Sanofi sues Glenmark, Torrent over sclerosis drug

Sanofi had received letters from Torrent and Glenmark, with a notice of their new drug applications

French drug maker Sanofi has sued Glenmark and Torrent Pharmaceuticals in a US court over their plans to launch a generic version of its multiple sclerosis drug, Aubagio.

Sanofi holds the patent for Aubagio and had global sales of euros 928 million in the first nine months of 2016. A majority of these sales were from the US, according to company filings.

The lawsuits against the two Indian companies comes in the wake of their applications to the US Food and Drug Administration to launch the generic version. 

Filed in a district court at Delaware on December 30, this was reported in the  Life Sciences Intellectual Property Review. The lawsuit claims patent infringement.  

Sanofi had received letters from Torrent and Glenmark in November, with a notice of their new drug applications. 

The letters claimed Sanofi's patents were invalid, unenforceable and would not be infringed by the manufacture and sale of the generic version of Aubagio, reported LSIPR.

The new drug applications were filed under the Para IV process. Companies use this process to challenge patents held by innovator companies. Applicants filing for drug approvals are required to serve notices to the patent holders; the latter may then sue the companies on charges of  infringement.

Glenmark refused to comment on the lawsuit, while Sanofi did not respond to a query. Responses from Torrent had not come in till the time of going to press. 

Multiple sclerosis (MS) is a central nervous system ailment and according to some estimates, a little over two million people in the US suffer from it. The North America market for MS was valued at around $13 billion in 2015. Drug makers Biogen, Novartis and Teva are key entities in the segment, along with Sanofi.

Glenmark has 20 Para IV new drug applications which are pending approval. It is aiming to grow its US business through in-licensing of drugs and developing new dosage forms. 

An Edelweiss report says Torrent Pharma is targeting a base business of $500 million in the US. A little more than 20 Abbreviated New Drug Applications will be filed yearly from year FY17 onwards, it said.