Many have been said and written about compulsory licensing and IP waivers in the last couple of months as the COVID-19 cases surged dramatically in India. While the second wave has hit the country so badly, the government is trying hard to better the situation and provide relief to those affected. With the run for vaccines increasing with every passing day, compulsory licensing and IP waivers are seen as rays of hope to tackle the situation.
India has once again shown the world that we are going to leave no stone unturned in our fight against the pandemic. We are a leading pioneer of compulsory licensing for life-saving drugs.
Let discuss what is compulsory licensing?
When a government allows the production of a patented product or process without the patent owner’s consent or plans to use the patent-protected invention itself, this is termed compulsory licensing. It is regarded as one of the flexibilities in patent protection included within the WTO’s agreement on intellectual property – the TRIPS (Trade-Related Aspects of Property Rights) Agreement. (Ref- wto.org)
The weakness of India’s vaccination program has come to the fore over the last month because the brutal Covid-19 second wave exploded everywhere in the country. Vaccination centres around the nation have faced shortages, and therefore the current pace wouldn’t allow India to succeed in herd immunity by the end of the year.
Some political leaders, like Delhi CM Arvind Kejriwal, have demanded that the Centre invoke its powers to issue compulsory licenses. Vaccine production is often ramped up to help the states vaccinate more people over a shorter period.
A Division Bench of the Kerala SC asked the Centre to reply to a plea that involved invoking the compulsory licensing to permit other capable vaccine manufacturers to produce Covid vaccines. The Bench comprised of Justice Raja Vijayaraghavan and Justice M.R.Anitha. They passed the directive when public interest litigation during this regard came up for hearing.
The petition said that the scarcity of vaccines was mainly due to the lack of manufacturers of the vaccines to build up their production. All capable Indian companies might be allowed to supply Covid-19 vaccines by invoking the compulsory licensing system. This has been approved by the World Trade Organisation (WTO).
There have been recent shortages within the supply of remdesivir and tocilizumab, among other drugs, across hospitals in India because of the sudden surge in covid cases from April 2021.
Several companies manufacture Remdesivir through a voluntary license issued by Gilead Sciences, and Sun Pharmaceutical Industries makes the drug in partnership with Syngene.
Tocilizumab, imported from Roche, is distributed in India by Cipla under the brand name Actemra.
In its position paper, IDMA said that property rights got to be urgently waived off across the planet for covid drugs to speed up their production and ensure adequate supply during the pandemic. (Ref – Economic Times, Livemint, IDMA)
All these facts show that there is an urgent requirement for compulsory licensing.
In October 2020, India and South Africa submitted a proposal that suggested a waiver for all WTO members to implement, apply, and enforce specific TRIPS Agreement provisions concerning preventing, containing, and treating COVID-19.
More than six months after the idea of relaxing vaccine patents, the US government announced its support for the proposal. US Trade Representative Katherine Tai said that “extraordinary times call for extraordinary measures“.
Earlier this week, China too backed the IP waiver for coronavirus vaccines.
Let us dive a little deeper into this issue.
What are vaccine patents?
Patents are a type of contract between the government and an individual/company/firm- the patent owner. Patents are devised to reward and protect innovation by preventing competitors from copying a discovery and launching a rival, competitive product.
In the US, patents on medicines typically last 20 years from the date they are filed, which usually happens once a drugmaker thinks it’s a lucrative drug.
It often takes over ten years to get a drug approved, so pharma companies and drug manufacturers typically enjoy about a dozen years of competition-free sales. Drugmakers usually find ways to improve their product, and by doing so, they secure additional patents, which will extend their monopoly for several more years.
One of the essential reasons why patent protection is essential to drugmakers is its cost and investment to build and develop a drug. Medicines are incredibly expensive to develop, and most drugs fail at some point during the years of laboratory, animal, and eventually human testing. The cost of experiments is high, and an immense amount of time investment goes into making any drug.
Vaccines are made with utmost care and are crucial in improving the health care scenario in a given country or place.
Can an IP waiver resolve the vaccine shortage?
This is a question to which there’s, so far, no clear answer. Vaccines need to be made in very controlled, high-tech facilities, and the technology to produce them does not exist across the globe so that IP waivers can help in some capacity. However, there are several limitations.
First of all, there could be severe issues related to manufacturing vaccines, such as those supported messenger RNA (mRNA) technology. Just an easing of the associated intellectual property rights rules is not enough. Support in terms of infrastructure and manufacturing should be provided to generic pharmaceutical firms in countries like India and South Africa. This is because a “technology transfer” is also needed for the latter to commence production, especially for mRNA vaccines, especially the ones produced by Moderna and Pfizer along with BioNTech. To illustrate, Pfizer has stated that its vaccine production requires the utilization of 280 components from 86 suppliers and highly specialized manufacturing equipment. So, these manufacturing plants need to be set up apart from relaxing the IP regulations.
Most vaccine production is currently concentrated in high-income countries. The production by middle-income countries has been happening through licensing or technology transfer agreements which is a relatively slow process. Gearing up production capacities will be a lengthy process, which is why pharmaceutical companies are cited against the move. Most analysts believe this to take at least a few months. It is most likely that the agreement will be targeted by the WTO’s next ministerial conference scheduled in end-November.
The bottom line is that even with a patent waiver, some countries may not have the know-how to produce their vaccines.
Disclaimer: The present article intends to provide general guidance on the subject, and you can also consult us in your specific case.