Development of vaccines for new diseases typically takes decades. However, less than 11 months after the sequence of SARS-CoV-2 was published, the United Kingdom gave temporary regulatory approval to the mRNA COVID-19 vaccine developed by Pfizer and BioNtech. The Oxford University and AstraZeneca vaccine followed shortly thereafter, with the Moderna vaccine now also approved.
COVID-19 vaccination programmes have been implemented at an impressive speed in, for example, Israel, the UK and the United States, but the pace of vaccination in developing countries has been far slower. In many cases, those countries home to pharmaceutical companies that have developed vaccines have been ahead of the curve in deploying them. This is in part due to being first in the queue to place orders and in part due to contractual obligations being enforced, requiring that supply agreements with home nations be fulfilled first.
Inequality
Richer nations acknowledge the global nature of the pandemic and agree that the incidence of the virus in other populations poses a continuing risk to them despite their own vaccination success. As a result, the COVID-19 Vaccines Global Access (Covax) programme is a worldwide initiative initiated by the World Health Organisation where higher-income countries pay for vaccine doses and lower-income countries receive vaccines paid for by donations. Pharmaceutical firms are also expected to make concrete pledges to increase supplies in these developing countries. Nevertheless, vaccine inequality remains, and some have pointed to the world of intellectual property as a cause.
Given the cost of vaccine development, it is not a surprise that companies will utilise the patent system to recoup some of that investment. However, a clear picture of the patent landscape is difficult to ascertain, with patent applications not being published until 18 months after they have filed. Furthermore, the work to develop the vaccines has built on previous vaccine development and mRNA virus manufacturing is known to be patent protected.
The campaign was initiated by India and South Africa as early as October 2020 and is being backed by more than 100 countries. The argument is essentially that a temporary patent waiver would allow multiple parties to start production sooner, rather than manufacturing being concentrated in a small number of companies holding patents that serve as a block to others. The relevant legal basis for a World Trade Organisation (WTO) decision would be the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), which was concluded by the members of the WTO in 1994.
Earlier this year, the Biden administration announced that the US would support a proposal to waive patents on COVID-19 vaccines in response to the need for more global supply. Members of the European Parliament also proposed to start negotiating a temporary waiver of the TRIPS Agreement on patents to improve global access to affordable COVID-19-related medical products and to address global production constraints and supply shortages. However, Germany and the UK remain against the move, along with the drug industry.
Crown Use
In the UK, statutory provisions exist for gaining access to patented intellectual property. So-called “Crown Use” under section 55 of the Patents Act 1977 (Patents Act) provides for the government to order the making of a patented product or use of a patented process without consent from the patentee, rather than allowing a third party to do so upon request. This can be seen as a more extreme measure than compulsory licensing (where a third party can apply for a compulsory licence at any time after the expiration of three years from the date of grant) and was drafted specifically for use in emergencies, which would include a pandemic. Compensation for patent holders whose patents have been subject to Crown Use is provided for in section 57A of the Patents Act.
The above UK provision is in line with the TRIPS Agreement. Any country that is a WTO member is already able to enact such legislation and therefore take action if they feel that a patent covering a COVID-19 vaccine is being used to limit the supply of vaccine doses/manufacturing. However, in accordance with this legislation, the patentee would have to be compensated. Since the outbreak of COVID-19, both Israel and India have invoked compulsory licensing provisions in order to license pharmaceutical patents owned by US producers and Bolivia has applied to the WTO to use this process to allow it to manufacture Johnson & Johnson’s COVID-19 vaccine. In September 2021, Brazil amended its compulsory licensing laws due to the political momentum of the COVID-19 pandemic, such that any confidential data and trade secrets must be surrendered. Some argue that the compulsory licensing provisions are too complex. The proposed patent waiver, however, goes further than the existing TRIPS Agreement provisions for compulsory licensing/Crown Use, as it would effectively disregard, without compensation, the relevant patents.
Any such proposal does not have the backing of the pharmaceutical industry. Much of the cost of vaccine development has been funded by the industry itself with no initial expectation of success. Companies have pledged to sell their vaccine at cost and greater funding of Covax has been proposed as a reasonable alternative. Furthermore, in the race to find treatments for COVID-19, many pharmaceutical companies have already taken action to relinquish their exclusive rights. For example, Gilead Sciences previously applied for and obtained “orphan” drug status for the use of Remdesivir in the treatment of Ebola, giving it access to additional protection due to its involvement in developing a treatment for a “rare” disease. This right has now been waived and Gilead Sciences is supporting new clinical trials of the drug. AbbVie announced that it will not enforce its patents for COVID-19 trials involving the use of Kaletra, a combination drug which is approved for use in the treatment of HIV.
Incentive
Another key argument against a patent waiver is the premise of the patent system. Patents incentivise the creation of new inventions and without the protection a patent affords, there is no R&D incentive given the huge investment which is required. For example, some of the already patented mRNA technology which has taken much time, effort, and money to develop offers hope for vaccines for other diseases. If there were to be a patent waiver, there is little incentive for companies to invest in these technologies, many of which have positively assisted in COVID-19 vaccine development.
And can it really be argued that patents are the bottleneck? In many of the countries where vaccination rates are low, the vaccines are unlikely to be patent protected. What about the supply of raw materials? Or the proprietary know-how required to manufacture vaccines that are not patent protected? How would that be negotiated? There is a reason that only a small number of companies are currently manufacturing COVID-19 vaccines and many of those have undertaken licensing agreements to supply doses to lower-income countries.
Any waiver would still require additional measures to be put in place to incentivise and fund the transfer of technology to low- and middle-income country manufacturers and to facilitate the supply of essential equipment and raw materials. In view of these issues, would a patent waiver be effective? Taking into account the significant manufacturing challenges and the need for any new party to conduct clinical trials, it would seem that a patent waiver/Crown Use/compulsory licensing is unlikely to significantly speed up manufacture and vaccine inequality. Moreover, the vaccine landscape is changing constantly and the development of new vaccines may overtake the debate. Although the discussion gained momentum with the announcement by the US administration, at the time of writing little progress has been made in reaching any WTO patent waiver terms.
This article was first published in Venner Shipley’s Intellectual Property Magazine Inside IP Autumn Winter 2021