An important patent issue in the health sector arises when a new therapeutic use is found for a known product which had no previous pharmaceutical use. Because patents protect inventions but not discoveries, the discovery of a new purpose for a product cannot render a known product patentable under general principles of patent law⁴³. Therefore, the patentability of the product as such would be rejected.

⁴³ Unless in connection with the new purpose the product is forced to be present in an amended new form. See, e.g., Hansen and Hirsch, 1997, p. 104.

Some jurisdictions, however, have adopted special rules for the protection of the first indication of a known product, expanding the scope of protection beyond its ordinary boundaries. In Europe, for example, a legal fiction allows the patentability of a known product for such an indication⁴⁴. Under article 54(5) of the European Patent Convention, the identification of the first medical indication of a known product may suffice to get a patent on the product⁴⁵. The United States, by contrast, has adopted a more restrictive approach, confining patents on uses to a particular “method-of-use.” Such method-of-use patents do not encompass protection of the product as such⁴⁶.

⁴⁴ See, e.g., Stieger, 1982.

⁴⁵ The Technical Board of Appeal of the EPO has ruled that such claims should be deemed as covering all therapeutical uses of the product as in the case of claims on a pharmaceutical composition. Infringement of such claims would only take place when the product is commercialized for direct therapeutical use, and not in bulk (Grubb, 1999, p. 218). The approach of granting patents for first medical indication of a known product may be deemed discriminatory vis-a-vis other sectors, although it may be justified as a limitation to the exclusion of the patentability of therapeutical methods. See sub-Section II.4 on “Methods for Treatment and Diagnostics”.

⁴⁶ See, e.g., Merges, 1992, p. 489.

Under the TRIPs Agreement, countries are free to expand patent protection beyond the general principles of patent law, but they are under no obligation to do so. WTO Member countries are thus free to decide whether or not to allow the patentability of products for first indication.

Countries concerned about “bio-piracy” may wish to exclude the patentability of the use of known products in order to prevent the appropriation under patent rights of biological products.