An important issue in relation to the protection of TRM is the extent to which the “use” of a known product can be subject to patent protection. This issue may arise, for instance, when the therapeutic properties of a natural product are identified and claimed.
The patenting of use inventions, where admitted, depends on whether the purpose of the use is novel and non-obvious. In countries that permit the protection of use inventions, claims may be either product or process claims, depending on the context.113 Some national laws treat the new use as a process patent claim of one of two kinds: “use” claims (such as “the use of X as an antihistamine”) or claims on one or more actual process steps (e.g. “a method of preventing…”).114 In the United States, patents on uses are confined to a particular “method-of-use”, which does not encompass protection of the product as such (Merges, 1992, p. 489).115
113 Thus, in Europe, first medical indications (that is, a medical use for a product previously not used for that purpose) have been dealt with as a product claim, whereas the second medical indication (that is, when a new use is discovered for a product that already had pharmaceutical use) as a process claim. See, e.g. Grubb, 1999, p. 208.
115 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 methods. See, e.g., Hansen and Hirsch, 1997, p. 120.
In contrast, the European Patent Convention allows for the patentability of a known product for a new specific purpose (Stieger, 1982). Under article 54(5) of the European Patent Convention, the identification of the first medical indication of a known product may suffice to allow patenting of the product.116
116 The Technical Board of Appeal of the European Patent Office has ruled that such claims should be deemed as covering all therapeutic 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 therapeutic use, and not in bulk (Grubb, 1999, p. 218).
In the case where the application refers to the second medical indication of a known pharmaceutical product, however, an obstacle to patentability arises. Patent applications over the therapeutic use of a known product are written as instructions to the physician on how to employ a certain substance to treat a particular disease. Such a new use, hence, is equivalent to a method of therapeutic treatment, which is deemed non-patentable under European law.117
117 In order to overcome this barrier, the European Patent Office admitted since 1984 (under a legal fiction), claims on the second medical indication of a known pharmaceutical product when framed under the so-called “Swiss formula”, that is, “Use of X for the manufacture of a medicine to treat Y”. However, 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” (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 the protection for processes covers “uses” or “methods of use”.
The TRIPS Agreement seems to leave freedom to Members to decide whether or not to protect new uses, since it only obliges them to grant patents for products and processes (article 27.1). They also are free to adopt or not the “Swiss formula” approach.