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

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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.

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