Integrating Public Health Concerns into Patent Legislation in Developing Countries: IV. PATENTABILITY REQUIREMENTS: IV.3 Industrial Applicability

Integrating Public Health Concerns into Patent Legislation in Developing Countries
(2000; 140 pages) [French] [Spanish]

Table of Contents

THE SOUTH CENTRE
FOREWORD
ACKNOWLEDGEMENTS
GLOSSARY*
I. INTRODUCTION
	I.1 Context
	I.2 A Public Health Perspective
	I.3 Scope
II. PATENTABLE SUBJECT MATTER
	II.1 Products
	II.2 Substances Existing in Nature
		II.2.1 Options - Substances Existing in Nature
	II.3 Uses
		II.3.1 First indication
		II.3.2 Second indication
		II.3.3 Options - Uses
	II.4 Methods for Treatment and Diagnostics
		II.4.1 Options - Methods
	II.5 Traditional Medicines
III. SCOPE OF CLAIMS
	III.1 Options - Scope of Claims
IV. PATENTABILITY REQUIREMENTS
	IV.1 Novelty
		IV.1.1 Options - Novelty
	IV.2 Inventive Step
		IV.2.1 Options - Inventive Step
	IV.3 Industrial Applicability
		IV.3.1 Options - Industrial Applicability
V. SPECIAL CASES IN PHARMACEUTICALS
	V.1 Selection Patents
	V.2 Prior Public Availability
	V.3 Polymorphism
	V.4 Analogy processes
	V.5 Compositions
	V.6 Optical Isomers
	V.7 Active Metabolites
	V.8 Prodrugs
VI. DISCLOSURE
	VI.1 Options - Disclosure
VII. EXCEPTIONS TO EXCLUSIVE RIGHTS
	VII.1 Experimental Use
		VII.1.1 Options - Experimental Use
	VII.2 Early Working
		VII.2.1 Options - Early Working
	VII.3 Parallel Imports
		VII.3.1 Options - Parallel Imports
	VII.4 Individual Prescriptions
		VII.4.1 Options - Individual Prescriptions
VIII. EXAMINATION AND OBSERVATION PROCEDURES
	VIII.1 Options - Third Parties Opposition
IX. CLAIMS INTERPRETATION
	IX.1 Options - Claims
X. COMPULSORY LICENSING
	X.1 Grounds for Granting Compulsory Licenses
	X.2 Imports/Exports
	X.3 Registration
		X.3.1 Options - Compulsory Licenses
XI. FINAL REMARKS
REFERENCES
BACK COVER

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.

BOX 2
INDUSTRIAL APPLICABILITY IN COMPARATIVE LAW

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 effect^b), as illustrated by the large number of patents granted in the United States on “methods of doing business” ^c).

^a)See, e.g., Chisum and Jacobs, 1992, p. 2-50.

^b)See, e.g., Bainbridge, 1992, p. 270-272.

^c)See, e.g. “The growing flood of ‘Wall Street’ patents”, in Patnews (Internet Patent New Services) of 29.9.99.

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 sufficient^d).

^d)See, e.g., Dratler, §2.03[2]

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”.