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ENFORCEMENT

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Office of the Intellectual Property Enforcement Coordinator<br />

The increased globalization of trade, coupled with<br />

the intricacy of doing business in or with countries<br />

around the world, have given rise to an ever increasingly<br />

complex set of regulations and regulatory structures.<br />

Nontransparent—or worse, arbitrary—practices have<br />

the potential to hinder research and development,<br />

market access, foreign direct investments and other<br />

expenditures, especially in innovative technologies<br />

impacting agriculture, medical, and computer—related<br />

fields. These practices make it challenging to secure and<br />

enforce patents and other intellectual property rights<br />

critical to fostering innovation, economic growth, and<br />

global competitiveness.<br />

Patent Policy and Transparency<br />

In 2015, China “unveiled proposals in the<br />

pharmaceuticals sector that seek to promote<br />

government-directed indigenous innovation<br />

and technology transfer through the provision<br />

of regulatory preferences….[A] State Council<br />

measure issued in final form without having<br />

been made available for public comment calls<br />

for expedited regulatory approval to be granted<br />

to innovative new drugs where the applicant’s<br />

manufacturing capacity has been shifted to China.”<br />

similar investors seeking access to a market must have<br />

adequate information on new and revised regulations<br />

so that they can base their decisions on accurate<br />

assessment of potential costs, risks and market<br />

opportunities. However, as the Office of the U.S. Trade<br />

Representative (USTR) has explained in its 2016 Special<br />

301 Report, lack of transparency in IP-related rulemaking<br />

continues to be a problem as some foreign government<br />

regulatory agencies fail to make drafts of new rules<br />

widely and adequately available for public comment<br />

in the first instance, or fail to ensure that laws and<br />

regulations are administered in a uniform, impartial and<br />

reasonable manner.<br />

When the latest U.S. patented technology is<br />

infringed abroad because of lax patent protection<br />

and unpredictable legal standards, it threatens<br />

innovative economies worldwide. It is imperative that<br />

when formulating policies to promote innovation, all<br />

stakeholders must take account of the increasingly crossborder<br />

nature of commercial research and development,<br />

and champion transparent and fair practices. Ensuring<br />

open market access and effective intellectual property<br />

enforcement are indispensable for continued innovation<br />

and growth of the global economy.<br />

Source: USTR Report to Congress on China’s<br />

WTO Compliance (Dec. 2015), p. 9<br />

As the OECD has summarized, transparency is<br />

primarily understood in the international investment<br />

policy community “as making relevant laws and<br />

regulations publicly available, notifying concerned<br />

parties when laws change and ensuring uniform<br />

administration and application,” and for other<br />

practitioners “it may also involve offering concerned<br />

parties the opportunity to comment on new laws and<br />

regulations, communicating the policy objectives of<br />

proposed changes, allowing time for public review<br />

and providing a means to communicate with relevant<br />

authorities.” 39 Essentially, transparency and stakeholder<br />

participation “allow governments to avoid unintended<br />

consequences and facilitate stakeholder compliance<br />

with legislative and regulatory changes.” 40<br />

It is particularly the case that foreign firms and<br />

ACTION NO. 4.15: Support efforts to<br />

strengthen promotion of transparent and<br />

fair trade practices. USTR and the USPTO, in<br />

collaboration with the relevant members of the<br />

U.S. Interagency Strategic Planning Committees<br />

on IP Enforcement, will continue to promote and<br />

enhance efforts to advance transparent and fair<br />

trade practices related to intellectual property,<br />

including by bilateral and multilateral discussions<br />

prioritizing these issues; facilitating workshops<br />

with trading partners focusing on best practices<br />

that provide fair and equitable market access;<br />

and considerations for effective enforcement of<br />

intellectual property rights.<br />

c. Enhancing Effectiveness of Design Systems<br />

Abroad.<br />

As U.S. companies and designers continue to expand<br />

products into foreign markets, it is important for the<br />

U.S. to also promote strong and effective design<br />

protection and enforcement worldwide, reflecting the<br />

importance of design innovation to economic growth.<br />

SECTION 4<br />

139

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