Waiving the way to drug discovery during Covid-19
As the Covid-19 pandemic continues, pharmaceutical companies are taking generous steps and removing intellectual property rights for many key drugs which could help fight the virus, writes Adrian Tombling – partner and patent attorney at Withers & Rogers.
In the global race to find new drugs and tests for use in the treatment of Covid-19, pharmaceutical companies are taking the unprecedented step of forgoing their intellectual property rights. Without the promise of commercial gains that accompany such exclusivity rights, these companies could be seen to be effectively putting cause before profits.
A series of pharmaceutical companies have already taken action voluntarily, although it is fair to say that in some cases there has been a certain amount of external pressure for them to do so. Even so, the industry-wide response is impressive and heart-warming.
Among them, Gilead Sciences is currently supporting clinical trials of its antiviral drug, Remdesivir. Previously developed for use in the treatment of Ebola, the drug has been shown to have benefits in the treatment of other diseases, including SARS. If the trials are successful, regulatory approval will follow, and the company could be first to market, which would give them a significant commercial advantage. However, in a recent statement, Gilead Sciences has indicated that it will provide around 1.5 million individual doses of Remdesivir for free. Furthermore, Gilead Sciences previously applied for and obtained ‘orphan’ drug status for the use of Remdesivir - giving them access to an extra layer of protection due to their involvement in developing a treatment for a ‘rare’ disease. Having faced some criticism for this action, the company has since decided to waive its ‘orphan’ rights.
In another example of voluntary action, Abbvie has announced that it will not enforce its intellectual property rights on trials involving the use of Kaletra, a combination drug which is approved for use in the treatment of HIV. This means pharmaceutical and biotech firms around the world are free to make Kaletra and use it in clinical trials for Covid-19, without needing to secure a licence and pay royalties. As the first firm to secure regulatory approval to produce a generic of Kaletra, Mylan has also waived its exclusive rights in the US to distribute Kaletra.
A similar causal response is evident in the search for diagnostic tests for Covid-19. Labrador Diagnostics has recently announced that it will grant royalty-free licences to third parties to use its patented diagnostic technologies for use in tests directed to Covid-19. Swiss pharmaceutical company, Roche, has also recently released details of a formulation used in testing kits for the virus, following a plea from the Dutch government.
Underlining the importance of removing barriers to Covid-19 related research and development activity, Francis Curry, director general of the World Intellectual Property Office (WIPO), has urged the pharmaceutical and biotech industry to do the right thing. Speaking at a UN-led discussion last week he warned that ‘extra measures’ might be needed if companies don’t respond appropriately and suggested that compulsory licensing orders could be employed at jurisdictional level where necessary. To avoid this scenario, he added that a ‘non-legislative mechanism would be a great way forward’.
The threat of multiple compulsory licence orders, which are generally only granted to address a national emergency, is real. In the current pandemic, the only example so far is in Israel where Abbvie had been forced to allow trials for Covid-19 treatments using their patented technologies to go ahead without a licence. Governments in the US, Germany, Canada and Chile have indicated a willingness to impose compulsory licence orders where necessary and the UK government has previously discussed such action.
To avoid such adversarial action from governments around the world, an industry-wide response is now urgently needed to find an alternative mechanism to support the search for Covid-19 treatments and tests. The Costa Rican government has recently put forward a proposal, backed by the World Health Organisation (WHO), for the industry to establish a ‘patent pool’ to support research and development activity directed to Covid-19. Patent pools are typically used to help make treatments for life-threatening diseases available in low-income countries. In this case, the creation of a patent pool would level the playing field globally, allowing any new tests and treatments for Covid-19 to be made available to as many people as possible, as quickly as possible.
With hopes raised of finding a vaccine or antiviral drug quickly, it is important that efficacy and safety tests are not compromised. The pharmaceutical and biotech industry has an important role to play in helping to protect and save lives, but there is also an opportunity to generate significant goodwill by demonstrating a willingness to collaborate and to be flexible with respect to intellectual property rights.