Endo Pharmaceuticals Solutions v. Custopharm Inc.
Court of Appeals for the Federal Circuit
1Opinion of the Court
Chen, Circuit Judge.
Endo Pharmaceuticals Solutions, Inc. (Endo) holds the approved New Drug Application for Aveed ® , a testosterone undecanoate (TU) intramuscular injection. Bayer Intellectual Property GmbH and Bayer Pharma AG (Bayer) own the two patents listed in the Orange Book for Aveed ® , U.S. Patent Nos. 7,718,640 (the '640 patent) and 8,338,395 (the '395 patent). Custopharm Inc.'s (Custopharm) predecessor-in-interest, Paddock Laboratories, LLC, submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for approval to produce and market a…
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