The Patent Trial and Appeal Board of the U.S. Patent and Trademark Office ruled yesterday that the claims of United Therapeutics‘s (NSDQ:UTHR) patent, which covers Remodulin, are unpatenable due to obviousness. SteadyMed (NSDQ:STDY) challenged the patent in October last year.
The patent, No. 8,497,393, relates to the process to purify prostacyclin derivatives, including treprostinil, which is the active ingredient in United’s Remodulin and SteadyMed’s Trevyent. Both candidates are designed to treat pulmonary arterial hypertension.
“We are very pleased with this decision by the [Patent Trial and Appeal Board], which confirms our position that the claims in the … patent were invalid, and the patent should not have been issued to United Therapeutics,” SteadyMed president & CEO Jonathan Rigby said in prepared remarks. “We have a growing body of market research data that we believe strongly indicates a significant need for Trevyent that, if approved, has the potential to take a meaningful share of the PAH market.”
SteadyMed’s shares jumped 40% premarket on robust volume yesterday, but today is trading at $6.65 apiece, down -11.3%. The company said it plans to file a New Drug Application for Trevyent with the FDA this quarter.
This is the latest in a slew of problems for United. Yesterday, shares in United Therapeutics (NSDQ:UTHR) fell after the company said that the U.S. commercial launch of Remosynch, Medtronic‘s (NYSE:MDT) implantable infusion pump for Remodulin, will be delayed until 2018.
In March, the FDA updated Medtronic’s Class I recall for the company’s SynchroMed II and EL implantable drug pumps over a priming bolus issue. which Medtronic said it can fix with a software update. But analysts are concerned that any delay in debuting an alternative delivery option for Remodulin will make it harder for United to protect its sales as it faces generic competition in the year ahead.
“United Therapeutics’ commitment to bringing better therapies to patients transcends temporary delays or setbacks,” United chairman & CEO Martine Rothblatt said in prepared remarks. “We are sorry to have missed our 2017 launch target, but it is a small miss in the context of our providing more U.S. pulmonary arterial hypertension patients with helpful medicines than any other company.”
Shares in United were trading at $124.22 apiece in mid-morning activity today, up 0.2%.