Reported by Lee Shu-Jen and Chang Yi-Hua from Taipei
The Legislative Yuan passed the third reading of the amendment of the Pharmaceutical Affairs Act at the end of last year to bring the patent linkage system into effect in Taiwan. Wu Hsiu-Mei, Director-General of the TFDA, pointed out that the patent linkage system applies to new drugs developed in other countries as well as in Taiwan. The system aims to encourage innovation in the industry. Dr Chang Hong-Jen, the President of the TRPMA, an association of domestic drug developers, pointed out that the government should formulate comprehensive corresponding measures to support the pharmaceutical industry in Taiwan.
Wu Hsiu-Mei expressed that there are four categories of generic drugs: P1 generics refer to drugs without patents; P2 generics refer to off-patent drugs; P3 generis refer to the generics in the regulatory review process while the original drugs are still under patent protection; P4 generics refer to the generics of patented drugs. The patent linkage system affects P4 generics.
According to the current regulations in Taiwan, drug companies have to obtain a prior approval and declare that there is no infringement of patent rights before they can start to manufacture P4 generics. As a result, some original drug companies only find out the infringement after drug licenses have been issued to generics. This has caused a lot of controversies. Wu Hsiu-Mei expressed that the patent linkage system is to solve this problem. Generic drug companies have to inform original developers of the innovative aspects of their development of P4 generics. That is to say they have to challenge the patent.
After receiving the notice, original developers have 45 days to file a patent infringement lawsuit. Wu Hsiu-Mei expressed that during the litigation, the TFDA and NHIA will continue processing the applications filed by generic drug companies.
According to current regulations, biosimilars can get the TFDA license as soon as in 7 months, and obtain the NHI payment price in 3 months. The process takes about 10 months in total. A patent infringement lawsuit takes about a year to conclude. As a matter of fact, generic drug companies do not lose too much time on challenging patents.
The first generic drug company who has successfully challenged the patent and obtained a drug license can enjoy a 12-month market exclusivity right which can be extended to 18 months to cover the manufacturing preparation time.
However, Dr Chang Hong-Jen is not so optimistic. He reckoned that the government’s industrial development policy should keep a balance between generics and original drugs. Most drug companies in Taiwan are generic manufacturers; and only a small number of them have the capital and the skills to develop new drugs. The government should formulate comprehensive corresponding measures and educate doctors and the publics about the stability and safety of generic drugs so as to increase the use of generics.
Su Mu-Huan, the General Manger of Syn-Core Bio, a drug company in Taiwan, expressed that he supported the government’s measures to protect new drugs as an incentive to encourage investment in innovation. However, the new system may delay the launch of generic drugs. In order to reduce the impact on the pharmaceutical industry, Su urged the government to formulate corresponding measures or delay the implementation of the patent linkage system until the government signs the FTA with the US or enters the CPTPP.
【2018-01-28/ United Daily News】