Patent Filings Attribute Covaxin Invention Solely to Bharat Biotech, Excluding ICMR Despite Government Claims

India’s first indigenously developed COVID-19 vaccine, Covaxin, was publicly described as a joint effort between the Indian Council of Medical Research (ICMR) and Hyderabad-based Bharat Biotech International Limited (BBIL), with intellectual property rights reportedly shared between both organizations. However, an examination of patent filings by BBIL in India, the United States, and Europe reveals that only BBIL scientists are credited as inventors, with no mention of ICMR personnel.

Documents reviewed show that BBIL scientists Deepak Kumar and Krishna Murthy Ella, Chairman and Founder respectively, are named as the sole inventors in these patent applications. This stands in contrast to a statement made by the Union Health Ministry in the Rajya Sabha in July 2021, which asserted that the intellectual property over Covaxin is “jointly owned” by ICMR and BBIL.

In response to a parliamentary question by Congress president Mallikarjun Kharge, then Minister of State for Health Bharati Pravin Pawar detailed the collaboration framework. The ICMR was to provide a “well characterised” virus strain, while BBIL would develop the vaccine formulation and receive a non-exclusive license to commercialize it within two years. The Minister explicitly stated that the intellectual property would be jointly owned by both parties, with ICMR entitled to a 5% royalty on net sales, remitted biannually.

The ICMR clarified that it did not fund BBIL’s vaccine development directly but that its National Institute of Virology (NIV) in Pune allocated funds toward Covaxin development. Additionally, ICMR funded phase-3 clinical trials conducted at 25 sites involving 25,800 participants, investing approximately ₹35 crore in total. By January 2022, the government reported that ICMR had received ₹171 crore in royalties from Covaxin sales.

Despite this, the Health Ministry’s parliamentary response did not elaborate on the specifics of patent rights sharing. BBIL, which has a history of research collaborations with public bodies such as the Council of Scientific and Industrial Research (CSIR) and ICMR, typically lists scientists from partner institutions as inventors in patent applications. However, in Covaxin’s case, only BBIL personnel appear as inventors.

A BBIL spokesperson told The Hindu that the patent filings pertain specifically to “process development” related to vaccine manufacturing and include the use of an adjuvant licensed from Kansas-based ViroVax. Indian patent law permits both product and process patents; product patents grant exclusivity over the vaccine itself, while process patents protect the method of manufacture. The spokesperson emphasized that BBIL innovated the process after procuring the virus strain from NIV under an agreed consideration, and that NIV was responsible for testing against variants and animal challenge studies. BBIL owns the process development and the new adjuvant added to the vaccine.

Regarding clinical trial data ownership, BBIL did not clarify who holds rights to the human trial information, which pharmaceutical companies typically keep confidential.

The ICMR’s involvement in Covaxin’s development is well documented. Former ICMR chief Dr. Balram Bhargava, in his book Going Viral: The Making of Covaxin, describes how ICMR scientists isolated the SARS-CoV-2 strain from Italian tourists in March 2020 and provided it to BBIL, which developed vaccine candidates by April 30. These candidates underwent preclinical animal studies and subsequent human trials. Publications reporting trial results, including those in The Lancet, list both ICMR and BBIL scientists as co-authors.

An intellectual property expert noted that collaborative entities typically define IP and patent rights sharing explicitly in a memorandum of understanding (MoU). The ICMR has declined Right to Information requests for details of such an MoU, citing third-party confidentiality.

Dr. Zakir Thomas, formerly involved in IP development at CSIR, remarked that if intellectual property is jointly owned, all inventors must be named in patent applications. Failure to do so can be grounds for patent rejection, particularly in jurisdictions like the United States. He urged the ICMR to clarify its parliamentary statement on co-ownership and its role in Covaxin’s development.

Attempts to obtain comment from ICMR Director-General Dr. Rajiv Bahl were unanswered at press time. Dr. Bhargava, now retired, declined to comment.

The discrepancy between government statements and patent filings raises important questions about the precise nature of intellectual property rights and inventorship in the development of Covaxin, a vaccine critical to India’s COVID-19 response.