Context:
Bharat Biotech International Limited (BBIL), the creator of the Indian coronavirus vaccine Covaxin, admitted to an unintended mistake in its patent filings. These filings aim to protect the vaccine’s Intellectual Property Rights (IPR).
- Despite being one of India’s top biotechnology companies, BBIL forgot to list the scientists from the Indian Council of Medical Research (ICMR) as co-inventors in the patent documents for Covaxin.
Relevance:
GS II: Health
Dimensions of the Article:
- Controversy Surrounding the Covaxin IPR
- Roles of BBIL and ICMR
- What are Patents and IPR?
- Conclusion
Controversy Surrounding the Covaxin IPR
- Patent Explanation:
- BBIL patented the vaccine-making process using virus strains from ICMR-NIV (National Institute of Virology).
- ICMR-NIV focuses on extracting, identifying, and testing viruses from blood samples.
- Vaccine Development:
- Industrial-scale vaccine production requires specialized facilities.
- Covaxin, developed by BBIL, is an inactivated COVID-19 vaccine.
- The vaccine stimulates the body to produce protective antibodies, with an added adjuvant to boost effectiveness.
- Vaccine manufacturers use unique methods to combine these steps, maintaining a competitive edge and preventing process copying to secure temporary monopolies and profits.
- Patent Process:
- Companies can apply for patents in multiple countries, but approval requires proving novelty or inventiveness.
- Bharat Biotech has not yet received these patents.
Roles of BBIL and ICMR
- Collaboration:
- BBIL and ICMR-NIV collaborated on every step of Covaxin’s development, with an agreement detailing each organization’s responsibilities.
- The agreement was made public due to ICMR being a public entity and the COVID crisis scale, partially revealed in the Rajya Sabha in July 2021.
- Beyond providing virus strains, ICMR tested the vaccine on animals and humans to ensure efficacy.
- ICMR funded clinical trials with ₹35 crore, incurring development costs, and was to receive 5% of royalties from Covaxin sales.
- Intellectual Property Rights:
- Initially, it was believed both entities would share intellectual property rights.
- BBIL initially claimed a distinction between rights to make the vaccine and rights to clinical trial data, excluding ICMR from patent applications due to its lack of investment in production.
- Following scrutiny, BBIL acknowledged an error and plans to file new applications listing ICMR personnel as co-inventors.
What are Patents and IPR?
- Definition:
- A patent is a significant Intellectual Property Right (IPR) granting an exclusive monopoly by the government to an inventor for a limited, pre-defined period.
- It provides a legal right to prevent others from replicating the invention.
- Types of Patents:
- Product Patent: Protects the rights to the final product, preventing anyone other than the patent holder from manufacturing it during a specified period.
- Process Patent: Allows others to manufacture the patented product by altering certain processes in the production exercise.
- History in India:
- Initially, India adopted process patenting in the 1970s, which enabled the country to become a significant producer of generic drugs on a global scale.
- Due to obligations under the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement, product patenting is now also permitted in India.
- TRIPS is an international legal agreement among all member nations of the World Trade Organization.
Conclusion
- Complexity of IPR:
- IPR is intricate and encompasses all facets of product invention.
- Pharmaceutical Development:
- Creating pharmaceutical products necessitates diverse expertise, making it challenging for individual firms to manage everything independently.
- Licensing Agreements:
- Companies frequently enter into multiple licensing agreements, similar to BBIL’s collaboration with Virovax for an adjuvant.
- Collaboration and Inventorship:
- When multiple entities collaborate on a single product, being listed as an inventor influences the distribution of IPR, royalties, and product usage.
- Common Disputes:
- Disputes over IPR are prevalent in all fields. In patent filings, particularly in the U.S., failing to list all inventors can lead to the rejection of patent applications.
-Source: The Hindu
