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Territorial Patent Linkages New Entity Taiwan Joined the Troop

In today’s modern era of Technological and Medical advancement, we as an IPR fraternity are dealing with the most leveraged and valued assets ‘Patents’. The dictionary definition of a Patent is “a government authority or license conferring a right or title for a set period, especially the sole right to exclude others from making, using, or selling an invention.” Indeed, when considered with respect to a pharmaceutical product, patents open up an entirely new angle of viewing the medicinal products. In most of the countries yet, there occurs no patent listing with regards to a medicinal product launched in that territory’s specific market. However, there are few nations that conduct and manage this strenuous task of patent linkage or listing for medicinal products with a detailed record maintenance system in place. They are the United States of America, Canada, Australia, and South Korea; while recently Taiwan has put hands together to join this troop of patent linkage establishing countries.

As we all are familiar with the fact that every new system comes with ties-and-knots of rules and regulations to be bound with, Taiwan patent linkage is no different from this familiarity. Within the perimeter of the Pharmaceutical Affairs Act, Chapter 4-1, Articles 92-1, 100, and 100-1 have been amended and brought in force from 20th August 2019. They narrate the provisions relating to the patent linkage system for pharmaceutical products in Taiwan. They include:

  1. Regulations for New Drug Marketing Approval Holder
    1. Any New Drug MA Holder, who has obtained marketing approval prior to 20th August 2019 shall be allowed to get their patents enlisted in the newly launched Patent Linkage System within 3 months (i.e. up to 20th November 2019) from the date on which the patent linkage system came into force.
    2. Linking patents with their respective pharmaceutical product shall be the sole responsibility of the New Drug MA Holder.
    3. In order to get patents enlisted in the Patent Linkage System, the New Drug MA Holder shall request a listing, within 45 days from the date of receipt of Marketing Approval from Taiwan Food and Drug Administration, of all the related information about that approved drug’s relevant patents.
    4. Types of patents that can be requested for enlisting in Taiwan Patent Linkage System:
      1. Drug Substance or Active Pharmaceutical ingredient related patent
      2. Composition or Formulation related patent
      3. Therapeutic Indication or Medical Use Patent, congruent with all or parts of indications mentioned in Marketing Approval
    5. For any patent granted after receipt of the new Drug MA, it must be enlisted by the new Drug MA Holder within 45 days from the next day’s date of grant of such patent.
    6. Further, if the new Drug MA Holder fails to file such submission within the stipulated time period, the Regulations pursuant to this Chapter (Patent Linkage of Drugs) do not apply.
  1. Regulations on Provision of Patent Information Provision by New Drug Marketing Approval Holder
    1. New Drug MA Holder shall provide the following with request of enlisting patents pursuant to Article 48-4:
      1. Patent Certificate numbers of the relevant patent(s); if the patent refers to medical use, the number of claims shall be concurrently provided.
      2. Patent(s) Expiry Date
      3. Name, nationality, place of domicile, or business office of the Patentee; for any patentee having a legal representative, the name of the legal representative shall be provided for the listing. If the said patent has been exclusively licensed and has been recorded in accordance with the Patent Act, the aforementioned information of the exclusive licensee shall be provided for the listing.
      4. If the patentee or the exclusive licensee in Item (3) hereunder does not have a domicile or a business office in the Republic of China (R.O.C. — an official name for Taiwan), an agent thereof shall be appointed. The appointed agent’s name, place of domicile, or business office shall be submitted.
    2. If the New Drug MA Holder is different from the patentee, the patentee’s consent shall be obtained when submitting the patent information; if the patent has been exclusively licensed and has been recorded in accordance with the Patent Act, it is only required to obtain the exclusive licensee’s consent.
    3. Pursuant to amendments made in Article 100 and 100-1, if the New Drug MA Holder submits the patent information in accordance with Articles 48-3 through 48-6 but provides such information under a fraudulent or incorrect way, and if criminal liability is involved therein, such matter shall be transferred to judicial authority for handling. Furthermore, if any criminal liability involved in the cases subject to the imposition of fines under this Act shall be referred to, and dealt with separately by the judicial authority.
  1. Regulations related to amendment or deletion of the listed patent information 
    1. If any changes happen within 45 days after the next day to the occurrence of any matter shall be provided by the New Drug MA Holder as under:
      1. The patent term extension, if any, is approved and issued by the Competent Patent Authority.
      2. The post-grant amendment to patent claim(s), if any, are approved and issued by the Competent Patent Authority.
      3. The patent has been revoked finally and bindingly.
      4. The patent has become extinguished.
      5. Any information related to Patentee’s details as name or address or any other such as discussed above in II. has been amended.
    2. If the New Drug MA Holder is different from the patentee or the exclusive licensee, b. of II. shall be applied hereto mutatis mutandis when dealing with the matters stipulated in a. of III.
  1. Regulations on Notification by any interested party to the Central Competent Health Authority
    1. Any interested party to the Central Competent Health Authority with written explanations and evidence attached for any one of the under given
      1. Irrelevance of listed patent information to the approved drug
      2. The listed patent is not one from either API, Composition, or Use type of patents
      3. Incorrect patent information
      4. No amendment or deletion has been made for any of the occurrences
    2. Central Competent Health Authority shall, within 20 days after the next day to its receipt of the notification, notify the New Drug MA Holder of the same.
    3. The New Drug MA Holder shall, within 45 days of the next day to its receipt of said notification, respond to the Central Competent Health Authority with written explanations, and may amend or delete the patent information as the case may be deemed.
  1. Regulations on roles of Generic Drug Manufacturer in obtaining relevant Certification and Central Competent Health Authority in the maintenance of this Patent Linkage System
    1. The applicant for a generic drug permit shall, with respect to the patent(s) of the approved new drug listed by the New Drug MA Holder, declare one of the following item(s) when applying for a generic drug permit:
      1. No patent information of said new drug has been listed.
      2. The patent(s) corresponding to said new drug has extinguished.
      3. The Central Competent Health Authority will issue the generic drug permit after the patent(s) corresponding to said new drug extinguishes.
      4. The patent(s) corresponding to said new drugs shall be revoked, or the patent(s) corresponding to said new drugs will not be infringed by the generic drug subject to the application for a drug permit.
    2. The Central Competent Health Authority shall establish a Registration System for Patent Linkage of Drugs to list and publish the patent information submitted by the New Drug MA Holder. 
    3. This Registration System shall also incorporate the amendment and deletion of the patent information.
    4. Upon the occurrence of changes in the listed patent information, the Central Competent Health Authority shall publish the third party’s allegations and the written responses made by the New Drug MA Holder.

Though these provisions most commonly coincide with The Hatch-Waxman Act Provisions of USA (HWAP), there are some evident differences from the same in Taiwan Patent Linkage System (TPLS) as under:

SystemMedicament type eligible for listingTypes of Patents that can be enlistedStay on New Generic Drug MAMarket Exclusivity GivenInfringement Lawsuit Filing 
TPLSNCEs including BiologicsAPI, Formulation and Medical Use Patents12 Months12 MonthsWithin 45 days period
HWAPNCEs except for BiologicsAPI, Formulation, and Method Of Treatment Patents30 Months6 MonthsBefore the expiration of 45 days after the date on which the notice was received

Therefore, the Patent Linkage System in Taiwan seems to be introduced as a tool to enhance patent monopoly and thus innovation booster for the pharmaceutical sector. In fact in the history of Patent Linkage Systems, introduction for Pharmaceutical Products, innovation, and drug price management have remained major areas of concern and improvement.

Written by:

Excelon IP

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