SynAct Pharma announced today that the United States Patent and Trademark Office (USPTO) has granted a significant patent term extension for its resomelagon (AP1189) combination therapy for rheumatoid arthritis (RA). The USPTO has issued notification for US patent 12,303,489, which will be officially issued on May 20, 2025, with an additional 769 days of Patent Term Adjustment (PTA).
The patent covers a method of treating rheumatoid arthritis using resomelagon in combination with methotrexate (MTX), a widely used first-line therapy for RA. With the granted extension, SynAct's market exclusivity for this combination will now extend until June 15, 2042, well beyond the original expiration date of May 7, 2040.
"Extension of a patent term in the US can happen as a compensation for the time spent by the patent authorities for processing the application towards grant and is calculated relative to the applicant's response time," explained Thomas Jonassen, CSO at SynAct Pharma. "I am pleased that our team has been very efficient and obtained a significant extension. The extra patent term will provide further exclusivity on the market at a time when resomelagon, if successfully marketed, will reach its peak sales, and thus significantly add to the value of the asset."
Strategic Importance of Patent Portfolio
This patent issuance represents a critical component of SynAct's intellectual property strategy, particularly for the US market. The company's leading clinical program positions resomelagon as an add-on therapy to methotrexate for RA treatment, making patent protection for this specific combination especially valuable.
"A strong patent portfolio, which ensures exclusivity in key markets like the US, potentially has a very big value for us and our potential partners," said Jeppe Øvlesen, CEO at SynAct. "A patent on the combination treatment of RA with resomelagon and one of the most widely used drugs for RA, such as MTX, is certainly consolidating our position."
The newly issued patent complements SynAct's existing US patent US 12,239,63, which covers the crystal form of the specific resomelagon salt used in clinical trials. Together, these patents create multiple layers of protection for SynAct's intellectual property rights regarding resomelagon.
Patent Term Adjustment Significance
The 769-day Patent Term Adjustment is particularly noteworthy as it extends protection during what would likely be the peak commercial period for resomelagon, assuming successful clinical development and market approval. This extension was granted as compensation for processing time at the USPTO and reflects the efficiency of SynAct's patent team in responding to patent office actions.
For pharmaceutical companies, such extensions can significantly impact the commercial lifetime of a drug, potentially adding billions in revenue during the extended exclusivity period. The adjustment pushes SynAct's patent protection well into 2042, providing the company with a stronger position for potential partnerships or licensing agreements.
Resomelagon Development Program
Resomelagon (AP1189) is SynAct's lead compound, currently being developed as an add-on therapy to methotrexate for rheumatoid arthritis. The drug represents a novel approach to treating RA, with the potential to address unmet needs in the current treatment landscape.
The patent protection now secured for the combination therapy is particularly valuable as methotrexate remains one of the most commonly prescribed first-line treatments for RA worldwide. By protecting this specific combination approach, SynAct has secured its position in what could be a significant treatment pathway for RA patients.
Global Patent Strategy
While this announcement focuses on US patent protection, SynAct has indicated that it is actively pursuing similar patent protections in other key markets worldwide. This comprehensive approach to intellectual property protection aligns with the company's global commercialization strategy for resomelagon.
The extended patent term in the US market—one of the largest pharmaceutical markets globally—represents a significant milestone in SynAct's efforts to build a robust intellectual property portfolio around its lead compound.
