Varuni Paranavitane, IP Solicitor, AA Thornton.
As the world faces unprecedented challenges caused by the SARS-Cov-2 virus, we look at the science behind vaccine technology being investigated and how intellectual property rights may play a part in its protection.
What is a Vaccine?
The immune system can be ‘trained’ using a vaccine to recognise and combat new pathogens such as the coronavirus. A vaccine is a modified version of the pathogen which triggers an immune response by the body without causing virulence. SARS-Cov-2 which causes COVID-19, has a ‘spike protein’ on its surface which latches on to certain human cells, invades them, and uses the cells’ ‘machinery’ to replicate itself to invade other cells.
In the body ‘antigen presenting cells’ engulf the virus and display parts of it, for example the spike protein, on their surface. This causes immune cells called T-helper cells to enable B-cells to make antibodies which mark the virus for destruction and also prevent it from infecting further cells. In addition, cytotoxic T-cells can identify and destroy infected cells. ‘Memory’ B-cells and T-cells that recognise the virus can guard against future infections by quickly recognising and attacking the virus thus providing immunity for months or even years.
Following the publication of the genetic sequence of SARS-Cov-2 on 10 January 2020, researchers began developing vaccines using various traditional and novel approaches.
One approach is to use protein subunits as a vaccine by using fragments of the SARS-Cov-2 proteins to elicit an immune response. Most research teams are focussing on the spike protein, and Sanofi and GlaxoSmithKline are collaborating on this protein subunit approach using the spike protein together with an adjuvant, a chemical which stimulates a stronger immune response.
Others are investigating viral-vector vaccines using a genetically engineered virus, such as an adenovirus which causes the common cold, but modified such that it cannot cause disease, and manipulated to express SARS-CoV-2 proteins. The Astra Zeneca and Oxford University vaccine uses chimpanzee adenovirus to carry DNA encoding the spike protein. It is expected that this approach would generate robust B-cell and T-cell responses. The Ebola vaccine which was approved last year, 43 years after Ebola’s discovery, is an example of a viral-vector vaccine.
Another approach uses genetic material (such as DNA or RNA) to encode a coronavirus protein and promote an immune response. The vaccine being developed by Imperial College uses self-replicating mRNA encoding for the spike protein, while Pfizer is collaborating with BioNTech to produce an mRNA vaccine.
Several teams are taking a more traditional approach by using the virus in a weakened or inactivated form, similar to the way in which measles and polio vaccines are made, for example Sinovac Biotech is using inactivated SARS-CoV-2. This type of vaccine will require extensive testing as the risks are higher.
Currently there are around 160 Covid-19 vaccine candidates in pre-clinical evaluation, and around 50 vaccines in clinical trials around the globe to assess the safety and efficacy of the candidates. Following trials, companies will need to submit safety and efficacy data to gain regulatory approval. Earlier this month, the UK’s Department of Health and the MHRA granted authorisation for the temporary supply of the Pfizer/BioNTech mRNA vaccine for individuals over the age of 16, and the first immunisations have taken place in the UK.
Coronavirus Vaccines and Intellectual Property rights
Some large pharmaceutical companies have pledged that they do not seek to make a profit from their Covid-19 vaccines “during the pandemic” and they have the budgets to be able to fund development themselves. However, smaller companies which rely on investment may require an incentive to secure that investment. One way of providing that incentive is to obtain patent protection which gives the proprietor a monopoly right allowing them to prevent others using their new technology without permission.
Given this humanitarian crisis, there are practical, PR, moral and legal factors to be considered by an entity considering enforcing their patents during the pandemic. The UK Patents Act 1977 has ‘Crown Use’ provisions permitting use of a patented product without the proprietor’s consent when authorised by a government department ‘for services of the Crown’ including the ‘production or supply of specified drugs and medicines’. There are also ‘Compulsory licensing’ provisions ‘where patented invention is a product and demand for that product is not being met on reasonable terms’.
It remains to be seen how the UK courts would apply these statutory carve outs. However, if they are used, the proprietor is entitled to reasonable compensation. This means that the commercial and incentive value of patent protection is maintained, even if the usual control over the technology may be temporarily lost. It is therefore sensible to consider patent protection for any commercially important innovation.