• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Appeals court affirms ruling in United Therapeutics, SteadyMed patent spat

November 14, 2017 By Sarah Faulkner

SteadyMed TherapeuticsA 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.”

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Filed Under: Drug-Device Combinations, Featured, Legal News, Pharmaceuticals, Vascular, Wall Street Beat Tagged With: SteadyMed Therapeutics, United Therapeutics

IN CASE YOU MISSED IT

  • Breakthrough T1D, Mattel debut Barbie doll with type 1 diabetes
  • Medtronic Diabetes names CFO with consumer experience ahead of separation
  • Diabeloop launches insulin delivery algorithm in Germany
  • GlucoModicum has positive data for needle-free CGM
  • Lifecare takes next steps in CGM implant development

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS