What laws govern the patentability of a vaccine’s intellectual property?
For what reason was the ICMR left out?
Bharat Biotech International Limited (BBIL), the company that produces the domestic coronavirus vaccine Covaxin, has acknowledged making a “inadvertent error” in the filing of a patent to safeguard the intellectual property rights (IPR) of the vaccine. Despite being one of the top biotechnology businesses in India, the Covaxin patent filings did not list scientists from the Indian Council of Medical Research (ICMR) as co-inventors.
Which legal framework applies to patents on vaccines?
Both product and process patents are governed by Indian patent law. With a product patent, an inventor can control, for example, a medicine. Process patents prevent rivals from producing a comparable medication by following the same methodology. Bharat Biotech stated that it had patented the method of producing a batch of vaccinations using viral strains provided by the ICMR-NIV (National Institute of Virology) in response to questions from media interactions. This lab is skilled at removing viruses from blood samples, defining their traits, and carrying out a range of tests to determine their infectiousness and evaluate them against similar strains.
But producing a vaccine on this scale industrially is beyond the capability of a laboratory and needs a different kind of facilities that are only available to well-established vaccine manufacturers. When injected into the body, covaxin, an inactivated form of the coronavirus that causes COVID, stimulates the production of antibodies that may offer protection against serious illness caused by a coronavirus infection. In order to achieve this, a “adjuvant” is added, which boosts the effectiveness of the vaccination. Given the competitive nature of the industry, vaccine manufacturers may have their own methods for combining all of these procedures, and they work to prevent rivals from copying them in an attempt to temporarily monopolise the market and profit.
While businesses are free to apply for a product or process patent in as many nations as they choose, a patent is only awarded when regulatory bodies approve the application or determine that the process is truly unique or original. As far as the public is aware, BBIL has not yet received these patents.
BBIL and ICMR: What were their roles?
Throughout the whole vaccine development process, BBIL and the ICMR-NIV worked together. An agreement outlining each organization’s responsibilities had been signed by the two. Due to ICMR’s status as a public organisation and the severity of the COVID-19 pandemic, requests for access to this agreement were made under the right to information.
Parts of the deal, however, were not made public in the Rajya Sabha until July 2021.
According to the deal, ICMR would not only transfer the strains and create vaccines, but it would also test them on animals, from rodents to monkeys, and then on humans, to ensure that the shots were effective.
In addition, the ICMR paid ₹35 crore for these clinical trials and incurred expenses in the development of Covaxin. It received five percent of the royalties that BBIL received from the sale of Covaxin in exchange. It was well acknowledged that both the BBIL and the ICMR would contribute to the vaccine and, as declared in Parliament, would consequently enjoy “joint intellectual property rights” following the announcement of their collaboration.
The Hindu was informed by BBIL first that there was a difference between the rights controlling vaccine manufacturing and the rights to the data produced by clinical trials. The ICMR was left out of patent filings because it had not contributed to the vaccine’s actual development. But, BBIL acknowledged its error and promised to make apologies by filing new applications that named ICMR employees as inventors the day after the situation went public. What caused this is unknown.
How come it matters to be acknowledged as an inventor?
IPR covers even the smallest details of the process of developing a new product and is a broad, intricate field.
Pharmacies require a wide spectrum of knowledge, thus it is difficult for single firms or institutions to develop everything in-house. firms may enter into multiple licencing arrangements with different firms, similar to the BBIL-ICMR collaboration. For example, BBIL had a technology licencing agreement with Virovax for the adjuvant. Becoming identified as an inventor affects the sharing of intellectual property rights, royalties, and even deciding how a product can be used if a single product so incorporates numerous businesses and partners.
IPR issues are present in every aspect of human endeavour.
In patent filings, failing to include the names of all inventors may potentially result in the rejection of patent applications, particularly in the United States.
ABHISHEK VERMA
Author: This news is edited by: Abhishek Verma, (Editor, CANON TIMES)
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