Stakeholder Input Sharpens, Focuses U.S. Work on Pharmaceutical IPR in the TPP

In the Trans-Pacific Partnership the United States is working to do something new and important when it comes to medicines in the TPP region: striking the right balance to make life-saving medicine more widely available while creating incentives for the development of new treatments and cures. 

USTR’s public engagement process – sharing information and integrating feedback into our negotiating positions –helps us in our efforts to pursue the strongest possible outcomes in the 12-country Trans-Pacific Partnership. This week we have another example of how our interactions with Congress and stakeholders has informed our thinking and helped us refine what we’re trying to do in the TPP. 

In October of 2011, the United States publicly announced an initial proposal regarding intellectual property rights related to pharmaceuticals, particularly access to innovative and generic medicines in the Asia-Pacific region. We got a wide range of feedback on this proposal and other pharmaceutical IPR issues – from access to medicines (particularly in developing countries) to the array of options for the term of patent protection for research-intensive, leading-edge biologic medicines. 

In response to that input, we began talking with our trading partners in recent months about a new set of ideas that would give more weight to concerns of developing countries. While intellectual property issues – particularly with regard to pharmaceuticals – are some of the toughest items to negotiate, we hope these ideas willlead us to a sound solution amenable to all partners in the TPP talks. During last week’s meetings in Salt Lake City, we listened to helpful, in-depth feedback from our TPP partners on these ideas. 

Access to Medicines 

The United States is a leading voice both for strong IPR protections and for access to medicines for the world’s poor, including in developing country TPP partners. We believe the best approach to pharmaceutical IPR issues in the TPP would be one that offers countries flexibility based on their individual circumstances. That’s why we’ve begun to work with TPP partners to gauge their interest in a “differential approach,” and to identify ways to tailor potential flexibilities based on countries’ existing laws and international obligations. 

This flexible approach is based on precedent: Previous U.S. trade agreements covered by the May 10, 2007 bipartisan agreement. Under May 10, developing free trade agreement partners (like Peru) were offered greater flexibility relative to more developed trade agreement partners (like Korea). In TPP, we are seeking to pursue a similar idea, using previous agreements – like those with Peru, Australia, Chile, Korea, and Singapore – as benchmarks, but keeping an open mind as to how these standards can be tailored to reflect the situations of individual partners. 

Biologic Medicines 

One critical area of innovation that’s responsible for U.S. jobs and innovation is biologic medicines. These new drugs offer great potential for new treatments and cures that will benefit all of humankind and the United States is doing its part to ensure that the incentives will be there not just to increase the availability of existing drugs but to ensure that there is a strong pipeline of new medicines. 

Biologic drugs need data protection because those drugs require enormous amounts of time and money to develop. Before entrepreneurs (in the United States and across the world) are willing to make the investment in new therapies, they want to know that they will have rights to their own research for a certain period of time in order to see a return on their investments. 

In the TPP negotiations, opinions vary on the best term of patent protection for biologics. Standards also vary across the TPP region. Some TPP countries currently have no data protection for biologic drugs. Some have 5 years. Others have 8. Traditionally, the U.S. approach to trade negotiations has been to base proposals on existing U.S. law, where the current standard is 12 years. 

Patent Opposition 

Reflecting input from stakeholders, the U.S. now supports a more flexible approach under which partners could retain reasonable patent pre-grant opposition procedures. These procedures, available in some countries, allow third parties to formally object to a patent at the initial application phase. Based on stakeholder input and ongoing discussions with TPP countries, we believe that other elements in TPP will meet the larger goals of ensuring that patents are of high quality and provide appropriate incentives for innovation, while ensuring access to medicines. 

What’s Next

Informed by ongoing discussions with Congress and stakeholders from across the public and private sector, U.S. negotiators will work with counterparts from the other TPP countries to reach a 12-country agreement on how the final TPP should tailor pharmaceutical IPR protection to reflect the situations of individual countries and address the term of data protection for biologics.