COVID-19 (short for coronavirus disease 2019) is caused by Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), more commonly referred to as coronavirus. Coronavirus has dominated world headlines in 2020, leading to nationwide quarantines, international and national travel bans, and stockpiling of essentials.
COVID-19 is one of seven currently known coronaviruses that have the ability to infect people, and the current outbreak represents the third major global outbreak of a coronavirus in the past 20 years.
There has been an exponential growth in the reported number of COVID-19 cases in almost every country that has been affected by the virus. If the exponential nature of the infection rate of coronavirus is not stemmed then healthcare systems across the world will be overwhelmed, as we have seen happen in Italy. Early development of a vaccine is therefore imperative.
Currently, there is no known vaccine for COVID-19, and the foremost question is: when will an effective vaccine become available? Following on from that, once a vaccine does become available, who will own the vaccine?
Over 35 companies and academic institutions have announced their intention to develop a vaccine for the virus. Remdesivir, which is a patented antiviral drug originally developed for treatment of the Ebola virus, albeit unsuccessfully, is the focus of many of these companies as it currently seems like the most promising candidate for use against COVID-19. As yet, Remdesivir has not been licensed or approved for use on humans, although given the impact of COVID-19 to date, vaccine development is proceeding at unprecedented speeds, with clinical trials of vaccine candidates already taking place.
Vaccine development is time and cost intensive, with human clinical trials being an essential precursor to regulatory approval. As such, at each stage of the development process, patents have the potential to play a very important role. Ensuring patent protection at each stage provides an assurance that the patent applicant is adequately compensated for their contribution.
What can and cannot be patented?
The virus itself?
The short answer is no.
In most jurisdictions, including Australia, products of nature that have not been modified are not eligible for patent protection.
However, patent protection can cover:
- virus-like particles (VLPs); or
- viruses obtained by recombinant DNA technology.
In order to successfully patent VLPs or viruses produced by recombinant DNA, it needs to be shown that they are substantially different to the virus as it exists in nature. Simply put, this means that the virus needs to have been modified or “made” by human action.
A good example of what could potentially be patented is a genetically modified virus comprising a gene sequence that is not found in the wild-type strain of the virus.
A vaccine for the virus?
Under Australian patent law, patent protection is available for modified products of nature, provided that they function in a way that their naturally occurring counterparts do not, and that their enhanced function sufficiently distinguishes them.
Hence, a live attenuated vaccine based on a virus comprising a gene sequence that has been mutated to reduce its virulence would be able to be patented.
Alongside the vaccine itself, patents can also be obtained for:
- the production processes of the virus;
- antigens for the vaccine;
- dosage regimens of a said compositions;
- methods of diagnosing the virus; and
- diagnostic kits.
However, even if a vaccine or drug for COVID-19 is created and successfully patented, it is likely that compulsory licences will be requested and granted in order to allow the vaccine to be widely manufactured and supplied to countries in need. Particularly, if the supply is inadequate or the cost of the vaccine or drug is seen to be unfair.
Under the Australian Patents Act there are provisions that allow the Court to grant a compulsory licence to exploit a patented pharmaceutical invention. Compulsory licences may be granted for the manufacture and exportation of an invention to an eligible country in national emergencies, like the one we are currently facing, provided a reasonable compensation as determined by the Court is paid. If such a licence were granted, this would significantly reduce the patentee’s ability to fully financially benefit from their work on a COVID-19 vaccine or drug.
It’s clear that this pandemic has focused the public’s attention on the role that patents can play in vaccine development. However, regardless of any patent dynamics surrounding COVID-19, the primary concern, as it should be, is the application of expert knowledge and skills to find a safe and effective vaccine.