SINGAPORE--India is not a member of the 12-nation Trans-Pacific Partnership, but its intellectual property rules governing pharmaceutical patents lie at the core of a dispute ginning up this year to reach a final agreement. India's resistance to relaxing its rules has been a model for the emerging-market members of the TPP to seek similar compulsory licensing arrangements for generic drugs.
|President Barack Obama|
U.S. President Barack Obama is expected to focus on much broader trade issues when he visits India beginning Jan. 25, but the major one of removing roadblocks to foreign investment in local industry is of particular interest to U.S. pharmaceutical companies, with IP protection against generics always at its base.
Harrison Cook, vice president of International Affairs at Eli Lilly ($LLY), based in Washington, DC, told FiercePharma that India is important because of a potential higher bar set on intellectual property in an expected TPP agreement will be the basis for any future trade deals.
"Any country could join the TPP once passed and for India to get any of the benefits of that agreement that would mean acceding to a higher intellectual-property standard," Cook said in a phone interview.
Cook noted that lead negotiators for the 12-nation pact will meet in New York next week in preparation for a likely ministerial-level meeting in February or March that was given added push by Obama's comment in the State of the Union speech to give him authority to negotiate the TPP and a pending Trans-Atlantic Trade and Partnership pact for an up-or-down vote in Congress.
"The Atlantic pact is likely to be up first and if approved gives a lot of momentum for a TPP deal," Cook said. "And there is support in Congress across parties for the trade deals, so I would say prospects are good this year."
Cook particularly noted that the language in the Atlantic trade deal on the issue of 12 years' data exclusivity for biologics shows a more cooperative framework with the understanding that national governments have their own laws.
For India, where Obama will attend the Jan. 26 Republic Day parade in New Delhi, at least one side item on the agenda is expected to cover India's intellectual property rules for drugs and the indirectly related access of its generics companies to the key U.S. market.
The fallout from those talks could have an impact on the strength of Pacific Basin members of the TPP, such as Brunei, Malaysia, Singapore and Vietnam and their neighbor members Australia, Japan and New Zealand in fighting for India-type IP rules governing pharmaceuticals. In addition to the U.S., the other members are Canada, Chile, Mexico and Peru.
Obama's India visit occurs just as Japan and the U.S. completed a two-day bilateral trade discussion, after which Japanese participants felt the Americans were keen to wrap up the TPP talks in the next few months. The United States is concerned that it needs to complete action well ahead of next year's presidential election when Congress would be less likely to approve a deal. Japan also faces major parliamentary elections next year.
Leaked draft intellectual-property texts for the TPP suggest that the data exclusivity period for biologic medicines has been whittled down to 7 years with many countries balking at that length. Under the U.S. Affordable Care Act, biologics enjoy a 12-year data exclusivity period and trade negotiations are under the requirement to broadly follow U.S. laws.
Ironically, a Republican-controlled Congress is considered friendlier to a TPP trade deal than Democrats now in the minority in both houses as U.S. business interests push for greater access to major Asian markets in China and India.
The just-completed round of Japan-U.S. discussions involved nondrug issues, but the internecine nature of multilateral trade discussions often leads to strange bedfellows. Japan, for example, played the role of mediator at one point between the U.S. and the emerging-market members of pharma's IP dispute.
Japan and the U.S. are also pushing for a ministerial-level meeting of the TPP in early March with the hope of reaching a broad agreement. Their negotiators plan their own meeting in New York by the end of this month.
If the TPP talks are completed this year, they are likely to end without consideration of Taiwan's request to join them, according to Washington experts. The interests of the U.S. and other TPP members in having good trade relations with China have just about ensured that will not happen, but there has been talk about adding a second group of TPP members in the near future.
The current TPP members already account for a third of world trade and 40% of global production.