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Overview of the State-of-play of WTO Disputes





http://www.wto.org/wto/dispute/bulletin.htm#_Toc468170750



Overview of the State-of-play of WTO Disputes

                                         



I.Implementation Status of Adopted Reports 



(8) India - Patent Protection for Pharmaceutical and Agricultural
Chemical Products, complaint by the United States (WT/DS50). The period
of implementation was agreed by the parties to be 15 months from the
date of the adoption of the reports i.e. it expires on 16 April 1999.
India has undertaken to comply with the recommendations of the DSB
within the implementation period. At the DSB meeting on 28 April 1999,
India presented its final status report on implementation of this matter
which disclosed the enactment of the relevant legislation to implement
the recommendations and rulings of the DSB.


(15) India - Patent Protection for Pharmaceutical and Agricultural
Chemical Products, complaint by the European Communities (WT/DS79/1).
India indicated at the DSB meeting of 21 October 1998, that it needed a
reasonable period of time to comply with the DSB recommendations and
that it intended to have bilateral consultations with the EC to agree on
a mutually acceptable period of time. At the DSB meeting on 25 November
1998, India read out a joint statement done with the EC, in which it was
agreed that the implementation period in this dispute would correspond
to the implementation period in a similar dispute brought by the US
(DS50). At the DSB meeting on 28 April 1999, India presented its final
status report on implementation of DS50, which report also applies to
implementation in this dispute. The report disclosed the enactment of
the relevant legislation to implement the recommendations and rulings of
the DSB. 

VI.Active Panels 

(4) Canada - Patent Protection of Pharmaceutical Products, complaint by
the European Communities (WT/DS114/1). This request, dated 19 December
1997, is in respect of the alleged lack of protection of inventions by
Canada in the area of pharmaceuticals under the relevant provisions of
the Canadian implementing legislation (in particular the Patent Act).
The EC contends that Canada's legislation is not compatible with its
obligations under the TRIPS Agreement, because it does not provide for
the full protection of patented pharmaceutical inventions for the entire
duration of the term of protection envisaged by Articles 27.1, 28 and 33
of the TRIPS Agreement. On 11 November 1998 the EC requested the
establishment of a
panel. At its meeting on 1 February 1999, the DSB established a panel.
Australia, Brazil, Cuba, India, Israel, Japan, Poland, Switzerland, and
the United States reserved their third-party rights.

(19) Canada - Patent Protection Term, complaint by the United States
(WT/DS170/1). This request, dated 6 May 1999, is in respect of the grant
of patent term in Canada. The United States contends that the TRIPS
Agreement obligates Members to grant a term of protection for patents
that runs at least until twenty years after the filing date of the
underlying protection, and requires each Member to grant this minimum
term to all patents existing as  of the date of the application of the
Agreement to that Member. The United States alleges that under the
Canadian Patent Act, the term granted to patents issued on the basis of
applications filed before 1 October 1989 is 17 years from the date on
which the patent is issued. The United States contends that this
situation is inconsistent with Articles 33, 65 and 70 of the TRIPS
Agreement. On 15 July 1999, the United States requested the
establishment of a panel. At its meeting on 22 September 1999, the DSB
established a panel. 

VII.Pending Consultations (most recent listed first) 


(55) Argentina - Patent Protection for Pharmaceuticals and Test Data
Protection for Agricultural Chemicals, complaint by the United States
(WT/DS171/1). This request, dated 6 May 1999, is in respect of (i) the
alleged absence in Argentina of either patent protection for
pharmaceutical products or an effective system for providing exclusive
marketing rights in such products, and (ii) Argentina's alleged failure
to ensure that changes in its laws, regulations and practice during the
transition period provided under Article 65.2 of the TRIPS Agreement do
not result in a lesser degree of consistency with the provisions of the
TRIPS Agreement. Under the first limb, the United States contends that
the TRIPS Agreement does not permit WTO Members to allow third parties
to market products subject to exclusive marketing rights without the
consent of the right holder. According to the United States, Argentina's
law does not provide product patent protection for pharmaceutical
inventions, or a system that conforms to Article 70.9 of the TRIPS
Agreement with regard to the grant of exclusive marketing rights. The
United States therefore contends that Argentina's legal regime appears
to be inconsistent with Articles 27, 65 and 70 of the TRIPS Agreement.
Under the second limb, the United States contends that prior to August
1998, Argentina provided a ten year term of protection against unfair
commercial use for undisclosed test data or other data submitted to
Argentine regulatory authorities in support of applications for
marketing approval for agricultural chemical products. The United States
further contends that since  the issuance in 1998 of Regulation 440/98,
which inter alia revoked earlier regulations, Argentina has provided no
effective protection for such data against unfair commercial use. The
United States therefore alleges that Argentina's legal regime is
inconsistent with Article 65.5 of the TRIPS Agreement.

(54) South Africa - Anti-dumping Duties on the Import of Certain
Pharmaceutical Products from India, complaint by India (WT/DS168/1).
This request, dated 1 April 1999, is in respect of a recommendation for
the imposition of definitive anti-dumping duties by the South African
Board on Tariffs and Trade (BTT), contained in its Report No. 3799,
dated 3 October 1997, on the import of certain pharmaceutical products
from India. India alleges that       South Africa initiated anti-dumping
proceedings against the importation of ampicillin and amoxycillin of
250mg capsules from India. The BTT allegedly made a preliminary
determination on 26 March 1997 that ampicillin and amoxycillin of 250mg
and 500mg capsules, exported by M/S Randaxy Laboratories Ltd of India,
were being dumped into the South African Customs Union (SACU). This was
allegedly followed by a recommendation to impose final duties on these
products by the BTT, which was reported on 10 September 1997. India
contends that the definition and calculation by the BTT of normal value
is inconsistent with South Africa's WTO obligations, because erroneous
methodology was used for determining the normal value     and the
resulting margin of dumping. India further contends that the
determination of injury was not based on positive evidence and did not
include an evaluation of all relevant economic factors and indices
having a bearing on the state of the industry, which led to an erroneous
determination of material injury suffered by the petitioner. India is
also of the view that the South African authorities' establishment of
the facts was not proper and that
their evaluation was not unbiased or objective. India also claims that
the South African authorities have not taken into account India's
special situation as a developing country. India alleges violations of
Articles 2, 3, 6(a) to(c) individually and in conjunction with 12, 12
and 15 of the Anti-Dumping Agreement; and Articles I and VI of GATT
1994.

(48) European Communities - Patent Protection for Pharmaceutical and
Agricultural Products, complaint by Canada (WT/DS153/1). This dispute,
dated 2 December 1998, is in respect of the protection of inventions in
the area of pharmaceutical and agricultural chemical products under the
relevant provisions of EC legislation, particularly Council Regulation
(EEC) No. 1768/92 and European Parliament and Council Regulation (EC)
No. 1610/96, in relation to EC obligations under the TRIPS Agreement.
Canada contends that under the above Regulations, a patent term
extension scheme, which is limited to pharmaceutical and agricultural
chemical products, has been implemented. Canada alleges that Regulations
(EEC) No. 1768/92 and (EC) No. 1610/96 are inconsistent with the EC's
obligations not to discriminate on the basis of field of technology, as
provided by Article 27.1 of the TRIPS Agreement, because these
Regulations only apply to pharmaceutical and agricultural products.

VIII.Completed Cases (most recent listed first) 
           A.Appellate and Panel Reports Adopted before 1 January 1999 

(18) India - Patent Protection for Pharmaceutical and Agricultural
Chemical Products, complaint by the European Communities (WT/DS79/1). 
This request, dated 28 April 1997, is in respect of the alleged absence
in India of patent protection for pharmaceutical and agricultural
chemical products, and the absence of formal systems that permit the
filing of patent applications of and provide exclusive marketing rights
for such products. The EC contends that this is inconsistent with
India's obligations under Article 70, paragraphs 8 and 9, of the TRIPS
Agreement (see similar US complaint in DS50, where the Panel and
Appellate Body reports were adopted on 16 January 1998). On 9 September
1997, the EC requested the establishment of a panel. At its meeting on
16 October 1997, the DSB established a panel. The US reserved its
third-party rights. The Panel found that India has not complied with its
obligations under Article 70.8(a) of the TRIPS Agreement by failing to
establish a legal basis that adequately preserves novelty and priority
in respect of applications for product patents for pharmaceutical and
agricultural chemical inventions, and was also not in compliance with
Article 70.9 of the TRIPS Agreement by failing to establish a system for
the grant of exclusive marketing rights. The report of the Panel was
circulated to Members on 24 August 1998. At its meeting on 2 September
1998, the DSB adopted the Panel Report.

(8) India - Patent Protection for Pharmaceutical and Agricultural
Chemical Products, complaint by the United States (WT/DS50). This
request, dated 2 July 1996, concerns the alleged absence of patent
protection for pharmaceutical and agricultural chemical products in
India.  Violations of the TRIPS Agreement Articles 27, 65 and 70 are
claimed. The United States requested the establishment of a panel on 7
November 1996. The DSB established a panel at its meeting on 20 November
1996. The Panel found that India has not complied with its obligations
under Article 70.8(a) or Article 63(1) and (2) of the TRIPS Agreement by
failing to establish a mechanism that adequately preserves novelty and
priority in respect of applications for product patents for
pharmaceutical and agricultural chemical inventions, and was also not in
compliance with Article 70.9 of the TRIPS Agreement by failing to
establish a system for the grant of exclusive marketing rights. The
report of the Panel was circulated on 5 September 1997. On 15 October
1997, India notified its intention to appeal certain issues of law and
legal interpretations developed by the Panel. The Appellate Body upheld,
with modifications, the Panel's findings on Articles 70.8 and 70.9, but
ruled that Article 63(1) was not within the Panel's terms of reference.
The report of the Appellate Body was circulated to Members on 19
December 1997. The Appellate Body report and the Panel report, as
modified by the Appellate Body, were adopted by the DSB on 16 January
1998. At the DSB meeting of 22 April 1998, the parties announced that
they had agreed on an implementation period of 15 months.


B.Settled or Inactive Cases 

(16) Pakistan - Patent Protection for Pharmaceutical and Agricultural
Chemical Products, complaint by the United States (WT/DS36). In its
request for consultations dated 30 April 1996, the United States claimed
that the absence in Pakistan of (i) either patent protection for
pharmaceutical and agricultural chemical products or a system to permit
the filing of applications for patents on these products and (ii) a
system to grant exclusive marketing rights in such products, violates
TRIPS Agreement Articles 27, 65 and 70. On 4 July 1996, the United
States requested the establishment of a panel. The DSB considered the
request at its meeting on 16 July 1996, but did not establish a panel
due to Pakistan's objection. At the DSB meeting on 25 February 1997,
both parties informed the DSB that they had reached a mutually agreed
solution to the dispute and that the terms of the agreement were being
drawn up, and would be communicated to the DSB once finalized. On 28
February 1997, the terms of the agreement were communicated to the
Secretariat.