TRIPS Agreement to a large number of U.S. trading partners. Such assistance is provided by a number of U.S. Government agencies, including the U.S. Patent and Trademark Office, the U.S. Copyright Office, the Department of State, the U.S. Agency for International Development, U.S. Customs and Border Protection, the Department of Justice, and the Department of Commerce. This assistance is provided on a country-by-country basis, as well as in group seminars, including those co-sponsored with the World Intellectual Property Organization (WIPO) and the WTO. In addition, U.S. industry is actively involved in providing specific enforcement-oriented training in key markets around the world. Technical assistance involves the review of, and drafting assistance on, laws concerning intellectual property and enforcement. Training programs usually cover the substantive provisions of the TRIPS Agreement, including IPR enforcement. The United States will continue to work with WTO Members and expects further progress in the near term to complete the TRIPS implementation process. However, in those instances in which additional progress is not achieved, the United States will consider other means of encouraging implementation, including the possibility of dispute settlement consultations.
One of the key implementation priorities that we have focused on in this year's review is the implementation of Article 39.3 of the TRIPS Agreement, which requires WTO Members to protect test data submitted by companies to health authorities against "unfair commercial use" for pharmaceutical and agricultural chemical products.[1]
Most countries, including the United States, impose stringent regulatory testing requirements on companies seeking to market a new drug or agricultural chemical product. Many countries have recognized, however, the value of allowing abbreviated approval procedures for "second-comers" seeking to market a product identical to one that has already been approved. Generally, these second applicants may be required to demonstrate the bioequivalence of their products with the product of the first company, and will be allowed to rely on the test data, rather than repeat all of the expensive and laborious clinical tests conducted by the first company to prove the safety of the product.
However, because of the considerable effort involved in producing the safety and efficacy data needed to obtain marketing approval, the TRIPS Agreement requires that the original applicant must receive protection for that data against unfair commercial use. Accordingly, the United States and other countries provide a period of protection during which second-comers may not rely on the data submitted by the innovative company to obtain approval for their copies of the product. This means that, during the period of exclusivity, the data provided by the originator cannot be relied upon by regulatory officials to approve similar products. This period of protection is five years in the United States and six to ten years in the EU Member States. Other countries that provide a period of protection against reliance on data include Australia, China, Japan, Jordan, Korea, Mexico, New Zealand, and Switzerland. We commend Bulgaria on its recent implementation of data protection for pharmaceutical and agricultural chemical products. We urge all WTO members to swiftly complete their implementation of TRIPS Article 39.3, including certain Andean countries, Israel and Turkey.
- ↑ Such data is typically required by health authorities in order to establish the safety and efficacy of a drug, and to obtain government approval to market the drug.
