Amgen was an exclusive licensee to two patents for the “biological product” Enbrel.  Sandoz wished to create a product of its own and would seek to apply for approval under the FDA’s requirements for “biosimilarity.”  Sandoz had communicated to the FDA its intention to file such an application in the future, and, on the day that Sandoz began its Phase III trial of its product, Sandoz filed the present declaratory judgment case against Amgen.  The Federal Circuit affirmed the district court’s dismissal of Sandoz’s complaint on the grounds that the court lacked subject-matter jurisdiction over Sandoz’s claims, as those claims lacked sufficient “immediacy and reality.”  None of Sandoz’s activities at the time of the complaint would have exposed it to liability to Amgen (Sandoz’s Phase III trials were being conducted outside of the U.S.) and Sandoz had not yet filed any applications with the FDA.  The Phase III trials were not yet complete, and therefore significant uncertainties existed regarding infringement, as failures in the trial may cause changes to the proposed product.

Sandoz Inc. v. Amgen Inc., Case No. 2014-1693 (December 5, 2014); Opinion by: Taranto, joined by Dyk and Chen; Appealed From: Northern District of California, Chesney, J.  To read the full opinion, click here.

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