Contact

RESOURCES

Methods of medical treatment

8.31 Methods of medical treatment are a specific exclusion under industrial applicability. The exclusion only applies to methods that are therapy or surgery, as well as diagnostic methods practised on the human or animal body, as set out in Section 16(2):

“An invention of a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body shall not be taken to be capable of industrial application.”

8.32 Section 16(2) is primarily intended to ensure that medical or veterinary practitioners are not hindered from properly exercising their professional skills by patent rights. This is consistent with G 05/83 EISAI/Second medical use OJEPO 1985, 64, which highlights that

“The intention of Article 52(4) EPC … is only to free from restraint noncommercial and non-industrial medical and veterinary activities.”

8.33 Section 16(2) corresponds to Article 52(4) EPC 1973, which states that “Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body shall not be regarded as inventions which are susceptible of industrial application …” and similarly to Section 4(2) of the UK Patents Act prior to the 2004 amendments. In Singapore, the general approach is set out in Bristol-Myers Squibb v Baker Norton Pharmaceuticals Inc [1999] RPC 253 by Jacob J at [51]:

“A like approach is indicated in Plant Genetic Systems/Plant Cells (EPO [1995] 545, T0356/93 OJ). There is also the limited purpose of the exception to be considered. It is not so broad as to stop doctors using whatever they feel they need to treat patients. If that were the purpose then one would not allow patents for medicines or medical implements at all. The purpose of the limitation is much narrower, merely to keep patent law from interfering directly with what the doctor actually does to the patient. Patent monopolies are permitted to control what he administers to, or the implements he uses on, the patient. The thinking behind the exception is not particularly rational: if one accepts that a patent monopoly is a fair price to pay for the extra research incentive, then there is no reason to suppose that that would not apply also to methods of treatment. It is noteworthy that in the US any such exception has gone, and yet no-one, so far as I know, suggests that its removal has caused any trouble.”