Integrating Public Health Concerns into Patent Legislation in Developing Countries
(2000; 140 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentTHE SOUTH CENTRE
View the documentFOREWORD
View the documentACKNOWLEDGEMENTS
View the documentGLOSSARY*
Open this folder and view contentsI. INTRODUCTION
Open this folder and view contentsII. PATENTABLE SUBJECT MATTER
Open this folder and view contentsIII. SCOPE OF CLAIMS
Open this folder and view contentsIV. PATENTABILITY REQUIREMENTS
Open this folder and view contentsV. SPECIAL CASES IN PHARMACEUTICALS
Open this folder and view contentsVI. DISCLOSURE
Close this folderVII. EXCEPTIONS TO EXCLUSIVE RIGHTS
Open this folder and view contentsVII.1 Experimental Use
Close this folderVII.2 Early Working
View the documentVII.2.1 Options - Early Working
Open this folder and view contentsVII.3 Parallel Imports
Open this folder and view contentsVII.4 Individual Prescriptions
Open this folder and view contentsVIII. EXAMINATION AND OBSERVATION PROCEDURES
Open this folder and view contentsIX. CLAIMS INTERPRETATION
Open this folder and view contentsX. COMPULSORY LICENSING
View the documentXI. FINAL REMARKS
View the documentREFERENCES
View the documentBACK 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.

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