Patent Linkage of Western Pharmaceuticals comes into force in August
E190820Y1．E190820Y9 | Aug. 2019（E237）
Taiwan Food and Drug Administration under the Ministry of Health and Welfare issued a press release on August 20, 2019 to the effect that:
The new chapter “Patent Linkage of Western Pharmaceuticals” incorporated into Taiwan Pharmaceutical Affairs Act as promulgated by presidential order on January 31, 2019 has officially come into force as of August 20, 2019 according to the Executive Yuan’s approval. Under the patent linkage system, a generic drug approval applicant who seeks grant of drug approval for his/her generic drug shall make relevant certification or declaration in regard to the patent(s) listed by the new drug approval holder with the competent authority, and the competent authority will stay issuance of drug approval for a period of 12 months to clear relevant patent disputes. The first applicant of generic drug approval to successfully challenge patent validity or make non-infringement declaration against the new drug and to have produced complete in full the materials required of his/her application for approval of the generic drug will be granted an exclusive marketing term of 12 months as a reward.
Intellectual property rights protection for pharmaceuticals is on the rise around the world. Following this tendency, Taiwan’s enforcement of the patent linkage of western pharmaceuticals will form a new protective force for pharmaceutical IP rights. The patent linkage system balances the relationship between the brand-name drug company and the generic drug company. On the one hand, the patent linkage system will actualize the legal purpose of patent right protection of the Patent Act, accredit R&D performance of new drug approval holder, and ultimately cultivate a perfect IPR protection regime that will attract more R&D investment in Taiwan. On the other hand, the patent linkage system will enable generic drug companies to get hold of relevant patenting status through the listed patent information and encourage generic drug companies to create design-around inventions. By clearing possible infringement occurrences before launch of generic drugs on market, generic drug companies may be able to avoid cessation of sale due to infringement issues that will impact patients’ rights. (August 2019)
For the highlights of the amendments of the Taiwan Pharmaceutical Affairs Act, please refer to the article provided by clicking the link below.
Brief Introduction：Taiwan Pharmaceutical Affairs Act Amendment