Aurobindo sued for patent infringement over Gilenya generic

Novartis, Mitsubishi Tanabe Pharma and Mitsui Sugar have filed a complaint against Aurobindo Pharma for patent infringement.

The case, which was filed yesterday, January 19, at the US District Court for the District of New Jersey, was brought to court after Aurobindo filed an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA).

Aurobindo is seeking to sell a generic version of Novartis’s Gilenya (fingolimod), a treatment for multiple sclerosis.

The patent involved is US number 5,604,229, which was issued in February 1997 by the US Patent and Trademark Office. It is owned by Mitsui and Mitsubishi and is exclusively licensed to Novartis.

The suing companies stated in their complaint that, “by filing [an] ANDA … Aurobindo has necessarily represented to the FDA that, upon approval, Aurobindo’s ANDA product will have the same active ingredient, method of administration, dosage form, and strength as Gilenya, and will be bioequivalent to Gilenya.”

The companies have asked the court for a judgment in their favour, as well as an injunction which will stop Aurobindo from bringing the generic drug to market before the expiration of the patent involved.

Novartis, Mitsubishi and Mitsui said: “If Aurobindo’s infringement of the '229 patent is not enjoined, plaintiffs will suffer substantial and irreparable harm for which there is no remedy at law.”

They have asked the court for an award of damages.