Recent interesting reports highlight an emerging practice borne out of necessity in which medical professionals are 3D printing parts for patented mechanical ventilators. The reports say it was an emergency life saving measure because the authorised suppliers were unable to make enough in time to treat the growing number of COVID-19 patients. Medical devices and their components are often patented and so there is a risk that some patent holders could try to prevent such actions (e.g. making and using part, or whole, of a medical device) by enforcing their patent rights; despite the obvious moral implications of this course of action.
Patent owners who are aware of emergency actions like this might choose to temporarily look the other way, because the last thing that medical professionals dealing with the COVID-19 crisis need to be thinking about is whether or not they are infringing a patent. They are instead focused on saving lives against the clock, by any means necessary and at great personal risk. Starting infringement proceedings against medical professionals under these circumstances would also likely be a PR disaster for the patent owner. However, these factors could be less likely to dissuade a patent troll (a company that obtains and enforces patents from other companies, but does not invent or manufacture anything themselves). On balance, patent infringement proceedings are an unlikely outcome, but it raises some interesting legal points.
Crown Use
Given the very unique circumstances, one possibility under UK patent law would be for the Government to step in and allow the acts under the relevant patents for “services of the Crown”. The UK Government has the power to authorise the performance of acts that would otherwise infringe a patent, without the consent of the patent owner. This authority can be granted retrospectively and is intended for use in emergencies. But it is the Government who would ultimately decide whether to step in and protect medical professionals treating COVID‑19 from patent infringement proceedings. The medical professionals could only lobby the Government from the side-lines. This provision is rarely used, as disrupting the protection afforded by a patent is disconcerting for many patent owners and raises fears about the vulnerability of similar patents. Crown Use was lobbied for in 2019 during negotiations for the NHS to buy an expensive cystic fibrosis drug Orkambi. The idea was dismissed by the Government because a commercial negotiation was not considered an emergency. But the current COVID-19 pandemic certainly is considered an emergency. The Government would still be required to provide reasonable compensation to patent owners for any loss of profit. Interestingly, the Government of Israel has just used its corresponding provision to make anti-retroviral medications available to treat COVID-19 when the patent owner was not able to supply sufficient quantities. It is also possible that Crown Use could also be invoked in the UK in the future should it become necessary for the widespread distribution of a COVID-19 vaccine.
Compulsory Licencing
Another possibility would be to apply for a compulsory licence. Anyone may apply for a compulsory licence, but only more than three years after grant of the relevant patent. However, the Government can also intervene and apply for a compulsory licence on behalf of a third party. It is a requirement that the relevant party has tried to obtain a licence from the patentee within a reasonable period and on reasonable terms. This could be a sticking point in an emergency situation where there is unlikely to be time to do this properly. So any compulsory licence that is granted would need to have a retroactive effect. This would be unusual as a compulsory licence takes effect at the time the terms of the licence are settled. A Court would therefore need to include a retroactive term in any compulsory licence that it grants. Moreover, if the acts were not performed more than three years after grant, it is unlikely that this provision could be relied upon at all because the agreement of Parliament is required for any reduction in this period. Obtaining a compulsory licence cannot be guaranteed and patent owners can also oppose the application, which can prevent or prolong grant. The parties involved would likely be required to pay reasonable compensation to the patent owner under the terms of the licence.
Right to Repair
In cases where only a part of a patented medical device is made to replace a faulty or missing part, then medical professionals in the UK may be able to rely on the ‘right to repair’ as laid down in a UK a patent case Schütz v Werit [2013] UKSC 16. This is an implied licence that allows the legitimate owners of a broken patented product to restore it to its original condition. This could be useful in cases where every medical device counts and so any repairs must be performed immediately to keep the devices running to prevent loss of life. But it does rely on having purchased the medical devices in the first place. There are many factors to consider to determine whether an a patented article was in fact made (infringement) or repaired (not infringement). Therefore the outcome would very much depend on the specific details in each case.
The Future
As evident from the above brief analysis, despite the social and moral desirability it is not clear whether any of the above would be effective or available as a defence. Indeed, it may be that infringement is upheld by a Court but damages are awarded set on the basis of royalties or fees which would have been due had the medical professionals obtained a licence beforehand. But it would still seem heavy handed under the circumstances to find that there was infringement. It could perhaps be argued that there is no time for a medical professional to consider whether a patent existed in an emergency. If successful, this argument would restrict the award of damages.
With the increasing widespread availability of personal manufacturing technology such as 3D printing, there is now the possibility of making medical devices on the spot which would otherwise not be available in time to save a life. Perhaps there is scope for a retrospective ‘emergency licence’ as a sub-provision of the existing compulsory licence provision? It could, for example, explicitly replace the requirement for attempting to seek a licence from the patent owner beforehand with a requirement to show that a loss of life would have otherwise occurred because authorised suppliers could not meet demand. Although not ideal, the licence terms for reasonable compensation could then be concluded retrospectively.
It may also be that, sometime in the more distant future, many hospitals will have advanced 3D printers through which orders for medical devices (or their parts) can be placed legitimately from an online catalogue, as and when they are needed. This could help eliminate supply and demand issues between authorised suppliers and hospitals. It is likely that the purchase would include temporary access to a 3D printing design file along with a limited licence to print the design according to the purchased amount. This distribution and manufacturing approach could be taken for any patented product that can be 3D printed.
