Astrazeneca LP et al. v. Breath Limited et al.

Docket No. 2013-1312, -1352

October 30, 2013


Brief summary: DC claim construction reversed and remanded because there was no “clear and unmistakable disclaimer” and the ordinary meaning controls. Obviousness conclusion affirmed as prior art showed “that once-daily dosing would have been preferred”.

Summary: Astrazeneca appeled DC judgment holding its US 7,524,834 (directed to a micronized powder composition of the asthma drug budesonide (sold as Pulmicort Respules®) not infringed and US 6,598,603 (administration of budenoside using nebulizer) invalid as anticipated and obvious. Apotex cross-appealed DC dismissal of its counterclaim of invalidity of certain ‘603 claims. The opinion first considered the DC determination that “micronized powder composition” in the ‘834 patent means “heat sterilized finely divided dry particles” and that “’heat sterilized’ refers to ‘particles that have been sterilized through a process, consistent with heat sterilization, that allows them to essentially maintain the same pharmacological activity, physico-chemical properties, chemical purity, and physical form as the starting material.’” It explained that while “the patent refers only to dry heat sterilization as the preferred method of achieving the claimed ‘micronized powder composition’ and criticizes, often sharply, other forms of sterilization”, “[m]ere criticism of a particular embodiment encompassed in the plain meaning of a claim term is not sufficient to rise to the level of clear disavowal”, “[i]t is…not enough that the only embodiments, or all of the embodiments, contain a particular limitation” and, in this case, “statements with respect to ‘the invention’ are ambiguous at best”. Thus, there was no “clear and unmistakable disclaimer” so the ordinary meaning (which would include non-heat sterilized micronized powder compositions) controls (Thorner, FC 2012). Regarding obviousness of the nebulization claims of the ‘603 patent, the panel agreed with the DC that the prior art showed that “‘compliance and convenience’ factors, as well as the recognized stepwise approach to dosing suggest that once-daily dosing would have been preferred, especially with respect to young children” (“a known problem existed at the time of the invention”), “the evidence established a reasonable expectation of success for once-daily treatment of children”, the alleged secondary considerations (e.g., AstraZeneca’s clinical trials and alleged long-felt, unmet need) were insufficient to overcome the evidence of obviousness. The panel also concluded that the DC had not abused its discretion in dismissing Apotex’s claims and affirmed its conclusion regarding the bond for damages.

This entry was posted in Claim Construction, Generics / ANDA, Obviousness. Bookmark the permalink.

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