The ICMR said that while it has not funded Bharat Biotech for the development of Covaxin, one of its institutes – the National Institute of Virology (NIV), Pune – has spent “funds for the development of Covaxin”. File | Photo Credit: The Hindu
The first coronavirus vaccine developed in India, Covaxin, is a joint collaboration between the Indian Council of Medical Research (ICMR) and Hyderabad-based Bharat Biotech International Limited (BBIL) with intellectual property (IP) rights shared between the two organizations. This is a general note. However, BBIL’s filings with patent offices in India, the United States and Europe show that only scientists and personnel are credited as ‘inventors’ of the vaccine without mentioning ICMR scientists.
The Hindu have seen documents detailing the patent application. If the personnel of BBIL, credited in the application as Deepak Kumar and Krishna Murthy Ella – Chairman and Founder, BBIL – are really the only opinion, this contradicts the statement of the Union Ministry of Health, the nodal Ministry of ICMR, in the Rajya Sabha, which claims that IP rights “jointly owned”.
Responding to a question in the Rajya Sabha in July 2021 by Congress president Mallikarjun Kharge, who demanded details of the agreement between ICMR and BBIL for the development of Covaxin, Minister of State (Ministry of Health) Bharati Pravin Pawar then explained. detailed response.
The Minister’s statement said that while ICMR will provide “well-characterized” virus strains for vaccine development, BBIL will develop the final vaccine formulation and, granted a “non-exclusive” license to commercialize the product for two years. It is clearly stated that “..intellectual property in respect of these products will be jointly owned by ICMR and BBIL.” ICMR will also receive a royalty of 5% of net sales which will be remitted semi-annually.
The ICMR said that while it did not fund BBIL for the development of Covaxin, one institute – ICMR-National Institute of Virology (NIV), Pune – had spent “funds for the development of Covaxin”.
It also funded Covaxin’s phase-3 clinical trial in 25 locations, involving 25,800 participants. In all, ICMR spent ₹35 crore to develop Covaxin. From January 2022 – according to the government’s update to the Rajya Sabha – ICMR received ₹171 crore as royalties for Covaxin.
Ms. Pawar’s answer to the Parliament, but did not clarify the division of patent rights. BBIL, which for years has had research collaborations with public research bodies such as the Council of Scientific and Industrial Research (CSIR) and ICMR itself, has listed scientists from all institutions as ‘inventors’ in patent applications.
A BBIL spokesperson said The Hindu that the patent filed by Bharat Biotech is only for “process development” and specifically for manufacturing the vaccine. It also includes the use of adjuvants (ingredients used in vaccines to elicit a stronger response) licensed from Kansas-based ViroVax and added to Covaxin.
Indian patent laws allow product and process patents. Product patents give the inventor a monopoly over, say, a drug. The patent process prevents competitors from making the same drug using the same sequence of steps. “Bharat Biotech is the innovator of the process developed after obtaining the strain from NIV through considerations agreed between both parties. In addition, NIV is also responsible for testing for other variants. It should be noted that while ICMR / NIV has animal challenge studies (clinical trials on animals), Bharat Biotech has a new process and adjuvant added to the vaccine. In the case of CSIR, the product development involved funding from CSIR and BBIL and hence obtained the title of co-inventor during the patent application, a BBIL spokesperson advised clarifies who has rights to human clinical trial data – information that pharmaceutical companies typically do not disclose.
Close involvement of ICMR
ICMR’s close involvement in all aspects of Covaxin development is well known, especially – as explained by former leader Dr. Balram Bhargava in his book, Going Viral: The Making of Covaxin, how ICMR scientists isolated the Sars-Cov2 strain from an Italian tourist in March 2020, gave it to Bharat Biotech that developed several vaccine candidates on April 30 that were then used to conduct pre-clinical animal studies on mice, hamsters, monkeys and follow encouraging results, trials in humans. All publication results that describe the results of these trials – some published in leading journals such as AtLancet – list ICMR scientists as well as scientists from BBIL as co-authors in the study.
Independent experts say that cooperating entities usually clearly explain how the IPR and patent rights of the resulting inventions will be shared in the Memorandum of Understanding (MoU). “There are various agreements and only reading the MoU can clarify the matter,” said an IPR lawyer, who declined to be identified when asked by the two organizations. The Hindu. The ICMR has earlier turned down Right to Information requests by activists and the media about the terms of this MoU citing “third party confidentiality”.
“This raises some important questions. If the intellectual property is jointly owned, the patent application requires all the inventors. In the United States, for example, not mentioning all the inventors can be a strong reason to reject the patent,” said Dr. Zakir Thomas, who was previously involved in intellectual property development at CSIR, said The Hindu. “While intellectual property is a broad term, only one is patentable, the ICMR should clarify the statement made to Parliament about what is meant by joint ownership and what is collaboration in development.” The Hindu sent an email to Dr. Rajiv Bahl, Director General, ICMR, however did not receive a response till going to press. Dr Bhargava, who has now retired from ICMR and the All India Institute of Medical Sciences, declined to comment.
