Strong IP Protection is Critical Component of Trade Agreement

Patently BIOtech

The next round of discussion on the Trans-Pacific Partnership (TPP) began yesterday in nearby Leesburg, VA.  The TPP currently includes eleven countries (Australia, Brunei, Canada, Chile, Malaysia, Mexico, New Zealand, Peru, Singapore, U.S. and Vietnam) and other countries in the region, such as Japan and Korea, may join in the future.

The TPP will set an important precedent for global trade rules.  It is described by the U.S. Trade Representative as “an ambitious, 21st-century … agreement that will enhance trade and investment among the TPP partner countries, promote innovation, economic growth and development, and support the creation and retention of jobs.”

The U.S. Chamber of Commerce’s Global Intellectual Property Center (GIPC) recently highlighted the importance of the TPP and stressed need to ensure robust intellectual property (IP) protection abroad. In a blogpost entitled, “Golden Opportunities for a Gold-Standard TPP,” the GIPC referenced the number of U.S. jobs at stake:

The TPP provides an opportunity for U.S. companies to access one of the most dynamic economies in the world and to set the rules of the road for future agreements. Of critical importance for this agreement is securing robust intellectual protections modeled on the U.S.-Korea Free Trade Agreement. This is vital to the 55 million U.S. jobs that rely on IP and which fuel 74 percent of U.S. exports.

Leaders within the states have also stepped forward to call for strong IP protection in the TPP.  Julio Fuentes, president and CEO of the Florida State Hispanic Chamber of Commerce, explained why in an editorial published yesterday:

A smartly structured agreement — one that protects American workers — will generate a massive boost for our state’s economy and ensure that Florida remains one of the most important destinations for innovation in the country. A critical section of the TPP for Florida workers is the establishment of intellectual property protections.

BIO agrees that the U.S. government must consistently advocate for strong IP protection here and abroad.  We have also joined with other stakeholders (including the former union official who recently opined in The Hill) to urge the U.S. Trade Representative to advocate for established U.S. law on data protection for innovator biologics.

The pathway for biosimilars, one of the few provisions in the Affordable Care Act that received broad bipartisan support in both Chambers of Congress, provides 12 years of data exclusivity for innovator biologics.  During that time, other manufacturers can conduct their own clinical trials and bring competitive products to market without regulatory restriction, but cannot rely on the innovator product’s safety and efficacy data to achieve a shortcut to market until 12 years after the innovator’s approval.  This reflects a careful balance between encouraging competition to reduce prices and expand access with providing continued incentives for the lengthy and expensive research and development needed to bring innovative new medicines to market and into the hands of the patients who need them.

It is critical for the U.S. to stand firm on intellectual property in TPP and in future trade agreements.  Our nation’s global competitiveness depends upon it.

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