United Therapeutics Corporation wins Yutrepia PH‑ILD patent ruling

Shares of United Therapeutics Corporation NASDAQUTHR rose 12.55 per cent to US$541.89 at 4 p.m. EDT on Sept. 30 in New York after a Delaware court found a rival induced infringement by marketing Yutrepia for PH-ILD. The finding covered claims 1 and 14 of United's inhaled treprostinil patent.

In its Sept. 30 release, United said it believes it is entitled to an order instructing the U.S. Food and Drug Administration to withdraw approval of Yutrepia's new drug application. The court gave the parties one week to submit an agreed form of final judgment that would address any such order.

United Therapeutics is a U.S. drug developer that sells inhaled treprostinil treatments for pulmonary hypertension and works on other rare diseases. Its Tyvaso medicines are approved for pulmonary hypertension associated with interstitial lung disease, or PH-ILD.

Shares of Liquidia Corporation NASDAQLQDA fell 57.19 per cent to US$30.26 at 4 p.m. EDT on Sept. 30 in New York. Liquidia's investor page describes Yutrepia as a treprostinil inhalation powder for both PH-ILD and pulmonary arterial hypertension, or PAH.

The Patent Finding Covers Two Claims

The United release said the U.S. District Court for the District of Delaware found that Liquidia Technologies, Inc. induces infringement by marketing Yutrepia for PH-ILD. United said the court also concluded that Liquidia failed to prove claims 1 and 14 invalid.

Liquidia's Sept. 30 investor summary says the court found two of the six asserted claims valid and infringed. That count puts the legal dispute around specified claims of U.S. Patent No. 11,826,327, which United describes as a method of improving exercise capacity in PH-ILD patients through particular inhaled treprostinil doses.

United markets nebulized Tyvaso and Tyvaso DPI, both approved for PH-ILD, according to its release. The two products use inhaled treprostinil, the same active ingredient Liquidia says is in Yutrepia, so the proposed remedy reaches a contested treatment category in which the companies sell rival medicines.

"Our immediate priority is ensuring that no patient goes without the therapy they need, and we are ready to support a seamless transition to Tyvaso or Tyvaso DPI should PH-ILD be removed from the Yutrepia label."

United Therapeutics president and chief operating officer Michael Benkowitz said this in the Sept. 30 release.

The Final Judgment Will Set the Remedy

United says a court order instructing the FDA to withdraw Yutrepia's approval may result in the drug leaving the U.S. market until the agency can approve a label without PH-ILD. The company also intends to seek monetary damages for past infringement, potentially including a royalty on past Yutrepia sales.

That conditional sequence could affect the entire Yutrepia approval while the FDA considers labeling without PH-ILD, even though the patent finding concerns that one indication. Liquidia's investor page also lists a PAH use for Yutrepia, which gives the labeling question a wider commercial reach than the disputed PH-ILD claims alone.

The iShares Biotechnology ETF NASDAQIBB slipped 0.24 per cent to US$210.53 at 4 p.m. EDT on Sept. 30 in New York. Both company stocks moved much more than the broad biotechnology fund during the same session, with United rising and Liquidia falling.

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Liquidia's investor summary says the parties must propose a remedy within one week of the Sept. 30 ruling. If they cannot agree on the scope of final judgment, United's release says the district court will decide that question.

By Oct. 7, one week after the Sept. 30 opinion, the parties are due to submit an agreed form of final judgment. That submission, or a later court decision if they disagree, will determine whether any order instructing the FDA to withdraw Yutrepia's approval is entered.