Life Sciences Litigation Update

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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Published In: Civil Remedies Updates, Intellectual Property Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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