01.05.2018
New regulations about the exclusivity protection and patent linkage system for new drugs in Taiwan
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Amendments to parts of the Pharmaceutical Affairs Act were endorsed by the Legislative Yuan on December 29, 2017 after the third reading. The main issues addressed by the amendments are to enhance the exclusivity protection for drugs and to establish a patent linkage system. The key points about the exclusivity and the outline of the patent linkage system are as follows. Please be advised that the Executive Yuan has not published relevant details and guidelines with regard to the patent linkage system and the date for launching the system has not been determined yet.
I. Exclusivity protections.
New chemical entities: Five-year market exclusivity including three-year data exclusivity
New indications: Three-year market exclusivity including two-year data exclusivity
New indications with domestic clinical trials conducted: Five-year market exclusivity including two-year data exclusivity
II. Patent Linkage System
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I. Exclusivity protections.
New chemical entities: Five-year market exclusivity including three-year data exclusivity
New indications: Three-year market exclusivity including two-year data exclusivity
New indications with domestic clinical trials conducted: Five-year market exclusivity including two-year data exclusivity
II. Patent Linkage System
- Voluntary submission of the patent information (for patent rights of substances, compositions or formulations and medical uses) by the license holders of new drugs within 45 days after the receipt of the permit licenses/the grant of the patents. If the holders do not submit the information, the patent linkage system will not apply to the new drug.
- Applications for the permit licenses of generic drugs should include certifications with regard to the status of approved patents of new drugs based on the information submitted by the license holders of new drugs.
- Notifcation of possible infringement of drug patents and stay (only once for 12 months) of the prosecution of permit licenses for generic drugs in the case that the patentee initiates an infringement suit within 45 days after the receipt of the notification.
- Marketing exclusivity (12 months) for the first non-infringing generic drug.
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