Shilpa Pharma Alleges ‘Willful’ Patent Infringement Against Novartis Drug Gilenya

On Wednesday in the District of Delaware, Shilpa Pharma Inc. filed a complaint against Novartis Pharmaceuticals Corporation, alleging that the defendant’s drug Gilenya infringes on one of the plaintiff’s patents.

Shilpa is the assignee of United States Patent No. 9,266,816 (the ’816 patent), “Fingolimod Polymorphs and Their Processes,” according to the complaint.

Novartis holds New Drug Application (NDA) No. 022527 for Gilenya capsules in 0.5 and 0.25 mg strengths, which is listed in the Food and Drug Administration (FDA)’s drug patent database, Orange Book. The active ingredient in Gilenya is fingolimod hydrochloride, which is used to treat multiple sclerosis in patients 10 years and older.

The listed patents corresponding with Gilenya do not include the ’816 patent, but the plaintiff alleged — through a granular analysis of how Gilenya purportedly is made by the same process protected by the patent-in-suit — that the product infringes on claims 2 through 4 of the patent.

Shilpa claimed that the defendant’s alleged infringement was willful because the company knew about the patent and the plaintiff’s suspicions. In March 2016, Shilpa notified Novartis of its issuance of the patent-in-suit and that the plaintiff believed one or more of its claims covered the brand-name drug. Representatives from both parties met to discuss the issue — but Novartis did not take Shilpa up on its offer to become a licensee of the patent, according to the complaint.

“Thus, Novartis has had notice of the ‘816 patent, and Shilpa’s view that the GILENYA® Products were covered by one or more of its claims, since early 2016,” the complaint asserted.

If the defendant is not enjoined from its allegedly infringing conduct, the plaintiff argued, Shilpa will be “irreparably harmed.” The plaintiff also requested monetary damages and declaratory relief.

Smith, Katzenstein & Jenkins LLP represents Shilpa.