Section 107A of the Indian Patent Act, 1970, also known as the “Bolar Provision,” allows for the early working of a patented invention for the purposes of obtaining regulatory approval for the commercialization of the invention. This provision enables generic drug manufacturers to get marketing approval for their products before the expiry of the patent on the corresponding innovator product.

The Bolar Provision was introduced in India in 2005 as a part of the amendment to the Indian Patent Act. The provision allows for the early working of a patented invention for the purposes of obtaining regulatory approval for the commercialization of the invention. This provision enables generic drug manufacturers to obtain marketing approval for their products before the expiry of the patent on the corresponding innovator product. ⚡

📍Section 107A of the Patents Act 1970 of India incorporates it as:

107A Certain acts not to be considered as infringement –

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 199 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 provision applies to pharmaceutical and agrochemical products and is intended to promote timely access to affordable medicines by allowing generic manufacturers to prepare and sell their products in anticipation of the expiry of the patent. The provision enables generic manufacturers to start obtaining regulatory approval for their products well before the expiry of the patent, thus reducing the time required for the product to reach the market after the patent expires.

📌 The Bolar Provision has been a subject of debate in India, with some arguing that it undermines the rights of patent holders, while others argue it is necessary to promote access to affordable medicines. Supporters of the provision argue that it promotes competition and innovation by allowing generic manufacturers to enter the market earlier, which leads to lower prices for consumers. They also argue that it promotes timely access to medicines by reducing the time required for new products to reach the market.

📌 Critics, however, argue that the provision undermines the rights of patent holders by allowing generic manufacturers to copy their products and sell them at lower prices before the patent has expired. They also argue that it may discourage innovation by reducing the financial incentives for companies to invest in the research and development of new products.

📌 Despite these debates, the stakeholders have widely accepted the Bolar Provision in India, as it has helped to promote timely access to affordable medicines. Several other countries have also adopted the provision, including the United States, Canada, and the European Union, as a way of balancing the rights of patent holders with the need to promote access to affordable medicines.

📌 It’s also noteworthy that the Indian Patent Act is in line with the TRIPS agreement, which allows for the early working of patented inventions for the purposes of obtaining regulatory approval. The provision has also been supported by various judgments of Indian courts which have held that the provision is in compliance with the Indian patent law and the TRIPS agreement.

👉 In conclusion, the Bolar Provision in the Indian Patent Act is a provision that enables generic drug manufacturers to obtain marketing approval for their products before the expiry of the patent on the corresponding innovator product. The provision allows for the early working of a patented invention for the purposes of obtaining regulatory approval for the commercialization of the invention. The provision is intended to promote timely access to affordable medicines by allowing generic manufacturers to prepare and sell their products in anticipation of the expiry of the patent. Despite some criticism, the provision has been widely accepted in India as it has helped to promote timely access to affordable medicines.

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