraZeneca’s long-felt-need argument unpersuasive due to the fact that a nonsterile version of the drug was available in Europe and had been successful. Additionally, the court found that AstraZeneca’s evidence related in large part to limitations or elements that did not form part of the asserted claims. Therefore, there was no evidence to infer that other embodiments of the asserted claims would have satisfied that long-felt, unmet need. In addressing the “failure of others” indicium, the court took issue with AstraZeneca’s evidence of its own failures, finding that such evidence was legally irrelevant. Instead, the court emphasized, the proper inquiry was whether others failed, not AstraZeneca’s failures.  But in the end, AstraZeneca had successfully created a sterile product known as Preferid^® as early as the 1980s. While AstraZeneca did produce some evidence of failure by others, the court largely disregarded it because it failed to provide enough detail in relation to the nature of such purported failures. The court accorded this factor very little weight. Finally, the court considered AstraZeneca’s evidence of commercial success.  Much of AstraZeneca’s evidence of commercial success was based on its regulatory compliance. In this case, sterility was an FDA requirement, but it did not actually drive demand for the product. Whether or not there is a nexus between the novel features of the patented product and the commercial success must be evaluated in terms of what is driving sales, not what is allowing the product to reach the shelf in the first place. The court afforded more weight to Breath’s expert’s testimony that the drug experienced strong sales because of features unrelated to sterility, such as safety of the budesonide molecule, and nebulized delivery.  Thus, AstraZeneca failed to establish a nexus between the product’s sterility and demand for the drug in the market.

The court also rejected the defendant’s arguments that the ’834 patent was anticipated, not enabled or lacked adequate written description.