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A key claim in a patent related to Eli Lilly and Co.’s antidepressant drug Prozac is invalid for double patenting, the U.S. Court of Appeals for the Federal Circuit ruled Aug. 9 ( Eli Lilly and Co. v. Barr Laboratories Inc., et al., Nos. 99-1262, 99-1263, 99-1264 and 99-1303, Fed. Cir.). The court partially reversed a ruling in favor of Lilly in an action alleging that an abbreviated new drug application (ANDA) filed by Barr Laboratories infringed claims in two of its patents. Barr filed the ANDA in December 1995, seeking approval from the U.S. Food and Drug Administration (FDA) under the Hatch-Waxman Act to market fluoxetine hydrochloride, the active ingredient in Prozac, as an antidepressant. Lilly alleged in a suit brought in U.S. District Court for the Southern District of Indiana that the ANDA infringed claim 5 of its U.S. Patent No. 4,314,081 and claim 7 of its U.S. Patent No. 4,626,549. The action was later consolidated with infringement suits against other generic drug manufacturers. Barr and the other defendants argued that claim 5 of the ’081 patent and claim 7 of the ’549 patent are invalid for failure to comply with the best mode requirement and that claim 7 of the ’549 patent is invalid for double patenting. The parties filed cross-motions for summary judgment; the District Court granted Lilly’s motion. Barr appealed. Partially affirming, the Federal Circuit found no violation of the best mode requirement in either of the two claims. The panel concluded that the evidence on which Barr relied “relates to considerations of costs, volume and available resources for manufacturing fluoxetine hydrochloride, all details that are superfluous to the best mode requirement” and noted that “failure to disclose an unclaimed, preferred mode for accomplishing a routine detail does not violate the best mode requirement because one skilled in the art is aware of alternative means for accomplishing the routine detail that would still produce the best mode of the claimed invention.” DOUBLE PATENTING However, the court reversed with respect to the double patenting issue, finding that the fluoxetine hydrochloride covered in claim 7 of the ’549 patent is also one of the compounds encompassed by claim 1 of U.S. Patent No. 4,018,895, which was issued to Lilly in 1977 and expired in 1994. “In effect, under the ’895 patent, Lilly had the right to exclude others from engaging in the very conduct for which Barr currently seeks FDA approval,” the panel said. “Now, by asserting claim 7 of the ’549 patent, Lilly attempts to extend the term of exclusivity it enjoyed under the ’895 patent for an additional nine years beyond the statutorily prescribed term.” Lilly is represented by Charles E. Lipsey, Allen M. Sokal, Kenneth M. Frankel and David S. Forman of Finnegan, Henderson, Farabow, Garrett & Dunner in Washington, D.C., and Douglas K. Norman and James P. Leeds of the company’s legal department in Indianapolis. Barr is represented by George C. Lombardi, James F. Hurst, Dan K. Webb, Bradley C. Graveline, Christine J. Siwik and Taras A. Gracey of Winston & Strawn in Chicago and Mark E. Waddell and Derek J. Sarafa of Bryan Cave in New York. � Copyright 2000 Mealey Publications, Inc.

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