Bausch Health Ireland and Salix Pharmaceuticals filed a suit in a New Jersey federal court over MSN Pharmaceuticals' alleged efforts to obtain U.S. Food and Drug Administration approval for a generic version of Trulance, a medication used to treat irritable bowel syndrome.

Takeaway: Litigation over new drug applications, often referred to as NDAs, remains an active area for law firms. This patent infringement lawsuit was filed by attorneys with Gibbons and Finnegan, Henderson, Fabrow, Garrett & Dunner on behalf of two pharmaceutical giants against a rival drugmaker over an FDA application to make a generic version of an IBS medication.

Court: New Jersey, U.S. District Court

Case Type: Patent infringement

Industry: Pharmaceuticals

Lawyers: William P. Deni Jr. and J. Brugh Lower of Gibbons and Bryan C. Diner and Justin J. Hasford of Finnegan, Henderson, Farabow, Garrett & Dunner; counsel has yet to appear for the defense.

Liability: The two-count complaint alleged MSN violated the plaintiff’s patent on Trulance by submitting an abbreviated NDA for the manufacture, use and sale of a generic version of the drug. Bausch and Salix alleged that MSN is seeking approval for plecanatide, a generic oral tablet based on their patented medication, Trulance.

The complaint claimed the plaintiffs received a letter from MSN on March 15, 2021, informing them of the abbreviated NDA. Salix currently holds the approved NDA for Trulance.

The complaint alleged also that the plaintiffs received a second letter in May 2023 and a third letter this May. As a result of receiving these letters, Bausch and Salix filed their complaint. Despite still waiting to receive a patent notice letter from MSN, the plaintiffs alleged that the previous three letters demonstrate infringement of their patent on Trulance.

Damages: Bausch and Salix contended that if MSN’s marketing and sale of generic plecanatide oral tablets take place before the expiration of the Trulance patent, the companies will suffer “substantial and irreparable harm.” The date of the patent expiration was not noted in the complaint.

The plaintiffs sought a judgment that MSN infringed on their patent by submitting the abbreviated NDA. Also, they requested an order that the effective date of FDA approval for the generic version of Trulance be at the expiration of their patent. They also sought to enjoin the manufacture, sale and marketing of the generic version and to enjoin others from helping MSN gain approval from the FDA.

What the lawyers are saying: Plaintiff’s counsel did not immediately respond to requests for comment.

Radar scan: This case is part of a steady stream of cases targeting pharmaceutical companies over their purported efforts to receive FDA approval to manufacture generic versions of drugs.

Caption: Bausch Health Ireland v. MSN Laboratories Private

Date filed: Dec. 16

Judge: U.S. District Judge Stanley R. Chester

Read the complaint here.

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