Wednesday, December 20, 2017

Cabazitaxel - USA

By an order of Dec 17, 2017, New Jersey district court found claims 7, 11, 14, 15, 16, 21, 26, and 30 of U.S. Patent No. 8,927,592 (expiring on 04/27/2031) are invalid & claims 1 and 2 of U.S. Patent No. 5,847,170 (expiring on 09/26/2021) are valid and are infringed by Defendants’ proposed generic products.

This consolidated action arises under the patent laws of the United States (Sanofi-Aventis US LLC et al v. Fresenius Kabi USA, LLC NJD-3-14-cv-07869). The Court conducted an eight-day bench trial on September 18-20 and September 25-29, 2017. The parties submitted post-trial briefs on October 31, 2017 and the Court heard closing arguments on November 8, 2017. The parties filed supplemental correspondence on November 17, 2017, December 4, 2017, and December 11, 2017. Pursuant to Court order, the parties filed supplemental legal briefs on December 13, 2017. The Court has set forth its Findings of Fact and Conclusions of Law in an accompanying Opinion pursuant to Federal Rule of Civil Procedure 52(a)(1).

The Patent Trial and Appeal Board in Sep 2017 also held the US’592 patent invalid, rejecting arguments that the drug’s success weighed against finding various claims were obvious in an inter partes review (IPR) filed Mylan Laboratories Ltd.

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