Sanofi files cases against Glenmark on patent infringement

French drug-maker filed the suit seeking to prevent Glenmark and Actavis from commercialising its ANDA product prior to the expiration of certain US patents

French drug-maker Sanofi filed patent infringement petition against Glenmark on cardiac drug Multaq, in the district court of Delaware, on three counts.

According to the petition, the Indian drug maker had submitted its application to seek US Food and Drug Administration's (USFDA's) approval for its generic version of the drug on January 24, 2014.

Sanofi and Sanofi-Aventis US LLC filed the suit against Glenmark and Dublin-based Actavis (Watson) on February 26, 2014 in the US court seeking to prevent the duo from commercialising its ANDA product prior to the expiration of certain US patents.

The lawsuit was filed under the provisions of the Hatch- Waxman Act, resulting in a stay on final FDA approval of Actavis' ANDA until Jan 1, 2017, or final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.

Multaq, is an anti-arrhythmic drug indicated to reduce the risk of hospitalisation for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF.

For the 12 months ending December 31, 2013, Multaq had total US sales of approximately $319 million, according to IMS Health data.

Actavis in its statement claimed that it may get the first filer advantage.

"Based on available information, Actavis believes it may be a 'first applicant' to file an ANDA for the generic version of Multaq and, should its ANDA be approved, it may be entitled to 180 days of generic market exclusivity," Actavis said.

In case of Glenmark, it was not clear whether the domestic drug firm would also get any exclusivity as mails sent to the company seeking their comments were not answered.

Alok Dalal, VP Research-Healthcare, Motilal Oswal Securities Ltd said, though the separate petitions against Actavis and Glenmark on the same day, it is important who filed the ANDA first.

Actavis is most likely to get the 180 days exclusivity of the drug. However, based on the outcome of the court and FDA approval, if Glenmark negotiates successfully they may get shared exclusivity, Dalal said.

A first-to-file status on generic application allows the generic drug firm 180 days of marketing exclusivity after the innovator patent expiry.