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The consent judgment was confirmed on January 22 at the US District court for the District of Delaware.
Actelion, held that a proposed generic version of the drug Opsumit by the Indian drug maker Laurus infringed its patent, US number 7,094,781.
Opsumit is used in the treatment of pulmonary arterial hypertension to reduce the risks of disease progression and hospitalisation for people with the condition.
Actelion owns the ’781 patent, titled “Sulfamides and Their Use as Endothelin Receptor Antagonists,” which was issued in August 2006.
The ’781 patent is listed in Approved Drug Products with Therapeutic Equivalence Evaluations (also known as the “Orange Book”), as covering Actelion’s Opsumit brand macitentan tablets.
In August last year, Laurus sent a letter stating that it had filed an Abbreviated New Drug Application seeking approval from the US Food and Drug Administration to commercially manufacture, use, or sell generic macitentan in the US prior to the expiration of the ’781 patent.
On Friday, Laurus conceded that its product would infringe if it came to market. “Laurus admits that the claims of the licensed patent are valid and enforceable, and that the claims of the licensed patent would be infringed by the commercial manufacture, use, sale, offer for sale, or importation of the Laurus product prior to expiration of the licensed patent,” it stated.
Laurus also accepted that it was barred for producing generic versions of the treatment until the patent had expired. “Unless otherwise specifically authorised by Actelion, Laurus, including any of its affiliates, successors and assigns, is enjoined from infringing the licensed patent, on its own part or through any affiliate, by making, having made, using, selling, offering to sell, importing or distributing of the Laurus product,” the filing said.
Opsumit had US sales of $729 million during the first nine months of 2020, up from $581 million during the same period, Bloomberg reported.
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Johnson & Johnson, patent infringement, generics, pulmonary hypertension, US District court for the District of Delaware