Sunovion settles patent clash with MSN and Sandoz

Pharmaceutical company Sunovion, a subsidiary of Sumitomo Dainippon, has settled a patent infringement claim it filed against MSN Laboratories and Sandoz.

Sunovion filed the claim at the US District Court for the District of New Jersey in February 2017, alleging that MSN and Sandoz had infringed US patent number 5,532,372.

The patent, called “Imide derivatives, and their production and use”, relates to Latuda (lurasidone hydrochloride) which is used in the treatment of schizophrenia and depression associated with bipolar disorder. Latuda was developed by Sumitomo and is marketed by Sunovion in the US.

In January 2017, MSN filed an Abbreviated New Drug Application (ANDA) at the Food and Drug Administration (FDA) to make and sell generic lurasidone hydrochloride tablets before the ‘372 patent’s expiration date.

According to the claim, Sandoz is the authorised US regulatory agent overseeing MSN’s ANDA application. It is the regulatory agency’s responsibility to enforce the standards of a product.

The claim said that Sunovion was informed of the ANDA application in 2017.

In its original claim, Sunovion requested a permanent injunction against MSN and Sandoz and an award of damages.

But yesterday, July 5, the district court said that MSN will no longer be seeking FDA approval for the ANDA application before the ‘372 patent expires.

As a result, the patent infringement claim has been dismissed, and each party will bear its own costs.

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