[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

[[Page 35858]]

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