SynAct Pharma AB (publ) announced that the Unites States Patent and Trademark Office (USPTO) has provided the issue notification of US patent 12,303,489 with issue date 20 May 2025 and more than 2 years of Patent Term Adjustment added to the patent's expiry date. SynAct's recently announced that US patent application 17/609,849 with claims covering a method of treating rheumatoid arthritis (RA) with resomelagon (AP1189) in combination with methotrexate (MTX) had been allowed for grant of a US patent. The USPTO has now provided the Issue Notification with an issue date for US patent 12,303,48 of 20 May 2025.
Importantly, the Issue Notification also determines that the US patent is awarded a Patent Term Adjustment (PTA) of 769 days, which period is added to the ordinary expiration date of 7 May 2040 to extend the duration of the US patent until 15 June 2042. In the lead development program, resomelagon (AP 1189) is used as an add-on to first-line therapy with MTX for the treatment of RA. Ensuring optimal exclusivity in the US for this combination treatment is central to the strategy to fortify SynAct's intellectual property rights with respect to resomelagon (AP189).
