SK Biopharmaceuticals and MSN Laboratories Reach Settlement in U.S. Patent Dispute Over XCOPRI®

SK Biopharmaceuticals announced on August 19, 2024, that it has reached a settlement agreement with MSN Laboratories, an Indian generic pharmaceutical company, resolving ongoing patent litigation in the United States related to SK Biopharmaceuticals’ innovative epilepsy treatment, cenobamate, sold under the brand name XCOPRI®.

The patent dispute was adjudicated in the United States District Court for the District of Delaware. It concerned follow-on patents distinct from the primary compound patent protecting cenobamate. These follow-on patents provided an opportunity to extend patent protection for XCOPRI® beyond the expiration of the main compound patent, which is set to lapse in 2032.

Under the terms of the settlement, which remain confidential, SK Biopharmaceuticals has granted MSN Laboratories the right to launch a generic version of cenobamate in the future. This agreement effectively concludes the pending patent litigation between the two companies.

The exact timing and conditions of the generic product’s market entry will depend on regulatory approval processes in the United States and the specific terms outlined in the settlement agreement, which have not been publicly disclosed.

SK Biopharmaceuticals views this settlement as a strategic step to secure a foundation for the continued growth of XCOPRI® and to maintain a stable, long-term market position within the U.S. epilepsy treatment sector.

The resolution of this patent dispute highlights the complex interplay between patent protection strategies and regulatory pathways in the pharmaceutical industry, particularly for innovative therapies facing generic competition.

While the compound patent for cenobamate provides protection until 2032, follow-on patents often serve as critical tools for extending exclusivity periods, and settlements such as this one can shape the competitive landscape by defining the terms under which generics may enter the market.

SK Biopharmaceuticals’ decision to settle with MSN Laboratories may also reflect a broader industry trend favoring negotiated resolutions to patent disputes to avoid protracted litigation and uncertainty in drug commercialization timelines.