Patent filings credit Bharat Biotech as ‘inventor’ of Covaxin, omit ICMR

India’s first indigenously developed coronavirus vaccine, Covaxin, was a joint collaboration between the Indian Council of Medical Research (ICMR) and the Hyderabad-based Bharat Biotech International Limited (BBIL) with intellectual property (IP) rights jointly shared between the two organisations. That is what the public record states. However, filings by the BBIL at patent offices in India, the United States and Europe suggest that only its scientists and personnel are credited as ‘inventors’ of the vaccine with no mention of ICMR scientists.

The Hindu has viewed documents detailing these patent applications. If BBIL personnel, credited in applications as Deepak Kumar and Krishna Murthy Ella — Chairman and Founder, BBIL— are indeed the only inventors, it contradicts a statement by the Union Health Ministry, the nodal Ministry of the ICMR, in the Rajya Sabha, which claimed that the IP rights are “jointly owned”.

In response to a question in the Rajya Sabha on July 2021 by Congress president Mallikarjun Kharge, who demanded details of the agreement between the ICMR and the BBIL for the development of Covaxin, the then Minister of State (Health Ministry) Bharati Pravin Pawar laid out a detailed response.

The Minister’s statement said the ICMR would provide a “well characterised” virus strain for vaccine development, the BBIL would develop the final vaccine formulation and, be given a “non-exclusive” licence granted to commercialise the product within two years. It was explicitly mentioned that the “..intellectual property over the product would be jointly owned by the ICMR and the BBIL.” The ICMR would also receive as royalty 5% of net sales to be remitted half-yearly.

The ICMR said that while it had not funded the BBIL for Covaxin development, one of its institutes — the ICMR-National Institute of Virology (NIV), Pune — had spent “funds for Covaxin development“.

It also funded phase-3 clinical trials of Covaxin at 25 locations, involving 25,800 participants. All in all, the ICMR spent ₹35 crore for developing Covaxin. As of January 2022 — as per an update by the government to the Rajya Sabha — the ICMR received ₹171 crore as royalty for Covaxin.

Ms. Pawar’s response to Parliament, however, did not elaborate on the sharing of patent rights. The BBIL, which has over the years had several research collaborations with public research bodies such as the Council of Scientific and Industrial Research (CSIR) and the ICMR itself, has listed scientists from all institutions as ‘inventors’ in patent applications.

A BBIL spokesperson told The Hindu that the patent filed by Bharat Biotech was only for “process development” and specific to the making of the vaccine. It also covered the use of an adjuvant (an ingredient used in vaccines to elicit a stronger response) that was licensed from the Kansas-based ViroVax and added to Covaxin.

India’s patent laws allow both product and process patents. Product patents grant an inventor a monopoly over, say, a drug. Process patents bar competitors from making a similar drug using the same sequence of steps. “Bharat Biotech is innovator of the process developed after procuring strain from the NIV through an agreed consideration between both the parties. Moreover, the NIV was also responsible for testing for other variants. It is to be noted that while ICMR/NIV owns the animal challenge (clinical trials on animals) studies, Bharat Biotech owns the process development and new adjuvant added to the vaccine.” In the case of the CSIR, product development involved funding from both the CSIR and the BBIL and hence merited co-inventorship during patent applications, the spokesperson’s email suggested. The BBIL did not clarify on who owned the rights to the human clinical trial data — information that is usually not disclosed by pharmaceutical companies.

Close involvement of ICMR

The ICMR’s close involvement in all aspects of Covaxin development is well known, particularly — as former chief Dr. Balram Bhargava has described in his book, Going Viral: The Making of Covaxin, how ICMR scientists isolated the Sars-Cov2 strain from Italian tourists in March 2020, gave it to Bharat Biotech which developed a batch of vaccine candidates by April 30 that were then used to conduct pre-clinical animal studies on rats, hamsters, monkeys and following encouraging results, trials on humans. All of the resulting publications that describe the results of these trials — some published in leading journals such as TheLancet — list both ICMR scientists as well as scientists from the BBIL as co-authors in the study.

An independent expert said collaborating entities usually clearly spell out how IPR and patenting rights from a resulting invention would be shared in a memorandum of understanding (MoU). “There could be multiple kinds of agreements and only a perusal of the MoU can clarify on such matters,” an IPR lawyer, who declined to be identified as he consulted both of these organisations, told The Hindu. The ICMR has previously declined Right to Information requests by activists and media on the terms of this MoU citing “third party confidentiality”.

“This raises some important questions. If intellectual property is jointly owned, then patent applications require that all the inventors be mentioned. In the United States, for instance, not mentioning all inventors can be strong grounds for the rejection of patents,” Dr. Zakir Thomas, who was previously been involved in intellectual property development at the CSIR, told The Hindu. “While intellectual property is a broad term, only one of which is patents, the ICMR should clarify the statement made to Parliament on what it means by co-ownership and whether it collaborated in the development.” The Hindu emailed to Dr. Rajiv Bahl, Director-General, ICMR, but has received no response till going to press. Dr. Bhargava, who has now retired from the ICMR and All India Institute of Medical Sciences, declined comment.