13 March 2020

Global research rush spurs COVID-19 patent challenges

In this article for Managing IP, Mathys & Squire partner Anna Gregson explains why early adoption of a robust patent strategy in the search for a COVID-19 vaccine is crucial, particularly as the volume of published research increases by the day.

In the COVID-19 global health crisis, the now-official pandemic is making news headlines around the world. While the global health challenges of combating COVID-19 are rightly the primary concern of scientists and public health organisations, the particular circumstances around the development of a cure for this strain of the virus raise specific issues in relation to obtaining patent protection for related innovations.

According to the World Health Organization (WHO)’s epidemic experts, there are no set definitions for a pandemic. The US Centers for Disease Control and Prevention identifies three criteria for a pandemic: (i) a disease has killed people; (ii) it demonstrates sustained person-to-person spread; and (iii) it has spread worldwide. Yesterday, March 11, WHO classified COVID-19 as a pandemic.

The advent of modern medicine means that more recent pandemics have not been as deadly as some historic examples, such as the Black Death in the mid-14th century and the 1918 Spanish flu pandemic, where it is estimated that one third of the world population was infected, with 50 million deaths. However, globalisation and urbanisation increase the risk of transmission, making it more difficult to stop the spread of disease. Further, even more recent pandemics have the potential to cause significant mortality, for example, a 2009 WHO-sponsored study estimated that the 2009 H1N1 (swine flu) pandemic killed between 123,000 and 203,000 people.

History teaches us that it is possible to contain outbreaks and prevent pandemics. In 2003, the global health community was able to slow the transmission rate of SARS-CoV sufficiently that the chain of transmission was broken. Individual SARS epidemics were kept localised and did not develop into a pandemic. Whether that will be possible with COVID-19 is not yet known.

Search for a vaccine

Unsurprisingly, therefore, COVID-19 is a public health priority, and a massive amount of research into the virus, potential treatments and vaccines is underway. Millions, if not billions of US dollars have been pledged by governments and funding bodies around the world. The UK Department for Health and Social Care issued two rapid response calls in February 2020 totalling £20 million ($26.1 million) and China has reportedly allocated almost $16 billion.

There are over 20 potential COVID-19 vaccines in development. A number of pharmaceutical companies, such as GSK and Sanofi, are working on vaccines. Regeneron is developing new antibody candidates and Fujifilm’s flu drug has been mentioned by the Japanese government as a possible therapy. In addition, scientists at many academic institutions and public sector organisations all around the world are working on COVID-19 treatments.

This frenzy of scientific research has the potential to generate many patentable innovations. All the usual reasons and considerations in relation to patenting innovations still apply. However, the extreme level of global interest, the sheer volume of research activity and the rapid spread of the disease present unique challenges for patenting inventions in relation to pathogens responsible for global health crises.

Given the number of researchers actively investigating COVID-19, the volume of published research is increasing daily. Each published document is potentially relevant prior art against later filed patent applications. Therefore, with each day that passes, the risk of a novelty-destroying document, or documents that render an invention obvious, increases. This is the case for any new innovation, but what differs in the COVID-19 crisis is the sheer number of publications. According to the WHO’s COVID-19 publication database, in 2020 to date, there have been 1,143 separate publications on COVID-19. In contrast, in the same period, there have been only 29 publications on HIV. Clearly, the number and rate of publications on COVID-19 is a strong motivation for researchers and innovators to file patent applications as early as possible.

At the same time, the applicant must still include enough information in their patent specification to render it plausible that the claimed invention would work. For claims directed to a medical use, the breadth of a patent claim and the amount of supporting data can be relevant to both sufficiency and inventiveness of the claimed subject matter. In relation to sufficiency, the question is whether the invention could be carried out across the scope claimed. For the inventive step, the question is whether the underlying technical effect or advantage is achieved across the whole of the scope claimed.

Under European practice, if an invention relies on a technical effect, which is neither self-evident nor predictable nor based on a conclusive theoretical concept, at least some technical evidence is required to show that a technical problem has been solved. The UK courts have held that, while data is not strictly required, an application must provide a “reasonable prospect” that the assertion will prove to be true, based on “a direct effect on a metabolic mechanism specifically involved in the disease”. Although not required, supporting data certainly strengthens an application, which may lead to delays in filing while data is generated and analysed prior to drafting a patent specification.

Therefore, while there is always a balance to be struck between filing early to improve an applicant’s position over prior art and delaying filing to generate sufficient evidence (particularly data) to establish plausibility, this is driven to the extreme for innovations relating to active pandemics or global health crises just short of this classification, such as COVID-19. In such circumstances especially, it is critical to seek good advice on filing strategy.

Further challenges

Also of particular relevance in the context of global health threats are the ethical implications of patenting. The tension between public good and private interest has existed for as long as the patent system, particularly in the field of healthcare, and nowhere more than where the public good is public health. This is the reason why, historically, some countries did not permit pharmaceuticals to be patented, or else limited the scope of the granted monopoly.

However, in modern drug discovery, research and development (R&D) is a hugely expensive, time-consuming and risky task. A blanket exclusion on new pharmaceuticals from patent protection disincentivises research into new pharmaceutical agents, as companies are unlikely to recover their R&D costs without exclusivity, and will look for alternative areas of research with more profitable outcomes.

The importance of enabling protection for new pharmaceutical products was considered by the World Trade Organization (WTO) when drafting the TRIPS Agreement, which sets out minimum standards of patent protection. While the TRIPS Agreement allows a permissible exception from patentability in order to protect human health, this exception is only available if the commercial exploitation of such subject matter is also prohibited. As a result, pharmaceutical products per se are usually not excluded from patentability, at least in WTO member states. Patent monopolies give innovators spending vast sums on new drug development the best chance of recovering costs and providing for future R&D.

Furthermore, most jurisdictions already have provisions which provide public access to innovations to address immediate public health crises, such as COVID-19. For example, the UK has both compulsory licence and ‘Crown use’ provisions. These provisions allow the government to act in the public interest by allowing important patented technology to be exploited, such as to address the COVID-19 threat and to provide a balance between the interests of innovators and the benefit to public health.

This article was first published in Managing IP – click here to read (login required).