July 22, 2015

U.S. Chamber Reiterates Importance of Twelve Years Data Protection for Biologics in TPP

By Patrick Kilbride

Let’s be clear:  Government negotiators will determine the final terms of a TPP agreement.  From an industry perspective, the term of data protection for biologics in the Trans-Pacific Partnership (TPP) agreement should be 12 years, consistent with U.S. law.  Anything less risks the support of U.S. industry.

As negotiators arrive in Maui, Hawaii for what could be the final round of talks among 12 Asia-Pacific countries, the question everyone is asking is where does industry draw its  bright lines on support for an eventual deal.

On perhaps the most high-profile issue outstanding in the talks, the U.S. Chamber’s position has been and remains clear and consistent:  Biologics, at the cutting-edge of life sciences technology today, need 12 years of regulatory data protection (also known as “data exclusivity”) to maintain the current high levels of investment into new cures for previously untreatable diseases.  Anything less than 12 years does a disservice to the needs of current and future patients, and it would risk putting TPP countries at a competitive disadvantage in this highly sought-after industry.

U.S. law, enacted by the Affordable Care Act, established regulatory data protection for biologics in the United States at 12 years, which remains the global benchmark.   U.S. legislators did not arrive at this figure by chance.  Among their considerations was the fact that biologics, distinct from conventional pharmaceutical products, are composed of living organisms.  Each treatment with these products is inherently and individually unique, a factor which makes it more likely that typical patent protections afforded new discoveries may not be readily available for innovative medicines in all cases.  Regulatory data protection in those circumstances fills a void by “securing for limited times… the exclusive right to their … discoveries” afforded by Article 1, Section 8 of the U.S. Constitution.

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