- The Trans-Pacific Partnership (TPP) talks have been going on for five years and have finally reached a conclusion. The major sticking point was patent exclusivity for biologics. The U.S. wanted 12 years, while other countries, such as Australia, wanted five years of exclusivity. They netted out a compromise agreement that would provide at least five years of exclusivity and up to eight years of exclusivity.
- This trade liberalization deal, which involves 12 participating countries, still has to be ratified by Congress and approved by lawmakers in the other countries. It will encompass 40% of the global economy.
- The TPP is intended to lower trade barriers across 12 countries, including Brunei, Chile, Singapore, New Zealand, Australia, Canada, Japan, Malaysia, Mexico, Peru, Vietnam, and the United States
In the final analysis, there were hundreds of trade-related details and geo-economic issues to address, ranging from agriculture, to auto-trade, to dairy exports and much more. However, at the eleventh hour, the issue that was still hotly contested was the issue of patent exclusivity for biologics.
U.S. Trade Representative Michael Froman pushed hard for the TPP to adopt the 12-year protection policy that the U.S. has. However, both Australia and New Zealand pushed for a limit of five years of patent protection for biologics, with a great deal of backing from various patient-advocacy groups and other nations.
The TPP has agreed on between five and eight years of exclusivity for biologics, which is seen by many outside the industry as a victory. The Wall Street Journal reported on Sunday that the complex compromise came as a result of negotiations between the U.S. and Australia, and that nations would have "an alternative of either providing eight years of exclusivity to biologic drugs, or providing five years of so-called data exclusivity plus up to three more years under a regulatory framework in the TPP."
Representative Froman and others, notably BIO, aren't thrilled with that outcome. "We are very disappointed in reports from Atlanta that suggest Trade Ministers have failed to include 12 years of data exclusivity for biologics in the Trans-Pacific Partnership (TPP) agreement," said BIO in a statement. PhRMA, the largest pharmaceutical trade organization, expressed similar disappointment.
Many advocates of 12-year exclusuvity for biologics point to the need to protect innovation and the incentive to create new drugs. BIO makes the point clearly in its statement: "While the TPP agreement will not impact the U.S. data protection period, we believe the failure of our Asian-Pacific partners to agree to a similar length of protection is remarkably short-sighted and has the potential to chill global investment and slow development of new breakthrough treatments for suffering patients."