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The race for a Covid-19 vaccine or treatment is on. With around 400 potential candidates in development, according to BioCentury, pharma companies have recognised their role in resolving the crisis. They have applied themselves to the challenge without hesitation.
However, the situation is bringing some difficult questions to the fore, not least the balancing act between public health and private interests. The pharma industry, as a rule, tends to be fiercely protective of its intellectual property (IP) and indeed sees patents as key to innovation.
“Intellectual property has not been an impediment to the common goal of ending this pandemic and rather has enabled the development of several medicines and vaccines that are now being tested for additional use in the fight against the COVID-19,” argues Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Association (IFPMA).
He adds that the private R&D business model, underpinned by IP rights, has been foundational to most of the existing treatments that are now being tested for coronavirus. It has also enabled companies to make bold investments in R&D for new products.
“We have never needed innovation so much as now,” he says. “This is probably the worst possible time to weaken intellectual property, when biopharmaceutical companies are investing significantly and are taking many risks without any guarantee that their medicines or vaccines will make it past the finishing line.”
At the same time, we are seeing pushback from some commentators and academics, who feel that IP rights ought to be waived in an emergency. As they see it, it is only through temporarily dropping patents that we will see equitable and extensive access to medicines.
“We’re always going to spend millions of pounds in developing medicines, so a strong patent regime makes sense in normal times,” says Dr Enrico Bonadio, a reader in intellectual property law at City University. “But in emergency situations, it’s important be able to relax those rules to guarantee a quick and widespread supply of patented medicines. You need to balance patent protection against the fact that the patent owners have a monopoly and therefore the opportunity to raise prices.”
Voluntary licenses and collaborations
It is a nuanced issue, with heated arguments on both sides. And if present indications are anything to go by, the issue will not be resolving itself any time soon.
Some pharma companies are taking the initiative and are waiving their intellectual property rights voluntarily. Most notably, US firm AbbVie has suspended its global patent rights for Kaletra, an HIV drug that has been identified as a potential treatment for coronavirus.
Other companies are exploring various forms of collaboration. The World Health Organization (WHO) has launched a taskforce called Covid-19 Tools Accelerator, which brings together many different organisations to speed up drug development. The Medicines Patent Pool has temporarily expanded its mandate to include health technologies related to Covid-19. Pfizer has entered into a partnership with biotech company BioNTech, to jointly develop the latter’s vaccine candidate. And Sanofi has teamed up with GSK to share technologies.
“IFPMA member companies are collaborating widely to ensure that our expertise is shared across the scientific community as part of the global fight against this devastating virus,” says Cueni. “A great deal of this effort is being carried out by putting aside normal competition and instead working in collaboration with partners in academia, philanthropy, public and private sector, pooling knowledge and sharing expertise.”
However, it’s clear that not all pharma companies are jumping at the prospect of losing their IP rights. As early as January, the Wuhan Institute of Virology applied for a national patent on the experimental antiviral drug remdesivir.
Gilead, the US company that first developed this drug, also applied for ‘orphan drug’ status in the US – a decision that would have granted it seven years of market exclusivity. It was only following significant public pressure (and criticism from then-presidential candidate Bernie Sanders) that the company backtracked on its decision.
A number of pharma executives have also condemned the concept of patent pools. A WHO-backed initiative called Solidarity Call to Action, which was due to launch May 29th, would have created a mechanism for patent sharing. However, its future is up in the air after pharma leaders expressed their reservations. The CEO of Pfizer called it ‘nonsense’, with the CEO of AstraZeneca stating: “if you don’t protect IP, then essentially there is no incentive for anybody to innovate.”
Compulsory licenses and government action
Given the mixed response from the pharma industry, we may soon start to see governments imposing the compulsory license of patents. This is a legal mechanism, effective on a national level, which can be granted in an emergency. It allows rival companies to manufacture and sell generic versions of a patented drug, thus breaking the inventor’s monopoly and keeping prices as low as possible.
“The usual narrative pushed by the pharma industry is that compulsory licenses discourage investment,” says Dr Bonadio. “But there are in fact very few cases of compulsory licenses being granted, as they are only justified in exceptional circumstances. Covid-19 is a circumstance that does justify the issuance of a compulsory license if a patent owner doesn’t want to co-operate.”
Take AbbVie’s decision to drop its global patent rights for Kaletra. While that decision was taken voluntarily, it actually followed on from a compulsory license issued in Israel. Several other governments (notably Germany, Canada, Chile and Ecuador) have also begun plans to limit patent rights and potentially issue compulsory licenses.
“This doesn’t mean we want to jeopardise intellectual property – it’s just that we need to act urgently to provide cheap medicines quickly to fight this virus,” says Dr Bonadio. “This is a temporary suspension of patent rights to resolve this crisis, and of course once it is resolved the IP rights that have been relaxed temporarily could be expanded with the full weight of their force.”
A balancing act
Dr Bonadio isn’t sure how this will play out over the months ahead. However, he feels that relatively few pharma companies will want to kick back against compulsory licenses. While patent owners could, in theory, ask the judge to grant an injunction towards the generic company that wanted to copy their medicine, this kind of litigation could be something of a PR disaster.
“The moral of all this is we need to find a balance between two opposing interests,” says Dr Bonadio. “On the one hand you have the pharma company that has spent so much in order to develop the medicine, and on the other hand you have the overarching public interest. Opinions differ on how this balance should be reached.”
In the meantime, the pharma industry continues to defend the role of intellectual property, and resist insinuations that it might be putting profit ahead of public health. Cueni points out that the pharma industry is working hard to ensure fast, equitable and affordable access to COVID-19 vaccines and treatments. He sees intellectual property as an integral part of this overall ecosystem.
“The biopharmaceutical industry recognises that a flexible approach is needed to accommodate and support different R&D and access efforts, and that no easy ‘one size fits all’ solution exists,” he says. “In this spirit, we are open to explore innovative approaches and partnerships to facilitate further R&D to develop new medicines and vaccines for patients suffering from COVID-19 and to expand access.”