Integrating Public Health Concerns into Patent Legislation in Developing Countries: VII. EXCEPTIONS TO EXCLUSIVE RIGHTS: VII.3 Parallel Imports: VII.3.1 Options

Integrating Public Health Concerns into Patent Legislation in Developing Countries
(2000; 140 pages) [French] [Spanish]

Table of Contents

THE SOUTH CENTRE
FOREWORD
ACKNOWLEDGEMENTS
GLOSSARY*
I. INTRODUCTION
	I.1 Context
	I.2 A Public Health Perspective
	I.3 Scope
II. PATENTABLE SUBJECT MATTER
	II.1 Products
	II.2 Substances Existing in Nature
		II.2.1 Options - Substances Existing in Nature
	II.3 Uses
		II.3.1 First indication
		II.3.2 Second indication
		II.3.3 Options - Uses
	II.4 Methods for Treatment and Diagnostics
		II.4.1 Options - Methods
	II.5 Traditional Medicines
III. SCOPE OF CLAIMS
	III.1 Options - Scope of Claims
IV. PATENTABILITY REQUIREMENTS
	IV.1 Novelty
		IV.1.1 Options - Novelty
	IV.2 Inventive Step
		IV.2.1 Options - Inventive Step
	IV.3 Industrial Applicability
		IV.3.1 Options - Industrial Applicability
V. SPECIAL CASES IN PHARMACEUTICALS
	V.1 Selection Patents
	V.2 Prior Public Availability
	V.3 Polymorphism
	V.4 Analogy processes
	V.5 Compositions
	V.6 Optical Isomers
	V.7 Active Metabolites
	V.8 Prodrugs
VI. DISCLOSURE
	VI.1 Options - Disclosure
VII. EXCEPTIONS TO EXCLUSIVE RIGHTS
	VII.1 Experimental Use
		VII.1.1 Options - Experimental Use
	VII.2 Early Working
		VII.2.1 Options - Early Working
	VII.3 Parallel Imports
		VII.3.1 Options - Parallel Imports
	VII.4 Individual Prescriptions
		VII.4.1 Options - Individual Prescriptions
VIII. EXAMINATION AND OBSERVATION PROCEDURES
	VIII.1 Options - Third Parties Opposition
IX. CLAIMS INTERPRETATION
	IX.1 Options - Claims
X. COMPULSORY LICENSING
	X.1 Grounds for Granting Compulsory Licenses
	X.2 Imports/Exports
	X.3 Registration
		X.3.1 Options - Compulsory Licenses
XI. FINAL REMARKS
REFERENCES
BACK COVER

VII.3.1 Options - Parallel Imports

National laws may contain a provision relating to parallel imports on an international scale, as follows:

Parallel Imports
Model Options

1. A patent shall have no effect in relation to a product which has been put on the market in any country by the patent holder or with his consent.

2. A patent shall have no effect in relation to a product which has been put on the market in any country by the patent holder, with his consent or in other legitimate manner.

3. A patent shall have no effect in relation to a product which has been put on the market in any country by the patent holder or by an authorized party.

Option 1 provides for an exception relating to parallel imports originating in any country, subject to the condition that the product was marketed in such country by the patent owner or with his consent.

Option 2 broadens the exception, as it would also allow parallel imports in cases where the product was marketed in a foreign country in a legitimate manner, even without the authorization of the patent owner, such as where the product was not protected¹⁴⁰ in the exporting country, or where it was sold under a compulsory license. This Option may be more vulnerable to challenge in the WTO than Option 1.

¹⁴⁰ With the implementation of the TRIPs Agreement, pharmaceutical product patents will be recognized in all countries which are Members of the WTO. Therefore, the situation of lack of protection will become exceptional. It may still occur in cases where the inventor company decides not to apply for a patent in a given country, or where an application has been refused and, therefore, the respective product remains in the public domain.

A possible compromise between these two Options would be to limit the cases in which parallel imports without the consent of the patent owner are permitted, by requiring that the sale in the exporting country be made by an authorized party (Option 3). The authorization may be given by the patent owner or by a State authority under a compulsory license.