Novartis Sues Over Generic Leukemia Treatment

On Friday, Novartis Pharmaceuticals and Dana-Farber Cancer Institute Inc. filed a complaint against fellow pharmaceutical company Dr. Reddy’s Laboratories Inc. in the District of New Jersey. The plaintiff alleged that the defendant is infringing on its patent for the drug Rydapt, used to treat leukemia.

This suit comes in response to a letter sent by Reddy Labs notifying Farber and Novartis that it submitted an abbreviated new drug application (ANDA) to the Food and Drug Administration (FDA) in an attempt to engage in commercial manufacturing of generic 25 mg Midostaurin tablets, which is a kinase inhibitor that is used to treat patients suffering from leukemia. The ANDA was submitted pursuant to the Hatch-Waxman Act, which sets forth the procedure for regulatory approval and commercial marketing of pharmaceuticals, including generic drugs. 

Under the Hatch-Waxman Act, each ANDA must include a certification or statement for each patent listed in the Orange Book. In this case, the defendant is citing paragraph IV of 21 U.S.C. Sec. 355(j)(2)(a)(vii), which states that the patent is not valid or will not be infringed by the new drug. After receiving the notice, the plaintiffs, holders of the New Drug Application (NDA) on Rydapt, decided to file the lawsuit out of fear that not doing so would result in great financial loss.

The plaintiff stated that contrary to the claims made in the notice letter, the defendant’s generic version of the drug does directly infringe upon claims within its patent and its relation to their brand name drug Rydapt. Bayer argued that this ANDA was filed for the specific purpose of infringing upon the patent and will do so immediately once it is approved. 

The plaintiff stated that the filing was dishonest on the defendant’s part because Reddy Labs made it for the sole purpose of infringement. The plaintiff said the defendant’s product has no non-infringing uses and had no reason to think that it did. The plaintiff added it fears that Reddy Labs’ intent to manufacture, offer for sale, sell, distribute, and/or import their ANDA Products, thus infringing on the patent, will cause substantial and irreparable harm to Dana -Farber and Novartis.

The plaintiffs are represented by McCarter & English, LLP.