Pharmaceutical company Neurocrine Biosciences, Inc. filed suit last Friday in the District of New Jersey against Zydus Pharmaceuticals and a number of affiliated entities. The suit was prompted by Zydus’ Abbreviated New Drug Application (ANDA) filing and subsequent notice letter of their intent to produce valbenazine capsules pending approval from the United States Food and Drug Administration (FDA). The plaintiff believes the defendant is infringing on 13 separate patents.
Neurocrine is a company “engaged in the business of researching, developing and bringing to market innovative pharmaceutical product for the treatment of neurological, endocrine and psychiatric disorders.” On April 11, 2017, Neurocrine had a New Drug Application approved by the FDA for INGREZZA capsules. The capsules are intended to treat tardive dyskinesia and contain valbenazine.
Zydus filed an ANDA with the FDA in an effort to gain approval to both produce and market valbenazine capsules prior to the expiration of 13 patents that protect INGREZZA capsules (patents-in-suit). The valbenazine capsules would function as a generic version of INGREZZA capsules.
After Zydus filed the ANDA, they provided a notice letter to Neurocrine describing their intent to “obtain approval to manufacture, use, import, offer to sell and/or sell Zydus’ generic products.” The letter also alleges that certain claims of the patents protecting INGREZZA are either invalid and unenforceable or will not be infringed upon by the activities Zydus is seeking approval for.
Neurocrine asserts that any additional or further action on behalf of Zydus to produce and market valbenazine capsules would result in the plaintiff being “irreparably harmed.” As a result of the perceived patent infringements, the plaintiff is seeking judgements of infringement for all patents along with orders enjoining the defendants from further infringement until the patents-in-suit expire.
The plaintiff is represented by McCarter & English LLP.