Section107A of the Indian Patent Act is known as India’s Bolar Exemption. It is a defence used against patent infringement.
When an invention is made, it is either used or sold by a third party for certain purposes in order make further research and development. Thus, this provision is made extremely important for the very fact that the generic drug manufacturers who seek to boost their business in the market soon after the expiry of the innovator companies’ patents, and thereby having the necessary time or opportunity for conducting research on the product while the patent being still valid.
It is also to be noted that in the Bayer v. Natco, the dispute created jurisprudence for affirmatively deciding the scope of India’s ‘Bolar Exemption’ as being the first post-TRIPS grant of compulsory license.
The Bolar Exemption According to the Section 107A of the Indian Patent Act, 1970, the concept of “Bolar Exemption” in simple terms provides for an exception in infringements of patents, that is to say, the exception is given to generic manufacturers from using and in furtherance to importuning such patented drugs for their research and development in order to get regulatory approvals.
The prime purpose of the Section107A is to ensure that the patented products are ready with the approval for market launch as soon as the innovators’ products get expired.
The Bolar exemption under the Indian Patent Act, 1970
The fundamental object of the Section 107A talks about certain acts not to be considered as infringement. The section says –
“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 authorised under the law to produce and sell or distribute the product,
Shall not be considered as an infringement of patent rights.”
India is the nation which has the highest production of generic drugs as compared to any other developing nations.
Under Article 30 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), the exceptions may be provided as follows:
- prior use,
- private non-commercial use,
- And experimental use.
The aforementioned exceptions should meet the three-step test:
- They are limited
- Do not unreasonably conflict with the normal exploitation of the patent
- Do not unreasonably prejudice the legitimate interests of the patent owner
(Taking account of legitimate interests of third parties)
The Bolar exemption can be largely marked by a good or legitimate reason as in consonance with the Doha Declaration, which is continuing firmly or obstinately in an opinion or course of action in spite of difficulty or opposition for the need of providing medicines at a cheaper cost.
However, the present issue is the comparing observation in such a way as to emphasize differences on regard to the issue of commercial purposes. Albeit Section 107A is yet to undergo the judicial scanner.
India’s market is highly sensitive with low per capita income, though it being a developing country, masses of people are largely dependent upon the conditions of the market for survival.
In layman terms, it can be said that patent right is a temporary government-granted monopoly right and a market oriented right.
That is why the perspective of patent law is a critical issue such that the Bolar exemption has paramount importance for the public at large.
In short, the need of Bolar exemption in India can be justified with the following points:-
- It is useful for promoting the market competition.
- It is useful in providing the people an access to essential lifesaving drugs.
- The Bolar exemption further promotes research and development in the medical field.
The Bolar exemption is very relevant to the Indian scenario; it plays a crucial role in the protection of major part of the population in India that is suffering from deadly diseases.
It is a blessing for serving the needs of the pharmaceuticals industries in the generic drug production albeit, the lack of judicial interpretation is posing several doubts with questions that bring the patent law under the scanner of criticisms that are in abundance per se.
According to my opinion a step to move forward would require a reformation of the prevalent law which is inclusive of the data exclusivity period, prohibition of over stockpiling of drugs etc. Also, in order that there shall be a rise in genuine pharmaceutical companies the existing law must be amended so that the new law would focus on the international requirements, so as to ensure that patent rights are respected and in furtherance the research and development of generic drugs will be encouraged.
 Section 107A, clause (a) of the Indian patent Act,1970
 Section 107A, clause (b) of the Indian patent Act,1970