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22nd June 2024 (10 Topics)

Patent Filings Credit Bharat Biotech as ‘Inventor’ of Covaxin, Omit ICMR


India's first indigenously developed coronavirus vaccine, Covaxin, was a joint collaboration between the Indian Council of Medical Research (ICMR) and Bharat Biotech International Limited (BBIL). However, recent patent filings by BBIL in India, the United States, and Europe credit only BBIL scientists as inventors, omitting any mention of ICMR scientists.

Key Highlights of the Issue

  • ICMR and BBIL Collaboration: The official records state that Covaxin's intellectual property (IP) rights are jointly shared between ICMR and BBIL. ICMR provided the virus strain, while BBIL developed the final vaccine.
  • Patent Filings: Documents show that BBIL personnel, such as Deepak Kumar and Krishna Murthy Ella, are credited as inventors. This contradicts statements by the Union Health Ministry that the IP rights are jointly owned.
  • Government Response: In July 2021, the Health Ministry stated in the Rajya Sabha that the IP rights over Covaxin would be jointly owned by ICMR and BBIL, and ICMR would receive a 5% royalty from net sales.
  • Financial Contributions: ICMR did not fund BBIL for Covaxin development but spent ?35 crore through its institute, ICMR-National Institute of Virology (NIV), Pune, and on phase-3 clinical trials. As of January 2022, ICMR received ?171 crore in royalties.

1: Dimension - Discrepancies in Intellectual Property Credit

  • Patent Credit Controversy: The omission of ICMR scientists in the patent filings contradicts the government’s statement about joint IP ownership, raising questions about transparency and recognition in public-private collaborations.
  • Legal and Ethical Concerns: This discrepancy highlights potential legal and ethical issues in acknowledging contributions from all collaborators, which is crucial for fostering trust and fairness in joint ventures.

2: Dimension - Impact on Public Health and Governance

  • Public Trust: Such discrepancies can undermine public trust in governmental institutions and their collaborations with private entities, affecting public health initiatives' credibility.
  • Policy Implications: This situation calls for clearer policies and guidelines on IP rights and credit-sharing in government-funded research to prevent similar issues in future collaborations.
3: Dimension - Required Measures
  • Clear Guidelines and Agreements: Establish comprehensive guidelines and transparent agreements on IP rights and credit-sharing at the start of collaborations to avoid disputes.
  • Strengthening Oversight: Enhance oversight mechanisms to ensure all contributors are adequately credited and their contributions are recognized in patents and other formal documents.
  • Promoting Fair Practices: Foster a culture of fairness and recognition in scientific collaborations to encourage future public-private partnerships and innovation in public health.
Mains Practice Question

Q: “Transparency in public-private partnerships is essential for fostering innovation and trust in public health initiatives.” Discuss in the context of the Covaxin patent controversy.

Fact Box: India’s Patent System
  • A patent grants exclusive rights to its holder for an invention. In India, patents last for 20 years from the date of application.
  • To qualify for a patent under the Indian Patent Act of 1970, the innovation must meet these criteria:
    • Novelty: It must be new.
    • Non-obviousness: It should not be obvious to someone skilled in the field.
    • Industrial Applicability: It should be usable in industries.
    • Patentable Processes: Only manufacturing techniques or processes can be patented.
    • Exclusions: It shouldn’t be subject to sections 3 and 4 of the Patents Act of 1970’s provisions.
  • International Compliance: India aligns its patent laws with international standards.
    • It joined the World Trade Organization in 1995, leading to compliance with the TRIPS Agreement.
    • Amendments in 2005 introduced pharmaceutical product patents in line with TRIPS.
    • India is also part of various intellectual property conventions, including the-
      • Berne Convention for copyright
      • Budapest Treaty
      • Paris Convention for Industrial Property protection
      • Patent Cooperation Treaty for patent matters
  • In a globalised world, intellectual property rights assume significance and are a source of litigation. Broadly distinguish between the terms – copyrights, patents and trade secrets. (2014)
  • Bringing out the circumstances in 2005 which forced an 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. (2013)

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