Federal Circuit Affirms Preliminary Injunction in Pharmaceutical Case: In AstraZeneca LP v. Apotex, Inc., 2010 WL 4286284 (Fed. Cir. Nov. 1, 2010), the Federal Circuit affirmed a preliminary injunction entered by the U.S. District Court for New Jersey to prevent Apotex from launching a generic version of AstraZeneca?s budesonide inhalation suspension product, marketed as “PULMICORT RESPULES.” Each “respule” is a plastic vial containing a single dose of budesonide suspended in sterile liquid. AstraZeneca owns two patents covering its product: United States Patent Nos. 6,598,603 and 6,899,099. Each patent includes method claims directed to administering a budesonide composition once daily and product claims directed toward a kit containing either a budesonide composition or a suspension and labeled to indicate once-daily administration by nebulization.
Apotex sought approval for a twice-daily generic version of AstraZeneca?s drug product. To avoid infringing AstraZeneca?s patents, Apotex unsuccessfully attempted to obtain approval for a label that did not explicitly mention the once-daily administration of its generic suspension formulation. The FDA, however, required Apotex to include statements regarding the down titration (causing dosage decreases over time) of its generic drug.
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