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 documentGLOSSARY*
Open this folder and view contentsI. INTRODUCTION
View the documentII.1 Products
Close this folderII.2 Substances Existing in Nature
View the documentII.2.1 Options - Substances Existing in Nature
Open this folder and view contentsII.3 Uses
Open this folder and view contentsII.4 Methods for Treatment and Diagnostics
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 contentsIX. CLAIMS INTERPRETATION
Open this folder and view contentsX. COMPULSORY LICENSING
View the documentXI. FINAL REMARKS
View the documentREFERENCES
View the documentBACK COVER

II.2.1 Options - Substances Existing in Nature

If national legislation aims to provide no specific restriction on the patentability of substances existing in nature - as is currently the case in the USA and Europe - there is no need for a special provision on the matter. If, on the other hand, a country wants to avoid providing patents for substances as found in nature, a provision excluding the patentability of mere “discoveries” may suffice (Option 1). If a more explicit and restrictive approach is preferred, national laws may provide for specific exclusion (Option 2).

Discoveries and Substances Existing in Nature
Model Options

1. Discoveries shall not be regarded as inventions.

2. A substance found in nature, including DNA, even if purified or isolated, shall not be regarded as an invention.

Under Option 1, a substance which existed in nature but which has not yet been identified in its characteristics and in its utility may become patentable, depending on the interpretation given to the concept of “discovery”. Option 2 would exclude such a possibility. Under Option 2, patentability would require making changes in the structure of the material. In the case of genetic materials, in particular, patentability would require modification of their genetic structure in a manner that leads to a new and inventive product.

Neither of these Options would prevent an interested party from patenting the processes employed to isolate, purify or produce a biological material, if the process met the patentability requirements.

Countries should recognize that choosing among the options presented here will determine key aspects of their biotechnology legislative policy.

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