Regulatory Affairs

Sanofi-aventis Settles Eloxatin Patent Spat With Additional Defendents

PBR Staff Writer Published 06 April 2010

Sanofi-aventis has settled US patent infringement suits related to certain generic versions of Eloxatin (oxaliplatin) with additional defendants involved in the litigation.

Sanofi-aventis and Debiopharm, licensor of the involved patent rights, signed settlement agreements with each of Teva Pharmaceuticals USA, Fresenius Kabi (formerly Dabur), Sandoz as announced on April 1, 2010 and have now additionally settled with Mayne/Hospira, MN/Par and Actavis (the six defendants collectively, the generic manufacturers) - thus resolving the litigation over certain formulations of Eloxatin (oxaliplatin).

Eloxatin, combined with the chemotherapy regimen of 5-FU/LV, is approved by the FDA for the treatment of advanced colorectal cancer (cancer of the colon and/or rectum).

Sanofi, under licensing agreement with Switzerland-based Debiopharm, markets Eloxatin. It has filed lawsuit against Par, along with other makers of generic versions of Eloxatin, in 2007.

As per the terms of the settlement agreements, the generic manufacturers would cease selling their unauthorised generic oxaliplatin products in the US from June 30, 2010, to August 9, 2012, at which time the generic manufacturers would be authorised to sell generic Oxaliplatin products under a license, before expiry of the patents at issue. Moreover, all of the settlement provisions, including the dates noted above, are subject to contingencies.

The lawsuits relate to the quality and formulation of Oxaliplatin, available in the US under the brand name Eloxatin. The settlement agreements are subject to review by the Federal Trade Commission.

Additionally, Sun Pharmaceuticals is currently marketing a generic Oxaliplatin product. The US District Court for the District of New Jersey recently found that a proposed settlement agreement between Sanofi-aventis and Sun Pharmaceuticals was enforceable. That decision is subject to appeal.

Under the Court-determined settlement in the Sun case, it is Sanofi-aventis’ position that Sun can continue to market their product until the generic manufacturers cease selling their unauthorised generic Oxaliplatin products. Sanofi-aventis has asked the Court to enter a judgment reflecting that agreement.