Would a global vaccine IP waiver stifle future biopharma breakthroughs?
Published on 22nd Apr 2021
Pressure for an IP rights waiver to fight the pandemic threatens vaccine companies' ability to develop and protect their trade secrets and the reward and incentive to innovate
The People's Vaccine Alliance, endorsed by 170 Nobel Laureates and former heads of state, in an open letter (14 April 2021) has called on President Biden to support a temporary waiver of the World Trade Organization (WTO) rules on intellectual property (IP) during the Covid-19 pandemic.
The waiver request is, according to the People's Vaccine Alliance, "…a vital and necessary step to bringing an end to this pandemic. It must be combined with ensuring vaccine know-how and technology is shared openly…This will save lives and advance us towards global herd immunity".
Gordon Brown, the former British prime minister, brought his rhetoric to bear in The Guardian stating: "Home to the major vaccine developers, the G7 countries are in the best position to agree to transfer vaccine technology to low-income countries. The temporary waiver of patents proposed by the People’s Vaccine Alliance will help Africa create its own manufacturing facilities and end months of vaccine nationalism."
But is this correct? Is there any evidence that patents or IP rights have been a factor in the lack of vaccine availability and production in low income countries? And would waiving the rights of IP owners remedy the situation and achieve the aims of the People's Vaccine Alliance?
First proposed to the WTO by India and South Africa in October 2020, the request to the WTO would take the form of a waiver of the obligations of the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement and would cover "Section 1 on copyright and related rights, Section 4 on industrial designs, Section 5 on patents and Section 7 on the protection of undisclosed information". The waiver would "last for a specific number of years, to be agreed by the General Council, and until widespread vaccination is in place globally and the majority of the world's population is immune. Members would review the waiver annually until termination."
While the focus of the recent news stories has been concentrated on patent rights, the proposed waiver goes much further. It covers all IP rights, including trade secrets, relevant to the protection of the vaccine and the optimal manufacturing processes for producing it in a safe and efficacious way at industrial scale.
The patent bargain
So what of patents? The patent bargain – the disclosure of your invention to the world for a time-limited monopoly – has been available in many countries for many hundreds of years (the Venetian patent system started granting patents in 1474). And this is a crucial point: the technical advance taught by a patent is available to the world already. How the invention works must be described in sufficient detail for it to be replicated. This is an essential basis for grant and failure to do so makes the patent vulnerable to being revoked entirely. In addition, the function of the various national and international patent registers is to make patents available to the world at large.
Once granted, there is a risk that developers of vaccine technology will enforce their patent rights against infringers using it without permission. In normal circumstances, this would be the case. The legal systems of all technologically sophisticated countries are careful to recognise valid patent rights, as with all legal property rights. Not to do so would create uncertainty and discourage investment in research and development.
Since patents are state-granted monopolies, the state is usually very careful to reserve the right to override the patentee's property rights in extraordinary circumstances. As a result, most national patent systems have a mechanism to grant compulsory licences (or Crown Use in the UK) where the invention can be made available more broadly if public policy or public health demands it.
Why then do the countries requesting access to vaccine patents not simply invoke these provisions? François Hollande, former president of France, recently said: "The extreme inequality in access to vaccines around the world creates an unbearable political and moral situation… If the United States supports the lifting of patents, Europe will have to take its responsibilities." Was he overlooking that the French state has chosen not to exercise its pre-existing rights to grant a licence to patented vaccine technology in France in the interests of public health (see Articles L.613-16 and L.613-17 of the French Intellectual Property Code)?
The truth is that European countries, and most others, are already in a position to override the patent rights they have granted but seem to prefer the US to go first before they are prepared to follow suit. That is probably because such action by a single country alone is likely to be interpreted by industry (i.e. the owners of the relevant IP rights) as a very drastic measure.
What of the other traditional IP rights mentioned in the waiver request? Copyright and industrial designs are unlikely to feature prominently in the fundamental IP protecting vaccine technology and manufacturing.