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Sanofi Bid to Block Generic Aprovel Goes to EU Courts

A patent dispute between Actavis Group HF and Paris-based Sanofi over a drug to treat diabetes and hypertension was referred to a European Union court by a London judge.

Actavis, owned by Iceland-based private equity firm Novator EHF, wants to sell a generic version of Sanofi’s Aprovel treatment, according to a written ruling by Judge Richard Arnold today. Aprovel, also sold as Avapro, generated 1.3 billion euros ($1.7 billion) in sales in 2011, according to Sanofi’s annual report.

Sanofi and the drug’s distributor Sanofi Pharma Bristol-Myers Squibb SNC argue that, although Aprovel’s patent expired, their right to exclusively sell the product is covered by a supplementary protection certificate.

The issue is unclear and should be referred to the European Court of Justice, Arnold said.

The referral to the European court to determine the meaning of rules covering supplementary protection certificates will be made shortly, Sanofi spokeswoman Marisol Peron said in an e-mail.

Actavis spokesman Frank Staud said in an e-mail the certificate was invalid and the company sought to have it revoked by the European court.

“Actavis is confident” the court will decide in its favor, he said.

The case is: Actavis Group PTC EHF & Anr v. Sanofi-Aventis, High Court of Justice, Chancery Division, HC12C02525.

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