萬國法律事務所

Taiwan’s Intellectual Property Office plans to add the “experimental use exemption” clause, already stipulated in the current Pharmaceutical Affairs Law, to the Patent Law. The official said that the amendment affirms the government’s determination to promote the development of generic drugs and that once the amendment has passed, it will curtail the time for the generic drugs to be released into the market.

The so-called “experimental use exemption” is a mechanism that exempts the user of a third party’s patent from patent infringement liabilities if the purpose of the use is for experiment or research and not for manufacture or sale.

The Patent Law aims to promote technology and to protect innovative inventions. However, the development of generic drugs has no connection with innovation as it is utilizing the manufacturing process of patented drugs for release into the market once the patent protections have expired. Nonetheless, the officials said generic drugs are vital to public welfare due to the fact that its price is relatively low. And hence, the lawmakers have stipulated the “experimental use exemption” clause in the current Pharmaceutical Affairs Law.

The generic drug companies must obtain the registration of Department of Health (“DOH”) before releasing the drug into the market. The registration process involves testing the safety and efficacy of the generic drug to make sure it is equivalent to its brand name counterpart. The registration process usually takes a period of time and thus allowing the protection to the patented drugs to be lengthened into 20 (patent protection period) plus a few years, which is disadvantageous for the public to obtain drugs at lower prices. To enable the generic drug developers to market their drugs immediately after the expiration of the relevant patents, it will be necessary to allow the research, experiment and even application for DOH’s approval, to be conducted in advance by this exemption provision.

The amendment has been submitted to the Executive Yuan for consideration and approval.