The Patents Act, 1970 was framed keeping in mind the vulnerable position of an inventor but exemptions are as important as granting exclusive rights to the inventor. Both granting of exclusive rights and exemptions play a significant role in the progress of science and technology; while the former encourages inventions, the latter encourages development in the targeted fields of technology. For an efficient progress of science and technology, a proper balance must be struck between the inventor’s exclusive right and the exemptions granted for research purposes.

Emergence from the US law

Research exemptions otherwise called as Bolar Exemptions has its roots in Roche Products, Inc V Bolar Pharmaceuticals where Bolar, a generic drug manufacturer used Roche’s patented Active Pharmaceutical Ingredient (API) to make generic versions of its drug in order to conduct clinical trial which was essential to secure regulatory approval from the US Food and drug Administration.  When Roche moved the court for infringement, the allegations were rejected on the ground that the patented API was not used for commercial purpose and does not amount to infringement. The court held that “Bolar’s use of the patented compound for federally mandated testing was not infringement of the patent in suit because Bolar’s use was de minimis and experimental”. This was subsequently reversed by the appellate court. Meanwhile the Hatch-Waxman Act was introduced which incorporated the decision of the lower court and hence the name Bolar Exemption.

Research Exemption under Indian Law

Section 48 of The Indian Patents Act, 1970 provides a monopoly right to the patent holder to make, use, sell or distribute his patented products. The rights conferred upon a patent holder under this section is not absolute to which Section 107A acts as an exception. The section was brought in by the 2003 amendment which states that any act of making, constructing, using, selling or importing a patented invention solely for uses related to the development and submission of information for regulating the manufacture, construction, use, sale or import of any product will not amount to infringement of patents. In short, the new provision was added whereby research exemption was granted as an exception to the general rule of patent. Such an addition emerged as a benefit to the pharmaceutical industry because the generic drug[1] manufacturers had the opportunity to put together their own version of the patented drug before the innovator drug’s patent term ends.

Bayer’s Corp V UOI

The concept of Research Exemption was put to test in the case of Bayer Corporation v. Union of India & Anr. In March, 2008, Bayer Corp was granted patent rights for the drug “Sorafenib Tosylate” [ST]. CIPLA announced the introduction of “Soranib” which was a substitute of ST and filed for an application with the Drug Controller General of India (DCGI) for obtaining marketing approval of the generic drug. Bayer, being the patentee, filed a writ restraining the DCGI from granting license to CIPLA to manufacture, market, imitate or substitute the drug “sorafenib tosylate”. Though initially an interim ex-parte order was granted by a Single Judge in favour of Bayer, the same was vacated later on the objections raised by CIPLA. Thereafter, Bayer preferred an appeal before the High Court of Delhi to make the DCGI liable for granting marketing approval for the drug “soranib” introduced by CIPLA. It was counter–argued by CIPLA that DCGI cannot be held liable for doing his job because it was not the role of DCGI to examine the infringement of patents but merely to assess the drug and grant marketing approval. Granting of such approval cannot be termed as patent infringement and CIPLA also took cover under S. 107A of the Patent’s Act, which provides for Bolar Exemption. It was put forth by CIPLA that bolar exemption was provided to encourage competition. “The greater the competition, the better it is for the protection of public health.” Finally, in the year 2010, the Delhi High Court ruled in favour of CIPLA stating that the DCGI can grant marketing approval to generic version of patented drugs without trespassing the law in force. A further appeal was preferred before the Supreme Court by Bayer and the same was dismissed.


The concept is highly relevant in the Indian scenario. India being one of the developing nations should bring in laws in favour of R&D. Research exemption is a boon to the pharmaceutical industries and generic drug dealers and it is the legal obligation of the court to assess whether the infringement has been caused due to R&D or for profit or for academic purpose. There exists a thin line between pure scientific research and a commercial interest and this has to be distinguished by the Court in each and every instance.

[1]A drug which is bio-equivalent to a branded drug in terms of dosage and composition and sold at a lower price than the branded drug because of the low cost of manufacturing it.

This article has been authored by Jayashri Suresh, an IP Law practitioner.

Related Posts: