- 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.4.1 Options - Methods
A typical exclusion from patentability, as contained in many laws in force, may contain the following:
Diagnostic, Therapeutical and Surgical Methods
Patents shall not be granted in respect of diagnostic, therapeutic and surgical methods for the treatment of humans and animals.
It should be noted that, even in the absence of specific provisions excluding the patentability of the referred methods, they may be deemed non eligible for protection due to the lack of industrial applicability, one of the essential requirements for patentability (see Section IV.3 below).
If the patentability of such methods were, however, admitted by national laws, its implications for the supply of health services should be assessed. Diagnostic, therapeutic and surgical patents, even if rarely granted, may negatively affect low-income patients’ access to required treatments, particularly in new areas such as gene-therapy59.
59 Though the gene therapy methods may not be patentable as such (if the suggested exclusion is provided for) the vectors and constructs that may be used could be patentable, as well as ex vivo process steps not involving the administration of the transformed cells to the patient (Grubb, 1999, p. 244).
In any case, the non-patentability of methods would not affect the patentability of equipments and substances necessary to execute them60.
60 In cases where the protection of such equipments and/or substances could lead to a de facto monopolization of the non-patented method, governments may have recourse to compulsory licenses, See Section X below.