The global struggle to secure supply of remdesivir, a drug that has been found to be effective in treating Covid-19, recently hit the headlines with news that the U.S. has secured all available inventory.
Amid a flurry of analysis, some pointed to the absurdity of a situation that effectively put the world at the mercy of one company. Surely, in the middle of a global health crisis, if an effective treatment has been identified, the overriding need is to find the quickest way of ensuring an adequate supply?
In questioning the reason for the shortage of this drug, some have highlighted the fact that it is protected by a patent. In practice, however, the barriers to accessing remdesivir are much more to do with logistics and infrastructure, rather than the existence of IP rights.
IP has historically underpinned investment in technologically complex areas and that investment continues to be crucial as the pharmaceutical industry seeks to find effective treatments. Indeed, the incentives provided by patent protection have already resulted in a diverse range of drugs that have undergone extensive safety testing in relation to other diseases—drugs that are now being mined by a large number of companies to see if they can be repurposed for Covid-19.
Without the patent system, existing drugs, such as remdesivir, would perhaps not have existed and would not now be available so quickly to treat Covid-19.
The Complexities of Large-Scale Pharmaceutical Manufacturing
The current crisis has shone a spotlight on aspects of pharmaceutical development that were previously unappreciated. It has illustrated the length of time that it takes to make medical advances and to get from early-stage science to meaningful diagnostic tests and effective treatments. It has also highlighted the number of parties involved; the complexity of interactions; and the difficulties in building technical capability and capacity.
Taking all of this into account, mass production is not something that can simply be turned on at the flick of a switch. In the case of remdesivir, Gilead Sciences—the company behind the drug—has been vocal about its efforts to scale up production since the beginning of the year. But, given that remdesivir was not in active production prior to January 2020, Gilead was responding to the crisis from a standing start.
As well as ramping up its own production capabilities, Gilead has also signed licensing agreements (on a royalty-free basis for the duration of the public health emergency) with pharmaceutical manufacturers in South Asia to expand the supply for low and middle-income countries. However, this leaves other parts of the world where cases are still relatively high with limited or no ongoing access to this drug.
Unlocking Access to Remdesivir Through the IP System
The U.K. Intellectual Property Office could grant a compulsory patent license to allow for increased supply through manufacture in or import to the U.K.
However, manufacturing capability in the U.K. is limited and U.K. manufacture could potentially divert most, if not all, of the available capacity to the production of one drug. There is a difficult balance to be achieved in responding to potentially effective treatments right now and risking a situation where valuable resources are tied up in a drug that is already perceived as limited in its effectiveness and could be clinically irrelevant in six months’ time.
It remains to be seen how the supply issue around remdesivir will unfold, but the way Gilead responds at a time of crisis will be closely scrutinized. All owners of IP rights will have to take a holistic view as to what they want to do in a particular situation, and have cogent reasons for the action they are taking and how it fits with their values and public position.
How IP Rights Are Underpinning Covid-19 Response
In the long term, intellectual property rights provide a mechanism to support the rapid scale-up of manufacturing capacity. An example of this is the licensing deal between the University of Oxford and AstraZeneca for the development of a SAR-CoV-2 vaccine, and further sub-licensing deals to provide capacity for production of the vaccine if it is to be effective. With the infrastructure and resources already in place, AstraZeneca can provide an efficient and effective roll-out on a global scale.
A further example is the vaccine being developed by Imperial College. This uses a different approach by delivering self-amplifying RNA, which it is hoped will allow for rapid development and scale-up through distributed, localized manufacturing systems—likely through a social enterprise partnership. Again, licensing of intellectual property rights is likely to underpin efforts to roll out the product at scale.
More broadly, patent protection can provide a driver for research to find alternatives to the potential treatments that have been identified so far—alternatives that may prove more effective and accessible. The Covid-19 challenge illuminates the inherent risks and uncertainties of biomedical research—there is no certainty that any particular approach will lead to success; and even if there is initial success, it may be overtaken by new developments which may be more effective and cheaper to implement.
In this high profile and changeable landscape, responding to the global health crisis is the overriding driver—not commercial gain, as underlined by the two vaccine development programs noted above. Rather than acting as a barrier, intellectual property rights have a key role in driving projects forward and supporting the diversity of approaches that is likely to be vital to long-term success in combating the present pandemic, as well as future challenges.
The reality is that the world faces many challenges right now, not just coronavirus. If those challenges are to be effectively addressed, proper long-term incentivization and support for innovations will be necessary. If there is unpredictability in incentivization and support, then long-term innovation simply will not progress as fast as it could. Ultimately, current IP systems provide a framework to avoid and prevent abuse whilst maintaining long-term incentive for innovators.
This column does not necessarily reflect the opinion of The Bureau of National Affairs, Inc. or its owners.
Stephanie Pilkington is a partner, board member, and patent attorney at IP law firm Potter Clarkson LLP. A specialist in molecular biology, her clients range from start-ups and university spinouts through to established international corporations.