Why in the News?

Bharat Biotech International Limited (BBIL), the company that created the Indian coronavirus vaccine Covaxin, has admitted to making an unintended mistake in its patent filings. These filings are meant 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.

What’s in Today’s Article?

• About Patents & IPR (Meaning, Categories, etc.)
• About the Controversy (Details, Role of BBIL & ICMR, Conclusion)

What are Patents and IPR?

• A patent represents a powerful Intellectual Property Right (IPR), and is an exclusive monopoly granted by a Government to an inventor for a limited, pre-specified time.
• It provides an enforceable legal right to prevent others from copying the invention.
• Patents can be of two types:
• A product patent ensures that the rights to the final product is protected, and anyone other than the patent holder can be restrained from manufacturing it during a specified period.
• A process patent enables any person other than the patent holder to manufacture the patented product by modifying certain processes in the manufacturing exercise.
• Initially, India adopted process patenting in 1970s which enabled India to become a significant producer of generic drugs at global scale.
• However, due to the obligations under the TRIPS(Trade-Related Aspects of Intellectual Property Rights) Agreement, product patenting is also allowed in India.
• TRIPS is an international legal agreement between all the member nations of the World Trade Organization.

Controversy Surrounding the Covaxin IPR:

• BBIL explained that they patented the process of making vaccines from virus strains provided by the ICMR-NIV (National Institute of Virology).
  • The ICMR-NIV specializes in extracting viruses from blood samples, identifying their characteristics, conducting tests to measure their infectiousness, and comparing them to related strains.
• However, turning this research into a vaccine on an industrial scale requires facilities that only established vaccine manufacturers have.
• Covaxin, the vaccine developed by BBIL, is an inactivated version of the coronavirus that causes COVID-19.
• When injected, it stimulates the body to produce antibodies that may protect against severe illness from the virus.
• To enhance its effectiveness, an ‘adjuvant’ is added to the vaccine.
• Vaccine manufacturers have their own methods for combining these steps, and because the field is highly competitive, they try to prevent others from copying their processes to maintain a temporary monopoly and earn profits.
• It’s important to note that while companies can apply for product or process patents in as many countries as they can afford, a patent is only granted after regulatory authorities are convinced that the process is indeed novel or inventive.
• As far as publicly known, Bharat Biotech has not yet been granted these patents.

What were the Roles of BBIL and ICMR?

• BBIL collaborated with ICMR-NIV on every step of developing the Covaxin vaccine. They signed an agreement outlining each organization's responsibilities.
• Due to ICMR being a public entity and the scale of the COVID crisis, there were requests to make this agreement public under the Right to Information Act.
  • Portions of the agreement were revealed in the Rajya Sabha in July 2021.
• The agreement specified that beyond providing the virus strains and making the vaccines, ICMR would also test the vaccines on animals—from rodents to monkeys—and then on humans to ensure the vaccine's efficacy.
• 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.
• Since the collaboration was announced, it was generally understood that both entities would share the intellectual property rights.
• Initially, BBIL said that there was a distinction between the rights to make the vaccine and the rights to the data from clinical trials.
  • They stated that because ICMR had not invested in the actual production of the vaccine, it was not included in the patent applications.
• Following public scrutiny, BBIL admitted to an error and announced plans to file new applications listing ICMR personnel as co-inventors.

Conclusion:

• IPR is a complex field that covers all aspects of product invention.
• Developing pharmaceutical products requires various types of expertise, making it difficult for single firms to handle everything alone.
• Companies often enter into multiple licensing agreements, as BBIL did with Virovax for an adjuvant.
• When multiple entities collaborate on a single product, being listed as an inventor affects the sharing of IPR, royalties, and product usage.
• Disputes over IPR are common across all fields. In patent filings, especially in the U.S., not listing all inventors can result in patent application rejections.