What was the controversy regarding Covaxin IPR? | Know in detail

What was the controversy regarding Covaxin IPR? | Know in detail


For image representation.

Image representation. | Photo Credit: The Hindu

the story So Far: Bharat Biotech International Limited (BBIL), the manufacturer of the indigenous coronavirus vaccine, Covaxin, has admitted an “inadvertent mistake” in patent filings to protect the intellectual property rights (IPR) of the vaccine. One of India’s leading biotechnology companies, it failed to include Indian Council of Medical Research (ICMR) scientists as co-inventors in the Covaxin patent filings.

What types of rights govern vaccine patents?

India’s patent laws govern both product and process patents. Product patents grant an inventor a monopoly on, say, a drug. Process patents prevent competitors from making the same drug using the same sequence of steps. In response to queries from The Hindu, Bharat Biotech said it had patented the process, that is, making a batch of vaccines from virus strains provided by ICMR-NIV (National Institute of Virology). This is the laboratory that specializes in extracting the virus from blood samples, identifying its characteristics, conducting various tests to assess its infectivity and qualifying it against related strains. However, making a vaccine from it on an industrial scale is beyond the capacity of a laboratory and requires a set of facilities that only established vaccine manufacturers have. Covaxin is an inactivated version of the COVID-causing coronavirus; once injected into the body it induces the production of antibodies that can potentially protect against severe illness from coronavirus infection. To do this effectively, an 'adjuvant' is added which enhances the potency of the vaccine. Vaccine manufacturers may have their own methods of bringing all these steps together and, given the competitive nature of the sector, they attempt to prevent competitors from copying these processes in order to gain a temporary monopoly in the market and make profits.

Of course, companies can apply for patents in as many countries as they want for a product or process, but a patent is granted only when the regulatory authorities grant them a patent or are convinced that the process is truly new or inventive. As far as is publicly known, BBIL has not yet been granted these patents.

What was the role of BBIL and ICMR?

BBIL ​​had collaborated with ICMR-NIV for all stages of developing the vaccine. The two organisations had signed an agreement that clarified the responsibilities of each entity. Since ICMR is a public body and given the scale of the Covid crisis, requests were made under the Right to Information to make this agreement public. However, it was only in July 2021 that parts of the agreement were made public in the Rajya Sabha.

The agreement stated that apart from transferring the strains and making the vaccines, ICMR would also test these vaccines on animals – from mice to monkeys – and then on people to ascertain whether the vaccine worked the way it was supposed to. ICMR also funded these clinical trials – to the tune of ₹35 crore – and bore the cost of developing Covaxin. In return it was to get 5% of the royalties earned by BBIL from the sale of Covaxin. Since the announcement of the BBIL and ICMR collaboration, it was generally accepted that both entities would contribute to the vaccine and therefore hold “joint intellectual property rights”, as was stated in Parliament.

However, BBIL had earlier pointed out Hindu It made a distinction between the right to manufacture the vaccine and the right to data generated from clinical trials. ICMR had not invested in the actual manufacture of the vaccine and was therefore not included in the patent applications. However, a day after the matter became public, BBIL said it had made a mistake, and that it would rectify it by filing fresh applications in which ICMR personnel would be listed as inventors. It is not clear why this was done.

Why does it matter to be cited as an inventor?

IPR is a vast, complex domain and extends to the smallest parts of the product invention process. Since the development of pharmaceutical products involves a wide range of expertise, it is difficult for single firms or entities to develop everything in-house. Like the BBIL-ICMR collaboration, companies can enter into multiple licensing agreements – for example BBIL had a technology licensing agreement with Virovax for adjuvants, among other companies. If a single product involves multiple entities and collaborators, being listed as an inventor has a bearing on intellectual property rights, royalty sharing and even determining how a product can be used. There is no field of human activity that is untouched by disputes over IPR. In patent filings, not listing all inventors is a common practice – especially in the US


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