FTA Plus Issues in Asia — IP and Health NTU Summer+ FTA Plus Issues in Asia — IP and Health  Assistant Professor Tsai-Fang Chen National Chiao Tung University School of Law

Overview Reasons of FTA’s proliferation Political & economic background Deadlock of WTO’s Doha negotiation Asian Financial Crisis: a need to find a new trading partner Increasing scope of global supply chain within Asia

Asia-Pacific FTA Projects (before 1998)

Asia-Pacific FTA Projects (by end of mid-2013)

FTA Projects in Asia TPP vs. RCEP U.S.-led vs. China-led U.S.’s ambition: IP exporting state U.S.’s high level of domestic IP protection

Regional FTA Projects in East Asia and Asia-Pacific

Overview State FTAs initiatives Singapore 38 India 34 South Korea 32 Thailand 29 Malaysia, Pakistan & China 27 Japan 26 Australia & Indonesia 22 New Zealand 20 Vietnam 19 Brunei Darussalam 18 Philippines & Kazakhstan 16

Overview State FTAs & RTAs concluded Singapore 18 India & Japan 13 Thailand, China & Malaysia 12 South Korea, New Zealand & Australia 9 Philippines & Indonesia 7 Pakistan 6

FTAs with low level of IP content Many of Asia-Pacific Developing states were parties to TRIPs. TRIPs created a “floor” for IPRs, not a ceiling. Strong IP protection would result in problems, such as legitimacy and poverty alleviation.

IP Provisions Pressure for detailed IP provisions are from the U.S., EU and Japan. These provisions have entered the FTAs with Australia, Korea, Singapore, Thailand, Malaysia, Indonesia, the Philippines and Vietnam.

TPP’s IP Provisions

Patent Term Adjustment for Unreasonable Granting Authority Delays Article 18.46 “If there are unreasonable delays in a Party’s issuance of patents, that Party shall provide the means to, and at the request of the patent owner shall, adjust the term of the patent to compensate for such delays.” “[A]n unreasonable delay at least shall include a delay in the issuance of a patent of more than five years from the date of filing of the application in the territory of the Party, or three years after a request for examination of the application has been made, whichever is later.”

Patent Term Adjustment for Unreasonable Curtailment Article 18.48 “With respect to a pharmaceutical product that is subject to a patent, each Party shall make available an adjustment of the patent term to compensate the patent owner for unreasonable curtailment of the effective patent term as a result of the marketing approval process.”

Criminal penalties regarding trade secrets Art. 18.78 “Subject to paragraph 3, each Party shall provide for criminal procedures and penalties for one or more of the following: (a) the unauthorised and wilful access to a trade secret held in a computer system; (b) the unauthorised and wilful misappropriation of a trade secret, including by means of a computer system; or (c) the fraudulent disclosure, or alternatively, the unauthorised and wilful disclosure, of a trade secret, including by means of a computer system”

Geographical indications: challenges Art. 18.31 “If a Party protects or recognises a geographical indication through the procedures referred to in Article 18.31 (Administrative Procedures for the Protection or Recognition of Geographical Indications), that Party shall provide procedures that allow interested persons to object to the protection or recognition of a geographical indication, and that allow for any such protection or recognition to be refused or otherwise not afforded” on the grounds of causing confusion with a pre-existing trademark or the GI is comprised of a generic term.

Domain Names TPP protects trademark owners from unauthorized use of their trademark in domain names. Adoption of a domain name dispute resolution system modeled along the same lines as ICANN’s Uniform Domain Name Dispute Resolution Policy.

Trademark Art. 18.18 “No Party shall require, as a condition of registration, that a sign be visually perceptible, nor shall a Party deny registration of a trademark only on the ground that the sign of which it is composed is a sound.” “ “Additionally, each Party shall make best efforts to register scent marks.”

Copyright Art. 18.63 Duration: life plus 70 years

ISP Safe Harbor Provisions Art. 18.81-82 Insulate ISPs when they store content online a the direction of a user, or link to third-party content, so long as the ISPs create systems to “expeditiously remove or disable access to material residing on their networks upon obtaining actual knowledge of the copyright infringement” (a takedown request system)

Technological protection measures Art. 18.68 “anti-circumvention” rule to penalize individuals who tamper with the digital locks (, or help others to do so,) by civil and criminal penalties

Health Issues IP rights above human rights? 1/3 global population & 1/2 Asian population: no access to essential medicines Strong patent protection leads to: Higher price of medicine Less competition between medicine manufacturer

TPP and public health TPP has adverse effects on access to affordable medicines Lengthen, broaden and strengthen patent-related monopolies ISDS Transparency requirement for government Patentability provisions

TPP’s standards on health Data exclusivity standards Promotion of patent-linkage

ASEAN model

cooperation & collaboration ASEAN Framework Agreement on IP Cooperation, Article 1.1 : “Member States shall strengthen their cooperation in the field of IP through an open and outward looking attitude with a view to contributing to the promotion and growth of regional and global trade liberalisation.”

Article 1.2 : “Member States shall promote cooperation in the field of IP among government agencies as well as among the private sectors and professional bodies of ASEAN.” Article 3.1 : “Cooperation shall include, inter alia, the fields of copyright and related rights, patents, trademarks, industrial designs, geographical indications, undisclosed information and lay-out designs of integrated circuits.”

ASEAN IPRs Action Plan Context and Approach The ASEAN region is highly diverse and its transformation as a single bloc with a harmonized set of laws and procedures in IP has been a challenge.

Context and Approach ASEAN will move towards the agreed goals as a region even while preserving its diversity, without compromising the varying levels of development of Member States, but charting for the region a unique brand of an ASEAN IP System.

Strategic Goals and Areas of Focus Goal 1: A balanced IP system that takes into account the varying levels of development of Member States and differences in institution capacity of national IP Office to enable them to deliver timely, quality, and accessible IP services to promote the region as being conducive to the needs of users and generators of IP.

Strategic Goals and Areas of Focus Developed national or region legal and policy infrastructure that address evolving demands of the IP landscape and AMSs participate in global IP systems at the appropriate time.

Strategic Goals and Areas of Focus The interests of the region are advanced through systematic promotion for IP creation, awareness, and utilization to ensure that IP becomes a tool for innovation and development; support for the transfer of technology to promote access to knowledge; and with considerations for the preservation and protection of indigenous products and services and the works of their creative peoples in the region.