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Clinical trials necessary to determine invention works for intended purpose

By McKee, Voorhees & Sease, P.L.C.

In a recent decision, the Federal Circuit affirmed a district court's ruling in favor of AstraZeneca, holding that the generic drug manufacturers Apotex and Impax Laboratories infringed patents for the popular heartburn medication Prilosec^® (generic form omeprazole) in filing abbreviated new drug applications (ANDAs).  The Federal Circuit previously addressed these patents in the context of other defendants in a decision blogged about here.

The major issue in this appeal was whether the clinical trials of omeprazole constituted an invalidating public use under § 102(b).  The district court held the clinical trials were experimental use, and the formulation was not ready for patenting at the time of the trials.  Accordingly, the district court held the public use bar of § 102(b) did not apply.  The Federal Circuit affirmed the district court's holding on the basis that the invention was not ready for patenting at the time, as the clinical trials were necessary for the inventors to know that the invention would work for its intended purpose, a necessary predicate to a finding of public use.

The court also addressed a potpourri of other issues, including anticipation, obviousness and the permissible extension of a patent term due to prolonged delay for FDA testing and approval.  The Federal Circuit affirmed the district court's finding on these issues, ending a decade long series of litigation over the popular heartburn medication.

More on In re Omeprazole Patent Litig. after the jump.

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Full post as published by FileWrapper on August 27, 2008 (boomark / email).