President-Elect Donald Trump has announced that he will withdraw the United States from the Trans-Pacific Partnership (TPP) agreement on his first day in office. So ends more than five years of often heated negotiations led by President Barack Obama’s administration as part of an overall strategy to strengthen the US position in the Pacific Rim region.
As in any international trade agreement, intellectual property rights (IPR) were a central theme in the TPP. After all, IPRs are granted and enforced at the national level. International trade in knowledge products can only be promoted if there is IPR coordination across the countries entering into the agreement.
IPR issues were negotiated passionately during the drafting of the agreement and were the subject of some of the loudest opposition to the TPP. Although the TPP agreement itself is under the gun, the IPR issues raised and contested will continue to play a prominent role in the bilateral or multilateral trade agreements that will be negotiated in its place.
First of all, the 5Ws of the TPP
Who: 12 Pacific Rim countries (in alphabetical order): Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, USA, Vietnam. Note the conspicuous absence of China.
What: A mega-regional trade agreement that removes or reduces tariff barriers and harmonizes key commercial practices in order to promote a free yet safe flow of goods among the member countries.
When and Where: After five years of highly secretive negotiations, the TPP was finalized in Atlanta, Georgia on October 5, 2015 and signed on February 4, 2016 in Auckland, New Zealand – subject to ratification by the signatory countries within 24 months.
Why: According to the Office of the United States Trade Representative (USTR), the TPP is meant to “promote economic growth; support the creation and retention of jobs; enhance innovation, productivity and competitiveness; raise living standards; reduce poverty in our countries; and promote transparency, good governance, and enhanced labor and environmental protections.”
The TPP IP innovations
In general, the IPR-related TPP clauses are based on existing international IPR standards such as TRIPS (WTO agreement on Trade-Related Aspects of Intellectual Property Rights), WIPO and PCT. However, the US negotiators in particular were seeking to significantlystrengthen and broaden the protection for patents, trademarks, copyrights and trade secrets – including rights on digital media and pharmaceutical products. While not all of the US provisions were accepted, former World Bank Director of Economic Policy and Debt Carlos Braga provides an excellent summary of the noteworthy measures that did make it into the agreement:
- Extended trademark terms of protection
- A minimum copyright term of protection of at least 70 years (TRIPS’ minimum standard is 50 years)
- Stronger copyright enforcement, including the possibility of criminal prosecution and the requirement that TPP countries be signatories of WIPO Internet treaties
- Requirement to put in place enforceable legal means for the protection of trade secrets
- Protection of test data submitted for marketing approvals (at least 10 years for agricultural chemicals and 5 to 8 years for pharmaceuticals)
- Explicit protections for new pharmaceutical products that are or contain a biologic (the TPP is the first trade agreement to do this)
The test data exclusivity debate
As noted above, TPP granted 5 to 8 years of test data protection for pharmaceutical products. This clause was one of the most hotly contested issues during the TPP negotiations and, when publicized, aroused tremendous criticism from both the US pharma industry and from medical rights activists.
The US grants 12 years of test data exclusivity to pharmaceutical products and the US negotiators wanted the TPP negotiating partners to align themselves with this policy. In Atlanta, however, they had to compromise on the shorter term or the agreement would not have been finalized.
BIO President and CEO Jim Greenwood spoke for the industry when he st