Novartis, Dana-Farber seek to bar generic leukaemia drug

Novartis Pharmaceuticals and the Dana-Farber Cancer Institute have filed two lawsuits to bar generic versions of leukaemia drug, Rydapt (midostaurin).

The complaints were filed at federal courts in Delaware and North Carolina this week.

The parties cite a Hatch-Waxman action for patent infringement relating to an Abbreviated New Drug Application (ANDA) number 217342 filed by Accord Healthcare, a subsidiary of India-based Intas Pharmaceuticals.

The complaints outline how Rydapt is a kinase inhibitor indicated for the treatment of adult patients with acute myeloid leukaemia that is FLT3 mutation-positive, in combination with chemotherapy.

In July 2011, the US Patent and Trademark Office duly and legally issued the ’031 patent, entitled “Staurosporine Derivatives as Inhibitors of FLT3 Receptor Tyrosine Kinase Activity.”

The complaints note how the US Food and Drug Administration (FDA)’s official publication of approved drugs (the Orange Book) lists the ’031 patent in connection with Rydapt.

Accord has sought approval from the FDA for approval to engage in the commercial manufacture of generic versions of Novartis’ Rydapt 25mg capsules, before the expiration of ‘031 patent.

In April, 2022, Accord notified Novartis that it had submitted to the FDA ANDA number 217342 for a generic version of Rydapt seeking approval under the Federal Food, Drug, and Cosmetic Act (FDCA) to engage in the commercial manufacture, use, offer for sale, and/or sale of Accord’s ANDA Product prior to the expiration of the ’031 patent.

In its notice letter, Accord notified Novartis that, as a part of its ANDA, Accord had filed a certification, with respect to the ’031 patent asserting that it is invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, offer for sale, and sale of Accord’s ANDA product.

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