Silver Spring’s United Therapeutics Sues North Carolina Biotech For Patent Infringement On Key Drug
One of the biggest and most valuable biotechs in the Washington, D.C. area, once again finds itself having to keep the generic competition at bay through legal means. Silver Spring-based United Therapeutics Corporation (NASDAQ: UTHR) has several drugs on the market that brings the company well over $1 billion in revenues annually, but competing biotech’s entering its space have been trying to chip away at its profits and some do it unlawfully.
This time a lawsuit was filed against Morrisville, North Carolina-based Liquidia Technologies, Inc. United Therapeutics got word of Liquidia’s intentions to move forward when it filed a New Drug Application with the U.S. Food and Drug Administration (FDA). Liquidia made a request to market LIQ861, a dry powder form of United Therapeutics treprostinil — better known as Tyvaso — and one of United Therapeutics key drugs which is already on the market. According to United Therapeutics, Liquidia even referenced Tyvaso in their filing with the FDA.
In April 2020, Liquidia sent notification to United Therapeutics that said they would move forward with their application to the FDA because they believed United Therapeutics patents were invalid to begin with. United Therapeutics stated the two Tyvaso-related U.S. patents expire in December 2028.
As a result, United Therapeutics has taken swift action against Liquidia. Under the Hatch-Waxman Act, the FDA cannot approve Liquidia's application for up to 30 months unless a resolution is agreed to by both companies during litigation. If United Therapeutics wins its case to the full extent, Liquidia would ultimately lose its chance to take its product to market.
United Therapeutics specializes in drugs that treat pulmonary arterial hypertension. It has also made a name for itself by pursing some of the greatest advancements in medical history such as artificial organ manufacturing. The company is based at an urban biotech campus in downtown Silver Spring.