Section 107A of the Patent Act, 1970 is known as Bolar Exemption in India. It is a defence used against patent infringement. When an invention is made, it is either used or sold by a third party for specific purposes to 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 to have the necessary time or opportunity for researching the product while the patent is 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 defence 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 Section 107A is to ensure that the patented products are ready with the approval for market launch as soon as the innovators’ products get expired.
Bolar Exemption In India
The fundamental object of Section 107A talks about bolar exemption in India and individual acts not to be considered as an infringement. The section says:
- 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;
- 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.
Current Scenario Of Bolar Exemption In India
India is the nation which has the highest production of generic drugs as compared to any other developing countries. 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 exceptions mentioned above 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
A good or legitimate reason can largely mark the Bolar exemption in India 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 comparing observation in such a way as to emphasise differences regarding the issue of commercial purposes. Albeit Section 107A is yet to undergo the judicial scanner.
Purpose Of Bolar Exemption
India’s market is highly sensitive with low per capita income, though it is a developing country, masses of people are mostly 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 for Bolar exemption in India can be justified with the following points:-
- It is useful for promoting market competition.
- It is useful in providing the people access to essential lifesaving drugs.
- The Bolar exemption further promotes research and development in the medical field.
Bolar exemption in India is very relevant as it plays a crucial role in the protection of a significant 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.
A step to move forward would require a reformation of the common law which is inclusive of the data exclusivity period, the prohibition of over stockpiling of drugs etc. Also, so 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, to ensure that patent rights are respected and in furtherance, the research and development of generic drugs will be encouraged.