On Friday, Neurocrine Biosciences, Inc. filed a complaint in the District of Delaware against Teva Pharmaceuticals, Inc. and their subsidiaries for allegedly trying to manufacture, distribute and sell products that infringe upon Neurocrine’s patents.
The complaint recounts that throughout the past year, Neurocrine has sued Teva three times for patent infringement when they tried to file Abbreviated New Drug Applications (ANDA) to the Food and Drug Administration (FDA) for approval of their products. In total, Teva was accused of infringing 17 of Neurocrine’s patents across these lawsuits.
The present complaint is tied to Teva’s fourth notice letter for their generic Valbenazine capsules. Neurocrine claims it holds a New Drug Application (NDA) for Ingrezza, which are non-generic Valbenazine capsules, since 2017; they have held a US patent for their products since April 26, the complaint says.
The defendant allegedly claimed that “the patent-in-suit is invalid, unenforceable or will not be infringed by the manufacture, use, import, offer to sell and/or sale of Teva’s generic products” which the plaintiffs are contesting.
Neurocrine has claimed that Teva is producing a “pharmaceutically and therapeutically equivalent” product to their capsules, and has been attempting to do so for the past year. The plaintiff is concerned that Teva’s “proposed package insert will recommend, suggest, encourage and/or instruct others how to engage in an infringing use” since their generic product market is one of the largest in the world. Thus, Neurocrine is suing for the infringement of their ‘532 patent.
The plaintiff is seeking an order declaring that Teva has infringed upon the ‘532 patent, an order preventing any of Teva’s infringing products from becoming FDA-approved until the patent expires, injunctive relief enjoining Teva from continuing to produce and sell their infringing products, attorney’s fees and costs, and other relief.
Neurocrine is represented by Ashby & Geddes.