The United States District Court for the District of Delaware recently denied United Therapeutics Corporation‘s motion for a preliminary injunction.  The motion sought to prevent Liquidia Technologies, Inc. from launching its YUTREPIA, which is used to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD).  YUTREPIA is an inhaled dry power formulation of treprostinil delivered through a palm-sized inhalation device.

United Therapeutics Corporation moved for a preliminary injunction, alleging that Liquida’s launch of YUTREPIA would induce infringement of claims of U.S. Patent No. 11,826,327 (the ‘327 Patent) requiring a “pulse inhalation device.”  Liquidia argued that its product did not infringe because it was not a pulsed inhalation device.  Liquidia’s expert witness opined that the dry powder inhaler used with YUTREPIA “does not include any electronic machinery; it does not generate a ‘pulse’ of inhaled treprostinil; and it does not itself generate any energy or power to expel powder from the device.”  The Court found that United had not shown it was likely to prove infringement of some claims, stating that “[a]lthough the specification of the ‘327 Patent teaches that some pulsed inhalation devices are dry powder inhalers, the specification does not teach that all dry powder inhalers are pulsed inhalation devices.”  The Court also found that United failed to show that Liquidia’s obviousness defense lacked substantial merit.  The Court further found that United failed to show that the launch of YUTREPIA would cause irreparable harm to United, who sells its competing treprostinil-based TYVASO products.  Additionally, the Court found that United failed to show that a preliminary injunction of YUTREPIA was in the public interest.

Commenting on the decision, Dr. Roger Jeffs, Chief Executive Officer of Liquidia, stated:

We are pleased that Judge Andrews ruled that United Therapeutics’ request for an injunction failed on critical grounds, including UTHR’s failure to show our obviousness challenge lacks substantial merit and UTHR’s failure to show that the public interest weighs in favor of an injunction. While we await a final FDA action, we will continue to intensify our commercial preparations as we work to make this important treatment option available to pulmonary arterial hypertension (PAH) and PH-ILD patients.