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ASTRAZENECA AB v. MUTUAL PHARMACEUTICAL

No. 04-1100.

384 F.3d 1333 (2004)

ASTRAZENECA AB, AKTIEBOLAGET HASSLE, KBI-E, INC., KBI, Inc., and Astrazeneca LP, Plaintiffs-Appellees, v. MUTUAL PHARMACEUTICAL COMPANY, INC., Defendant-Appellant.

United States Court of Appeals, Federal Circuit.

DECIDED: September 30, 2004.

Attorney(s) appearing for the Case

Lisa B. Pensabene, Fitzpatrick, Cella, Harper & Scinto, of New York, NY, argued for plaintiffs-appellees. With her on the brief were Michael P. McGraw and Christopher P. Borello.

H. Michael Hartmann, Leydig, Voit & Mayer, Ltd., of Chicago, IL, argued for defendant-appellant. With him on the brief were Robert F. Green, Christopher T. Griffith and Paul J. Filbin.

Before MICHEL, Circuit Judge, ARCHER, Senior Circuit Judge, and BRYSON, Circuit Judge.

MICHEL, Circuit Judge.

Astrazeneca AB, Aktiebolaget Hassle, KBI-E, Inc., KBI, Inc., and Astrazeneca LP (collectively, "Astrazeneca") sued Mutual Pharmaceutical Co., Inc. ("Mutual") pursuant to 35 U.S.C. § 271(e)(2), under which it is an "act of infringement" to submit an Abbreviated New Drug Application ("ANDA") to the Food and Drug Administration ("FDA") to obtain approval to market a drug that is claimed in a nonexpired patent. Astrazeneca alleged that Mutual...

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