My authorities
have asked me to submit the following request on behalf of the Communities and their
Member States for consideration at the next meeting of the Dispute Settlement Body.The
Agreement on Trade-Related Aspects of Intellectual Property Rights contained in
Annex 1C to the Agreement Establishing the World Trade Organization (hereafter the
"TRIPS Agreement") obliges those Members of the World Trade Organization
(hereafter the "WTO"), which apply the Agreement since 1 January 1996 (Article
65.1 of the TRIPS Agreement), to grant patent protection for the subject matter specified
in Article 27 of the TRIPS Agreement for a defined period of time. More precisely, the
TRIPS Agreement provides in its:
-
Article 27.1 that "[...] patents shall be available and patent rights enjoyable
without discrimination as to the place of invention, the field of technology and whether
products are imported or locally produced";
-
Article 28 that a patent shall confer on its owner the exclusive right to prevent third
parties not having the owner's consent from the acts of making, using, offering for sale,
selling or importing the patented product;
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Article 33 that the "term of protection available shall not end before the expiration
of a period of twenty years counted from the filing date".
However,
the legal regime currently in force in Canada does allow with respect to pharmaceutical
patents only that a third party may, without the consent of the patent holder, use the
patented invention to:
-
carry out experiments and tests required (proof of safety and bio-equivalency) to obtain
marketing approval of the copy of an innovative medicine before the expiration of the
relevant patent in order to ensure market access immediately following the patent expiry
(in particular, Section 55.2 (1) of the Patent Act);
-
manufacture and stockpile patented products for a period of up to six months before patent
expiry for sale after expiry (in particular, Section 55.2 (2) of the Patent Act in
conjunction with the "manufacturing and Storage of Patented Medicines
Regulation").
As
a consequence of the above, Canada's legal regime appears to be inconsistent with its
obligations under the TRIPS Agreement, including but not limited to Articles 27, 28, and
33 of the TRIPS Agreement.
In
a communication, dated 19 December 1997 (WT/DS114/1), the European Communities and their
Member States requested consultations with Canada pursuant to Article 4 of the
Understanding on Rules and Procedures Governing the Settlement of Disputes (hereafter the
"DSU"), contained in Annex 2 of the WTO Agreement and Article 64 of the TRIPS
Agreement in conjunction with Article XXII of the General Agreement on Tariffs and Trade
1994 (GATT 1994). Consultations were held on 13 February and 12 June 1998, but did not
result in a satisfactory solution of the dispute.
Accordingly,
the European Communities and their Member States request the establishment of a panel to
examine the matter in the light of the relevant provisions of the TRIPS Agreement and to
find that Canada fails to conform to the obligations contained in Articles 27, 28, and 33
of the TRIPS Agreement and thereby nullifies or impairs benefits accruing directly or
indirectly to the European Communities and their Member States under the TRIPS Agreement.
The
European Communities and their Member States ask that the panel be established with the
standard terms of reference as provided for in Article 7 of the DSU. |
