CLARKSBURG — Bausch Health Ireland and Salix Pharmaceuticals have filed a patent infringement lawsuit against Mylan Pharmaceuticals for its generic plecanatide oral tablets.
The complaint alleges patent infringement concerning United States Patent No. 11,834,521, known as the '521 patent, specifically regarding Mylan's filing of an Abbreviated New Drug Application (ANDA) for generic plecanatide oral tablets, which the plaintiffs claim infringement upon Trulance, a medication covered by the '521 patent, according to a complaint filed in U.S. District Court for the Northern District of West Virginia at Clarksburg.
Mylan's ANDA submission seeks FDA approval to market generic plecanatide oral tablets, which the plaintiffs argue infringe upon the '521 patent, according to the suit.
The plaintiffs argue in the complaint that Mylan's actions constitute patent infringement by submitting the ANDA before the '521 patent's expiration.
Mylan submitted its ANDA on March 6. The plaintiffs' patent still has not expired, according to the suit.
"Under 35 U.S.C. § 271(e)(2), Mylan has infringed at least one claim of the ’521 patent by submitting, or causing to be submitted to the FDA, ANDA No. 215686 seeking approval for the commercial marketing of Mylan’s generic plecanatide oral tablets before the expiration date of the ’521 patent," the complaint states. "Upon information and belief, Mylan’s generic plecanatide oral tablets will, if approved and marketed, infringe at least one claim of the ’521 patent."
The plaintiffs claim in the complaint that Mylan's actions constitute patent infringement under federal patent laws, which prohibit the submission of ANDAs for generic drugs before the expiration of relevant patents.
"Upon information and belief, Mylan will, through the manufacture, use, import, offer for sale, and/or sale of Mylan’s generic plecanatide oral tablets, directly infringe, contributorily infringe, and/or induce infringement of at least one claim of the ’521 patent," the complaint states. "If Mylan’s marketing and sale of Mylan’s generic plecanatide oral tablets prior to the expiration of the ’521 patent is not enjoined, Plaintiffs will suffer substantial and irreparable harm for which there is no adequate remedy at law."
The plaintiffs alleged irreparable harm if Mylan's tablets were marketed before the patent's expiration, according to the complaint
The Trulance makers allege it is the first medication for IBS-C or chronic idiopathic constipation that is designed to work like a natural peptide.
Salix has held an NDA with the FDA on Trulance since 2017 and the '521 patent was filed in 2023.
The plaintiffs are seeking judgment against Mylan for patent infringement, an order that the effective date for any approval by the FDA for Mylan's product would be after expiration, an order enjoining Mylan from commercially manufacturing, using, importing, offering for sale or selling the tablets until the expiration of the tablet and declaring the case an exceptional case, allowing the plaintiffs to be awarded costs, expenses and disbursements in the action.
The plaintiffs are represented by Daniel R. Higginbotham of Thomas Combs & Spann in Charleston.
The plaintiffs' attorneys declined to comment on the complaint.
U.S. District Court for the Northern District of West Virginia at Clarksburg case number: 1:24-cv-00036