This article elaborates the concept of Bolar Exemption, also known as Bolar provision, under the Indian Patent Act, 1970 (hereinafter called as Act). Different provisions with respect to the Bolar Exemption under this Act are discussed here. Several case laws are also elucidated on whether the patented products can be exported to other countries or not for research and development. Bolar exemption can be called a good defense against pharmaceutical patent infringement under the Indian Patents Act.


Section 107(A) of the Patents Amendment Act, 2002, can be presented as a defense instrument against patent infringement. This is especially important for pharmaceutical drugs under the Indian Patent Act, 1970. Under this provision, a newly invented drug or any invention can be used, or sold by any third party for further development or research purpose without any fright of legal consequences. Bolar exemption was named after the landmark United States case Roche Products v Bolar Pharmaceuticals, wherein it was held that Bolar's use of the patented compound for federally mandated testing was an infringement of the patent. However, soon after this judgment, the US Congress overturned the decision by enacting a law permitting the use of patented inventions in research to seek Food and Drug Administration approval.

Certain acts not to be considered as infringement - Sec 107(A) of the Indian Patents Act, 1970 lays down -

(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 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.


The basic objective of Section 107 (A) is to define certain acts which are not to be measured as infringement which are demonstrated as follows:

a. Marketing authorizations and clinical trials are also part of the Bolar exemption

  • Bolar exemption has conveyed a broader scope in India. When viewed from the perspective of the definition of S.107(A) 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 come under information required under the Drug controller 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 lack 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. This issue was discussed by Delhi High Court in the case of Bayer Corporation v. Union of India & Ors., and Bayer Intellectual Property GMBH & Anr v. Alembic Pharmaceutical Ltd., (2019), where the court ruled that "Section 107(A) is in the line with the TRIPS agreement, international guidelines and Article 47, 21 of the Indian Constitution upholds export as a valid part of the bolar exemption. So, exporting for research and clinical trials comes under the scope of Section 107(A) as the bolar exemption and there will be no impairment of the patentee's rights".1

  • With the above mentioned judgment, we can interpret marketing authorizations and clinical trials are also part of Bolar exemption.

b. Patented products can be exported to other countries for further research

  • 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 for 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 such manufacturers get the necessary time and opportunity for conducting research on the product while the patent is still valid.

  • In case of necessity of a medical drug to the society, the patented drug can be used for further study and experiment without the consent of the patent holder within the validity of the patent period provided under this Act. So, this provision is very useful for drug manufacturers to conduct trials without waiting for the expiry of the patent. In the duration of the patent, the patent holder has an exclusive right to sell, use or distribute or monopolize the patented product in the market and he shall also have a right to transfer his rights to any third party with his consent under Sec 48 of Indian Patent Act, 1970.

  • Some of the limitations of the patent rights include that the owner of a patent cannot transfer his rights without any agreement with the third party and only some of the terms and restrictions can be imposed on the third party. A patent right can be challenged before the court. A compulsory license is required to monopolize the patented products. The Indian Patents (Amendment) Act, 2005 regulates the use of patented products with the least cost to the customers.2

  • On November18, 2019, a case was filed before the Delhi High Court i.e., Merch Sharp & Dohme Corp & Anr v. Sanjeev Gupta & Ors, on the issue - whether selling or manufacturing of patented product for export amounts to infringement? The Delhi court observed that Section 48 of the Indian Patents Act, 1970, protects the rights of the patent holder from restricting the use of such patent by a third party without the consent of the patent holder, either for the sale, use or any other purpose. Hence, the court held that Sec 48 includes protection of patent from being manufactured for export.3


Section 107(A) is a defensive instrument against patent infringement, especially important for pharmaceutical drugs. Bolar exemption provides generic drug manufacturers sufficient time to conduct their research so that they can introduce their products into the market soon after the expiry of the innovator's patents. In addition, the provision has been recognized for ensuring continuous supply of life saving drugs in the market. Under bolar provision, the patented products can be exported abroad without the consent of the patent holder for further improvements, developments, or clinical trials. This means that generic manufacturers can use the invented drugs to carry out quality research and experiments. In this way, the bolar exemption can be called a good defense against patent infringement under the Indian Patents Act, 1970.

Bolar exemption has conveyed a broader scope in India. Care should be taken that under the bolar exemption no person can manufacture the patented products for profit and money-making business. The basic intention is that people must get medicine or patented invention at the minimum cost.





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