Following the global call for support from businesses to assist with research in the race to produce a vaccine for coronavirus, there have been some instances where companies that have done so have been met with a lawsuit.
In Italy, an engineering start-up produced 100 respiratory valves for a hospital that needed more to cope with the number of COVID-19 patients coming in. The start-up was then faced with the threat of patent infringement by a company who owned the IPR for the valves. The company later denied the threat of a lawsuit, but this begs the question, how should patent owners be responding to this situation? And equally, how can companies who want to support the cause do so without the possibility of legal ramifications?
Exceptions in patent law when public interest supersedes it
There are some mechanisms already in place and being used to aid and promote research and testing in relation to COVID-19 without it being halted by an injunction. For example, if a lawsuit is brought against someone for the use of technology that is already licensed by another, then the court may decide to restrict injunctive relief as the matter may be one of major public interest, especially if the technology in question could play a part in producing a vaccine for the coronavirus.
Another route to support the cause may be compulsory licensing. This has previously allowed for medicines to be accessed in developing countries where there are “relevant grounds” to award a compulsory licence “where patented invention is a product and demand for that product is not being met on reasonable terms”.
There may also be grounds for patent law to be eased during these unprecedented circumstances under section 55 of The Patents Act 1977 which permits the use of a patented product or process without consent of the proprietor when authorised by the government or “for the services of the Crown”, including “for the production or supply of specified drugs and medicines”.
But getting the balance right between open access to and protection of intellectual property rights is a tricky line to walk. In any other instance, it’s likely that the overt use of another company’s IP would be met with an injunction and the appropriate remedies.
But in the current environment where more and more businesses are reaching out to help with medical equipment and producing a vaccine, what will be the mechanism to adjust the standard implementation of patent protection?
The Open COVID Pledge
The pledge is, essentially, the coming together of scientists and legal professionals who have created a voluntary commitment so that IP owners of critical technology during the pandemic will not seek royalties, helping to promote continued research and testing that could save thousands of lives.
Our intellectual property partner, Lindsay Gledhill commented:
“Given the speed at which this crisis developed it is admirable that businesses mobilised so quickly to put something in place so that crucial research was not stifled. That said, something produced so quickly can never be flawless and we are ready to step in and help our clients understand the implications of signing up (or not) to the pledge”.
So, what are the pros and cons?
The pledge details a limited set of licences designed to be simple to understand and use, making it clear to all firms involved, that they should be committed to not bringing a lawsuit for the limited period, engendering trust and the quick adoption of all technologies on the table. The commitment does not need a negotiated contract – it is a self-executing, public license, again, helping to speed up the process of collaboration.
The pledge, however, is not a waiver of all rights going forward. Instead, the commitment of the patent holder will only run for a limited period, defined to only cover the time necessary to respond to the pandemic. The period is defined in detail in the license, extending as long as the World Health Organisation declares the pandemic in effect, plus a year beyond that. It also states that the period will only extend as far as November 2023, so that companies involved with the pledge are not indefinitely committing their intellectual property to the cause.
The thought behind limiting the pledge is that this will offer you some form of protection, for example, the license will be suspended if any legal proceedings are threatened or brought against the pledgor. It also means that you are still able to license patents outside the scope of the pledge and once the pledge ends, still making it a part of your larger IP strategy going forward.
It should also be noted however, that the following is not included as part of the pledge and the licenses provided:
- Grant back of rights
The initiative has come under some criticism for not being an open source of information. It is a one-way license, not a share and share alike situation. If, for example, a company takes the intellectual property that you have pledged they will be free to take that and put it towards research, and if they were to come up with something useful in the process, they would not be committed to share that nor would they be committed to supplying it for free.
Even though the Open COVID Pledge has been met with some criticism, it could provide a short-term platform in support of working towards a vaccine and any other technology that might mitigate the risks associated with the coronavirus.
You can access further details on all of the Open COVID patent and copyright licenses available at https://opencovidpledge.org/. You will also find more information on customising or using your own license in conjunction with the pledge, the field of use for each of the licenses, along with updates as to which companies worldwide have decided to support or to commit themselves to the pledge so far.
If you are thinking of pledging your intellectual property to the cause, proceed with some caution. There are still risks that will come into play outside the scope of the Open COVID Pledge, so seeking the advice of an intellectual property solicitor is advised.