CHUN-YU LIN[1]

Draft amendments to parts of the Pharmaceutical Affairs Act proposed by the Ministry of Health and Welfare (MHW) were endorsed by the Executive Council on August 4, 2016. The draft amendments will be transferred to the Legislative Yuan for examination. According to the MHW, the amendments to the Pharmaceutical Affairs Act are made to meet the requirements for the Trade and Investment Framework Agreement (TIFA), to include the stipulations about the protection for the intellectual property in Chapter 18 for the Trans-Pacific Partnership Agreement (TPP), to enhance the protection of data exclusivity for drugs and to establish the patent linkage system for drugs in view of the development of the domestic pharmaceutical industry.

The key points in the draft amendments are as follows:

1. Amend the regulation about data exclusivity of drugs of new chemical entities. Considering that Article 60 of the Patent Act has clearly stipulated that the effects of the patent right shall not extend to research and trials necessary for obtaining registration and market approval of drugs, the stipulation that the patent right of the new drug shall not be applicable to research, teaching, or testing prior to the application for registration by the pharmaceutical firms is deleted from the Pharmaceutical Affairs Act. (Amended Article 40-2)
2. Include the protection of data exclusivity for new indications for drugs. (Amended Article 40-3)
3. Submission and publication of the patent information of new drugs. (Amended Articles 48-3 to 48-8)
4. Applications for the permit licenses of generic drugs should include certifications for the status of approved patents of new drugs. (Amended Articles 48-9 to 48-11)
5. Notification of possible infringement of drug patents and stay of the prosecution of permit licenses for generic drugs. (Amended Articles 48-12 to 48-15)
6. Challenge on the validity of patents or marketing exclusivity for non-infringing generic drugs. (Amended Articles 48-16 to 48-18)
7. Provisions for new drugs other than new chemical entities, transitional provisions and authorization to formulate the detailed regulations. (Amended Articles 48-20 to 48-22)
8. Obligation to notify the authority of any relevant agreement and penal provisions. (Amended Articles 48-19 and 92-1)
9. The date for implementation of the regulations in the amendments with regard to the patent linkage system will be determined by the Executive Yuan. (Amended Article 106)