A complaint was filed by plaintiff Neurocrine Biosciences, Inc. last Friday against defendants Sandoz International GMBH, Sandoz Inc., Sandoz AG, Crystal Pharmaceutical (Suzhou) Co. LTD., and Crystal Pharmatech Co. LTD in the District of Delaware. The complaint for patent infringement alleges that the defendant’s new ANDA product will infringe on three patents held by the plaintiff.
Neurocrine holds a new drug application for Ingrezza, prescription drugs intended to treat tardive dyskinesia. One of the active ingredients in Ingrezza capsules is Valbenazine.
The suit contends that the defendants have infringed upon three separate patents held by the plaintiff (collectively, the patents-in-suit). Two of the patents are titled “Substituted 3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11B-hexahydro-2h-pyrido[2,1-a]isoquinolin-2-ol Compounds and Methods Relating Thereto,” while the third is titled “High Dosage Valbenazine Formulation and Compositions, Methods, and Kits Related Thereto.” The patents are not due to expire for multiple years and are all listed in the FDA’s Orange Book in connection with the capsules.
The defendants recently submitted an abbreviated new drug application to the FDA seeking approval to manufacture and market Valbenazine capsules, which the plaintiff asserts are “generic versions of [their] INGREZZA Capsules.” In the defendants’ notice letter to the plaintiff, they argued that the claims of the patents-in-suit are invalid, unenforceable, or would not be infringed upon by the ANDA product.
Neurocrine maintains in the complaint that the “defendants have represented to the FDA that Defendants’ generic products are pharmaceutically and therapeutically equivalent to Neurocrine’s INGREZZA Capsules,” meaning that the ANDA product will infringe on the patents-in-suit and cause irreparable harm to the plaintiff.
The complaint cites three separate counts of patent infringement. The plaintiff is seeking favorable judgment on each count, an injunction preventing the defendants’ manufacturing and marketing of their ANDA product until after the expiration date of the patents-in-suit, attorney fees, and any other relief deemed proper by the Court.
The plaintiff is represented by Ashby & Geddes.