CANADA – PATENT PROTECTION OF PHARMACEUTICAL PRODUCTS
WORLD TRADE ORGANIZATION
WT/DS114/R 17 March 2000
(00-1012)
Original: English
CANADA ? PATENT PROTECTION OF PHARMACEUTICAL PRODUCTS
Complaint by the European Communities and their member States
Report of the panel
The report of the Panel on Canada ? Patent Protection of Pharmaceutical Products is being circulated to all Members, pursuant to the DSU. The report is being circulated as an unrestricted document from 17 March 2000 pursuant to the Procedures for the Circulation and Derestriction of WTO Documents (WT/L/160/Rev.1). Members are reminded that in accordance with the DSU only parties to the dispute may appeal a panel report, an appeal shall be limited to issues of law covered in the panel report and legal interpretations developed by the panel, and that there shall be no ex parte communications with the panel or Appellate Body concerning matters under consideration by the panel or Appellate Body.
Note by the Secretariat: This Panel Report shall be adopted by the Dispute Settlement Body (DSB) within 60 days after the date of its circulation unless a party to the dispute decides to appeal or the DSB decides by consensus not to adopt the report. If the Panel Report is appealed to the Appellate Body, it shall not be considered for adoption by the DSB until after the completion of the appeal. Information on the current status of the Panel Report is available from the WTO Secretariat.
WT/DS114/R Page i
TABLE OF CONTENTS
I. INTRODUCTION
1
II. FACTUAL ASPECTS
1
(a) Relevant Provisions of Canadian Patent Law
1
(b) Canada's Regulatory Review System for Drugs
3
III. FINDINGS AND RECOMMENDATIONS REQUESTED BY THE PARTIES
7
IV. ARGUMENTS OF THE PARTIES
9
A. EUROPEAN COMMUNITIES AND THEIR MEMBER STATES
9
(1) SECTION 55.2(2) AND 55.2(3) OF THE PATENT ACT TOGETHER
WITH THE MANUFACTURING AND STORAGE OF PATENTED
MEDICINES REGULATIONS
9
(a) Article 28.1 and Article 33 of the TRIPS Agreement
9
(b) Article 27.1 of the TRIPS Agreement
10
(2) SECTION 55.2(1) OF THE PATENT ACT
10
(a) Article 28.1 of the TRIPS Agreement
10
(b) Article 27.1 of the TRIPS Agreement
12
(3) HISTORICAL DEVELOPMENTS IN CANADIAN PATENT LEGISLATION AND
COMPARISON BETWEEN THE SITUATION IN CANADA BEFORE AND AFTER
THE INTRODUCTION OF BILL C-91 AND THE MANUFACTURING AND
STORAGE OF PATENTED MEDICINES REGULATIONS IN 1993
12
(4) ECONOMIC LOSSES SUFFERED BY THE EU PHARMACEUTICAL INDUSTRY
15
(5) ARTICLE 30 OF THE TRIPS AGREEMENT
16
B. CANADA
16
(1) ARTICLE 30 OF THE TRIPS AGREEMENT
16
(a) Object, Purpose and Meaning
18
(i) Section 55.2(1) and 55.2(2) create limited exceptions
21
(ii) Section 55.2(1) and 55.2(2) do not conflict with a normal
exploitation of the patent
24
(iii) Section 55.2(1) and 55.2(2) do not prejudice the legitimate
interests of the patent owner
24
(iv) Section 55.2(1) and 55.2(2) take account of the legitimate
interests of third parties
25
(b) Travaux Pr?paratoires and Subsequent Practice
27
WT/DS114/R Page ii
(2) ARTICLE 27.1 OF THE TRIPS AGREEMENT
30
(a) Object, Purpose and Meaning
30
(b) Travaux Pr?paratoires and Subsequent Practice
31
(c) Section 55.2(1) and 55.2(2) are not Discriminatory
32
(3) ARTICLE 33 OF THE TRIPS AGREEMENT
33
(a) Object, Purpose and Meaning
33
(b) Section 55.2(1) and 55.2(2) do not Reduce the Required Minimum
Term of Protection
34
(4) THE LEGISLATIVE HISTORY OF THE DISPUTED PROVISIONS, THEIR
FRAMING, THEIR LEGISLATIVE CONTEXT AND THE DEBATE ON
COST CONTAINMENT AND GENERIC DRUGS
34
(a) The Legislative History of the Disputed Provisions
35
(b) The Framing of the Disputed Provisions
37
(c) The Legislative Context
39
(d) Cost Containment and Generic Drugs
40
C.
EUROPEAN COMMUNITIES AND THEIR MEMBER STATES
45
(1) ARTICLE 27.1 OF THE TRIPS AGREEMENT
47
(2) ARTICLE 30 OF THE TRIPS AGREEMENT
49
(a) Preliminary Remarks
50
(i) The Preamble of the TRIPS Agreement and its Articles 1.1, 7 and 8.1 51
(b) Interpretation of the Conditions Enumerated in Article 30 for the Grant of
Exceptions to Rights Conferred
53
(i) The "prior use" exception
54
(ii) The "scientific/experimental use" exception
55
(c) Section 55.2(2) and 55.2(3) of the Canadian Patent Act together with the
Manufacturing and Storage of Patented Medicines Regulations
56
(i) "Limited"
56
(ii) "Do not unreasonably conflict with a normal exploitatio n
of the patent"
57
(iii) "Do not unreasonably prejudice the legitimate interests of
the patent owner, taking account of the legitimate interests
of third parties"
58
(d) Section 55.2(1) of the Canadian Patent Act
59
(i) "Limited"
59
(ii) "Do not unreasonably conflict with a normal exploitation of
the patent"
59
(iii) "Do not unreasonably prejudice the legitimate interests of
the patent owner, taking account of the legitimate interests
of third parties"
60
WT/DS114/R Page iii
(3) SUBSEQUENT PRACTICE
61
(a) Section 55.2(2) and 55.2(3) of the Canadian Patent Act together
with the Manufacturing and Storage of Patented Medicines
Regulations
61
(b) Section 55.2(1) of the Canadian Patent Act
62
D.
CANADA
63
(1) PRELIMINARY POINTS
63
(a) Section 55.2(1) and 55.2(2) of the Canadian Patent Act
64
(b) Subsequent Practice
66
(2) ARTICLE 27.1 OF THE TRIPS AGREEMENT
66
(3) ARTICLE 30 OF THE TRIPS AGREEMENT
70
(a) Articles 7 and 8 of the TRIPS Agreement
71
(b) Interpretation of the Conditions Enumerated in Article 30 for the
Grant of Exceptions to Rights Conferred
72
(i) The "prior use" exception
73
(ii) The "scientific/experimental use" exception
74
(c) Section 55.2(1) and 55.2(2) of the Canadian Patent Act
76
(i) "Limited"
76
(ii) "Do not unreasonably conflict with a normal exploitation
of the patent"
77
(iii) "Do not unreasonably prejudice the legitimate interests
of the patent owner, taking account of the legitimate interests
of third parties"
78
(4) EXCEPTION FOR A REGULATORY SUBMISSION TO A "COUNTRY
OTHER THAN CANADA"
79
(a) The Global Nature of the Pharmaceutical Industry
79
(b) The Global Need for Access to Essential Medicines
80
(c) The Context of the TRIPS Agreement
81
(d) Foreign Regulatory Approval and Article 30 of the TRIPS Agreement
82
(e) Creation of a Trade Barrier
83
(5) APPLICATION OF ARTICLE 33 OF THE TRIPS AGREEMENT
83
E.
EUROPEAN COMMUNITIES AND THEIR MEMBER STATES
83
(1) ARTICLE 27.1 OF THE TRIPS AGREEMENT
84
(2) ARTICLE 30 OF THE TRIPS AGREEMENT
84
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