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ARTICLE · 03 DECEMBER 2008

Anticipatory Prior Art Reference Must Enable Invention Without Undue Experimentation

McDermott Will & Emery
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The U.S. Court of Appeals for the Federal Circuit recently affirmed a district courts determination that a patent did not qualify as an enabling prior art reference and, therefore, was insufficient to support an anticipation rejection.

United StatesIntellectual Property
Philip Canelli
Philip Canelli
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The U.S. Court of Appeals for the Federal Circuit recently affirmed a district court's determination that a patent did not qualify as an enabling prior art reference and, therefore, was insufficient to support an anticipation rejection. Impax Laboratories, Inc. v. Aventis Pharmaceuticals Inc., Case No. 07-1513 (Fed. Cir. Oct. 3, 2008)(Rader J.)

The patent-in-suit, which is owned by Aventis Pharmaceuticals Inc., relates to the use of riluzole to treat amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). Aventis markets riluzole under the trade name RILUTEK.

Impax Laboratories, Inc. filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market generic riluzole tablets. One year later, Impax sued Aventis for a declaratory judgment that Impax did not infringe, induce infringement of or contribute to the infringement of the Aventis patent. In its suit, Impax alleged that the patent was invalid as anticipated and unenforceable.

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