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Federal Circuit Rules Against Patent Declaratory Judgment Actions Before Biosimilar Application Is Filed

On December 5, 2014, the Federal Circuit issued its opinion in Sandoz Inc. v. Amgen Inc. et al. In a unanimous panel opinion (Judges Dyk, Taranto and Chen), the Court held that clinical trials initiated to support a possible subsequent filing of a biosimilar application with the U.S. Food and Drug Administration (“FDA”) do not constitute sufficient activity to create subject matter jurisdiction for a declaratory judgment action.

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Consultation Period for Rules of Procedure for the Unified Patent Court (UPC)

Practices: Intellectual Property

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On 25 June, 2013, the Preparatory Committee for the EU Unitary Patent System published its draft Rules of Procedure for the Unified Patent Court. U.S. and international companies can now comment on the rules. Read the alert to find out how. 

The Committee is now soliciting public comment through 1 October, 2013. Comments should be submitted to the following address: secretariat@unified-patent-court.org

As we have discussed previously, the new Unitary Patent Court and its Rules of Procedure will substantially influence European patent litigation strategies for plaintiffs and defendants. Certain rules will be particularly important to U.S. and international companies. These include rules related to bifurcation, stay and injunctions, opting out of UPC jurisdiction, interplay between EPO oppositions and UPC revocation, and costs of proceedings and damages.

For questions about how the new EU System and its Rules of Procedure will impact your business or how to present comments to the Committee, please contact your usual Ropes & Gray attorney or one of the following Ropes & Gray attorneys: Anita Varma, Richard McCaulley, Christopher Harnett, Edward Kelly, Charles Larsen, and Christopher Carroll.                         



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