ENDO PHARMACEUTICALS SOLUTIONS V. CUSTOPHARM INC.

Endo Pharmaceuticals Solutions, Inc. holds the approved New Drug Application for Aveed®, a testosterone undecanoate intramuscular injection. Bayer owns the two patents listed in the Orange Book for Aveed®. Custopharm Inc.’s predecessor-in-interest, Paddock Laboratories, LLC, submitted an ANDA for approval to produce and market a generic version of Aveed®. In connection with the ANDA filing, Custopharm made a Paragraph IV certification and gave notice of the certification to Endo and Bayer. Endo and Bayer brought an action alleging infringement of the patents. During the proceedings, Custopharm stipulated to infringement, and Endo and Bayer limited their assertions to certain claims. After a trial on invalidity, the district court concluded that Custopharm had not proven that the claims were invalid under 35 U.S.C. § 103. Custopharm appealed. The CAFC finds, inter alia, that the district court did not err in rejecting Custopharm’s “overdose theory,” did not err in finding that Custopharm did not show the formulation was inherent in certain prior art, and properly found that Custopharm failed to show that a skilled artisan would combine the lowered dose with the injection schedule in the manner claimed.  In summary, the CAFC found no reversible errors in the district court’s conclusion and accordingly, affirms.