Deal reached on Trans-Pacific Partnership trade agreement
On October 5, 2015, the Pacific trade ministers from 12 nations reached a deal on the Trans-Pacific Partnership (TPP) trade agreement after 5 years of secret negotiations. The TPP is the most ambitious trade deal in history, with the member states governing nearly 40 percent of the global economy. Countries include: Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, the US and Vietnam.
One of the key and most controversial points in the negotiations has to do with the period of data exclusivity available to biological drugs, since the TPP members have very different regulations regarding this matter. For instance, in the US any maker of a biological drug is granted 12 years of data exclusivity from the granting of the health registration, meaning that the Food and Drug Administration (FDA) cannot approve a biosimilar drug that relies on the original data during this time. By contrast, other signatory countries have much looser rules, with Japan offering eight years of data exclusivity, and Brunei zero.
Regarding the Latin American TPP members, Mexican law is silent with regard to data exclusivity. In 2012, the Mexican Health Authority (COFEPRIS) issued internal guidelines that provided a 5 year-term of data protection for new chemical entities. In both Chile and Peru, the law establishes a data package exclusivity of 5 years for new chemical entities.
The terms of the agreement will now have to be ratified by each of the TPP countries in the following months. Until then, the complete text of the agreement will not be released publicly.
We will keep you informed on how the TPP trade agreement will affect IP and regulatory matters in Latin America once the agreement text is published.
Local associates in Mexico, Peru and Chile