- 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]
IV.3 Industrial Applicability
The third criterion for patentability relates to the industrial applicability of the invention. Patent law around the world aims to protect technical solutions to a given problem, not abstract knowledge. The application of this criterion to health-related inventions is particularly important vis-a-vis inventions consisting of uses of a product since uses of health-related inventions may be considered as methods of treatment of the human body, not industrially applicable, and therefore not patentable.
Countries differ in their treatment of industrial applicability. Under US law, certain developments that do not lead to an industrial product may be patented: an invention only needs to be operable and capable of satisfying some function of benefit to humanity (“useful”)a). This usefulness concept is broader than the “industrial applicability” concept required in Europe and other countries. The U.S. rule permits the patentability of purely experimental inventions that cannot be made or used in an industry, or that do not produce a technical effectb), as illustrated by the large number of patents granted in the United States on “methods of doing business” c).
The application of the industrial applicability requirement is often complex in the chemical, pharmaceutical, and biotechnology industries, where there are particular problems relating to the acceptable degree of speculative information. Thus, in the USA mere speculation about chemical homologues would be insufficient, while in vitro testing in animal tumour models of products intended for human use may be deemed sufficientd).
The TRIPs Agreement does not define the concept of industrial applicability95 and, therefore, leaves countries with considerable flexibility.
95 It allows a Member country to consider that “capable of industrial application” is synonymous with “useful”.