Huang Jin-shun, a national policy advisor to the Presidential Office and president of the Federation of Taiwan Pharmacists’ Association, in an op-ed stated that given the National Health Insurance global budget has nearly reached the scale of NT$ 1 trillion, raising the coverage of generic drugs and biosimilars has become an issue that deserves greater attention. However, he noted that the current patent linkage system could impede the development of domestically produced generic drugs.
Haung said that while the patent linkage system was established with the intention of streamlining the process for generic drug registration and obtaining marketing approval, by improving transparency on patent protection and granting a 12-month exclusive marketing period for the first generic maker to obtain a license, it has resulted in many Taiwanese generic makers becoming mired in patent infringement lawsuits by their multinational counterparts upon the submission of a Paragraph IV (P4) declaration.
Huang suggested that the licensing and pricing of generics should adopt a parallel review process, as is done with new drugs. He noted that some multinationals have intentionally filed new patents with little or no substantive innovation just as their original patents approach expiration, in order to extend the market exclusivity of the drugs in question. To address this challenge, Huang suggested the following:
- Strengthen the review process for patent applications to avoid the abuse of “defensive” patents aimed at creating unnecessary barriers to registering new generics by domestic manufacturers.
- Consider appropriate easing of patent protections, referencing precedents in the U.S. model, which ends patent protections for original drugs once generic manufacturers win a patent litigation case.
[2025-7-26/Liberty Times]
