96-17242. Initiation of Section 302 Investigation and Request for Public Comment: Practices of the Government of India Regarding Patent Protection for Pharmaceuticals and Agricultural Chemicals  

  • [Federal Register Volume 61, Number 131 (Monday, July 8, 1996)]
    [Notices]
    [Pages 35857-35858]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-17242]
    
    
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    OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE
    
    [Docket No. 301-106]
    
    
    Initiation of Section 302 Investigation and Request for Public 
    Comment: Practices of the Government of India Regarding Patent 
    Protection for Pharmaceuticals and Agricultural Chemicals
    
    AGENCY: Office of the United States Trade Representative.
    
    ACTION: Notice of initiation of investigation; request for written 
    comments.
    
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    SUMMARY: The United States Trade Representative (USTR) has initiated an 
    investigation under section 302(b)(1) of the Trade Act of 1974, as 
    amended (the Trade Act ) (19 U.S.C. 2412(b)(1)), with respect to 
    certain acts, policies and practices of the Government of India that 
    may result in the denial of patents and exclusive marketing rights to 
    U.S. individuals and firms involved in the development of innovative 
    pharmaceutical and agricultural chemicals products. The United States 
    alleges that these acts, policies and practices are inconsistent with 
    the Agreement on Trade-Related Aspects of Intellectual Property Rights 
    (TRIPs Agreement), administered by the World Trade Organization (WTO). 
    USTR
    
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    invites written comments from the public on the matters being 
    investigated.
    
    DATES: This investigation was initiated on July 2, 1996. Written 
    comments from the public are due on or before noon on Monday, August 
    12, 1996.
    
    ADDRESSES: Office of the United States Trade Representative, 600 17th 
    Street, N.W., Washington, DC 20508.
    
    FOR FURTHER INFORMATION CONTACT: Joseph Papovich, Deputy Assistant USTR 
    for Intellectual Property, (202) 395-6864, or Thomas Robertson, 
    Assistant General Counsel, (202) 395-6800.
    
    SUPPLEMENTARY INFORMATION: Section 302(b)(1) of the Trade Act 
    authorizes the USTR to initiate an investigation under chapter 1 of 
    Title III of the Trade Act (commonly referred to as ```section 301'') 
    with respect to any matter in order to determine whether the matter is 
    actionable under section 301. Matters actionable under section 301 
    include, inter alia, the denial of rights of the United States under a 
    trade agreement, or acts, policies, and practices of a foreign country 
    that violate or are inconsistent with the provisions of, or otherwise 
    deny benefits to the United States under, any trade agreement.
        On July 2, 1996, having consulted with the appropriate private 
    sector advisory committees, the USTR determined that an investigation 
    should be initiated to determined whether certain laws and regulations 
    of India affecting the grant of patents and exclusive marketing rights 
    in innovative pharmaceutical and agricultural chemical products are 
    actionable under section 301(a). Article 70 of the TRIPs Agreement 
    requires all countries that do not provide product patent protection 
    for pharmaceuticals and agricultural chemicals on January 1, 1995, to 
    establish by that time a means by which applications for patents for 
    such inventions can be filed, which is commonly referred to as a 
    ``mailbox.'' These applications are to be reviewed when such protection 
    is ultimately provided in accordance with the transitional provisions 
    of the TRIPs Agreement. This provisions allows ``mailbox'' applicants 
    to preserve their original filing date for the purposes of novelty and 
    nonobviousness considerations in patentability determinations. Article 
    70 of the TRIPs Agreement also requires those WTO members delaying the 
    grant of pharmaceutical and agricultural chemical product patent 
    protection to grant ``mailbox'' applications up to five years of 
    marketing exclusivity if such applicants are granted a patent and 
    marketing approval in another WTO member and marketing approval in the 
    member providing marketing exclusivity. India has not yet established a 
    permanent formal ``mailbox'' system for the filing of pharmaceutical 
    and agricultural chemical product patent applications, nor has it 
    established a system for the grant of exclusive marketing rights. The 
    Indian Government did attempt to establish such systems in early 1995 
    (although the marketing exclusively system appeared flawed), but the 
    Indian legislature failed to act in the area and they expired. United 
    States Government officials have repeatedly raised this issue with 
    their Indian counterparts, but have received no satisfactory response. 
    Indian's failure to establish such systems permanently in a way that 
    gives legal assurances to the parties that file ``mailbox'' 
    applications would appear to be inconsistent with the obligations set 
    forth in Article 70 of the TRIPs Agreement.
    
    Investigation and Consultations
    
        As required in section 303(a) of the Trade Act, the USTR has 
    requested consultations with the Government of India regarding the 
    issues under investigation. The request was made pursuant to Article 4 
    of the WTO Understanding on Rules and Procedures Governing the 
    Settlement of Disputes (DSU) and Article 64 of the TRIPs Agreement (to 
    the extent in incorporates by reference Article XXII of the General 
    Agreements on Tariff and Trade 1994). If the consultations do not 
    result in a satisfactory resolution of the matter, the USTR will 
    request the establishment of a panel pursuant to Article 6 of the DSU.
        Under section 304 of the Trade Act, the USTR must determine within 
    18 months after the date on which this investigation was initiated, or 
    within 30 days after the conclusion of WTO dispute settlement 
    procedures, whichever is earlier, whether any act, policy, or practice 
    or denial of trade agreement rights described in section 301 of the 
    Trade Act exists and, if that determination is affirmative, the USTR 
    must determine what action, if any, to take under section 301 of the 
    Trade Act.
    
    Public Comment: Requirements for Submissions
    
        Interested persons are invited to submit written comments 
    concerning the acts, policies and practices of India which are the 
    subject of this investigation, the amount of burden or restriction on 
    U.S. commerce cause by these acts, policies and practices, and the 
    determinations required under section 304 of the Trade Act. Comments 
    must be filed in accordance with the requirements set forth in 15 CFR 
    2006.8(b) (55 FR 20593) and must be filed on or before noon on Monday, 
    August 12, 1996. Comments must be in English and provided in twenty 
    copies to: Sybia Harrison, Staff Assistant to the Section 301 
    Committee, Room 223, Office of the U.S. Trade Representative, 600 17th 
    Street, NW, Washington, D.C. 20508.
        Comments will be placed in a file (Docket 301-106) open to public 
    inspection pursuant to 15 CFR 2006.13, except confidential business 
    information exempt from public inspection in accordance with 15 CFR 
    2006.15. Confidential business information submitted in accordance with 
    15 CFR 2006.15 must be clearly marked ``BUSINESS CONFIDENTIAL'' in a 
    contrasting color ink at the top of each page on each of 20 copies, and 
    must be accompanied by a nonconfidential summary of the confidential 
    information. The nonconfidential summary shall be placed in the file 
    that is open to public inspection. An appointment to review the docket 
    (Docket No. 301-106) may be made by calling Brenda Webb (202) 395-6186. 
    The USTR Reading Room is open to the public from 10:00 a.m. to 12 noon 
    and 1:00 p.m. to 4:00 p.m., Monday through Friday, and is located in 
    Room 101.
    Irving A. Williamson,
    Chairman, Section 301 Committee.
    [FR Doc. 96-17242 Filed 7-5-96; 8:45 am]
    BILLING CODE 3190-01-M
    
    
    

Document Information

Published:
07/08/1996
Department:
Trade Representative, Office of United States
Entry Type:
Notice
Action:
Notice of initiation of investigation; request for written comments.
Document Number:
96-17242
Dates:
This investigation was initiated on July 2, 1996. Written comments from the public are due on or before noon on Monday, August 12, 1996.
Pages:
35857-35858 (2 pages)
Docket Numbers:
Docket No. 301-106
PDF File:
96-17242.pdf