Last week, in the District of New Jersey, Supernus Pharmaceuticals Inc. filed a complaint alleging infringement of its 10 patents covering epilepsy drug Trokendi XR against Ajanta Pharma Ltd. and a subsidiary.
According to the complaint, generic drug company Ajanta submitted Abbreviated New Drug Application (ANDA) No. 215663 seeking Food and Drug Administration (FDA) approval of extended-release capsules of topiramate — the generic version of Supernus’ Trokendi XR — in 25, 50, 100, and 200 mg strengths.
Pharmaceutical company Supernus is the owner of New Drug Application No. 201635, pertaining to Trokendi XR in 25, 50, 100, and 200 mg strengths, and of United States Patent Nos. 8,298,576; 8,298,580; 8,663,683; 8,877,248; 8,889,191; 8,992,989; 9,549,940; 9,555,004; 9,622,983; and 10,314,790, all covering Trokendi XR, according to the FDA’s patent database, Orange Book.
The defendant sent a letter on or about Feb. 10 to Supernus detailing information about Ajanta’s proposed ANDA products, including the indications, usage, dosage, and administration, but the notice did not include the noninfringement and invalidity contentions as to all patent claims that regulations require: “(A) letter notifying a patent holder of the filing of an ANDA containing a paragraph IV certification (must) ‘include a detailed statement of the factual and legal basis of the opinion of the applicant that the patent is invalid or will not be infringed,’” the complaint said, citing 21 U.S.C. § 355.
Further, according to the plaintiff, the parties did not come to an agreement for Supernus to review the defendants’ ANDA to assess the possible infringement.
Supernus argued that the defendants “acted without a reasonable basis for believing that they would not be liable for infringement” of the patents-in-suit. If Ajanta circulates its ANDA products, all of the patents-in-suit will be infringed, causing Supernus “irreparable harm,” according to the plaintiff.
The plaintiff requested a judgment that its patents are valid and enforceable, an enjoinment of the defendants from continuing its allegedly infringing conduct, and monetary damages, among other relief.