On Wednesday, Supernus Pharmaceuticals Inc. filed a lawsuit against fellow pharmaceutical company Torrent Pharmaceuticals Inc. in the District of New Jersey. The plaintiff alleged that the defendant is infringing on ten of its patent for the drug Trokendi XR, which the plaintiff has owned since as early as October 30, 2012. The most recent of the patents was issued on June 11, 2019.
This suit comes in response to a letter sent by Torrent on June 15 notifying Supernus 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, 50 mg, 100 mg, and 200 mg topiramate extended-release capsules, which “is an antiepileptic drug indicated: (i) as an initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures … as an adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome … and for the preventive treatment of migraine.
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, Supernus, the holder of New Drug Application (NDA) on Trokendi XR, 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 Trokendi XR. Supernus argued that this ANDA was filed for the specific purpose of infringing upon the patent and will do so immediately once it is approved.
Supernus stated that the filing was dishonest on the defendant’s part because they submitted the ANDA 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 Torrent’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 Supernus.
The plaintiff requests that its 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.The plaintiff is represented by Saul Ewing Arnstein & Lehr.