ANDA Suit Filed Over Generic Multiple Myeloma Treatment

On Wednesday, pharmaceutical company Celgene filed a lawsuit against Torrent Pharmaceuticals in the District of New Jersey for allegedly infringing on their drug patents.

This suit comes in response to a letter sent by Torrent notifying Celgene that they have submitted an abbreviated new drug application (ANDA) to the FDA in an attempt to get approval for the commercial manufacturing of generic Lenalidomide tablets. Lenalidomide is a drug used to treat myelodysplastic syndrome and certain types of cancers such as multiple myeloma. This letter is pursuant with the Hatch-Waxman act, which sets forth the procedure for regulatory approval and commercial marketing of pharmaceuticals, including generic drugs. 

Under Hatch-Waxman, 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, Celgene, the holder of the nine different New Drug Applications (NDA) in relation to Lenalidomide since March 2007 and on, decided to exercise their right to sue as they believe that their patent is valid and enforceable. They believe that if not enforced, it would result in significant monetary damages.

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 Revlimid. Celgene argued that this ANDA was filed for the specific purpose of infringing upon the patent and will do so immediately once it is approved. They also assert that the notice letter provides no factual basis for contending that its Lenalidomide ANDA product will not infringe the claims of the patent, and that the defendant’s product has no non-infringing uses and had no reason to think that it did.

If the defendant’s marketing and sale of generic Lenalidomide tablets prior to expiration of the patent and all other relevant exclusivities is not enjoined, Celgene said it will suffer substantial and irreparable harm. The plaintiff requests that their accusation of infringement is affirmed and that there is an injunction enjoining, Torrent and all persons acting in concert with Torrent, from the commercial manufacture, use, sale, offer for sale, or importation into the United States of Torrent’s ANDA Products, or any other drug product whose use is covered by the patent until that patent has reached its expiration.

The plaintiff is represented by Saul Ewing Arnstein & Lehr.