Integrating Public Health Concerns into Patent Legislation in Developing Countries: VII. EXCEPTIONS TO EXCLUSIVE RIGHTS: VII.2 Early Working: VII.2.1 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.2.1 Options - Early Working

The “early working” exception, as noted above, may in some cases be considered as part of the experimental use exception. However, given the importance of this issue, and the uncertainty surrounding judicial interpretation, it seems advisable to include a specific provision on the matter. It may include the following:

Early Working
Model Option

The patent shall have no effect with respect to any acts, including testing, using, making or selling the invention, solely for purposes reasonably related to the development and submission of information required under any law of ... (country) or of another country that regulates the manufacture, construction, use or sale of any product.

The proposed wording includes, among the possible non-infringing acts, the limited manufacturing of the patented product in order to undertake the tests required by the health authorities. This option would not allow for production and stockpiling before the expiration of the patent.