1. MEASURE AND PRODUCT AT ISSUE - World Trade Organization
CANADA ? PHARMACEUTICAL PATENTS1
(DS114)
PARTIES
AGREEMENT
Complainant Respondent
European Communities Canada
TRIPS Arts. 27, 28 and 30
TIMELINE OF THE DISPUTE
Establishment of Panel
1 February 1999
Circulation of Panel Report 17 March 2000
Circulation of AB Report
NA
Adoption
7 April 2000
1. MEASURE AND PRODUCT AT ISSUE
? Measure at issue: Certain provisions under Canada's Patent Act: (i)"regulatory review provision (Sec. 55.2(1))"2; and (ii)"stockpiling provision (Sec. 55.2(2))" that allowed general drug manufacturers to override, in certain situations, the rights conferred on a patent owner.
? Product at issue: Patented pharmaceuticals from the European Communities.
2. SUMMARY OF KEY PANEL FINDINGS
Stockpiling provision ? TRIPS Arts. 28.1 (patent owner rights) and 30 (exceptions): (Canada practically conceded that the stockpiling provision
violated Art. 28.1, which sets out exclusive rights granted to patent owners.) Concerning Canada's defence under Art. 30, the Panel found that the measure was not justified under Art. 30 because there were no limitations on the quantity of production for stockpiling which resulted in a substantial curtailment of extended market exclusivity, and, thus, was not "limited" as required by Art. 30. Accordingly, the Panel concluded that the stockpiling provision was inconsistent with Art. 28.1 as it constituted a "substantial curtailment of the exclusionary rights" granted to patent holders.
Regulatory review provision ? TRIPS Arts. 28.1 (patent owner rights) and 30 (exceptions): (Canada also practically conceded on the inconsistency of
the provision with Art. 28.1) The Panel found that Canada's regulatory review provision was justified under Art. 30 by meeting all three cumulative criteria: the exceptional measure (i) must be limited; (ii) must not "unreasonably conflict with normal exploitation of the patent"; and (iii) must not "unreasonably prejudice the legitimate interests of the patent owner", taking account of the legitimate interests of third parties. These three cumulative criteria are necessary for a measure to be justified as an exception under Art. 30.
? TRIPS Art. 27.1 (non-discrimination): The Panel found that the European Communities failed to prove that the regulatory review provision discriminated based on the field of technology (i.e. against pharmaceutical products in this case), either de jure or de facto, under Art. 27.1.
3. OTHER ISSUES3
? Burden of proof (TRIPS Art. 30): Since Art. 30 is an exception to the obligations under the TRIPS Agreement, the burden was on the respondent (i.e. Canada) to demonstrate that the patent provisions at issue were justified under that provision.
1 Canada ? Patent Protection of Pharmaceutical Products 2 The regulatory review provision permitted the general manufacturers of pharmaceuticals to produce samples of the patented product for use during the regulatory review process. The stockpiling provision allowed producers of generic drugs to make the drugs and begin stockpiling them six months prior to the expiration of the patent. 3 Other issues addressed: application of principles of treaty interpretation (VCLT) to the provisions under the TRIPS Agreement; interpretation of three cumulative criteria under Art. 30 exception.
2021 EDITION 49
................
................
In order to avoid copyright disputes, this page is only a partial summary.
To fulfill the demand for quickly locating and searching documents.
It is intelligent file search solution for home and business.
Related download
- product monograph
- pharmaceutical pricing and reimbursement policies in canada
- internet drug outlet identification program national association of
- clicking into harm s way the decision to purchase regulated goods online
- com canadian medical association journal
- product monograph template standard takeda pharmaceutical company
- 1 measure and product at issue world trade organization
- report of the council on medical service american medical association
- sun pharma s ilumya tildrakizumab injection now available to help
- value in pharmaceutical pricing country profile canada oecd
Related searches
- world health organization rankings by country
- world health organization report 2018
- world health organization rankings 2016
- world health organization rankings 2018
- world health organization healthiest countries
- define enduring issue world history
- world war 1 causes and effects
- at t business trade in program
- at t next trade in terms and conditions
- at t device trade in program
- at t next trade in agreement
- at t next trade in program