Under the provisions of the current Taiwanese Patent Act, the protection of a patent right will not extend to a situation where the patented invention is put into practice for research, educational, or experimental purpose with no profit-earning activities involved therein. (Article 57(1) (i) of the Act) In enacting this specific article of law, the legislative body recognized the benefits brought by those exempted behaviors to the innovation and academic activities of the society and also considered the low or zero impact caused by those behaviors to the commercial interest of the patentee. While the use of the term “not for profit-earning activities” is construed as granting a broad and general protection, the Act does not, however, definitely regulate the exemption arising from the experimental use of a patented article for the sole purpose of applying for regulatory approval of medicaments.
 
On the other hand, Article 40-2(5) of the Act of Pharmaceutical Affairs promulgated in February 2005 stipulates that “the patent right of a new drug shall not be applicable to researches, teachings or testing prior to the application for registration of a generic drug by pharmaceutical traders”. In accordance with Article 7 of the Act of Pharmaceutical Affairs, the term "new drugs" shall refer to drugs which are of the preparations having new compositions, new therapeutic compounds or new methods of administration as verified and recognized by the central competent heath authority. By a suitable construction of law, the legal exemption awarded by the Act of Pharmaceutical Affairs is rather narrow compared with the typical Bolar-type exemption existing in other countries as it only extends to a new drug, and is only applicable to pharmaceutical companies.
 
Now, in the latest revisions to the Patent Act, which will come into effect from January 1, 2013, a new provision (Article 60) is added to specially exempt acts necessary for putting an invention into practice for the purpose of research, experiment or testing to obtain a regulatory approval. It is regulated in the new article that “The effects of an invention patent shall not extend to the acts of research and experiment, and other acts related thereto, necessary for obtaining registration and market approval of medicaments under the Pharmaceutical Affairs Act or for obtaining market approval of pharmaceuticals imported from a foreign country.” As explained in the legislative reasons for the amendments, the term “medicaments” include drugs and medical devices as defined in Article7 of the Act of Pharmaceutical Affairs. Therefore, the statutory exemption specially for the purpose of obtaining regulatory approval of medicaments has been established and codified in Taiwan.