Less than two years into the pandemic, there is light at the end of the tunnel – thanks in large part to the rapid development of effective vaccines. Yet access to these life-saving jabs has been far from universal around the globe. The World Health Organization (WHO) has warned that Africa’s relatively low vaccination coverage, for instance, is likely to make the continent a breeding ground for further Covid variants for the foreseeable future.
What part, if any, has IP law played in impeding the global effort to end the pandemic? For example, Moderna is engaged in a long-running patent wrangle in which the firm is challenging the role claimed by the US government’s National Institutes for Health in the creation of its highly effective mRNA-1273 vaccine. The dispute could end up restricting output, especially if Moderna secures sole ownership rights, continues to protect crucial technical data and retains control over production and pricing decisions.
Richard Wilder is general counsel and director of business development at the Coalition for Epidemic Preparedness Innovations (CEPI), a multi-sector partnership founded in 2017 by the governments of Norway and India, the Bill & Melinda Gates Foundation, Wellcome and the World Economic Forum “to accelerate the development of vaccines against emerging infectious diseases”. It has since secured backing from several other organisations, including the UK government.
“An integral part of our funding is that we address equitable access, right from the get-go,” Wilder says. “Any time you fund any kind of research project, IP is one of the elements that’s discussed. As long as all the parties agree in the beginning what’s going to be done with the output, they can jointly decide how IP can be managed to achieve that.”
Without the patent system, companies would keep a lot more of their developments as a trade secret
Contrary to what some headlines have indicated, Wilder’s experience of the pharmaceutical industry’s approach to vaccine IP so far has been positive. “The entities we work with – companies large and small, the university sector and government labs – have approached the matter along constructive lines,” he reports.
They have acknowledged that the CEPI’s mission is to get as many shots in arms around the world and have managed their IP rights to achieve that, Wilder adds.
The patent system has actually served as “a facilitator, rather than a bottleneck”, according to Neil Thornton, a partner at patent law specialist Reddie & Grose.
He explains that, without patents and the protection these offer, pharmaceutical companies could never be certain that their huge R&D investments would be viable.
“Without the patent system, companies would keep a lot more of their developments as a trade secret,” Thornton says.
Anna Gregson, a partner at IP law firm Mathys & Squire, agrees. “The patent system is a motivator to innovators,” she says. “I don’t think patents have been anywhere near the biggest problem.”
Yet there remains a stark disparity between the world’s advanced and emerging economies concerning the progress of their vaccination programmes. In late August, researchers at the University of Oxford reported that 32.5% of the world’s population had been given at least one jab. In the UK, 50.8 million people – three-quarters of the population – have received at least one dose to date. But in lower-income countries, many of them in the Global South, only 1.4% of citizens had been vaccinated on average.
That’s partly because richer nations moved faster and spent more to snap up vaccines. An OECD analysis in March found that high-income countries had bought half of the world’s supply, despite accounting for only 16% of its population.
“One of the things we have struggled with, from the beginning of Covid-19 and more significantly over the past six months, is so-called vaccine nationalism,” Wilder says.
This phenomenon isn’t the preserve of the richest nations. For instance, the Indian government has withheld consignments of AstraZeneca vaccine that had been manufactured for export by the Serum Institute of India, so that more doses could be distributed inside the country.
There are other problems at play too. For example, Africa produces only 1% of all the vaccines used within the continent any given year. The African Union has set itself the goal of increasing that figure to 60% by 2030. Doing so would enable member states to respond more quickly to outbreaks, rather than having to wait for large global manufacturers to get round to them.
That would be an outstanding achievement, according to Thornton. It would plug enormous gaps in the global distribution of medicines, which could prove vital when it comes to tackling future epidemics.
“These vaccines are highly complex biological products with several components,” he says. “The main factors limiting their production are the supply of raw materials required; manufacturing capacity; and the availability of specialist equipment and trained personnel.”
A shortage in any of these areas could lead to a sluggish response, notes Thornton, who adds: “There simply aren’t companies out there with experience of producing these complex vaccines, sitting around waiting to roll them out.”
That said, the WHO has appointed a South African startup called Afrigen Biologics and Vaccines to work out how to make a product that is as close as possible to the vaccine created by Moderna, which has confirmed that it will not litigate during the pandemic to enforce its IP rights. Meanwhile, Moderna is planning to invest up to $500m (£375m) in constructing a vaccine factory of its own in Africa.
Gregson believes that big pharma has stepped up in an extraordinary way wherever it has had a reasonable opportunity to do so. “There are numerous examples of where it has appreciated the global crisis and taken unprecedented steps to facilitate access to vaccines and other drugs,” she says.
Wilder acknowledges that the patent system has not been perfect and still needs to be refined. “This is one of those topics that are always under discussion,” he says.
There are tools that politicians could wield to make all of the information required to produce vaccines more widely accessible, according to Gregson. These include the ‘Crown use’ provision in the UK, by which the government can order the infringement of a patent in certain situations, and compulsory licensing elsewhere. But they have yet to resort to such measures so far.
That’s partly because this isn’t where the problems affecting vaccine roll-outs have arisen. “This is about looking at the bigger picture,” she says. “It’s about addressing bottlenecks wherever they arise, rather than focusing on IP, where there are already recognised mechanisms in place that perhaps aren’t being used.”
