Singapore Healthcare Newsletter
- Competition & Consumer Commission of Singapore Grants Conditional Approval for Private Clinical Laboratories Merger
- Ministry of Health to introduce guidelines for companies that provide non-clinical genetic testing
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.
Download the Global Guide to Patent Linkage
