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Covaxin Patent Filing Issue UPSC NOTE

 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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Learnerz IAS | Concept oriented UPSC Classes in Malayalam: Covaxin Patent Filing Issue UPSC NOTE
Covaxin Patent Filing Issue UPSC NOTE
Learnerz IAS | Concept oriented UPSC Classes in Malayalam
https://www.learnerz.in/2024/07/covaxin-patent-filing-issue-upsc-note.html
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https://www.learnerz.in/2024/07/covaxin-patent-filing-issue-upsc-note.html
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