Academic journal article Journal of Law and Health

Analysis of the Proposed Tpp-Related Patent Linkage System in Taiwan

Academic journal article Journal of Law and Health

Analysis of the Proposed Tpp-Related Patent Linkage System in Taiwan

Article excerpt

I. INTRODUCTION                                           57 II. TPP IP CHAPTER AND PATENT LINKAGE CLAUSE              60  A. Prerequisite of Patent Linkage                        60  B. Patent Linkage System                                 62   1. Notification Requirement                             62   2. Timing Requirement                                   63   3. "Procedure and Remedy" Requirement                   63  C. Alternative to the Patent Linkage System              65  D. Summary                                               66 III. DRUG PERMIT APPLICATION UNDER THE PHARMACEUTICAL AFFAIRS ACT                                               67  A. DRUG PERMIT                                           67  B. Submission of Test Data for a New Drug                68  C. Disclosure of Patent Information                      70  D. Test Data Protection                                  70  E. "Generic Drug Permit" Application                     71 IV. TAIWAN'S PROPOSED PATENT LINKAGE SYSTEM               71  A. Patent Information Submission                         71  B. Notification Made by a Generic Drug Permit Applicant  74  C. Stay of Issuance of a Drug Permit to a GDP Applicant  75  D. Exclusive Sales Period                                76  E. Anti-Competition Provision                            78 V. CONCLUSION                                             79 


The Trans-Pacific Partnership ("TPP") Agreement was signed on February 4, 2016 in Auckland, New Zealand. (1) Twelve countries, including Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, the United States and Vietnam, were involved in this multilateral free trade agreement ("FTA"). (2)

Like many FTAs, (3) the TPP Agreement has an intellectual property chapter which is Chapter 18. (4) Chapter 18 includes many provisions collectively setting a standard beyond the Agreement on Trade-Related Aspects of Intellectual Property Rights ("TRIPS Agreement"). (5) Article 18.53 of the TPP Agreement is a highly-criticized provision that relates to "patent linkage." (6) "Patent linkage" originates from the Hatch-Waxman Act of 1984. (7) The Hatch-Waxman Act established the Abbreviated New Drug Application ("ANDA") system which allows a pharmaceutical company to apply for a marketing approval of a generic version of a previously-approved drug without going through a full-scale experiment concerning the safety and efficacy of the generic drug. (8) But, to compromise with the benefits of pioneer drug companies, the Hatch-Waxman Act created a cause of action for pioneer drug companies to sue those generic drug companies for patent infringement simply because of the filing of an ANDA. (9) Australia, Canada, and Singapore also have a patent linkage system. (10)

While the TPP Agreement is under the national approval proceeding in each member state, Taiwan is eager to join the TPP Agreement. (11) Among other things, the Executive Yuan (12) announced a proposed amendment of the Pharmaceutical Affairs Act (13) ("PAA") on August 4, 2016. (14) The Proposed Amendment adds Chapter 4-1 governing a patent linkage system for generic drug permit ("GDP") applications. (15) The Proposed Amendment has been submitted to the Legislative Yuan. (16) The proposed patent linkage system forces a generic drug company to confront with patent law suits brought by a pioneer drug company. To do so, the Executive Yuan also introduced an amendment of the Patent Act. (17) The Patent Act Amendment provides a cause of action for a pioneer company to sue a generic drug company if the latter company files a GDP application. (18)

This article is intended to explore the Proposed Amendment to figure out whether the Proposed Amendment follows Article 18.53 of the TPP Agreement or goes beyond the minimal protection on pioneer drug companies. To answer that question, it is necessary to interpret Article 18.53 to figure out the scope of protection. …

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