A federal appeals court has affirmed an earlier ruling by the Patient Trial and Appeal Board of the U.S. Patent and Trademark Office, invalidating 22 claims of a patent owned by United Therapeutics (NSDQ:UTHR).
The patent covered treprostinil, the active ingredient in both SteadyMed‘s (NSDQ:STDY) Trevyent and United Therapeutics’ Remodulin. The court’s ruling sent STDY shares up 8% today, trading at $3.40 apiece in mid-morning activity.
“We are very pleased with the court’s decision to uphold the PTAB’s earlier ruling on the ‘393 patent,” SteadyMed president & CEO, Jonathan Rigby, said in prepared remarks. “Once again, this reaffirms our assertion that the claims of the patent were invalid and unpatentable.”
Earlier this year, the FDA issued a refusal to file letter to SteadyMed for the company’s Trevyent new drug application, signaling that the application was not complete enough to review. The regulatory agency requested more data regarding performance testing and additional design verification and validation testing, the company reported.
A month later, SteadyMed requested a meeting with the FDA to discuss a pathway to resubmit its NDA for Treyvent. The company said it held that meeting with the FDA on Nov. 1, and that it expects the FDA will allow for a resubmission. Also this month, the company’s EVP and chief operating officer, Peter Noymer, voluntarily resigned.
“Our Type A meeting with FDA earlier this month proved to be constructive and we are confident that we can sufficiently address the agency’s concerns relating to our NDA for Trevyent,” Rigby said in a press release.
“We completed the third quarter with a strong cash position of $37.4 million and have implemented a number of organizational changes which we believe will lead to a successful resubmission and acceptance of our NDA. We remain committed to bringing Trevyent to patients suffering from [pulmonary arterial hypertension] and look forward to providing further guidance once we receive the minutes from our meeting with FDA.”
