Introduction
The UK government is one of the biggest investors of potential vaccines against Covid-19, following the latest “in-principle” agreement to purchase a sixth vaccine that takes its stockpile to 340 million doses (md).
The vaccine trials are spread across 4 vaccine types: adenoviral vaccines – Oxford/AZ (100md) and Janssen (30md); mRNA vaccines – BioNTech/Pfizer & Imperial (30md); inactivated whole virus vaccines – Valneva (60md); protein adjuvant vaccines – GSK/Sanofi (60md) and Novavax (60md). According to Kate Bingham, the chair of the government’s vaccine taskforce, if all of them work, “we will be the vaccine supplier to the world… but the likelihood is most of these will fail”. Campaigners have warned, however, that vaccine nationalism will cause billions of people in poorer countries to lose out, as wealthy countries are able to take a gamble, signing deals for vaccines that may not work.
The first case of the coronavirus (COVID-19) was reported to the WHO in December 2019. Its shockwave then spread across the planet, seeming to skip over countries, intent on reaching the Occident, where westerners stood frozen like rabbits caught in the headlights. Now the explosion over, and the world cold, there are aftershocks of new first waves, and second mini-waves or ‘spikes’: a word we use to reassure ourselves – it’s only a spike! Bewildered, westerners have picked themselves up, and rallied round. The pandemic, its foothold gained, has been met by unprecedented innovation and new thinking. Undoubtedly, it would have been a different story had COVID-19 stayed put in Wuhan, Hubei Province. Let wealthy countries take the gamble, and seek the investment: it is what they have always done, and it is what they are best placed to do.
The call to action
One of the most headline grabbing aspect of this innovation has been the UK government’s investment in vaccine R&D. Through different collaborative financial instruments to help secure Europe’s global competitiveness in research and innovation, the UK government has often invested in R&D, albeit indirectly through private partnerships across the EU. The estimated direct UK investment in return for 340md is, so far, £500 million in finance and infrastructure, even though, according to Bingham, “the likelihood is most of these will fail”: such is the nature of investment. Then there is the curious case of the indemnity in the nightmare: the UK government’s indemnity for third-party claims of patent infringement, should equipment made in response to the Ventilator Challenge UK infringe third-party IP rights. The indemnity raised eyebrows, as the extent of the support, financially and practically, is not clear. Only last week, the UK government announced a £500 million funding package to be invested in next generation testing technology, and increased testing capacity. The numbers are eye wateringly staggering.
Meanwhile, in the private sector, contributions have been truly innovative. It is difficult to keep up with the weekly heralding of initiatives, all of which break with traditional IP protectionism, and clamber toward IP liberalism, and even showboating. Large pharma and medical device companies have ‘donated’ IP by making relevant information available to the public, or have offered voluntary licences:
- Medtronic has posted design specifications for its Puritan BennettTM560 (PB560) ventilator, and Smiths Group has provided IP, and advice in relation to its paraPAC Plus ventilator to the Ventilator Challenge UK;
- Novartis has announced it will make IP from its COVID-19 clinical trials available through non-exclusive voluntary licences or waivers, and has published a set of compounds from its libraries that it considers suitable for in vitro antiviral testing;
- AbbVie has announced that it will not defend its patent rights to its drug Kaletra, and Gilead Sciences has asked the FDA to rescind the orphan drug designation awarded for its drug remdesivir for the COVID-19 indication; and
- in other cases, time-limited licences have been granted, which will remain in force for a set period of years, or until a specific event occurs such as the lifting of the WHO’s PHEIC designation. Licences have included terms requiring any improvements to the IP to be made available under a licence on identical terms, so that innovation is passed forward.
Other initiatives from the private sector have seen collaborations and particularly pooling affect IP:
- the Open Covid Pledge calls upon organisations around the world to make their patents and copyrights freely available in the fight against COVID-19. Originally developed by an international group of researchers, scientists, academics and lawyers, seeking to accelerate the rapid development and deployment of diagnostics, vaccines, therapeutics, medical equipment, and software solutions in the fight against COVID-19, the project is now led and stewarded by Creative Commons, a non-profit organisation that helps overcome legal obstacles to the sharing of knowledge and creativity, in order to address the world’s pressing challenges;
- licensing pools such as the Medicines Patents Pool (MPP) have existed for some time to support low-income and middle-income countries. The MPP has expanded its mandate, in collaboration with Unitaid, to include medicines and diagnostics for COVID-19 in its licensing pools;
- the MPP is also gathering patent knowledge for products being used in clinical trials, and making it available on its patents and licences database, MedsPaL. Products already included in the database include: remdesivir, lopinavir/ritonavir, favipiravir, and two biologics: tocilizumab and sarilumab;
- the WHO is to create a pool of rights to test, medicines and vaccines for COVID-19, with free access or licensing on reasonable and affordable terms for all countries. The WHO has supported the proposal and, together with Costa Rica, has launched the COVID-19 Technology Access Pool (C-TAP);
- the Ventilator Challenge UK Consortium has been established to pool IP, technology, know-how and resources to respond to the shortage of ventilators; and
- many companies participating in the COVID-19 Therapeutics Accelerator, backed by the Bill & Melinda Gates Foundation, have agreed to share their proprietary libraries of molecular compounds that already have some degree of safety, and activity data to quickly screen them for potential use against COVID-19.
The responses to COVID-19 are unprecedented, and break with stereotypic models on thinking, as well as coordinating a multi-front response against a common opponent: intelligent thinking, while optimising multiple technologically advanced resources. Realistically, only wealthy countries, and advanced undertakings could ever achieve such responses, and at great risk both financially and reputationally. Such efforts should not be seen as nationalism, even by the stockpiling of vaccines, but instead be regarded as a global riposte for the common good.
Other options – compulsory licences
Compulsory licences are legal instruments, whereby a government, or a third-party authorised by a government, can produce or import the subject matter of a patent, without the authorisation of the rights holder. Their genesis lies in Article 31 of the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). As a member of the WTO, the EU is party to TRIPS. Under Article 31 of TRIPS, a compulsory licence may only be permitted, if the proposed user has made efforts to obtain authorisation from the rights holder on reasonable commercial terms, and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member “in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use.”: COVID-19 suits these descriptions very well.
Several countries around the world, including France, Germany, Canada and Chile, have passed new legislation to ensure that their governments have the power to implement compulsory licensing in the context of the COVID-19 outbreak. So far, Israel is the only country to actually grant a compulsory licence, for the importation of generic versions of Abbvie’s Kaletra (containing lopinavir and ritonavir). WIPO has published a ‘COVID-19 IP Policy Tracker’ that records IP policy changes implemented by WIPO member states in their response to the pandemic, including legislative and regulatory measures, as well as voluntary co-operation within the scientific community as outlined above. Depending upon your viewpoint, compulsory licensing is not always popular.
In the mid-1990s, South Africa faced a tremendous increase in HIV infection rates, which contributed to the magnitude of its public health problem. South Africa became the country with the highest absolute number of people living with HIV/AIDS. With an average annual income of US$2,600, most South Africans suffering from HIV/AIDS could not afford to pay for treatment with antiretroviral drugs, which at that time cost about US$1,000 a month. The South African government’s response, under Nelson Mandela, was to amend legislation to permit parallel importing and compulsory licensing. Large pharma, backed by the US government, sued to oppose the measures, complaining “compulsory licensing and parallel imports expropriate our patent rights“. Nevertheless, Mandiba signed into law the planned amendments on the 12th December 1997.
Crown Use
In the UK, as well as compulsory licensing, there is the possibility of the ‘Crown use’ of a patented invention under the Patents Act 1977 (PA 77). Under section 55 of PA 77, the UK government, or a third-party authorised by the UK government, may do certain acts in relation to a patented invention without the consent of the patent owner ‘for services of the Crown’. The provision allows for acts, where the invention is a product, to make, use, import or keep the product, or sell or offer to sell it, or in any event, for the production or supply of specified drugs and medicines. The provision has been successfully invoked in the past for a company supplying medicine to the NHS and, in a case this year, by a mobile network provider that allowed emergency responders privileged access to mobile phone networks. With so much investment by the UK government in vaccine R&D, however, it is highly unlikely that invoking Crown Use will be necessary.
Conclusion
Compulsory licensing, and Crown Use in the UK is nice to know, but in either case they are only ever going to be relevant if there is something to licence, and all other options have failed. With so much investment by the UK government in vaccine R&D, the priority of the UK government is to invest in its chosen programmes, as success in at least some vaccine development, would guarantee the UK of at least some number of doses. It is highly likely, however, that even with success in development, there will be insufficient quantities of vaccine to complete a worldwide programme of vaccination within 1 year, even assuming an optimistic start date of January 2021. The reality is likely to be first come, first served: the first being those who invested, and naturally being those from wealthy countries.
I am an optimist. I would like to believe a return to unaffordable, high cost drugs and medicines for poorer countries, is a thing of the past, even though South Africa felt strangled as recently as 1997. Large pharma has assured many that for a limited period, whatever that period may be, a successful vaccine would be sold at cost, whatever that cost may be. The sentiment was bolstered on the 4th June 2020, when world leaders pledged an additional US$ 8.8 billion for Gavi, the Vaccine Alliance, far exceeding the target of US$ 7.4 billion. The funding will help to immunise 300 million more children in the world’s poorest countries against diseases like measles, polio and diphtheria by the end of 2025. It will also support health systems to withstand the impact of coronavirus, and maintain the infrastructure necessary to roll out a future COVID-19 vaccine on a global scale.
The UK remains the Vaccine Alliance’s largest donor, pledging the equivalent of £330 million per year over the next five years. “To beat the COVID-19 pandemic, the world needs more than breakthrough science. It needs breakthrough generosity… When COVID-19 vaccines are ready, this funding and global coordination will ensure that people all over the world will be able to access them” said Bill Gates. The world’s biggest vaccine manufacturers also committed to continue supplying the billions of doses needed to continue increasing vaccine coverage across Africa and Asia. The Global Vaccine Summit held in London, also saw the launch of the Advance Market Commitment for COVID-19 Vaccines (Covax AMC), a new innovative financing instrument to provide access to COVID-19 vaccines for low- and middle-income countries. This is the first building block toward a global mechanism to ensure equitable access to future COVID-19 vaccines.
The warnings of campaigners must be heeded, and vaccine nationalism avoided at all cost. There is nothing wrong with wealthy countries gambling upon vaccines that may not work. Better they did, or there would be no vaccines. Open thinking, and bold assurances have placed the spotlight upon wealthy countries and advanced undertakings to deliver on their promises, and share their successes with the less fortunate. Time will tell.