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
Close this folderII. PATENTABLE SUBJECT MATTER
View the documentII.1 Products
Open this folder and view contentsII.2 Substances Existing in Nature
Open this folder and view contentsII.3 Uses
Close this folderII.4 Methods for Treatment and Diagnostics
View the documentII.4.1 Options - Methods
View the documentII.5 Traditional Medicines
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
Open this folder and view contentsVII. EXCEPTIONS TO EXCLUSIVE RIGHTS
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
 

II.4.1 Options - Methods

A typical exclusion from patentability, as contained in many laws in force, may contain the following:

Diagnostic, Therapeutical and Surgical Methods
Model Option

Patents shall not be granted in respect of diagnostic, therapeutic and surgical methods for the treatment of humans and animals.

It should be noted that, even in the absence of specific provisions excluding the patentability of the referred methods, they may be deemed non eligible for protection due to the lack of industrial applicability, one of the essential requirements for patentability (see Section IV.3 below).

If the patentability of such methods were, however, admitted by national laws, its implications for the supply of health services should be assessed. Diagnostic, therapeutic and surgical patents, even if rarely granted, may negatively affect low-income patients’ access to required treatments, particularly in new areas such as gene-therapy59.

59 Though the gene therapy methods may not be patentable as such (if the suggested exclusion is provided for) the vectors and constructs that may be used could be patentable, as well as ex vivo process steps not involving the administration of the transformed cells to the patient (Grubb, 1999, p. 244).

In any case, the non-patentability of methods would not affect the patentability of equipments and substances necessary to execute them60.

60 In cases where the protection of such equipments and/or substances could lead to a de facto monopolization of the non-patented method, governments may have recourse to compulsory licenses, See Section X below.

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