By Donald Zuhn --
Last Friday, the Federal Circuit affirmed the determination by the District Court for the District of Delaware that U.S. Patent No. 5,236,940 does not qualify as an enabling prior art reference, and therefore, does not anticipate claims 1-5 of U.S. Patent No. 5,527,814.
The '814 patent, which is owned by Defendant-Appellee Aventis Pharmaceuticals Inc., relates to the use of riluzole to treat amyotrophic lateral sclerosis (ALS), otherwise known as Lou Gehrig's disease. Aventis markets riluzole under the trade name RILUTEK.
Seeking approval to market a generic version of riluzole, Plaintiff-Appellant Impax Laboratories, Inc. filed an Abbreviated New Drug Application (ANDA) with the FDA. One year later, Impax filed suit for a declaratory judgment that it did not infringe, induce infringement of, or contribute to the infringement of the '814 patent, and further, that the '814 patent was invalid as anticipated and unenforceable.
After a bench trial, the District Court determined that Impax failed to show that the '814 patent was unenforceable or that claims 1-5 of the '814 patent were anticipated by the '940 patent. Impax appealed that determination to the Federal Circuit, which affirmed-in-part, vacated-in-part, and remanded to the District Court (see Patent Docs report on Impax II). On remand, the District Court found that because the '940 patent disclosed a formula encompassing hundreds or thousands of compounds for the treatment of several diseases, excessive experimentation would have been required to use riluzole to treat ALS (in view of the teachings of the '940 patent). In addition, the District Court determined that nothing in the '940 patent directed the skilled artisan to the use of riluzole for treating ALS, rejecting Impax's argument that "the mere mention of riluzole is sufficient to put one skilled in the art in the possession of the claimed invention."
In the second appeal, the Federal Circuit affirmed the District Court's finding of non-enablement, stating that "each component of the claimed invention -- identifying riluzole as a treatment for ALS and devising dosage parameters -- would require undue experimentation based on the teachings of the '940 patent." Because the District Court did not err in finding the '940 patent to be non-enabling, the Federal Circuit also found that the District Court had correctly determined that the '940 patent did not anticipate claims 1-5 of the '814 patent.
Impax Laboratories, Inc. v. Aventis Pharmaceuticals Inc. (Fed. Cir. 2008)
Panel: Circuit Judges Rader and Schall and District Judge Zobel
Opinion by Circuit Judge RaderAdditional Disclaimer: MBHB represented Aventis in the above appeal. To the extent that this case summary contains any opinions, the opinions would be of Dr. Zuhn and not Aventis or MBHB.
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