Leaked TPP Chapter on IP Sets Terms of Biologics Data Exclusivity

Information about exclusivity provisions biological data on the Trans-Pacific Partnership is still cloudy despite trailing copy the final chapter of TPP in WikiLeaks intellectual property rights Fridays.

The section of the chapter on the exclusivity of biological data seems to offer two options regarding the "first marketing authorization" of a new organic product. Affected countries should provide "effective protection market .. for a period of at least 8 years from the date of first marketing authorization "or" for a period of at least five years from the date of the first marketing authorization.

However, for the period of five years, the text seems to leave the door open to other provisions that could extend this period, with the ambiguous statement "other measures", which is just above the claim that countries recognize "that market conditions also contribute to the effective protection of the markets. "

The chapter also adds applicants organic businesses "may apply for approval of a pharmaceutical product is a biological product ... within five years after the entry into force of this Agreement, provided that other pharmaceutical products in the same class have been approved by the Party. "

In addition, a number of governments of the PPT, including Australia and New Zealand, said many do not require them to spend five years of exclusivity.

Some countries have transition periods, and the text shows also beyond these periods would last from three to ten years.The much says PPT Committee will consider the exclusivity period after 10 years.The TPP negotiating countries include the US, Mexico , Canada, Japan, Australia, Malaysia, Chile, Singapore, Peru, Vietnam, New Zealand and Brunei. The US Congress has 90 days to approve the final terms of the agreement, to be officially released in November.