India: Bolar Exemption In India

Section 107A of the Indian Patent Act is known as India's Bolar Exemption. The fundamental objective of Section 107A is to delineate certain acts which are not to be considered as infringement.

The relevant section has been reiterated below- "For the purposes of this Act- (a) any act of making, constructing, using, selling or importing a patented invention solely for uses reasonably related to the development and submission of information required under any law for the time being in force, in India, or in a country other than India, that regulates the manufacture, construction, use, sale or import of any product;

(b) Importation of patented products by any person from a person, who is duly authorized under the law to produce and sell or distribute the product, Shall not be considered as an infringement of patent rights"

India is the largest producer of generic medicines. The huge demand for a costeffective medicine is one of the most important factors behind the establishment of generic manufacturing companies in India. In a recent notification by the Indian Government, it has been clearly informed to the Medical Association of India and their registered doctors that only generic medicines need to be prescribed to the patients. The cost of any generic medicine is very less comparative to the parallel patented drugs. In order to prepare a drug, most of the generic companies rely on the patented drugs. A patented drug is protected for 20 years by way of rights conferred under section 48 of the Indian Patents Act, 1970. The patent holder has the monopoly rights to make, use, sell or distribute his patented products for protection period i.e. for 20 years. Bolar exemption applicable within this protection period wherein patented drug has been used by third or interested parties for further research and development.

Bolar Provision is a defense used against patent infringement. When an invention is made, it is either used or sold by a third party for certain purposes for further research and development. Thus, this provision assumes extreme importance because the generic drug manufacturers, who seek to boost their business in the market soon after the expiry of the innovator company's patents, through the application of Bolar provision have the necessary time and opportunity for conducting research on the product while the patent being still valid.

In simple words, we can say that the exemption that enables generic manufacturers to experiment with patented drugs and produce them in limited quantities for research, is known as the Bolar exemption. The exemption enables generic drug manufacturers to use an inventor's pharmaceutical drug before the patent expires, which not only aids in the early launch of generic versions of the drug once the innovator drug's patent term ends, but also promotes further R&D.

Comparison of India's Bolar provision with United States:

In India, the Bolar provision is comparatively broader than its US equivalent. While the US provision restricts the safe harbour available to generic manufacturers to making, using, offering for sale or selling the patented invention solely for uses that are reasonably related to the development and submission of information under US federal law in the United States only, its Indian counterpart does not specify such territorial limits. Thus, a sale, even if outside India, will fall within the sweep of Section 107A, if it is reasonably related to the development and submission of information required for regulatory approval under the law of the country in which the sale takes place.

Are marketing authorizations and clinical trials, also part of the Bolar exemption?

The Bolar exemption in India is broader in terms of scope of coverage and provides greater liberal provision(s) when compared to its counterparts. When viewed from the perspective of the definition of S.107A of the Act ,'......development and submission of information required under any law for the time being in force in India....'; since the clinical trials and marketing approvals/ marketing authorization application would come under information required under the Indian Drug regulations viz. Drugs and Cosmetics Act, 1940 and Rules, 1945,it would be safe to interpret that generic manufacturers can use this pathway for clinical development (conduct of clinical trials) and filing of marketing authorization applications for their generic products of Invented Drugs / Patent Protected Drugs.

It is pertinent to mention here that there is paucity of cases regarding Bolar exemption in India, India has only one case regarding this provision wherein clinical trials have been mentioned as part of Bolar exemption, the case being Bayer Corporation vs. Union of India & Anr. It can be concluded that due to limited precedence of usage of Bolar exemption for the marketing authorizations and clinical trials by pharmaceuticals companies so far in India, we interpret marketing authorizations and clinical trials are also part of Bolar exemption.

The concept of Bolar exemption is highly relevant to the Indian scenario. In one of the statements by an Indian Pharma company it was said that, "Bolar exemption was provided to encourage competition. The greater the competition, the better it is for the protection of public health". India being one of the developing nations, should bring in laws favouring R&D. Further, the Bolar provision should be clearly explained by the supreme authority so that the rights of the patentee are never harnessed. Furthermore, the apex court should also assess whether the infringement has been caused due to R&D or for profit or for academic purpose.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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