(2002; 131 pages)
(i) Natural products
Traditional medicines include plants, animal and mineral materials, extracts, mixtures and herbal preparations. Obstacles for the patentability of such medicines may arise when they consist of or are based on natural materials that have not been processed or modified.
One of the basic problems is the extent to which a substance existing in nature for which a certain use has been identified, may be deemed to be an “invention” or a mere “discovery”. Such use may have been identified with regard to a product whose properties were not known, or in respect of products whose properties were known, the “invention” eventually being the determination of its chemical or genetic structure.
Patent protection of biological materials, including cells and genes, has been accepted in many countries. This remains, however, a controversial issue, particularly with regard to the patentability of materials existing in nature that have just been isolated, purified, or slightly altered. In some countries (e.g. the United States) an isolated or purified form of a natural product, including genes, is patentable. The European Directive on Biotechnological Inventions (No. 96/9/EC of March 11, 1996) adopted a similar approach. The Directive, essentially declaratory of long standing law throughout much of Europe,105 establishes that “biological material” and substances isolated from nature are patentable.106
105 See, e.g. Grubb, 1999, p. 213.
106 “Biological material which is isolated from its natural environment or processed by means of a technical process may be the subject of an invention even if it already occurred in nature” (article 3.2).
In some countries, however, the patenting of existing biological materials, unless they have been genetically altered, has been contested and denied. For example, in United Kingdom - before the adoption of the referred to European Directive - the High Court of Appeal had held that the isolation of gene sequences constituted a mere discovery and, hence, was not patentable. The Court argued that although the amino acid sequence of t-PA had not previously been determined, one cannot patent a known substance just by being the first to determine its structure (Thurston and Hall, 1988) It is uncertain the extent to which this doctrine can be maintained after the adoption of the European Directive on Biological Inventions.
Some laws do not allow the patenting of genetic materials. The Mexican patent law (1991, as amended in 1994) excludes the patentability of all genetic materials. The Argentine patent law (1995) and the Andean Group Decision 486 (2000), do not allow the patentability of materials existing in nature. The Brazilian patent law (1996), stipulates that no patents shall be granted with respect to living beings or “biological materials found in nature”, even if isolated, including the “genome or germplasm” of any living being.
Despite the possible exclusion of certain natural products from the patent domain, patents may still be granted for the processes used to produce them in a medicinal form. Since process patents do not prevent third parties from using alternative processes to obtain the same product, patenting processes (and not the products as such) may be the preferred option for countries sensitive to the problems of affordability of medicines.
The extent to which substances found in nature may be patented is of particular importance for TRM since, as mentioned, TRM extensively relies on such substances, often in an unmodified form. Countries wishing to promote access to traditional medicines should draw a clear dividing line between products existing in nature, which are not patentable (even if isolated or subject to standard procedures of purification), and products which have been modified or combined in a manner that gives rise to a genuine invention.