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Clinical trials necessary to determine invention works for intended purpose

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 […]

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On-sale bar cannot be avoided by experimentation conducted by patentee’s customer

In a decision Thursday, the Federal Circuit provided additional guidance on the on-sale bar of § 102(b). In the case, the patentee developed a series of prototypes that were then sold to its customer, who then experimented with the prototypes and requested modifications to the prototypes. The prototypes were also accompanied by offers to sell […]

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