Explore More Insight
29 November 2019
Learn about our Pacific Alliance initiative
Singapore Healthcare Newsletter
Download the Singapore Healthcare Newsletter
Global Guide to Patent Linkage
Patent linkage is generally understood to be the practice of linking the granting of marketing approval or any other regulatory approval for a generic or biosimilar medicinal product to the status of a patent for the originator reference product. Consequently, if there is a valid patent covering the drug which is the subject of a new drug approval, the drug authority, depending on the jurisdiction in question, may: refuse the application; refuse to grant a marketing authorization until the patent expiration; inform the patent owner to enable it to take any relevant action; or refuse to grant the application depending on the length of remaining term of the patent; among other actions.