Trade officials from the 12 countries hammering out the final details on the Trans-Pacific Partnership (TPP) in Atlanta appear to have reached a compromise on biologic drugs that will allow the pact to move forward while potentially setting a higher IP bar on the most promising area of drug discovery.
The main sticking point over the length of the period of exclusivity was overcome with Australia and the United States agreeing on a minimum of 5 years, the Wall Street Journal reported, during which pharmaceutical manufacturers will have data exclusivity on biologic drugs. Negotiators said several more years of protection would be added, but details were not available.
A second track was also proposed in which drugmakers would have 8 years of exclusive rights to a new product in some countries, the WSJ said. Several countries are concerned that longer periods of exclusivity would add to the costs of their national health plans by slowing the introduction of generic copies of biologics, the newspaper said.
To be sure, several TPP countries will have to pass domestic laws for a transition before applying new IP protection rules for drugs, including setting standards at the regulatory end, experts have noted.
Last-minute negotiations over TPP dairy rules, according to news reports, are said to have held up any official announcement on Sunday in Atlanta of the breakthrough, with details likely to be announced on Monday at a press conference.
Any agreement reached in Atlanta must be approved by other national legislatures as noted as well as the U.S. Congress before it can be implemented. Any proposed pact is expected to be a thorny issue in the 2016 U.S. presidential election, with Republicans in the odd spot of backing President Barack Obama in the main, while many in his own party have voiced opposition.
Countries taking part in the TPP include Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, the U.S. and Vietnam.
The United States has been pushing for the trade deal, which it wants to use as a foundation for "21st century trade rules" that would set standards on investment, data flows and intellectual property.