Background on the Covaxin Patent Filing Issue:
Bharat Biotech International Limited (BBIL), the manufacturer of Covaxin, an indigenous coronavirus vaccine, has acknowledged an "inadvertent error" in its patent filings.
BBIL failed to include scientists from the Indian Council of Medical Research (ICMR) as co-inventors in the Covaxin patent applications.
BBIL is one of India’s leading biotechnology companies.
Vaccine Patent Governance in India:
India's patent laws cover both product and process patents.
Product Patents: Grant an inventor monopoly over a product, such as a drug.
Process Patents: Prevent competitors from using the same sequence of steps to produce a similar product.
BBIL patented the process of manufacturing vaccines from virus strains provided by the ICMR-NIV (National Institute of Virology).
The ICMR-NIV specializes in extracting viruses, identifying their characteristics, and conducting tests to gauge their infectiousness.
Industrial-scale vaccine production requires facilities beyond the capabilities of standard labs.
Covaxin is an inactivated version of the coronavirus that prompts the body to produce antibodies against COVID-19.
An 'adjuvant' is added to enhance the vaccine's effectiveness.
Vaccine makers develop unique methods for these processes to maintain a competitive edge and secure temporary market monopolies.
Patent Granting Process:
Companies can file for patents in multiple countries, but patents are granted only after regulatory authorities verify the novelty or inventiveness of the process.
BBIL has not yet been granted patents for Covaxin as of the latest public information.
Roles of BBIL and ICMR in Developing Covaxin:
BBIL and ICMR-NIV collaborated on all vaccine development steps, formalized through an agreement detailing their responsibilities.
Due to the public nature of ICMR and the COVID crisis, there were Right To Information requests to disclose the agreement.
Parts were revealed in the Rajya Sabha in July 2021.
ICMR's roles included testing vaccines on animals and humans to ensure efficacy, funding clinical trials (₹35 crore), and incurring development costs.
ICMR was to receive 5% of royalties from Covaxin sales.
The agreement implied joint intellectual property rights between BBIL and ICMR.
BBIL’s Distinction in Patent Rights:
Initially, BBIL claimed a distinction between the rights for making the vaccine and the rights over data from clinical trials.
BBIL argued that since ICMR didn’t invest in vaccine production, it wasn’t included in patent applications.
After public scrutiny, BBIL admitted the mistake and promised to amend applications to list ICMR personnel as inventors.
Importance of Being Cited as an Inventor:
Intellectual Property Rights (IPR) are complex, covering every aspect of the invention process.
Development of pharmaceutical products typically involves multiple entities, necessitating several licensing agreements.
Being listed as an inventor affects the sharing of IPR, royalties, and usage rights of the product.
Omitting inventors in patent filings, particularly in the U.S., can lead to patent application rejections.
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