Taiwan’s New Patent Linkage System in accordance with the amended Pharmaceutical Affairs Act

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With effect from 20 August 2019, Taiwan, Republic of China will implement a patent linkage registration system in accordance with the amended Pharmaceutical Affairs Act.

The onus is on the applicant for the approval of the new drug to file the application for patent linkage. This must be done within 45 days from the date of receiving the certificate of new drug approval or before 20 November 2019 in instances where drug approval was obtained prior to the implementation of the patent linkage registration system.

Patents which are eligible for listing under the new patent linkage system are patents which relate to compounds (active ingredient of the drug), compositions comprising the active ingredients, and patents covering medical uses which correspond fully or partially to the indications obtained for the drug approval.

When listing the relevant patents, information regarding the patent number, expiry date, patent owner, exclusive licensee (if applicable), and the patent attorney on record must be provided to the Taiwan FDA. Where the listed patent relates to medical uses, the specific claims which correspond to the indications obtained on the drug approval must also be identified.

Upon implementation of the patent linkage system, generic drug manufacturers seeking to obtain regulatory approval for generic drugs must make a declaration when submitting the application for regulatory approval. The declaration may be chosen from one of the following:

  1. The new drug is not patented
  2. The patent on the new drug has expired
  3. The approval of the generic drug is not to be issued until expiry of the patent
  4. The patent on the new drug is either not valid or is not infringed by the generic drug

Where a declaration of non-infringement or patent invalidity is made, the generic drug manufacturer must notify the patent holder within 20 days of receiving notice from the Taiwan FDA. The patent holder would then have 45 days to file a lawsuit to delay the approval of the generic drug for up to 12 months.  If a court decision is rendered in favour of the patent holder during this 12-month period, the approval for the generic drug will only be issued after the expiry of the patent.

Please feel free to contact us should you require any information or assistance with this matter.

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