Patent Claim Invalidated, SteadyMed Drug Treatment Moves Forward

By William Vogeler, Esq. on November 29, 2017 | Last updated on February 06, 2023

An appeals court breathed more life into Trevyent, a treatment for pulmonary arterial hypertension. In United Therapeutics Corp. v. SteadyMed Ltd., the U.S. Court of Appeals for the Federal Circuit knocked out a competing patent claim. In a one-word decision, the court "affirmed" a ruling in favor of SteadyMed, a Northern California pharmaceutical company. It was one step forward for the drug treatment on a path marked by legal steps forward and back again.

Patent Dispute

United Therapeutics asserted a patent claim prior to SteadyMed's launch of its product, but the Patent and Trademark Office invalidated the claim. The appeals court upheld that decision. "We are very pleased with the court's decision to uphold the PTAB's earlier ruling on the '393 patent," said Jonathan M.N. Rigby, President & CEO of SteadyMed. The company says Trevyent is "designed to address a number of unmet needs in the treatment of pulmonary arterial hypertension." If the company's delivery system is approved by the U.S. Food and Drug Administration, it will offer patients a pre-filled, single-use, disposable system for administration the drug.

FDA Approval

The court ruling removes one hurdle, but the company must get past the FDA before it can sell its system for administering Trevyent. The federal agency recently rejected the company's application, instead requiring more information about the device. The PatchPump delivers the vasodilator drug subcutaneously or intravenously for two days. It is pre-filled and pre-programmed to alert patients when dosing is complete. In a press release, Rigby said that he is confident the issues will be resolve in the next application. "We believe that Trevyent holds the potential to significantly improve the lives of patients suffering from PAH compared to the current standard of care, and remain committed to bringing the product to patients in need," he said. Related Resources:
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