Taiwan: Taiwan's Patent Linkage System Takes Effect On August 20, 2019

Last Updated: 22 August 2019
Article by Fiona C.C. Yin

At the beginning of January 2018, a patent linkage system was promulgated and introduced into the Pharmaceutical Affairs Act. After almost 19 months, Taiwan's Government announced on August 6, 2019 that the patent linkage system shall be implemented from August 20, 2019.

Patent Listing

According to the amended Pharmaceutical Affairs Act and related bylaws, to prevent Taiwan's FDA from granting regulatory authorization to a generic medicine, owner of a new drug approval (rather than the patentee) has the right to file an application for recording information relating to a patent to be listed in a patent linkage system run by Taiwan's FDA.

The application must be filed within 45 days from the date the certificate of a new drug approval is received. However, if the certificate of a new drug approval is issued before the patent linkage registration system takes effect, the new drug approval holder is allowed to list its patent(s) by November 20, 2019 (i.e. within three months from the date the amended Pharmaceutical Affairs Act takes effect.)

Only invention patents for compounds, compositions or formulations, as well as medical uses are allowed to be listed:

  1. Compound: the active ingredient(s) of a drug;
  2. Composition or formulation: the composition or formulation of the active ingredients of a drug; and
  3. Medical use: the medical use(s) corresponding to all or part of the indication(s) on the certificate of drug approval.

In general, the information regarding a patent to be listed that need be submitted for recordation in the registration system includes: the patent number and expiry date of the patent, as well as the name of the patent owner, exclusive licensee and patent attorney. For a patent relating to medical use, the number(s) of the Claim(s) corresponding to an indication(s) identified on the certificate of the new drug approval must be specified.

Any changes, including an extension of the patent term, claim amendments, revocation of the patent, and ownership or patent attorney change, must be updated within 45 days from the date when such change occurs.

Public Inspection Proceeding

To prevent abuse of the right of the new drug owner, the patent information recorded in the registration system will be open to the public for inspection. If a third party finds out that any of the recorded information is questionable, such as the listed patent is not related to a compound, composition or formulation, or a medical use, or there is not an update of a listed patent, he may file a statement with Taiwan's FDA in writing along with evidence. Taiwan's FDA will serve a copy of the submitted statement with evidence on the owner of the new drug approval within 20 days from the date the statement and evidence is received. The owner of the new drug approval may file a counterstatement in writing, make a correction, or remove the listed patent within 45 days from the date he receives the statement and evidence from Taiwan's FDA.

It is against the Fair Trade Act and is criminally liable for the owner of a new drug approval to file an application for recording incorrect patent information regarding a listed patent by fraud or deception, with an attempt to prevent generic drugs from obtaining drug approval. Therefore, it is worth noting that all patent information to be recorded should be correct and up-to-date.

Generic Drug Company's Declarations

A generic drug company must make one of the following declarations when filing an application for approval of a generic drug equivalent to a new drug:

  1. The new drug has not been patented;
  2. the patent for the new drug has already expired;
  3. drug approval of the equivalent generic drug is not to be issued until the patent for the new drug has expired; and
  4. the patent for the new drug is not infringed or is invalid.

If there is no existing patent dispute between a generic drug company and a brand drug company (as shown in the yellow area of the figure), a generic drug company will receive drug approval if declaring (i) or (ii); and will receive drug approval upon expiry of a preceding brand name patent if declaring (iii).

Interplay Between the Patentee and the Generic Drug Company

If declaring (iv), the generic drug company must notify the holder of the new drug approval, the patentee and the exclusive licensee of the patent (if any) of its declaration in writing and with grounds and evidence within 20 days from the day the generic drug company receives a notice from Taiwan FDA that the application for its generic drug has completed.

After receipt of the declaration from the generic drug company, the patentee or the exclusive licensee may file a lawsuit within a 45-day time limit and then notify Taiwan FDA that a lawsuit has been filed.

If a lawsuit is not filed within the time limit, Taiwan FDA will issue drug approval of the generic drug. If a lawsuit is filed, Taiwan FDA will stay issuance of drug approval of the generic drug for up to 12 months.

Should the court render a final and non-appealable judgment in favor of the patentee or the exclusive licensee within the stay period (up to 12 months), the generic drug company will receive drug approval only after the patent for the brand name drug expires. Otherwise, the generic drug company will receive drug approval of the generic drug and further obtain a 12-month market exclusivity, assuming it is the earliest of those that have duly completed the application forms for the generic drug equivalent to the brand name drug.

The details of the patent linkage system are shown in the following figure.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
Saint Island International Patent & Law Offices
Saint Island International Patent & Law Offices
Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Saint Island International Patent & Law Offices
Saint Island International Patent & Law Offices
Related Articles
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions