Newsletter
Patent Linkage System Implemented as of 20 August 2019 in Taiwan
ALERT SHEET
To: Clients and Friends of Lee and Li
From: Lee and Li, Attorneys-at-Law
Subject: Patent Linkage System Implemented as of 20 August 2019 in Taiwan
Date: 19 August 2019
I. Introduction
The Legislative Yuan of Taiwan passed an amendment to the Pharmaceutical Affairs Act (PAA) on 29 December 2017. The amendment included, among others, introducing to the Taiwan legal system a "patent linkage practice" for the first time, after which the Taiwan Food & Drug Administration ("TFDA") spent more than one and a half years drafting relevant implementation rules for the practice (i.e., the Regulations for Implementing Patent Linkage, announced on 1 July 2019). On 6 August 2019, the Executive Yuan (Cabinet) announced that the amended PAA provisions related to patent linkage takes effect on 20 August 2019.
II. Major Aspects of Patent Linkage Practice
The major aspects of the implementation of patent linkage practice are as follows:
A. Deadline for Listing Patent Information
For market approval (MA)on a new drug obtained after the amended PAA takes effect (20 August 2019), the holder of such MA can list the patent(s) related to the drug within 45 days from the day on which market approval is collected from the TFDA by the MA holder.
For a MA obtained for a new drug prior to the amended PAA taking effect on 20 August 2019, the MA holder can list the patent(s) related to the drug within three (3) months from the date on which the amended PAA takes effect (i.e., by 20 November 2019).
B. Applicant for Patent Listing
According to the amended PAA, an application for patent listing must be filed by a holder of a MA covering a new drug application (NDA).
C. Patents Subject to Patent Listing
Patents subject to the patent linkage practice include drug substance patents, composition or formulation patents, and medical use patents.
D. Patent Listing Application
Otherimportantimplementation details are as follows:
(1)According to Article 48-3 of the amended PAA, a NDA holder can list the information for patent(s) that cover(s) the new drug within 45 days from the day after collecting a MA for the new drug; if the MA holder fails to make such patent listing within the stipulated time period, the desired patent listing is not accepted.
Drug substance patents, composition or formulation patents, and medical use patents are allowable for patent listing. Attention shall be paid to Article 3 of the Enforcement Rules of Patent Linkage, as follows.
• the term "substance" refers to the active ingredient(s) of a drug preparation, including inventions directed to different forms of polymorphs of a compound;
• the "composition or formulation" refers to the combination or formulation of the active ingredient(s) of a drug preparation; and
• the term "medical use" refers to the use corresponding to all or part of the indications identified on the drug permit.
(2)According to Article 48-4 of the amended PAA, for medical use patents, the claim numbers should be indicated in the patent listing. Article 5 of the Regulations for Implementing Patent Linkagefurther prescribes that, for a medical use patent, the claim number covering the medical use invention shall be specified and each claim shall correspond to the indication identified on the MA for the disclosed drug.
(3)As stated in Article 48-21 of the amended PAA, for patents subject to patent listing which have not expired before the patent linkage takes effect (20 August 2019), the MA holders can list these patents within three (3) months after the patent linkage practice in implemented (by 20 November 2019).
(4)According to Article 48-4, specific information (such as patent number, patent right expiration date, patentee information and exclusive licensee information) as to a listed patent should be submitted. If a NDA holder seeking patent listing is different from the patentee of the listed patent, the NDA holder should obtain the patentee's consent. For a patent for which an exclusive licensing arrangement has been recorded with the Taiwan Intellectual Property Office (TIPO), written consent from the exclusive licensee must be submitted to the TFDA and it is not necessary to further submit to the TFDA consent from the patentee.
(5)According to Article 48-6, where an already listed patent involves any specific changes, including patent term extension, post-grant amendment, patent revocation, patent extinguishment, or change of patentee information or exclusive licensee information, such change should be declared to the TFDA within 45 days after occurrence of the change.
E. Written Explanation Filed by a 3rd Party & MA Holder's Response
(1)As stated in Article 48-7, any third party who deems the listed patent information incorrect can file with the TFDA a written explanation regarding the incorrect listed information as well as any supporting evidence. Upon receipt of such written explanation, the TFDA will serve the MA holder with a copy of the third party’s written explanation and supporting evidence within 20 days of receipt of the written explanation. The MA holder must file a written reply with the TFDA within 45 days after receipt of the service.
(2)As prescribed by Article 48-8, the TFDA will publish and/or update the patent listing information provided by the MA holder as well as the later submitted information submitted pursuant to each of Articles 48-6 & 48-7 mentioned above.
F. Patent Certifications Certified by ANDA Filers
According to Article 48-9, when an abbreviated new drug application (ANDA) applicant submits an ANDA application, the ANDA applicant should simultaneously select one of the following as a declaration for each of the listed patents listed by the NDA holder:
• No patent information has been listed for the new drug;
• The patent corresponding to the new drug has become extinguished;
• The TFDA shall issue the generic drug permit after the extinguishment of the patent(s) corresponding to the new drug; and
• The patent corresponding to the new drugs should be revoked or will not be infringed on by the generic drugs for which the drug permit is applied.
According to Article 48-20, the above declaration mutatis mutandis applies to NDA for those not having a new ingredient. Under the Regulations for Implementing Patent Linkage, this kind of NDA refers to new therapeutic combination and new routes of administration.
G. Notification Sent to NDA Holder and Staying Effect of Drug Permit Issued to Generics
According to Article 48-12, an ANDA applicant making a declaration as prescribed in Paragraph 4 of Article 48-8 (i.e., the patent corresponding to the new drugs should be revoked or will not be infringed on by the generic drugs for which the drug permit is applied) shall inform the NDA holder and the TFDA in writing within 20 days from the date of TFDA's notification confirming the completion of filing all the required documents required for filing the drug permit. If the NDA holder is different from the patentee or an exclusive licensee, the ANDA applicant should inform the patentee or the exclusive licensee as well.
According to Article 48-13, after an NDA holder, a patentee or an exclusive licensee receives the mentioned notification, it can file a patent infringement suit within 45 days after the receipt of the notification under Article 48-12 of the amended PAA. Also pursuant to Article 48-13, the TFDA shall stay the issuance of the drug permit within 12 months after the patentee or the exclusive licensee receives the above-mentioned notification and files a patent infringement lawsuit unless any of the events prescribed in Article 48-3 exists (for example, the patentee or the exclusive licensee fails to file a patent infringement suit within the 45-day time period, the patent based on which the patentee or the licensee files an infringement suit is different from any of the listed patents, the concerned patent infringement suit filed by the patentee or the exclusive licensee is dismissed by court, the concerned patent is held invalid or being non-infringed by court, the concerned patent is held invalid by the TIPO, the concerned parties have reached settlement or mediation arrangement, the concerned patent has become extinguished).
Where the patentee or the exclusive licensee has received a court judgment confirming infringement within the 12-month staying period, the TFDA will issue a permit to the ANDA applicant after the concerned patent has become extinguished. Where the filing of a patent infringement suit by a patentee or an exclusive licensee pursuant to Article 48-13 is considered as an improper exercise of patent right, which has caused injury to the ANDA applicant due to the suspension of issuing a permit, the patentee or the exclusive licensee shall be obliged to compensate the injuries.
H. Marketing Exclusivity to the First Successful ANDA Applicant
According to Article 48-16, the first ANDA holder who successfully defends a patent infringement suit is granted a twelve-month period of marketing exclusivity. The TFDA shall not issue a drug permit to other applicants for a generic drug permit until the expiration of the aforementioned 12-month period. The generic applicant should launch the generic drug within 6 months after receipt of the drug permit under Article 48-17.
However, under Article 48-18, if the first ANDA holder fails to market the drug within 6 months after issuance of a drug permit, it may jeopardize the 12-month period of marketing exclusivity.
I. Possible Competition Law Concerns
According to Article 48-19, the TFDA should be notified of any settlement agreement on patent linkage-related arrangements between the NDA holder and the ANDA applicant or the first ANDA holder. The TFDA should establish guidelines on the details of such notification in the future. If the TFDA notices any potential anti-competition arrangements in such agreements, it shall transfer the matter to the Taiwan Fair Trade Commission (TFTC) for handling.
We hope that the information provided is helpful to pharmaceutical concern's assessment and decisions on how to handle patent linkage in Taiwan as well as to protect their legitimate rights and interests under this new practice. If you have any questions or need any assistance, please do not hesitate to contact us at patent@leeandli.com.