Patent waivers alone may not lead to quick vaccine access, say experts
The waiving off of patents alone is unlikely to help improve vaccine availability anytime soon, scientists, legal experts and pharma industry executives said, pointing to the complicated technical know-how, raw materials and infrastructure required to make vaccines while ensuring they are as safe and effective as the original developer intended it to be.
Several countries, including the US, France and the European Union are considering backing efforts by low and middle-income countries such as India and South Africa for a global waiver of coronavirus vaccine patents in order to boost supplies.
While such a move could well be the first step in helping broaden access, patents alone do little to allow someone else to make biological therapeutics such as vaccines, unlike in the case of generic drugs, which are chemicals and can be replicated more easily with a recipe book of sorts.
“Patents are a way of protection of your intellectual and commercial information, speaking from a legal point of view. But just by reading a patent, does not necessarily offer the ability to replicate the product or the process, because while a patent does share a lot of the generic information, it protects the specifics, and it is not a self-guide,” said Prabuddha Kundu, co-founder and managing director at Premas Biotech, which is working on an oral Covid-19 vaccine.
To understand the challenge, consider the case of some coronavirus vaccines: AstraZeneca and J&J’s vaccines involve a bio-engineered adenovirus that expresses the Sars-Cov-2’s spike protein; Novavax’s vaccine consists directly of the spike protein that has been cultured and grown in moth cells in labs.
“A chemical entity and a biological entity are very different. Even a simple protein, for example, is hundred times more complex or has more components than a drug like, say, paracetamol. There can be many ways to make paracetamol, and it would turn out to be exactly that but even if there were few ways to produce the protein, the final product varies in its final shape and form,” added Kundu, who is a biomedical engineer by training and specialises in scaling up.
And for that, he added, “you must understand the process so well, that every time you carry it out, you end up with exactly the same product. In many situations in biologics, the process is the product. So when patents are filed for a product or part of the process, it is to protect the geographical rights or commercial interest but in no way are we being provided with a to -do guide for how to do it”.
Legal experts in the pharma field said this constitutes know-how, which often is a trade secret. “There is a clear divide between a patent and a trade secret. The technical know-how is proprietary. TRIPS provides for protection of undisclosed information, which would not be found in patents,” said Dev Robinson, partner and head, Intellectual Property, at Shardul Amarchand Mangaldas.
TRIPS refers to the Trade-Related Aspects of Intellectual Property Rights agreement under the World Trade Organization (WTO), the specific framework that India and South Africa have sought waivers under – which has been backed by the United States and France as on May 6.
In an interview with HT published on March 26, Cipla chairman Yusuf Hamied too called vaccines “a different ballgame”, and said producing these was different from what the company did with an HIV drug in early 2000s, when it offered it to the world at a fraction of the cost.
“All drugs required for HIV-AIDS were synthetic drugs, and in the synthesis of drugs, India, even at that time, was quite proficient. But vaccines are a different ballgame. You can pick up a patent of a vaccine manufacturer, and you still won’t be able to produce,” he said.
The conversation around patents has been in the spotlight as the world struggles to make access to vaccine equitable. The wealthiest 27 regions in the world account for 10.5% of the population, but 35.6% of vaccinations, according to data compiled by Bloomberg.
Robinson added that securing a patent waiver in itself will be a long process and may do little to make the know-how available quickly. “How you can get private companies to part with trade secrets under changes to TRIPS agreement in the immediate future? I don’t know. The TRIPS agreement is still a treaty at the end of the day – what you have to do is get every member to agree, or at least by majority, to have it adopted.
“Then each of these countries or the country of interest will have to take it back to their local legislative bodies where they will have to turn it into a municipal law, only then will it become enforceable against a private party. It doesn’t happen overnight. Historically, it has taken years to get this thing done,” he said, adding that a short term solution may “therefore lie in getting the cooperation of the private players to part with their know-how and to not assert their IPRs”.
Analysts said the production of coronavirus vaccines till now has demonstrated the complicated challenges that these processes involve, and they are particularly harder for breakthrough technologies like the mRNA platform.
“There is a very big difference between vaccines and medicines. For vaccines, ingredients, formula etc are very important but equally important are the production and quality setup and the personnel needed to oversee that. We have actually seen where the number of staff required for quality checks is in a 10:1 ratio because it is a biological product,” said Rasmus Bech Hansen, CEO of London-based science analytics company Airfinity.
With Covid-19 vaccines, Hansen added, “you could argue that yes freeing patents would make sense but as we have seen with vaccine production, that really does not seem to be the bottleneck – it’s not so much the number of facilities but the ability for them to produce vaccines and the quality that has mattered”.
A second Airfinity analyst cited some examples. “Till now, we have seen more production from fewer sites than the other way around – mostly due to difficulties in setting up. For example, AstraZeneca set up plenty of sites all around the world, some of which we haven’t seen open up yet – for example, there are sites in Australia and Europe have been behind schedule,” said Caroline Casey.
Kundu agreed with the assessments. “The analysts are right in saying that not only do you need duly trained manpower who should have done this before, but you need adequate equipment, tools and critical reagents to tell, if you are on the right path or not,” he added.
Kundu said that patents can also involve other patents, or a family of patents, complicating efforts to wade past licensing restrictions, as well as a principle known as freedom to operate (FTO) for any recipient of a patent to have the legitimate rights to commercialise a product that is created using a wide variety of components, that may involve other proprietary components.
“That said, opening of IP can be beneficial on the long run to cater to a global crisis. The nuts and bolts have to be worked out,” he added.