Accord Healthcare and Intas Pharmaceuticals Sued For Infringement Over Rydapt Cancer Drug

Plaintiffs Novartis Pharmaceuticals Corporation and Dana-Farber Cancer Institute, Inc. (Dana Farber) filed a complaint against defendants Accord Healthcare Inc., and Intas Pharmaceutical LTD. On Tuesday in the Middle District of North Carolina. The complaint alleges that the defendants infringed on one of the plaintiffs’ patents when they filed an abbreviated new drug application, or ANDA, with the Food and Drug Administration (FDA) seeking approval to manufacture and market a generic version of the drug Rydapt.

Novartis, the complaint says, is involved in the business of “creating, developing, and bringing to market revolutionary drug therapies to benefit patients against serious diseases, including treatments for leukemia and mastocytosis.” They produce and sell the drug RYDAPT as a treatment option for adult patients with acute myeloid leukemia. The ‘031 patent, or the patent-in-suit, is entitled “Staurosporine Derivatives as Inhibitors of FLT3 Receptor Tyrosine Kinase Activity.”

The plaintiffs received notice on April 26 of the defendants’ intent to produce a generic version of their drug prior to the expiration of the patent-in-suit, as they had filed an ANDA with the FDA. In the ANDA, they asserted that the patent-in-suit is invalid, unenforceable, or will not be infringed upon by the commercial manufacture and sale of the defendant’s ANDA product.

Novartis and Dana Farber, who own all the rights to the patent-in-suit, assert in the complaint that the act of infringement by the defendants “has led to foreseeable harm and injury to Novartis, a Delaware Corporation, and to Dana Farber.”

The complaint cites one count of infringement of the ‘031 patent. The plaintiffs are seeking judgment that the patent is valid, enforceable, and will be infringed upon by the defendant’s ANDA submissions, an order prohibiting further infringement by the defendants, damages, litigation fees, and any other relief deemed proper by the court.

The plaintiffs are represented by Gibson, Dunn & Crutcher LLP.