At the end of 2017, the Pharmaceutical Affairs Act in Taiwan was amended to introduce the patent linkage system. However, because the detailed regulations were not settled at that time, the launch of the system was deferred. Recently, the Ministry of Health and Welfare, Food and Drug Administration of Taiwan proposed a second version of the Regulations for the Patent Linkage of Drugs and held an explanation session. Although the launching date of the system is still unclear, we are much closer to the implementation of the system than two years ago. Therefore, we summarize certain key points of the patent linkage system in Taiwan for patent applicants filing applications concerning pharmaceutical products.
1.  It is an optional measure to link the application of permit licenses for drugs and the statuses of relevant patents.
The holder of a permit license for a new drug may (i.e., is not obligated to) register patents related to the new drug under the permit license. In the case that the holder registers related patents for the new drug and an application of permit license for a generic drug referring to said new drug is filed, the new drug may benefit from a stay period of 12 months against the issuance of the permit license for the generic drug if requirements are met (please see Point 8 below).
The new drugs here include preparations with new therapeutic ingredients, preparations with new therapeutic effects (e.g., known therapeutic ingredients with new medical uses, preparations with decreased side-effects, etc.), or preparations with new routes of administration.
2.  Eligible types of patents for registration:

• Substances.
• Compositions or formulations.
• Medical uses (when patents of medical uses are registered, the holder has to specify the serial numbers of the claims related to the medical use).

Ineligible types of patents for registration: Preparation processes, metabolites, packages, and intermediates.
3.  Data to be submitted

• Certification number of the invention patents.
• Claim numbers (for patents relating to medical uses).
• Expiration dates of the patents.
• The patentee’s name, nationality, place of domicile or business office, and the name of the legal representative (if any); or such information of the exclusive licensee (if the patent has been exclusively licensed and the license has been recorded with the Intellectual Property Office).
• The name of the domestic attorney for the patentee or the exclusive licensee and the place of domicile or business office (if the patentee or the exclusive licensee does not have a domicile or a business office in Taiwan).

Being the attorney of the patents for registration, the patent applicants may provide the pharmaceutical firm in Taiwan processing the application of the permit license for their new drugs with Tai E’s information. Alternatively, the applicants may authorize Tai E to communicate with the pharmaceutical firm to facilitate the process.
4.  Update of the data
The data should be updated within 45 days from the day next to any of the following events:

• Allowance of a patent term extension.
• Allowance of post-grant amendments to patent claims.
• Patent revocation.
• Patent extinguishment.
• Change of information of the patentee or the exclusive licensee in Item 3 above.

5.  Review of the data

Currently, the authority would not substantively examine the information submitted. Anyone may review the information submitted and notify the authority of irrelevant or ineligible patents, incorrect information or expired information.
 
6.  Submitter
The information should be submitted by the holder of a permit license for a new drug (rather than the patentee) with the consent from the patentee or the exclusive licensee (document of proof required). The holder may also entrust attorneys (e.g., Tai E) to submit the information.
 
7.  Timing for submitting the information

• Patent granted before the permit license: Within 45 days from the day next to the receipt of the permit license.
• Permit license granted before the patent: Within 45 days from the day next to the publication of the patent.

Relevant information can still be submitted after the periods above expire. However, expired submission cannot bring on the benefit of issuance stay for permit license of generic drugs.
Because the patent linkage system has not been implemented yet, there is a transitional period of three months for new drugs for which both the permit license and related patents were granted more than 45 days ago. Holders of permit licenses for new drugs can register related patents and submit the information within three months after the implementation of the patent linkage system to bring on the benefit of said system as long as the patents are still valid.
8.  Notes for the stay
If the pharmaceutical firm of a generic drug applies for the permit license by referring to a referenced new drug and asserted that the patents registered under the new drug should be revoked or the generic drug does not infringe the registered patents, the patentee would be notified within 20 days. If the patentee would like to stay the issuance of the permit license for the generic drug, he should file an infringement litigation based on the patents registered prior to the application of the permit license for the generic drug within 45 days from the day next to the receipt of the notification and notify the authority.
9.  Carve-out provision for new medical uses
If only patents related to medical uses remain valid for a new drug, carve-out of the medical use is allowable for generic drugs and then there will be no stay of permit license issuance.
As the Regulations for the Patent Linkage of Drugs have not been confirmed yet, there are still questions about whether polymorphs and biosimilars should be included in the system. However, based on the latest draft of the Regulations and the discussion in the explanation session, it is likely that:
1.  For a particular substance serving as the ingredient of a new drug, the polymorphs (including crystallines, amorphous, hydrates, and solvates) of said substance will also be allowed to be registered in the patent linkage system under the permit license of said new drug. However, related test data should be included in the application for said permit license to demonstrate the equivalent effect of the polymorphs.
2.  In addition to chemical drugs, the patent linkage system will also apply to biologic new drugs (as new drugs) and biosimilars (as generic drugs).