Intellectual Property Rights in India

What was the tussle over Covaxin IPR?

Note4Students

From UPSC perspective, the following things are important :

Prelims level: Patent process in India, COVAXIN

Why in the News?

  • Bharat Biotech International Limited (BBIL), maker of the indigenous coronavirus vaccine Covaxin, admitted to an “inadvertent error” in patent filings. The error involved failing to include scientists from the Indian Council of Medical Research (ICMR) as co-inventors in the patent filings.

COVAXIN Story

  • BBIL patented the process of making a batch of vaccines from virus strains provided by ICMR-NIV (National Institute of Virology).
  • ICMR-NIV’s role involved extracting viruses, identifying characteristics, conducting tests, and qualifying strains for vaccine development.
    • ICMR funded these clinical trials with ₹35 crore and incurred costs in developing Covaxin.
    • In return, ICMR was to receive 5% of the royalties BBIL earned from the sale of Covaxin.

Vaccine Patents in India 

  • In India, patents, including those for vaccines, are governed by the Patents Act, 1970, and its subsequent amendments.
  • This act aligns with the TRIPS Agreement (Trade-Related Aspects of Intellectual Property Rights) under the World Trade Organization (WTO).

Key Provisions of the Patents Act, 1970:

  • Patentable Inventions:
      • An invention must be novel, involve an inventive step, and be capable of industrial application.
      • Section 3 of the Patents Act outlines what are not considered inventions, which includes methods of treatment, and processes for medicinal, surgical, curative, prophylactic, diagnostic, therapeutic, or other treatments of human beings.
  • India grants both process and product patents:
    • Product Patents: Grant a monopoly over a specific drug.
    • Process Patents: Prevent competitors from using the same sequence of steps to create a similar product.
  • Compulsory Licensing:
    • Under Section 84, compulsory licenses can be issued if the patented invention is not available to the public at a reasonably affordable price, or if the reasonable requirements of the public are not being met.
  • Bolar Provision:
    • Section 107A allows the use of patented inventions, including vaccines, for the purpose of research and development to obtain regulatory approval before the patent expires.

Why was the ICMR not included?

  • Bharat Biotech initially excluded ICMR from patent applications because they viewed the ICMR’s role primarily as providing virus strains and conducting clinical trials, rather than being directly involved in the technical processes of vaccine development.
  • There might have been a miscommunication or oversight regarding the understanding of intellectual property rights and inventorship between BBIL and ICMR initially.

 

PYQ:

[2013] Bringing out the circumstances in 2005 which forced amendment to the section 3(d) in Indian Patent Law, 1970, discuss how it has been utilized by the Supreme Court in its judgement in rejecting Novartis’ patent application for ‘Glivec’. Discuss briefly the pros and cons of the decision. (200 words)

[2014] In a globalized world, Intellectual Property Rights assume significance and are a source of litigation. Broadly distinguish between the terms—Copyrights, Patents and Trade Secrets.

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