- Keywords > compulsory licences
- Keywords > intellectual property laws
- Keywords > intellectual property protection (IPP)
- Keywords > parallel importation
- Keywords > patentability criteria - policy options
- Keywords > patents
- Keywords > pharmaceutical legislation
- Keywords > public health
- Keywords > Trade Related Aspects of the Intellectual Property Rights (TRIPS)
- Keywords > TRIPS flexibilities
(2000; 140 pages) [French] [Spanish]
II.3.2 Second indication
In some cases, a new use is discovered for a product that already has pharmaceutical use47. Many national laws treat the new use as process patent claims of one of two kinds: “use” claims (such as “the use of X as an antihistaminic”) or claims on one or more actual process steps (e.g. “a method of preventing...”)48. The patenting of use inventions depends on whether the purpose of the use is novel and non-obvious. Method inventions may be judged independently of the purpose. Even if intended for a novel purpose, the key consideration in determining the patentability of a method invention is whether it could be anticipated by other methods49.
47 This was the case, for instance, of nimodipine, a known cardiovascular agent for which an application to cerebral disorders was found.
48 See, e.g., Grubb, 1999, p. 208.
49 See, e.g., Hansen and Hirsch, 1997, p. 120.
Patent applications on the second medical indication of a known product are usually written as instructions to the physician on how to employ a certain composition to treat a particular disease. Such applications are accepted in some countries. The European Patent Office began granting such applications, when framed under the “Swiss formula,” in 198450.
50 “Use of X for the manufacture of a medicine to treat Y”.
However, countries may deem non-patentable an “invention” consisting of the second use of a substance because it fails to satisfy various traditional patent requirements:
• it is a “discovery”;
• it does not meet the requirement of industrial applicability;
• it is equivalent to a method of therapeutic treatment (when such methods are deemed non-patentable)51; and
• the “Swiss formula” suffers from “the logical objection that it lacks novelty, since it claims the use of the compound for preparation of a medicament, and normally the medicament itself will be the same as that already used for the first pharmaceutical indication”52.
51 See the following sub-Section.
52 See, e.g., Grubb, 1999, p. 221.
Many patent laws recently adopted in developing countries make no specific reference to the availability of patents for uses, leaving unclear whether their protection for processes covers “uses” and “methods of use.”
As in the case of the first indication, nothing in the TRIPs Agreement obliges countries to introduce additional protection for the second indication. While the TRIPs Agreement obliges Member States to protect products and processes (Articles 27.1 and 28), it does not specifically refer to the protection of new uses, thus leaving Member countries free to choose whether or not to protect them. In principle, a country that broadly excludes methods of medical treatment could also broadly exclude new therapeutic uses for old products. There are, however, limits to this approach, and consistency would be required in defining excludable therapeutic methods in all cases. The impact of any such exclusions on local needs and industry should also be taken into account.