Today's guest blog is written by Harrison Cook, Vice President for International Government Affairs here at Lilly. Before joining Lilly in 2003, Mr. Cook served as the Chief of Deregulation and Trade Policy in the U.S. Department of Commerce's Office of Japan, where he was the lead technical negotiator with Japan's Ministry of Health, Labour and Welfare.
This week, the Trans-Pacific Partnership (TPP) agreement negotiations are being held in Dallas, Texas. The TPP agreement seeks to further economic growth by strengthening US trade within the Asia-Pacific region.
As negotiations on the Trans-Pacific Partnership (TPP) continue in Dallas, I wanted to take the opportunity to highlight what success would look like for the trade agreement. During my time as the Chief of Deregulation and Trade Policy in the U.S. Department of Commerce's Office of Japan, I came to recognize the importance of strengthening intellectual property rights internationally for encouraging future innovation and strengthening American competitiveness. This sentiment has been echoed by numerous voices (link has expired) in the discussions on TPP.
In order to ensure that the United States can remain competitive in this crucial area, the TPP agreement must bring international standards in-line with current U.S. law. For patents, that means a linkage system in line with the Hatch-Waxman Act that protects the marketing rights for innovators of new medicines while the drugs are reviewed through a regulatory approval process.
Currently, U.S. law provides innovator companies 12 years of exclusivity for biologics test data. Setting this standard internationally would help support innovation and foster economic growth. As Pfizer's Chief Intellectual Property Counsel, Roy Waldron, stated, ""The 12 years of data protection set forth under U.S. law we believe is the key to the Trans-Pacific Partnership and other free trade agreement negotiations."
Under the access window provision of the trade agreement, pharmaceutical companies that seek marketing approval within a certain window of time receive a high level of intellectual property protection. A robust trade agreement with an access window of 6 years would allow innovative pharmaceutical companies time to submit new medicines for approval in other countries.
As discussions and negotiations continue, it is critical that the USTR keep pushing for data protection and intellectual property standards that are in accordance with U.S. law. The TPP agreement is poised to set the precedent for future trade agreements in this region. Pursuing the gold-standard of protection for intellectual property ensures that the United States can remain competitive in the global market.