As the international community raises protection of intellectual property, the Taiwan Food and Drug Administration (TFDA) on Aug. 20 announced that the patent linkage system has come into force, which would require generic drug applicants to clear up any potential patent disputes prior to seeking marketing approval. The patent linkage system encourages generic developers to leverage design-arounds to reduce the risk of patent infringement and ensures the public’s right to access drugs.
A presidential order on Jan. 31, 2018 incorporated the new Chapter 4-1 Patent Linkage of Drugs in the Pharmaceutical Affairs Act while the Executive Yuan announced the amended provisions related to patent linkage is to take effect on Aug. 20, 2019.
The patent linkage system entails that the approval criteria for certain drug products will include whether the the applicant is free of patent infringement to ensure that any potential disputes are cleared before an application is filed.
TFDA Medicinal Products Senior Technical Specialist Shirley Pan said in an interview that through the disclosure of patent information in the patent linkage system, marketing applications filed by generic drug developers could be halted for 12 months to clear up any potential disputes. In turn, generic drug applicants who are successful in winning non-infringement challenges or are able to successfully avoid patent infringement through design arounds are rewarded with a 12-month market exclusivity period.
Senior Technical Specialist Pan said that the implementation of the patent linkage system represents an important milestone in Taiwan’s progress towards bolstering protection of intellectual property. The system is aimed at balancing the relationship between innovator drug developers and generic drug developers by providing the full extent of intellectual property protection for patent holders afforded by the Patent Act, as well as recognizing the research and development efforts made by innovators in a bid improve Taiwan’s environment for innovation and pharmaceutical investments.
On the other hand, for generic drug developers, the patent linkage system provides a clearer picture of potential patent disputes ahead and encourages them to employ design arounds prior to applying for marketing approval, Senior Technical Specialist Pan said, adding that by removing concerns about potential patent infringement ahead of new product launchings, the patent linkage system provides generic drug developers with the stimulus to learn and prevent potential setbacks from the halt of sales due to infringement while also ensuring the right to drug access for patients.
【2019-08-20 / CNA】
