Patent filing names Bharat Biotech as 'inventor' of Covaxin, ICMR not named

Patent filing names Bharat Biotech as 'inventor' of Covaxin, ICMR not named

The ICMR said that though it did not fund Bharat Biotech for the development of Covaxin, one of its institutes - the ICMR-National Institute of Virology (NIV), Pune - did

The ICMR said it did not fund Bharat Biotech for the development of Covaxin but one of its institutes – the ICMR-National Institute of Virology (NIV), Pune – had spent “funds for the development of Covaxin”. File | Photo credit: The Hindu

India's first indigenously developed coronavirus vaccine, Covaxin, was a joint collaboration between the Indian Council of Medical Research (ICMR) and Hyderabad-based Bharat Biotech International Limited (BBIL), with intellectual property (IP) rights jointly shared between the two organisations. This is what is stated in public records. However, documents filed by BBIL in patent offices in India, the United States and Europe show that only its scientists and personnel have been credited as 'inventors' of the vaccine, while there is no mention of ICMR scientists.

Hindu BBIL ​​has seen documents detailing these patent applications. If the BBIL personnel credited in the applications as Deepak Kumar and Krishna Murthy Ella – chairman and founder, BBIL – are indeed the sole inventors, this contradicts a statement made in the Rajya Sabha by the Union health ministry, the nodal ministry for ICMR, that Claimed IP rights are “jointly owned”,

In response to a question asked in the Rajya Sabha by Congress president Mallikarjun Kharge in July 2021, in which he had sought details of the agreement between ICMR and BBIL for the development of Covaxin, the then Minister of State (Health Ministry) Bharati Pravin Pawar had given a detailed reply.

The minister's statement said ICMR will provide “well-identified” virus strains for vaccine development, BBIL will develop the final vaccine formulation and will be given a “non-exclusive” licence to commercialise the product within two years. It was clearly mentioned that “the intellectual property on the product will be jointly owned by ICMR and BBIL.” ICMR will also get 5% of net sales as royalty, which will be remitted on a half-yearly basis.

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

It also funded Covaxin’s Phase III clinical trials at 25 locations, involving 25,800 participants. In total, ICMR spent ₹35 crore on the development of Covaxin. By January 2022 — according to an update given by the government to the Rajya Sabha — ICMR received ₹171 crore as royalty for Covaxin.

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

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

India’s patent laws allow patents of both product and process. Product patents grant an inventor a monopoly on, say, a drug. Process patents prevent competitors from making a similar drug using the same sequence of steps. “Bharat Biotech is the originator of the process developed after receiving the strain from NIV through an agreed idea between both parties. In addition, NIV was also responsible for testing other variants. It should be noted that while ICMR/NIV owns the animal challenge (clinical trials on animals) studies, Bharat Biotech owns the process development and the new adjuvant added to the vaccine.” In the case of CSIR, the product development involved funding from both CSIR and BBIL

Close involvement of ICMR

ICMR’s close involvement in all aspects of Covaxin development is well known, especially – as described by former chief Dr Balram Bhargava in his book G.Viral: Manufacture of CovaxinICMR scientists who isolated the Sars-Cov2 strain from Italian tourists in March 2020 passed it on to Bharat Biotech which developed a batch of vaccine candidates by April 30 which were used to conduct pre-clinical animal studies on mice, hamsters, monkeys and after encouraging results, trials on humans. All the resulting publications describing the results of these trials – some published in leading journals such as Knife – The study lists scientists from ICMR as well as BBIL as co-authors.

An independent expert said collaborating entities usually clearly state in a memorandum of understanding (MoU) how IPR and patenting rights from the resulting invention will be shared. “There can be many types of agreements and only a perusal of the MoU can provide clarity on such matters,” said an IPR lawyer, who declined to be identified while consulting both these organisations. HinduThe ICMR had previously rejected Right to Information requests by activists and the media on the terms of this MoU, citing “third party confidentiality”.

“This raises some important questions. If intellectual property is jointly owned, patent applications must mention all inventors. For example, in the United States, not mentioning all inventors can be a strong ground for rejection of a patent,” said Dr Zakir Thomas, who was previously involved in intellectual property development at CSIR. Hindu. “While intellectual property is a broad term, of which patents are only one, ICMR must clarify its statement in Parliament as to what is meant by co-ownership and whether it has contributed to the development.” Hindu An email was sent to ICMR Director General Dr Rajiv Bahl but there was no response till the time of going to press. Dr Bhargava, who is now retired from ICMR and the AIIMS, declined to comment.

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