Developing countries could consider the exclusion from patentability of diagnostic, therapeutic and surgical methods for the treatment of humans or animals⁵⁶. Most countries do not grant patents on such methods due to ethical reasons or to difficulties with actually enforcing those patents. In addition, a method that is applied to the human body is not considered industrially applicable and, hence, does not comply with one of the key patentability requirements of most patent laws. However, in the United States, patent practice increasingly favours the patenting of medical methods if they satisfy the definition of process and the other conditions of eligibility⁵⁷.

⁵⁶ For instance, patent US 4,188,395 claimed “a method combating circulatory diseases in warm blooded animals in need of such treatment orally or parenterally which comprises administering to the animals an amount effective for combating circulatory diseases relating to heart action and blood pressure an active compound according to claim 1 either alone or in admixture with a diluent or in the form of a medicament”.

⁵⁷ A bill enacted in 1996 (amending US patent law, 35 USC 287.c) determined, however, that the use of patented surgical procedures is protected from infringement suits. See, e.g., Grubb, 1999, p. 220.

Article 27.3.a of the TRIPs Agreement explicitly allows Members not to grant patents for methods for therapeutic and surgical treatment and for diagnostics⁵⁸.

⁵⁸ Including when they apply to animals.