Option 1 would exclude the patentability of an invention consisting solely of the method of use or use of a known product, even when it is the first identified use. This solution has both advantages and disadvantages.
On the one hand, this solution may help to prevent so-called “bio-piracy” - that is, the appropriation of substances found in nature for which a new medical use is identified (often on the basis of available traditional knowledge). It should be noted, however, that due to the territoriality of the patent system and the independence of patents granted in different countries, such prohibition would not prevent a third country from granting a patent on a natural substance, unless its own national legislation or an international agreement forbids it.
Uses of Known Products
1. The new use or method of use of a known product shall not be patentable.
2. The identification of a new use for a known product does not render the product patentable.
3. When a new use for a known product has been identified, a patent may be obtained for such product as specifically applied to such use.
4. Patents shall not be granted in respect of the method of use or use for therapeutic purposes of a known pharmaceutical product.
On the other hand, it can be argued that developing countries could benefit from the patentability of new uses either because the identification of new uses may be more affordable than the development of new active ingredients, or because new uses could be directed at specific local diseases or maladies. If these considerations prevail, no exclusion should be provided for, although the law could specify that no use claim will qualify if the characteristic or advantage is inherent in the existing use of the product or process.
Option 2 would explicitly prevent the patentability of the product for which a new use was identified. This provision may be included in order to avoid any ambiguity on this issue, though it may not be strictly necessary. In the absence of any provision on the matter, the application of the general requirements of patentability would normally lead to the non-patentability of the product as such53.
53 As indicated above, in the case of Europe, such patentability is based on a legal fiction and on an express provision allowing for it.
Under Option 2, however, the patentability of pharmaceutical uses would be admitted for the first indication with respect to the method of use or use, but excluding the protection of the product.
A further, less restrictive alternative, would be to admit use-bound product claims (Option 3)54. Under this Option, a product would be claimed in relation to a specific use, and not in absolute terms55.
54 For instance, “a composition containing N for pressure control”.
55 See, e.g., Stieger, 1982, p. 157.
Finally, Option 4 addresses the issue of the “second indication” of a pharmaceutical product. If Option 1 were adopted, it may not be needed to also state Option 4, since the latter may be deemed a particular case of the former. Moreover, if the patentability of methods of therapeutical treatment were excluded, Option 4 may not be necessary. Nevertheless, it may be advisable to include Option 4 in order to avoid any possible ambiguity or misinterpretation.