Newest Amendments to the Examination Guide for Patent Term Extension

1. Introduction

 
According to Article 53 of the Taiwan Patent Act, where regulatory approval shall be obtained in accordance with applicable laws and regulations for the exploitation of an invention patent involving a pharmaceutical or agrichemical, or the manufacturing process thereof, if such regulatory approval is obtained after publication of the invention patent, the patentee may petition for one, and only one, extension of the patent term of said invention patent based on the first regulatory approval. In addition, regulatory approval is allowed to be used only once for seeking a patent term extension and the granted patent term extension is at most five years.
 
Also, under Article 53, the term “pharmaceutical” does not include any veterinary medicament. In addition, when requesting for patent term extension, a request form and evidentiary documents must be submitted to the TIPO within three months after obtaining the first regulatory approval; no request for patent term extension shall be filed within six months prior to the expiry of the original patent term.
 
The current examination guidelines for patent term extension have been implemented for four years since 1 January 2013 but some of the provisions are still not clear and cause concerns and inconsistencies upon interpretation. Therefore, Taiwan Intellectual Property Office (TIPO) set up an ad hoc group in 2017 to conduct a comprehensive review of the current examination guidelines and held public hearings to obtain external advice on the five major issues for patent term extension. By making reference to all the valuable advice provided by the public and the examination guidelines of the U.S., Japan, Korea, Europe and other countries, and in consideration of the current Pharmaceutical Affairs Act, Agro-Pesticides Management Act, and practical operations of the TIPO, the TIPO completed the amendments to the current examination guidelines for patent term extension.
 
The amendments are summarised in the following section.
 

1. Summary of the Amendments

1. Identification of Pharmaceuticals
 
The identification of pharmaceuticals, in principle, should be identified with reference to the medicaments defined in Article 6 of the Pharmaceutical Affairs Act, for example, the medicamentsused in diagnosing, curing, alleviating or preventing the diseases of human beings, or other medicamentswhich are sufficient to affect the body structure and physiological functions of human beings.
 
2. Identification of the Holder of the First Regulatory Approval:
 
The holder of the first regulatory approval may be patentee, exclusive licensee, or non-exclusive licensee.
 
If the holder of the first regulatory approval is a licensee, the petitioner shall submit evidentiary documents showing that the patent has been licensed at the time of petitioning the patent term extension. Failing to submit such evidentiary documents or submitting incomplete evidentiary documents will lead to a refusal of patent term extension.
 
3. Identification of the First Regulatory Approval:
 
In principle, different salts, different esters, or different hydrates of the same chemical moiety are deemed as different active ingredients. For example, when a claim of an invention patent which serves as a basis to petition for an extension is “compound A and its salts”, and if the petitioner obtains different regulatory approvals for a formate of the compound A and a bisphosphonate of the compound A respectively for the same purpose, both of the different approvals can be identified as the first regulatory approval. The petitioner may choose one of the regulatory approvals to petition for the patent term extension of the invention patent.
 
If, however, the regulatory approvals obtained for the active pharmaceutical ingredients (API) or technical grade agro-pesticides are used for manufacturing raw materials of pharmaceuticals or agro-pesticide rather than medical purposes, such regulatory approvals do not belong to the “first regulatory approval” under the Patent Act.
 
4. Statutory Period for Petitioning Extension:
 
The issuance date of the regulatory approval may not be the same as the date on which the patent or the licensee actually receives the regulatory approval. Therefore, the date of obtaining the first regulatory approval shall be the date on which the patentee or the licensee actually receives the regulatory approval.
 
5. Affixed Documents:
 
The following provision is determined unreasonable and will be removed: where a petition for patent term extension based on a foreign trial period of the pharmaceuticals or agro-pesticides, if a patent term extension was petitioned in the foreign country during the foreign trial period and has been approved, the petitioner shall submit the evidentiary documents showing foreign approval of the patent term extension.
 
6. Precautions of Examination:
 
If the patentee or the licensee obtains multiple regulatory approvals which are issued on the same date for the same active ingredient and the same use (for example, the same active ingredient and the same use, but different doses only), because the patentee may petition for only one extension based on the first regulatory approval and the approval may only be used one time, the petitioner may only choose one of the multiple regulatory approvals for petitioning extension. If the petitioner submits multiple regulatory approvals, the petitioner shall be notified and given one month to choose one of the multiple regulatory approvals for petitioning extension. If the petitioner fails to choose within the specified period, the petition may not be accepted, and if the petition has entered substantive examination after the specified period, the petition will be rejected.
 
If the patentee or the licensee petitions an extension on the basis of two (or more) regulatory approvals which are issued on the same date for the same active ingredient and the same use, and based respectively on two (or more) different invention patents, because the first regulatory approval may only be used for extending the patent term one time, the TIPO will notify the patentee to choose one of the regulatory approvals for petitioning the extension. If the petitioner fails to choose after the notification, the petitions shall be rejected. For example, if the patentee petitions Patent X’s term extension based on Regulatory Approval A and Patent Y’s term extension based on Regulatory Approval B, where Regulatory Approvals A and B were issued on the same date for the same active ingredient and the same use with merely different doses, the TIPO will notify the patentee to choose Patent X (Regulatory Approval A) or Y (Regulatory Approval B) for petitioning the extension. If the patentee fails to choose after the notification, the petitions for Patents X and Y shall be both rejected.
 

1. Conclusion

 
In conclusion, after implementing the new examination guidelines for the patent term extension, we believe that the rules for the patent term extension are clearer and the examination for the case which is petitioned for patent term extension can be expedited.
 
If the readers have any questions or needs in relation to patent term extension in this jurisdiction, they are very welcome to contact this firm using the following contact information: Yu-Li Tsai Patent Attorney, Deep & Far Attorneys-at-Law, 13th Fl., No. 27, Sec. 3, Chung San N. Rd. Taipei 104, Taiwan, R.O.C., Tel: 886-2-25856688 #8139, E-mail: yltsai@deepnfar.com.tw.
 
Yu-Li Tsai Partner Patent Attorney
Deep & Far Attorneys-at-Law
13th Fl., No. 27, Sec. 3, Chung San N. Rd. Taipei 104, Taiwan, R.O.C.
Tel: +886-2-25856688 #8139
Fax: +886-2-25989900/25978989
E-mail: yltsai@deepnfar.com.tw
Website: http://www.deepnfar.com.tw
 
Mr. Tsai graduated from the Department of Electrical Engineering at the National Taiwan University (NTUEE), which is the best engineering school in Taiwan. He then attended the Graduate Institute of Communication Engineering (GICE) of NTU and received his Master’s degree after two years research. During this period he also started to get involved in knowledge and skills of patent-related matters for taking the bar examination for Patent Attorneys.
 
He passed the exam and received the qualification of Patent Attorney. Mr. Tsai also attended and gained an IP Master degree from the Law School at the University of New Hampshire, also known as Franklin Pierce Center for Intellectual Property. Right after the graduation, he had an opportunity to work for InterDigital, Inc. in Delaware for a short period.