The United States District Court for the District of Delaware has ruled that Liquidia’s Yutrepia treprostinil DPI would infringe claims contained in US patents 9,593,066 and 10,716,793, which cover United Therapeutics’ Tyvaso inhaled treprostinil; however, the judge found that the claims in the ‘066 patent that would be infringed are invalid and the sole valid claim would not be infringed.
The US Patent Trial and Appeal Board (PTAB) recently found that none of the claims covering Tyvaso in the ‘793 are patentable; however, according to United Therapeutics, the District Court judge found that Liquidia failed to prove that any of those claims was invalid.
The FDA tentatively approved the Yutrepia DPI in November 2021. United Therapeutics says that it expects the judge to bar final approval of the Yutrepia NDA until the ‘793 patent expires in May 2027 and that it has also requested that the PTAB re-hear the ‘793 decision. If the PTAB reaffirms its decision, the company says that it will appeal that ruling and that it may appeal the ruling on the ‘066 patent as well. Liquidia says that it will also appeal any rulings that impede final approval of Yutrepia.
In 2020, after the FDA accepted Liquidia’s new drug application for Yutrepia for the treatment of pulmonary arterial hypertension (PAH), United Therapeutics sued, alleging infringement of US Patent No. 9,604,901 and the ‘066 patent. After the ‘793 patent was issued, United Therapeutics added the claims related to that patent. The company later agreed to a judgment that Liquidia had not infringed on the ‘901 patent.
United Therapeutics VP and Associate General Counsel Shaun Snader said, “We’re pleased with the court’s decision on the ’793 patent, and our legal team is evaluating options for the ’066 patent. Today’s decision vindicates our claims that Yutrepia is an infringing product, and we will continue to vigorously defend our intellectual property.”
Liquidia CEO Roger Jeffs commented, “We are pleased that all three patents asserted against us have been found to be either invalid or not infringed among the different legal proceedings. While we are disappointed with the Court’s decision on the ‘793 patent, we are optimistic that the PTAB’s favorable decision will be affirmed on appeal, thereby unlocking the path to potential approval of Yutrepia by mid-2024, if not earlier. We will aggressively pursue the appeals process, including an appeal of Judge Andrews’ decision, in hope of bringing the final resolution sooner. While this is not the perfect outcome we had hoped for, it is incrementally positive as it does provide us with a definitive path to resolving the patent dispute and making Yutrepia available as a treatment option for patients, which is our singular focus.”
Read the United Therapeutics press release.
Read the Liquidia press release.
