With the announcement that rivals GSK and Sanofi are joining forces in an "unprecedented collaboration” to find a vaccine for COVID-19, it is clear that the pharmaceutical "norms" for developing vaccines and the protection of IP are being set aside to accelerate the development of a vaccine to the coronavirus.
Sanofi is contributing an antigen which is an exact genetic match to proteins found on the surface of the coronavirus. GSK is contributing its adjuvant technology which could enhance the immune response to the Sanofi antigen.
With today [26 April] being World Intellectual Property Day, it is a pertinent time to discuss the link between intellectual property and the race for a coronavirus vaccine.
As vaccines are produced using live attenuated viruses or components which have markedly different characteristics from molecules found in nature, they can qualify for patent protection. Manufacturing processes for vaccines are proprietary know-how for pharmaceutical companies, often protected by trade secrets if patent protection is not an option.
The financial investment required for vaccine development is challenging for many pharmaceutical companies. Compared to small-molecule drugs, vaccines have smaller markets and are expensive to manufacture and test in human clinical trials. Without gaining exclusive rights so that research costs can be recovered, pharmaceutical companies may have no incentive to undertake necessary research to develop vaccines.
But pharma companies have to be acutely aware of any public backlash if they are seen to be profiteering from the current coronavirus crisis.
AbbVie, a US drugs company, will not enforce its patent rights on formulations of HIV drug Kaletra as the drug is being evaluated to treat severe COVID-19 in several clinical trials. This comes after Israel used compulsory licensing, which allows governments to use a patent without the owner’s consent when necessary to meet public health needs, to sidestep AbbVie’s patents. Swiss pharmaceutical giant Roche shared the formula for a key component of its coronavirus test so that other companies can also produce kits. And the Biotechnology Innovation Organization (BIO) says more than a third of its 1000 members are now working on coronavirus.
So, why has the search for a coronavirus vaccine caused such an unprecedented reaction from big pharma compared to the HIV and SARS pandemics?
AIDS was (and in some areas still is) one of the leading causes of death among adults in developing countries. In the 1990's more than 40 pharmaceutical companies, supported by the United States, sued the South African government to try to stop it enacting legislation aimed at reducing the price of medicines for South Africans (including antiretroviral medicines used to treat HIV). Now governments cannot afford to help enforce the IP rights of its corporations given the health crisis on their doorstep.
The coronavirus crisis has certainly focused attention on the current rules of intellectual property protection and how these rules benefit big pharma, without necessarily improving public health. Governments may realise that to provide the new drugs and vaccines which public health requires can't rely alone on investment encouraged by intellectual property right monopolies. Back in 2013 I wrote (following a talk from former head of R&D at AstraZeneca, Martin Mackay) that the traditional pharma model was broken given that research and development costs are substantially higher than revenues generated. Collaborations between pharmaceutical companies and universities have increased (the University of Edinburgh and GSK collaboration is an example of a successful partnership) in a bid to encourage university innovation while many pharmaceutical companies scale back on internal research and development.
We can hope that the GSK/Sanofi collaboration is indeed fruitful and results in a coronavirus vaccine. I have no doubt that the lawyers at both companies worked hard to draw up the agreement regulating the collaboration and the ownership of resulting technology. Our intellectual property protection regime is unlikely to change overnight as a consequence of coronavirus research, but perhaps a better balance between research for profit versus public health benefits can be struck.