Astrazeneca Ab, Aktiebolaget Hassle, Kbi-E, Inc., Kbi, Inc., and Astrazeneca Lp v. Mutual Pharmaceutical Company, Inc.
Court of Appeals for the Federal Circuit
1Opinion of the Court
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 infringed U.S. Patent No. 4,803,081 (the “'081 patent”), titled “New Pharmaceutical Preparations With Extended Release,” by submitting…
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