Plaintiff Neurocrine Biosciences, Inc. filed suit last Friday against defendants Lupin Limited, Lupin Pharmaceuticals, Inc., Lupin Inc., and Lupin Atlantis Holdings S.A. (collectively, Lupin) in the District of Delaware. The suit came about due to Lupin’s alleged infringement of three patents held by Neurocrine, all of which protect the drug Ingrezza.
Neurocrine is “engaged in the business of researching, developing, and bringing to market innovative pharmaceutical products for the treatment of neurological, endocrine and psychiatric disorders.” They currently manufacture and market Ingrezza capsules, which treat tardive dyskinesia.
The suit follows Lupin’s filing of an Abbreviated New Drug Application, or ANDA, with the Food and Drug Administration (FDA). Lupin filed the ANDA in attempt to gain approval to “manufacture, use, import, offer to sell and/or sell Valbenazine Tosylate Capsule [a generic version of the plaintiff’s Ingrezza].” Since the defendant is seeking to manufacture and produce Valbenazine Tosylate capsules prior to the expiration of the aforementioned patents held by the plaintiff, they need to gain approval from the FDA before they can go forward in production.
This is the second action that Neurocrine has filed against Lupin this year. The first suit came after the first notice letter sent out by Lupin, in which they informed the plaintiff of their intentions. Neurocrine responded by filing suit against them for the infringement of 16 separate patents.
On August 17, Lupin sent a second letter to Neurocrine, the complaint said, to inform the plaintiff that they had filed the ANDA with the FDA and pending approval would begin producing and marketing the generic products before the patent’s expiration dates. Lupin detailed within their ANDA their belief that the patents-in-suit are “invalid, unenforceable or will not be infringed by the manufacture, use or sale of Lupin’s generic products.”
Neurocrine counters that the defendant’s production of their capsules will infringe on the patents, despite Lupin’s claims otherwise. They add that Lupin’s products would be “pharmaceutically and therapeutically equivalent to Neurocrine’s INGREZZA Capsules.” The complaint cites three counts of infringement. The plaintiff is seeking favorable judgement of infringement, an injunction preventing the defendants from producing a generic version of Ingrezza, appropriate relief, and any other relief deemed just by the court.
The plaintiff is represented by Ashby & Geddes.
This is not the first patent suit filed by Neurocrine concerning Ingrezza; they sued another pharmaceutical company earlier this year.