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1 1 (July 26, 2016)

handle is hein.crs/govcdzt0001 and id is 1 raw text is: F. , ' -iE S .,. & t TPP: Intellectual Property Rights (IPR) July 26, 2016 The Trans-Pacific Partnership (TPP) is a proposed free trade agreement (FTA) among the United States and 11 Asia-Pacific countries that would reduce and eliminate tariff and non-tariff barriers on goods, services, and agriculture, and establish trade rules and disciplines, including on IPR protection, which expand on World Trade Organization commitments (WTO-plus). IP-creations of the mind embodied in physical and digital objects are a key source of U.S. comparative advantage. IPR are time-limited rights that governments grant to inventors and artists to exclude others from using their inventions and creations without permission. Advancing IPR protection globally has been a U.S. trade negotiating objective since 1988 (P.L. 100-418), first reflected in the North American Free Trade Agreement (NAFTA) and WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The 2015 Trade Promotion Authority (TPA, P.L. 114-26 ) includes prior U.S. trade negotiating objectives for U.S. trade agreements to reflect a standard of protection similar to that found in U.S. law (TRIPS-plus), and new objectives to combat cyber theft and protect trade secrets. TPP and IPR debate focuses on how to protect and enforce IPR to incentivize innovation, while also securing public benefits from these innovations. The TPP area is a mix of developed countries, historically IP generators, and developing countries, historically IP importers, but now are growing sources of innovation. The region presents a range of IPR challenges (Fig. 1), such as high counterfeiting and piracy rates, including in the digital environment, and weak enforcement of IPR laws. TPP potentially could address IPR concerns in the broader region, including with respect to China and India. Figure I. TPP Countries' IPR Regimes . . . . . . . . . . . ..:: :: :: :: :: : : .... . . . . . . ..........:::::::::::::::::::::::.... ... ..... , . . . . . . .... ..... .,u mokkommukkk:::::::: :. . . ...... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i :? JARAN 00VW7NAM E' tAAI AY:1 PERUJ NEW ZEMANO $E TPP Countrie (12) ® TPP countries with IPA issues, according to Special 301 review (5) Source: U.S. Trade Representative, 2016 Special 301 Report. 'n P a The IP chapter aims to support technological innovation to benefit both producers and users, while promoting a balance of rights and obligations. It is enforceable through dispute settlement. It includes phase-in periods for some countries to implement certain provisions. General obligations include upholding international agreements and not discriminating against foreigners on IPR. Specific provisions are discussed below. Selected IPR Provisions in TPP A number of provisions in TPP reflect new or updated issues for U.S. FTA, including in the following areas: Biologics. Contains provisions on data exclusivity period for biologics, large-molecule drugs developed from living organisms. Copyright balance. Provides for incorporation of fair-use exceptions in countryX's law. Internet Service Providers (ISPs). Requires notice and takedown to address ISP liability while al owing alternative systems for certain countries (e.g., notice and notice). Geographical indications (GIs). Requires administrative procedures for recognizing and opposing GIs, and specific GI commitments in international agreements. Trade secrets. Requires criminal procedures and penalties for trade secret theft, including cyber theft; clarifies that state- owned enterprises (SOEs) are subject to trade secret obligations. Enforcement. Extends enforcement to the digital environment. Patents protect new innovations, such as pharmaceutical products, chemical processes, business technologies, and computer software. TPP aims to establish consistent and harmonized patent regimes in the region. Some provisions specific to pharmaceuticals aim, based on U.S. trade negotiating objectives, to encourage innovation and access to medicine. Yet, stakeholders disagree on whether TPP appropriately incentivizes research and development for new medicines while also allowing affordable access to medicines through market entry of generic medicines. Patent rules include: Patent protection of new products and processes, as well as new uses, methods, or processes of a known product (based on TRIPS's 20 years of minimum protection). Adjustments of patent terms for unreasonable delays in the patent examination or regulatory approval processes with phase-in periods for Brunei, Malaysia, and Vietnam. Protection of test data (data innovators submit for regulatory approval on which generics may later rely): Chemical-based (small-molecule) drugs: Five years of data exclusivity for new drugs, and three years for new formulations of existing drugs. gogn, q \popmm- , goo g , q aS ' X 11LULANJILiN,

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