In an interview that punctures the euphoria created by the United States’ announcement it will support the waiver of intellectual property rights of COVID-19 vaccines, one of India’s most well-known vaccine manufacturers has said waiving IP rights is an important first step but by no means sufficient. To successfully copy a vaccine you need to have access to the technical know-how and process trade secrets of the inventor company. Prabuddha Kundu, the Co-founder and Managing Director of Premas Biotech, a company working on an oral COVID-19 vaccine, said, “There is a clear divide between a patent and a trade secret … just by reading a patent does not necessarily offer the ability to replicate the product or the process”.
In a 35-minute interview to Karan Thapar for The Wire, Kundu said, “patents are not written as books for everyone to copy. They are written in broad terms, not in detail”. Manufacturing, he added, involves tens of different things, each of which requires knowledge of the technical know-how and the process trade secrets developed by and fine-tuned by the inventor company. If these are not readily available then the mere waiver of IP rights will not lead to vaccine manufacture in an easy, simple, and straightforward way.
Kundu further made another very important point. He said a vaccine is a biological entity and not a chemical entity. Therefore, producing a vaccine is very different from the reverse engineering of HIV drugs, which was done so successfully by Cipla in the early 2000s. In fact, Yusuf Hamied, the Chairman of Cipla, has himself accepted this point. “Vaccines are a different ballgame”, he has said. “You can pick up the patent of a vaccine manufacturer but you still won’t be able to produce (the vaccine)”.
In the interview to The Wire, Kundu said that after acquiring the IP rights, it was still necessary to have access to technology and equipment, training and experienced manpower, raw materials, and, most importantly, the trade secrets that lie behind the manufacturing process of the inventor company.
This echoes the viewpoint of Sharvil Patel, the Managing Director of Zydus Cadila, another company working on a COVID-19 vaccine, who has said that no one knows “the exact process of manufacturing” used by the inventor company. “Minor changes in the process can change the product outcome. If we leave it in the fermentation for one hour more, it would fail. If we check the pH a bit late, it can fail. It is very important to know every nuance of a particular vaccine’s manufacture”.
Kundu said perhaps this is why no one had publicly admitted they were trying to copy the Moderna vaccine even though Moderna waived its patent rights in October i.e. six months ago.
Kundu pointed that in the event a generic manufacturer is able to overcome the hurdles of technology, lack of experienced manpower, and process trade secrets to produce a vaccine it would still need to go through clinical trials and receive regulatory approval. It’s also possible that some manufacturers might not submit the product for regulatory approval because they have doubts about its quality or efficacy.