Source: Taiwan Intellectual Property Office

The Ministry of Economic Affairs (the “MOEA”) announced on April 11 that it had amended the Regulations for Ratifying Extension of Patent Term (the “Regulations”), realizing structural goal of patent term extensions and simplifying the process for extending patent terms. The amendments took effect on April 1st.

The MOEA explained in the reasons for the amendment that the domestic and/or foreign clinical trials or tests conducted for the purpose of obtaining approval by an applicant for a drug or agricultural chemical respectively from the competent authority shall be limited to those sent by the patent agency to the competent authority and confirmed to be necessary by the latter for issuing such an approval. Also, when the applicant bases on the period of foreign clinical trials and applies for a patent term extension, whether or not an application for patent term extension was granted outside of Taiwan shall not be considered, It is not necessary to provide the documents of foreign patent term extension approval as proof. Therefore, one of the Paragraphs in Articles 5, and 7, which stipulates that the applicant must provide foreign document(s) as proof of application in order to obtain regulatory approval have been deleted.

Furthermore, regarding field tests undertaken to receive approval from the regulatory in charge of agricultural chemicals, information from at least three field tests conducted outside of Taiwan or information from tests conducted domestically must be provided in accordance with Article 5 of the "Pesticide Field Testing Guidelines." However, it was originally stipulated that while the applicant needs to conduct more than one field test, the calculation of duration of the tests can be combined only when there is a sequential relation among all tests. Otherwise, the longest period of time in one of the tests took place shall prevail. And, so as to implement the purpose of the patent term extension system and also to safeguard the rights and interests of applicants, the amendment of the Regulations removes language in Article 6 which stipulates that for field tests of no sequential relations, only the longest time period on one of the tests may be adopted in applying for an extension.

Amendment to the Regulations for Ratifying Extension of Patent Term

Article 1

These Measures have been formulated pursuant to Article 53(5) of ROC Patent Law (hereinafter referred to as “Patent Law”)

Article 2

The central competent authority for the matters covered in these Regulations shall be the Ministry of Health and Welfare, which shall take charge of matters pertaining to pharmaceuticals, or the Council of Agriculture, Executive Yuan, which shall take charge of matters pertaining to pesticides.

Article 3

A request for patent term extension pursuant to Article 53 of the Act shall be made in an application and duly signed or stamped by the patentee or an agent thereof and shall indicate the following information:

  1. The patent Certification Number
  2. The title of the invention
  3. The patentee’s name, nationality, residence or business establishment; and, the name of the representative, if any;
  4. The reason for the extension of the term of patent;
  5. The date in which regulatory approval was first obtained.

Two copies of lawfully obtained permits and domestic and/or foreign document(s) in supporting the application of regulatory approval shall be provided together with the written request referred to in the preceding paragraph, whereupon they will be reviewed.

The patent agency shall, upon the acceptance of the application referred to in paragraph on, publish the contents of the application form.

Upon being granted an extension for a patent term, the patent agency shall inform the patentee that the same must provide the patent certificate to enable the patent agency to endorse the extended patent term.

Article 4

The periods of time eligible for a request of patent term extension for a pharmaceutical product or the manufacturing process thereof includes:

  1. The period in which a domestic and/or foreign clinical trial is conducted for the purposes of obtaining approval for a pharmaceutical product from the central competent authority in charge of such matters; and
  2. The examination period for a drug which is undergoing the domestic regulatory approval process.

The domestic and/or foreign clinical trials or tests conducted for the purpose of obtaining approval by an applicant for a drug or agricultural chemical respectively from the competent authority shall be limited to those sent by the patent agency to the competent authority and confirmed to be necessary by the latter for issuing such an approval.

Where a request for the extension of a patent term is made pursuant to Paragraph 1, the period attributable to the requester's omission of act, the period in which there is overlap between the conducting of foreign and domestic clinical trials as well as the period of overlap between the time in which the clinical trials were concluded and examination period for regulatory approval, shall be deducted from the extension period granted.

Article 5

Where there is a request for an extension of patent term involving pharmaceutical product(s) or the manufacturing process(es) thereof, the following documents shall be provided:

  1. Documents proving the time period that the domestic and/or foreign clinical trials were conducted , including when the said trials began and ended, as well as a list containing the same.
  2. Documents detailing the period in which an applicant applies for the domestic regulatory approval for a pharmaceutical product as well as documents indicating when that period began and ended.
  3. A photocopy of the pharmaceutical product approval.

Article 6

The periods of time eligible for a patent term extension as it pertains to an agricultural chemical or the manufacturing process thereof includes:

  1. The periods when the domestic and/or foreign field tests were conducted for the purposes of obtaining approval for a pesticide from the central competent authority.
  2. The examination period for domestic regulatory approval

The domestic and/or foreign field tests referred to in Subparagraph 1 of the preceding paragraph shall be limited to those sent by the patent agency to the central competent authority and confirmed as necessary by the latter in its issuance of approval for pesticides.

Where the request for the extension of a patent term is made pursuant to Paragraph 1, the period attributable to the requester's omission of act, the period in which there is overlap between the conducting of foreign and domestic field tests as well as the period of overlap between the time in which the field tests were concluded and examination period for regulatory approval, shall be deducted from the extension period granted.

Article 7

Where there is a request for an extension of patent term involving agricultural chemical(s) or the manufacturing process(es) thereof, the following documents shall be provided:

  1. Documents proving the time period that the domestic and/or foreign field tests were conducted, including when the said trials began and ended, as well as list containing the same.
  2. Documents detailing the period in which an applicant applies for the domestic regulatory approval of an agricultural chemical as well as documents indicating when that period began and ended.
  3. A photocopy of the agricultural chemical approval

Article 8

With respect to the period of time in which the applicant is unable to make use of his invention in the course of obtaining approval for that invention, where the date in which foreign and/or domestic testing is before the date in which a patent is granted, the date of grant shall serve as the start date of this period for calculation purposes; where the date in which foreign and/or domestic testing is after the date in which a patent is granted, the date in which testing began shall serve as the start date of this period for calculation purposes.

The time period in which an applicant is unable to make use of his invention in the course of obtaining approval for that invention shall expire one day prior to receiving approval.

Article 9

In the event that the period in which an applicant is unable to make use of his invention in the course of obtaining approval for that invention exceeds the extension period for which the applicant has applied, the period of the patent term extension shall be limited to the same that the applicant has applied.

Article 10

These Regulations enter into force and effect on April 1, 2018.