4 July, 2018
The amended “Chapter 11 (patent term extension) of Part 2 (substantive examination for invention patent) of Examination Guidelines” became effective on April 1, 2018.
Below are some highlights of the amended Guidelines:
- When the applicant requesting the term extension is the exclusive licensee, it is not limited to making recordation of exclusive license with TIPO.
- When the holder of the first regulatory approval is the licensee, the applicant for term extension should submit the proof of the fact that the licensing has been completed at the time when the patent term extension is filed. However, the acceptable proof of licensing does not have to be the license recordation with TIPO.
- The determination of the effective ingredients of the first regulatory approval should base upon “the effective ingredients of the drug itself rather than the chemical moiety having the pharmacological action (free form).
- The regulatory approval for active pharmaceutical ingredients and technical grade pesticides are not considered the first regulatory approval for purpose of patent term extension.
- As for the determination of the relationship between claims and the first regulatory approval, the old guidelines that require the claims of a patent correspond to the first approval have been amended to require that the claims cover the first approval.
- The commencement date and the expiration date of the foreign clinical trials should be the trial commencement date and the trial completion date set forth in the clinical trial reports that meet the specification of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
- The proof that the extension has been granted in a foreign country is no longer required when a request for patent term extension is based upon the clinical trial period in the foreign country.
- The end date of the examination period of domestic regulatory approval for pesticides has been amended to the issue date of the agrichemical approval.
- The time period for conducting domestic and/or foreign field tests does not depend on the longest time needed among the various tests.
- When the data of academic clinical trials are converted to the data of domestic clinical trials for use in registration, the commencement date of the academic clinical trials may be used as the commencement date of the domestic clinical trials.
“Regulations for ratifying patent term extension” was correspondingly amended and became effective on April, 1, 2018.
The main aspects of the amended Regulations are as follows:
- If the request for patent term extension is based on the time period of clinical trials or field tests in a foreign country, it is not required to submit the proof that the extension for patent term has been granted in the foreign country. (amended Article 5 and Article 7)
- In the event that the applicant for patent term extension conducts more than one field tests where no sequential relation is present among the tests, the longest time period required for the tests is no longer the basis for requesting patent term extension (amended Article 6).
For further information, please contact:
Jennifer Lin, Partner, Tsar & Tsai Law Firm
jenniferLin@TsarTsai.com.tw
