Bausch Health Ireland Limited, Salix Pharmaceuticals, Inc., and Norgine B.V. have asked a New Jersey federal court to prevent defendants Lupin Ltd., Lupin Atlantis Holdings SA, Lupin Inc., and Lupin Pharmaceuticals, Inc. (collectively Lupin) from bringing a generic equivalent of their patented colon cleansing solution, Plenvu, to market. The District of New Jersey complaint, filed on Wednesday, centers on Lupin’s Nov. 3 Abbreviated New Drug Application (ANDA) filed with the Food and Drug Administration (FDA) that sought approval to market its generic product.
The plaintiffs’ filing explains that Salix is the holder of a New Drug Application (NDA) for Plenvu, which the FDA approved on May 4, 2018. The two patents at issue are listed alongside Salix’s NDA in the FDA’s “Orange Book” together with other patents, some of which are the subject of ongoing litigation.
The complaint states that Lupin’s proposed generic infringes on two colon cleansing kit patents to which the plaintiffs hold the substantial rights. The two, issued in September and October of this year, make claims related to “kits comprising compositions for the preparation of colon cleansing solutions, kits comprising colon cleansing solutions, and methods of cleansing the colon.”
The plaintiffs contend that Lupin intends to manufacture and sell a generic version of Plevnu prior to the expiration of their patents. By doing so, Lupin will infringe on one or more claims of both, they argue. If Lupin succeeds, they will allegedly suffer “substantial and irreparable harm for which there is no adequate remedy at law.” In turn, the plaintiffs seek to hold Lupin off until the patents-in-suit expire through a court-mandated injunction.
Gibbons, P.C. is listed as counsel for the plaintiffs. Finnegan, Henderson, Farabow, Garrett & Dunner, LLP represents Bausch Health Ireland Limited and Salix Pharmaceuticals, Inc. Dechert LLP represents Norgine B.V.