According to Article 53 of the Patent Act in Taiwan, for the practice of an invention patent involving a pharmaceutical or the manufacturing process thereof that is subject to regulatory approval, if such regulatory approval is obtained after publication of the grant of the concerned invention patent, the patentee may apply for one and only one extension of the patent term of said invention patent based on the first regulatory approval. If the time needed to obtain said regulatory approval exceeds five (5) years, the granted patent term extension shall still be at most five (5) years. Further, according to Article 4 of the Regulations for Ratifying Extension of Patent Term (hereinafter “Regulations for Extension”) in Taiwan, the periods of time allowable in a request for patent term extension include the period of domestic and/or foreign clinical trials. Furthermore, based on the Patent Examination Guidelines, the starting date of the domestic clinical trials is the date when the Health and Welfare Department approves starting of the domestic clinical trials, and the last date of the domestic clinical trials is the date when said Department approves the report of clinical trials. While the courts generally agree with the definition of the domestic clinical trials as set forth in the Examination Guidelines, they hold different opinions on the period of foreign clinical trials.
Recently, in Case No. (106) TAI-SHEN-TZU-No. 1904, the Supreme Civil Court ruled that the prior court, which in this case was the Intellectual Property Court, had erred in defining the period of the foreign clinical trials, and remanded the appeal. The Supreme Civil Court, the Intellectual Property Court, and the Taiwan Intellectual Property Office (hereinafter “TIPO”) had interpreted the starting date and the last date of the foreign clinical trials differently.
1. The TIPO
According to Article 4 of the Regulations of Extension that the case shall be applied, “Regarding pharmaceuticals or their manufacturing procedures, the periods of time allowable in a request for patent term extension include:…(3) the period of foreign clinical trials conducted for obtaining a pharmaceutical approval from the country of production”. In view of this, TIPO used the dates written on the first page of the clinical trials report as the starting and completion dates. As a result, the TIPO approved the extension of the patent right to be more than 2 years in this case.
2. The Intellectual Property Court
The Intellectual Property Court first stated that, in accordance with Article 16 of the Intellectual Property Case Adjudication Act, it has the right to review the decision of the TIPO and decide if the latter’s decision should be revoked. The Intellectual Property Court believed that the definition of the period of foreign clinical trials in Article 4 of the Regulations of Extension referred to the time from the date when the clinical trials started until the trial completion date, and does not include the preparation period before the clinical trials and the report finalization time after the completion of the clinical trials. Therefore, the starting date and the last date of the clinical trials shall be the dates when the first patient and the last patient, respectively, were given the drugs. As a result, the Intellectual Property Court revoked TIPO’s decision of extension of the patent term in this particular case.
3. The Supreme Civil Court
The Supreme Civil Court considered that clinical trials should be explored in accordance with the legislative purposes of the provisions of the Patent Act. According to the draft amendment to the Patent Act in 1992, the competent authority must review the report containing the results of clinical trials before issuing the drug license. Since the clinical trial report could only give the meaning of the test result after the data of clinical trials are analyzed and evaluated, the clinical trial period should be the date from the start of the clinical trial until the date of the trial results obtained, and the date of the trial results obtained shall be the test report date or some other date.
On April 11, 2018, TIPO announced the current version of Examination Guidelines. The new Examination Guidelines stipulate that the starting date of the foreign clinical trials should meet the specification of ICH’s study initiation date and the study completion date. According to ICH, the trial start date shall be the date of the first patient enrolled, or any other verifiable definition, and the trial completion date shall be the date of the last patient’s trial completed. The interpretation of this new Examination Guidelines by TIPO differs from that of the Supreme Civil Court. However, as this case is a civil one, the decision does not bind TIPO. TIPO, therefore, will still apply the new Examination Guidelines to all pending applications of patent term extension. On the other hand, the Supreme Civil Court remanded this case to the Intellectual Property Court in June of 2018. The development or influence of this case remains to be seen.