Clinical trials necessary to determine invention works for intended purpose

Wed, 27 Aug 2008 17:28:00-0500

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

Mon, 25 Feb 2008 11:56:00-0500

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 production models of the prototypes. The court was clear in that the experimental use exception only concerns the actions of the inventors and their agents, not another party doing experimental testing for a particular purpose. As a result, despite the fact that the customer was experimenting with the prototypes, that experimentation could not negate the on-sale bar of § 102(b).

Two of the panel's three judges also filed a concurring opinion. In that opinion, Judges Prost and Dyk "point out the confusion" in Federal Circuit law when it comes to the interaction between experimental use and the on-sale bar. While this case is not the proper vehicle, it's safe to add this issue to the list of near-future en banc issues for the court.

More detail of Atlanta Attachment Co. v. Leggett & Platt, Inc. after the jump.

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Clinical trials necessary to determine invention works for intended purpose

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