Abstract

A person who owns intellectual property usually has exclusive rights over it;however, this isn’t always the case. There are several circumstances in which these exclusive rights will be restricted and the innovation may be used by a third party for legal purposes that do not constitute infringement. Bolar provision is one such provision, which is covered in further depth in this research paper. ‘Bolar Provision’is amongst the key provisions in the Patents Act. Essentially, the patent holder has a monopoly over the patent for a certain period of time because of their ingenuity. However, by preventing generics and other interested parties from entering the marketplace just after the expiration of patents, since marketing permission takes not less than a year or two, they often prolong their monopoly rights. This results in a de facto monopoly for the patentee. Hence, to represssuch activities as well as to safeguard the interests of generic producers, the idea of Bolar exemption was cultivated. After the ‘Roche v. Bolar’ decision, the United States was the first country to implement the bolar exception in the Hatch Waxman Act. The research article sheds light on the concept of Bolar provision under The Patents Act, 1970 and its impact on innovation and accessibility of generic drugs.

KEYWORDS:Bolar provision, Patents Act 1970, Section 107 A, Drugs and pharmaceutical inventions, Patent infringement.

INTRODUCTION

An inventor can obtain a patent which prohibit others to make, use, import, and sell the protected invention for a specifiedtime span—typically twenty years in most of the countries. Only after a lengthy review process with a chance to oppose in front of the competent authority or obligatory proceedings before the courts, a patent is granted to the innovator which motivates him to add to the reservoir of inventions. Whilst granting exclusive right over an invention to a patent holder, it is taken into consideration that there will be situations in which some humanitarian responsibilities have to be fulfilled. It is because of this reason that the patent laws around the world provides for certain exceptions. One of these exceptions is the “Bolar Provision,” also known as the “Bolar Exception” or the “Regulatory Exception”. Most of the countries entered into various accords as part of WTO over the 1990s. One among them is TRIPS, under which the World Trade Organization members have a general obligation to grant patents for inventions which qualify for patent protection, but they also have wider autonomy to incorporatecertain exceptions to it in their domestic legislations, as long as they comply with certain conditions. Member countries can make available adequate exemptions under Article 30 of the TRIPS Agreement[1] with regard to patent owners’ interests.

The primary role of the bolar provision is to permit some developmental research on a product that is already patented. It is of great importance for ‘the pharmaceutical and/or biotechnology industries’ insofar as bringing a drug from the research lab to market takesa long time, and filing an application for patent that is the fruit of years of experiment, study and research is just an essential initial step that must be subsequent to at least three clinical trial phases and obtaining regulatory clearances when the required data has been submitted. Thus, some patented products must be allowed to be used exclusively for research purposes without any direct commercial interest so that at least the new product can be introduced into the market soon after the expiry of a patent.Sec. 107 A[2]is the ‘Bolar provision’ in India. It permits any interested party to use or market a newly manufactured medication or drug for additional research or development without fear of facing legal retribution. This paper will now delve into various facets of the bolar provision.

[1]WIPO, https://www.wipo.int/wipolex/en/text/305907#part2.5 (last visited March 06, 2026).

[2] The Patents Act, 1970, § 107A, No. 39, Acts of Parliament, 1970 (India).