97-16129. Pakistan: Conclusion of WTO Dispute Settlement Proceeding Regarding Patent Protection for Pharmaceuticals and Agricultural Chemicals  

  • [Federal Register Volume 62, Number 119 (Friday, June 20, 1997)]
    [Notices]
    [Pages 33695-33696]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-16129]
    
    
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    OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE
    
    
    Pakistan: Conclusion of WTO Dispute Settlement Proceeding 
    Regarding Patent Protection for Pharmaceuticals and Agricultural 
    Chemicals
    
    AGENCY: Office of the United States Trade Representative.
    
    ACTION: Notice of termination and monitoring.
    
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    SUMMARY: On April 30, 1996, the United States Trade Representative 
    initiated an investigation under section 302(b)(1) of the Trade Act of 
    1974 regarding the inadequate patent protection provided by the 
    Government of Pakistan to United States individuals and firms involved 
    in the development of innovative pharmaceutical and agricultural 
    chemical products, in light of Pakistan's obligations under the World 
    Trade Organization (WTO) Agreement on Trade-Related Aspects of 
    Intellectual Property Rights (TRIPS). Following consultations between 
    the United States and Pakistan, Pakistan issued Ordinance No. XXVI of 
    1997, establishing the framework for a filing system for patent 
    applications drawn to such products and for the grant of exclusive 
    marketing rights under certain circumstances. On February 28, 1997, the 
    United States and Pakistan jointly notified the WTO Dispute Settlement 
    Body (DSB) of the settlement of this matter in light of Pakistan's 
    planned implementation of Ordinance No. XXVI. Having reached a 
    satisfactory resolution of the issues under investigation, the USTR has 
    terminated this section 302 investigation and will monitor 
    implementation of the agreement under section 306 of the Trade Act.
    
    EFFECTIVE DATES: This investigation was terminated on June 9, 1997.
    
    ADDRESSES: Office of the U.S. Trade Representative, 600 17th Street 
    NW., Washington, DC 20508.
    
    FOR FURTHER INFORMATION CONTACT:
    Thomas Robertson, Associate General Counsel, Office of the United 
    States Trade Representative (202) 395-6800.
    
    SUPPLEMENTARY INFORMATION: On April 30, 1996, the United States Trade 
    Representative (USTR) initiated an investigation under section 
    302(b)(1) of the Trade Act of 1974 (Trade Act) regarding the inadequate 
    patent protection provided by the Government of Pakistan to United 
    States individuals and firms involved in the development of innovative 
    pharmaceutical and agricultural chemical products. 61 FR 19971 (May 3, 
    1996). The investigation specifically considered whether Pakistan 
    failed to meet its TRIPS Agreement obligations by failing either to 
    provide patent protection for pharmaceutical and agricultural chemical 
    inventions as specified in Article 27, or to establish systems for the 
    acceptance of applications for patents on such inventions and the grant 
    of exclusive marketing rights in accordance with Article 70.8 and 70.9. 
    See 61 FR 19771 for further details. Pursuant to section 303(a) of the 
    Trade Act, the USTR requested consultations with the Government of 
    Pakistan under the procedures of the WTO Understanding on Rules and 
    Procedures Governing the Settlement of Disputes (DSU) and Article 64 of 
    the TRIPS Agreement.
    
    Resolution of Dispute
    
        After consultation between the Governments of the United States of 
    America and Pakistan in accordance with DSU procedures, Pakistan 
    formally agreed to the United States' interpretation that Pakistan is 
    required to establish mailbox and exclusive marketing rights systems 
    under the TRIPS Agreement. On February 4, 1997, Pakistan President 
    Farooq Ahmad Khan Leghari issued Ordinance No. XXVI of 1997, to 
    establish these systems. In a February 28, 1997, notification to the 
    WTO DSB, the United States and Pakistan notified the WTO that Pakistan 
    would implement the ordinance in accordance with the TRIPS Agreement.
        Under the Ordinance, Pakistan will implement regulations which 
    establish a system by which WTO Members' nationals can file with 
    Pakistan's patent authorities a product patent application for a 
    pharmaceutical or agricultural chemical product invention until January 
    1, 2000, preserving as the filing date the date the application was 
    received by the authorities. After January 1, 2000, Pakistan will 
    implement the priority filing benefits provisions in Article 4 of the 
    Paris Convention on the Protection of Industrial Property, thus 
    allowing Members nationals who file patent applications with Pakistan's 
    patent authorities to claim up to one year priority. Those Members' 
    nationals who would have submitted applications between January 1, 
    1995, and the date the Ordinance issued, but were unable to do so 
    because Pakistan had no ``mailbox'' filing system in place, will be 
    able to file such applications for one year after the date the 
    ordinance was issued, and will receive the filing date of the original 
    application filed in another WTO Member.
        In addition, the Ordinance provides that exclusive marketing rights 
    will be granted if the applicant has been granted a patent and 
    marketing approval on the product that is subject of the application in 
    another WTO Member and the applicant is granted marketing approval in 
    Pakistan. The period of marketing approval shall be for a period of 
    five years after these conditions are met or until a product patent is 
    granted or rejected in Pakistan, whichever term is shorter. In 
    accordance with the Article 70.9 requirement that such marketing right 
    be ``exclusive,'' the Government of Pakistan will implement the 
    Ordinance so that under no circumstances will exclusive marketing 
    rights be subject to any limitation or exception, including the 
    imposition of a compulsory license. No party may be granted marketing 
    approval for a product that is the subject of exclusive marketing 
    rights without the express consent of the holder for such exclusive 
    marketing rights.
        Based on the developments of the formal consultations and the 
    measures Pakistan has undertaken to implement its obligations under the 
    TRIPS Agreement, the United States and Pakistan jointly notified the 
    WTO DSB that they have reached a mutually satisfactory solution to the 
    matter, and that the United States has formerly withdrawn this matter 
    from further consideration by the DSB. On the basis of the measures 
    Pakistan has undertaken to provide a satisfactory resolution to the 
    matter under investigation, the USTR has decided to terminate this 
    section 302 investigation. Pursuant to section 306 of the Trade Act, 
    the USTR will monitor Pakistan's implementation of its TRIPS Agreement 
    obligations in accordance with the Ordinance and the
    
    [[Page 33696]]
    
    terms of the U.S.-Pakistan joint notifications to the DSB.
    Irving Williamson,
    Chairman, Section 301 Committee.
    [FR Doc. 97-16129 Filed 6-19-97; 8:45 am]
    BILLING CODE 3190-01-M
    
    
    

Document Information

Published:
06/20/1997
Department:
Trade Representative, Office of United States
Entry Type:
Notice
Action:
Notice of termination and monitoring.
Document Number:
97-16129
Dates:
This investigation was terminated on June 9, 1997.
Pages:
33695-33696 (2 pages)
PDF File:
97-16129.pdf