Supernus Alleges Patent Infringement Against Alkem Over Antiepileptic Drug

Plaintiff Supernus Pharmaceuticals, Inc. filed suit on Wednesday in the Northern District of Illinois against defendant Alkem Laboratories LTD. The complaint alleges that the defendant’s abbreviated new drug application, or ANDA, will infringe on ten of the plaintiff’s patents protecting their antiepileptic drug, Trokendi XR.

Trokendi XR, the complaint says, is intended to treat individuals who experience partial-onset or primary generalized tonic-clonic seizures, seizures associated with Lennox-Gastaut syndrome, or migraines. Trokendi XR is sold and marketed under an NDA which was previously approved by the Food and Drug ADminsitration allowing the plaintiff to sell the topiramate extended-release capsules in 25 mg, 50 mg, 100 mg, and 200 mg.

Supernus has ten registered patents covering Trokendi XR. Each of the ten patents are listed in the FDA’s ‘orange book,’ the publication that is officially titled “Approved Drug Products with Therapeutic Equivalence Evaluations.” Each of the patents-in-suit is titled “Sustained-Release Formulations of Topiramate” and was issued to the plaintiff by the United States Patent and Trademark Office between 2012 and 2019.

The complaint explains that a recent abbreviated new drug application (ANDA) filed by Alkem is based upon the Trokendi XR topiramate extended-release capsules and will infringe on the patents-in-suit. The defendant’s ANDA indicates that the ANDA products, if approved, will treat the same individuals and require the same dosages as the plaintiff’s drug.

Along with the filing of the ANDA, the defendant is required to provide the plaintiff with a notice letter detailing their opinion that the existing patents are either invalid or will not be infringed by the ANDA product. However, the plaintiff asserts that the defendant’s May 25 notice letter does not include any noninfringement, invalidity, or unenforceability contentions for certain claims of the patents-in-suit. Further, the defendant has allegedly failed to provide Supernus with their ANDA.

The complaint cites ten separate counts of infringement. The plaintiff contends that the defendants “acted without any reasonable basis for believing that it would not be liable for infringement” of the patents-in-suit, and that their infringement will cause the plaintiff irreparable harm. Supernus is seeking judgment that the patents-in-suit are valid and enforceable, favorable judgment on each count, an order preventing the defendant from marketing the ANDA product prior to the expiration of the patents-in-suit, monetary relief in the event they go forward with production of the ANDA product, litigation fees, enhanced damages, and more.

The plaintiff is represented by Sugar Felsenthal Grais & Helsinger LLP and Haug Partners LLP.