United Therapeutics Commences Litigation to Ensure Fairness in the Drug Review Process - Seite 2

Under the Hatch-Waxman Act, when a company like Liquidia seeks approval of an application that relies on another drug’s prior approval and may infringe patents listed for that drug, a timely filed action for patent infringement prevents the FDA from approving an NDA for up to 30 months or until the resolution of the litigation, whichever occurs first. By filing an amendment to its existing NDA rather than a new NDA, Liquidia avoided a 30-month stay of approval for PH-ILD despite Liquidia’s decision to rely on United Therapeutics’ prior approval for Tyvaso. By filing this litigation, United Therapeutics seeks to protect the equity afforded true pharmaceutical and biotech innovators through the correct and consistent interpretation of the FDA’s rules, precedents, and procedures. If United Therapeutics is successful in its litigation with FDA, a stay of up to 30 months could prevent final approval for Liquidia’s PH-ILD indication to allow separate patent litigation to be resolved.

“The FDA is a global leader among public health agencies, but sometimes legal and regulatory precedents are missed,” said Dean Bunce, Executive Vice President, Global Regulatory Affairs at United Therapeutics. “We are simply asking that the FDA apply its own rules and precedents consistently to honor the Hatch-Waxman balance struck by Congress between innovators and imitators: Liquidia can rely on United Therapeutics’ innovation to speed its path to market, but the cost of that shortcut is that Liquidia must address the infringement claim against it before rushing to market.”

United Therapeutics previously sued Liquidia alleging infringement of U.S. Patent No. 11,826,327 (the ’327 patent) based on Liquidia’s efforts to obtain approval for the PH-ILD indication. The claims of the ’327 patent generally cover improving exercise capacity in patients suffering from PH-ILD by inhaling treprostinil at specific dosages. The patent infringement case is currently pending in U.S. District Court for the District of Delaware.

About PH-ILD

Interstitial lung disease (ILD) is a group of lung diseases that are characterized by marked scarring or fibrosis of the bronchioles and alveolar sacs within the lungs. Increased fibrotic tissue in ILD prevents oxygenation and free gas exchange between the pulmonary capillaries and alveolar sacs, and the condition can present with a wide range of symptoms, including shortness of breath with activity, labored breathing, and fatigue.