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United States Cites Its Leadership at WTO on Patent Issues

USTR releases fact sheets ahead of WTO Hong Kong ministerial meeting

The Office of the U.S. Trade Representative (USTR) issued fact sheets December 9 on issues related to protecting intellectual property in trade, ahead of the December 13-18 World Trade Organization (WTO) ministerial meeting in Hong Kong.

For additional information, see WTO Hong Kong Ministerial Meeting.

Following are the USTR fact sheets:

(begin fact sheet)

Facts on the Doha Round

Office of the United States Trade Representative
Doha Development Agenda Policy Brief -- December 2005

United States Leadership in Providing Access to Medicines

The United States has been a leader in efforts to harness international trade rules to help countries gain access to life-saving drugs and successfully fight pandemics such as HIV/AIDS.

-- In February 2001, the Bush Administration expressed its commitment to formulating and applying trade rules flexibly in order to be sensitive to health crises and protective of intellectual property rights. The Administration has stated that it supports efforts by WTO Members to avail themselves of the flexibility afforded by the TRIPS [Trade-Related Aspects of Intellectual Property] Agreement to address major health crises, such as the HIV/AIDS crisis in sub-Saharan Africa and elsewhere.

-- In November 2001, the United States provided critical leadership in developing support for a separate, landmark political declaration on public health and international trade rules. This declaration helped pave the way for a successful conclusion of the Doha Ministerial.

-- In December 2002, the United States announced a unilateral moratorium on the enforcement of TRIPS rules to allow countries to export drugs under compulsory license to those in need. That is, the United States announced that it would voluntarily waive its right under dispute settlement to allow countries to export drugs under compulsory license, even before formal agreement on an amendment or waiver had been reached in the WTO.

-- The United States was instrumental in creating a consensus to reach the August 2003 agreement on a mechanism to allow drugs to be exported under compulsory license.

-- The United States played a vital role in reaching an agreement on December 6, 2005, to make the August 2003 mechanism a permanent part of the TRIPS Agreement.

The United States is a leader in the global fight against HIV/AIDS and other infectious diseases. The President’s Emergency Plan for AIDS Relief (PEPFAR) is the largest commitment ever by a nation toward an international health initiative for a single disease. PEPFAR is a five-year, $15 billion, multifaceted approach to combating the disease in more than 100 countries around the world.

We are pleased that several U.S. pharmaceutical companies have formed partnerships with African countries and are working together to address many of the problems related to providing treatment to those in need. This includes the sale of critical medicines at very low prices, as well as the building of an improved infrastructure for getting these medicines to those in need.

Finally, we are reaching out to the public health and health care communities to ensure that their views are formally represented on our trade advisory committees where significant trade and health issues may arise. Specifically we are seeking, through a Federal Register Notice that we expect to be published this week, qualified applicants from the public health and health care communities to serve on the Industry Trade Advisory Committee on Chemicals, Pharmaceuticals, Health Science Products and Services (ITAC-3) and the Industry Trade Advisory Committee on Intellectual Property (ITAC-15). Earlier, we invited representatives of the generic pharmaceutical industry to join those committees. We look forward to the advice of these representatives.

(end fact sheet)

(begin fact sheet)

Facts on Global Reform

Office of the United States Trade Representative
Doha Development Agenda Policy Brief -- December 2005

Contract-Based Systems Provide Better Protection for Biological Diversity

CBD Negotiations in the WTO

Some countries believe that the patent provisions of the Agreement on Trade Related Aspects of Intellectual Property Agreement (TRIPS Agreement) need to be amended to implement the Convention on Biological Diversity (CBD). The CBD is an international treaty that addresses many aspects of biological diversity, including rules on how a country's genetic resources should be used. An example of a genetic resource is a plant.

U.S. Position

The United States is a biodiverse country with many genetic resources requiring protection. These resources are protected outside of the patent system through contracts between the provider of the resource and the user of the resource.

There is no conflict between the TRIPS Agreement and the CBD and therefore no need to amend the TRIPS Agreement to protect genetic resources. TRIPS and the CBD can be implemented in a mutually supportive manner.

Benefits

Contract-based systems provide many advantages for protecting access to and use of genetic resources or traditional knowledge of indigenous populations, many of which would not be available in a patent system. For example, contracts provide a mechanism to properly obtain genetic resources or traditional knowledge from the provider for research and permit benefit sharing arrangements between the provider of the resource and the user of that resource.

Contracts can also include research reporting requirements, rules on how to transfer, store or use the genetic resources or traditional knowledge, and set out clear ways to resolve any future disputes that may arise between the provider and user.

By contrast, the patent system is an ill fit. The patent system cannot ensure authorized access to genetic resources and equitable sharing of their benefits. Contracts can be precisely tailored to accomplish these goals. In addition, amending the patent system would introduce uncertainty that could discourage innovation and undermine any eventual benefit sharing.

(end fact sheet)

(begin fact sheet)

Facts on Global Reform

Office of the United States Trade Representative www.ustr.gov
Doha Development Agenda Policy Brief -- December 2005

Protecting Geographical Indications for Wine and Spirits

Geographical indications are place names (in some countries also words associated with a place) used to identify products with particular characteristics because they come from specific places. There are currently negotiations in the WTO on a register for wine and spirits, and two issues outside of these negotiations being discussed primarily by the European Union.

WTO Negotiations: A register for wine and spirits

The WTO is negotiating a system that will be used to notify and register geographical indications for wines and spirits.

U.S. position: The United States supports a voluntary system that helps Members make decisions on protecting geographical indications for wines and spirits but does not introduce new obligations. We oppose proposals to establish a legally binding register for all WTO members. This is because we are concerned that it could force countries to grant protection to products that are not entitled to protection.

Benefits: The U.S. proposal will facilitate protection without creating unnecessary new legal obligations. We want to avoid creating a complicated burdensome system that will be expensive for all Members, including developing country members to implement. We want to protect the trademark rights of U.S. producers, and producers in developing countries.

Issue #1: Extending the “higher level of protection” to new products

The Agreement on Trade-Related Aspects of Intellectual Property (TRIPS Agreement) provides a higher level of protection to geographical indications for wines and spirits than for other products. The European Union is seeking to start negotiations to “extend” additional protections to products other than wine and spirits.

U.S. position: The TRIPS Agreement already requires that all geographical indications be protected against any misleading use. The U.S., along with other countries, including many developing countries, opposes starting negotiations to amend the TRIPS Agreement to extend the special protections to additional products beyond wines and spirits.

Benefits: The United States is committed to avoiding unnecessary new obligations for geographical indications protection, for three reasons:

1. New levels of protection will be expensive to implement, especially for developing countries.

2. Extending protection to products other than wine and spirits is messy. The trade of food, for example, is nearly impossible to originate, and recent disputes over “feta” in the European Union prove the litigation that lies ahead of this path.

3. There is no evidence of harm from the lack of geographical indications protection in any area other than wine and spirits. Protection, on the other hand, would result in billions of dollars of charges to producers around the world forced to re-label and re-market products that have been sold to consumers under a particular name for decades.

Issue #2: “Clawback” protection

In the Agriculture negotiations, the European Union has submitted a proposal to “clawback” protection for certain names that have become generic outside of Europe, including parmesan, chablis, port, sherry and feta. The effect of the proposal is that the names, many of which are in wide-spread use in the U.S. and elsewhere as generic descriptive terms, could no longer be used, except by Europeans.

U.S. position: The United States opposes this effort.

Benefits: The United States and other countries around the world have a legitimate right to use generic names, and this proposal is clearly outside of the scope of the WTO mandate to negotiate a system that will be used to notify and register geographical indications for wines and spirits. This proposal would eliminate existing trademarks, lead to global consumer confusion, and eliminate the ability of all Members outside of the EU to produce a wide range of high-quality products.

(end fact sheet)

(Distributed by the Bureau of International Information Programs, U.S. Department of State. Web site: http://usinfo.state.gov)