Drugs, Public Health, and the Patent Linkage System in India and Japan

We may often come across mind boggling, incomprehensible doctor prescriptions quite difficult to decipher, with new drug names for the common flu and the usual ‘paracetamols’ found in other drugs under many different labels and names. This indicates nothing but the existence of a generic drug system. Generic drugs have same chemical formulas, properties and compositions as that of originator drugs or products. TRIPS plus concept of linking the drug regulatory authority and the patent authorities is prevalent in many states, emphasizing the prevention of generic drugs. This article will focus on patent linkage system of Japan and India and its functional details in these countries. The Japanese system is flexible, allowing the entry of generic drugs on certain conditions at the discretion of the Ministry of Health, Labor & Welfare and the results of the Japanese Patent Office. The uncertainties create a confusing view on the patent linkage system in Japan. The definition of original drugs and generic drugs are not clear in any of the provisions regulating the same, and permission or the prohibition of generic drugs or the determination of the status of a drug depends entirely on the ministries. Indian system, however, does not prohibit the entry of generics and promotes the usage of generics through various schemes, circulars and laws. It encourages doctors to prescribe the same for easy access to generic medicines. The article explores the contradicting provisions about generic drugs stipulated by the drugs & cosmetics act, 1940, expands on the bolar provisions in place and analyses the shortcomings of the system allowing generic drugs in India. The study highlights the need for a patent linkage system, supported by proper justifications and the concepts that could be implemented, for the effective functioning of both the drug regulatory authorities and the intellectual property authorities, protecting the interests of the patent owners as well as the common public, consequently.