Known as the patent linkage guideline, it is also to ensure generic drugs do not infringe on innovator drug patents. Malaysia has four-and-a-half years from the date of the agreement coming into force to implement the patent linkage measures. It introduces a transparent notification mechanism allowing patent disputes to be resolved through the courts,” the ministry said. Patent linkage will apply to all pharmaceutical product registration applications intended for human use, except for biologics. Patent linkage will only apply to product patents claiming the active pharmaceutical ingredient (API), formulation, polymorphs, salts, esters, dosage form, dosing regimen; as well as patents claiming approved medical use under the NDP.

Source: The Star April 10, 2026 02:04 UTC