The U.S. Patent and Trademark Office has upheld the validity of claims related to 5 patents of Mallinckrodt’s ($MNK) Inomax (nitric oxide) gas delivery systems used for inhalation.
The patents, which are valid until 2031, were challenged by Praxair Distribution ($PX) and are part of 17 total Inomax patents listed in the FDA’s Orange Book. The decision, announced by the company last week, was related to inter partes review proceedings, instituted by the Patent Trial and Appeal Board as a result of the petitions filed by Praxair.
The FDA-approved Inomax system is designed to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term neonatal patients with hypoxic respiratory failure associated with pulmonary hypertension in conjunction with ventilator support and other agents.
"Inomax is protected by comprehensive intellectual property covering both the drug and Inomax delivery systems--patents which extend late into the next decade and beyond,” Michael-Bryant Hicks, the company’s senior vice president and general counsel, said in a statement. "Mallinckrodt will continue to vigorously defend the validity of and enforce the company's intellectual property rights concerning Inomax.”
Earlier this year, Dublin-based Mallinckrodt bought regenerative medicine company Stratatech for an undisclosed sum, then exited the device arena by selling its nuclear imaging business to IBA Molecular for about $690 million, although it had been part of the company for more than 40 years.
At the time, Mallinckrodt said it planned to focus on building its portfolio in the area of high-growth specialty pharma.
- here’s Mallinckrodt’s release