Merz Pharmaceuticals Sues MSN Pharmaceuticals over ANDA for Generic Cuvposa

On Thursday, Merz Pharmaceuticals LLC (Merz) filed a complaint against fellow pharmaceutical company MSN Pharmaceuticals Inc. (MSN) for allegedly infringing its drug patent by seeking to make a generic version of Merz’s drug Cuvposa. 

This suit comes in response to a letter sent by MSN notifying Merz 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 glycopyrrolate oral solution, which is used to treat ulcers and prevent drooling for young patients and those with conditions that cause drooling. 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, Merz, the  holder  of  New  Drug  Application (NDA) on Cuvposa, 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 Cuvposa. Merz 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 MSN 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 MSN’s 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 Merz.

The plaintiff requests that its accusation of infringement is affirmed and that there is an injunction enjoining MSN, and all persons acting in concert with MSN, from the commercial manufacture, use, sale, offer for sale, or importation into the United States of MSN’s ANDA Products, or any other drug product whose use is covered by the patent.

The plaintiff is represented by McCarter & English LLP.