Benzinga | Oct 11, 2021 09:36AM EDT

Liquidia Late Friday Announced US Patent Trial And Appeal Board Ruled In Favor In Inter Partes Review Proceeding Against United Therapeutics' '901 Patent

Liquidia Corporation (NASDAQ:LQDA) announced today that the U.S. Patent Trial and Appeal Board (PTAB) ruled in its favor in the Inter Partes Review (IPR) proceeding against U.S. Patent No. 9,604,901 ('901 patent) owned by United Therapeutics Corporation (UTC) and listed in the Orange Book for Tyvaso(r) (treprostinil inhalation solution).

In its ruling, the PTAB found that seven of the nine claims were unpatentable. Only the narrower dependent claims 6 and 7 remain, both of which require actual storage at ambient temperature of treprostinil sodium. The PTAB's decision primarily relates to the issue of patentability based on a review of prior art. This decision does not preclude the invalidation of the remaining claims on other grounds as part of the ongoing Hatch Waxman litigation, nor does it mean that Liquidia infringes either of the surviving claims.

Damian deGoa, President and Chief Executive Officer of Liquidia said: "We are very pleased with this decision by the PTAB. This is a clear win in our on-going patent dispute with United Therapeutics, and we remain confident that we will ultimately prevail on all patent claims they have asserted against us. We will continue to vigorously defend our right to commercialize LIQ861 as soon as possible."

The PTAB's decision with respect to the '901 patent does not resolve the on-going litigation brought by UTC related to LIQ861. In June 2020, UTC filed a lawsuit against Liquidia under the Hatch-Waxman Act for infringement of three Tyvaso(r) patents, including the '901 patent, referenced in the 505(b)(2) regulatory filing for the LIQ861 New Drug Application (NDA). The lawsuit triggered a 30-month stay on an FDA regulatory approval of LIQ861, which expires on the earlier of October 24, 2022, or resolution of the litigation.

Tyvaso(r) is a registered trademark of United Therapeutics.