Debate Intensifies Over A Vaccine IP Waiver's Impact On Future Pharma And Biotech Discoveries

• Published date: 23 June 2021
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Coronavirus (COVID-19), Patent, Operational Impacts and Strategy
• Law Firm: Osborne Clarke
• Author: Will James and Tim Harris

Does a proposed patent suspension backed by Washington open a Pandora's box for vaccine R&D and investment?

On 5 May the US government unexpectedly swung behind the calls to waive intellectual property (IP) protections for Covid-19 vaccines, apparently greatly reducing the odds of such a step. The share prices of major vaccine manufacturers including Pfizer, Moderna, Novavax, BioNTech and CureVac all fell in response to the announcement.

However, EU leaders and others have subsequently pushed back against the proposed waiver, while nevertheless signalling an openness to discuss it. There is understandably considerable support from all quarters to increase vaccine production and distribution, but many speaking out against the waiver do not see IP rights limiting supply. There is concern that a threat to override IP rights, even in these limited and exceptional circumstances, may well be counterproductive.

WTO debate

The waiver was first proposed by India and South Africa at the World Trade Organisation (WTO) in October 2020. The WTO's Trade-Related Aspects of Intellectual Property Rights (TRIPS) council will continue to debate the proposal in the coming weeks, but alongside the clamour to override IP rights (notwithstanding that 45 - almost half - of the countries supporting a waiver are already exempt from TRIPS) there seems to also be a growing realisation of the difficulties and adverse consequences if the proposals are agreed. And that is assuming a timely agreement can be reached: the exemption provided by the 2001 Doha Declaration took years to reach.

Much debate so far has focussed on patent rights. However, a patent by definition contains a public disclosure of its scope and TRIPS already permits countries to override patents in specified circumstances. National legislation also generally allows government-sanctioned compulsory licensing to meet public health or policy requirements.

Trade secrets

Far more contentious is the call to ensure "undisclosed information" such as confidential information and trade secrets are shared. As we have previously explained, companies invest vast sums into developing what are often their "crown jewels", which derive value from not being publicly available. It is not clear what thought has been given to the practicalities and consequences of forcing companies to disclose these secrets to other, competing, companies as well as to states with less robust IP protections.

As a first step, companies would need to...