Covaxin is a joint venture of ICMR and Bharat Biotech International Limited (BBIL) in the development of Whole-Virion Inactivated Vero Cell, which is a time-tested and well-established platform of safe vaccine technology. This vaccine also includes immune potentiators, also known as vaccine adjuvants, which are added to the vaccine to increase its immunogenicity. After DCGI approval for 375 and 380 participants were respectively undertaken in Phase I & II human clinical trials in July 2020, individuals between the ages of 12 and 65 years old were included in the trial.

The development of Covaxin, comprising the help it received in the form of facilitation of the virus strain, the scientific intervention, and funds of INR 35 crore for supporting a phase-III clinical study with 25,800 participants in 25 locations for BBIL’s Covaxin from the ICMR, paved the way for ICMR to attain its royalty rights through the successful signing of the MoU with BBIL. This partnership highlights the Patent Act’s provisions for adaptable license agreements, which fetched a royalty benefit of INR 171 Crore.

Recently, a major dispute was caused when the Union Health Agency, acting through ICMR (the nodal agency), asserted joint ownership of the intellectual property rights of Covaxin. They were granted access to royalties through a confidential Memorandum of Understanding (MoU), even though they were not explicitly named as assignees in BBIL’s patent application.

The questions started to come up, and the Union Health Agency was under immense pressure as to why they passed a statement of patent ownership despite not being an assignee in the published patent application. Later, to calm the tides, ICMR informed the press about the signed MoU with BBIL that states joint ownership of patent-based royalty. However, ICMR gained royalty benefits from BBIL, which is easily understandable by a simple law where a patentee (in this case, BBIL) is already allowed under Section 68 of the Indian Patents Act, 1970, to grant licenses to other parties to use, manufacture, and sell the patented invention. This license can be exclusive or non-exclusive and can cover specific territories or fields of use.

However, BBIL announced in June 2024 to rectify and include the names as assignees of ICMR scientists in the patent application, explaining it as an “inadvertent mistake” that will be corrected in the fresh filing of patent purposes to the India Patent Office as soon as the document gets submission ready [Source]

The MoU is enough regarding the patent royalty / its monetary share for either the actual inventors or the interested parties that have exclusive/non-exclusive rights over the patent. However, being an assignee and inventor in the filed patent application dictates their dominance as the actual body that played a crucial role in coming up with the ideation, development, and execution of the invention.

Hence, it is good news for ICMR to finally get the awaited recognition on their patent application for their efforts in developing Covaxin with BBIL.

By: Dr. Nishat Fatima