Dr. Nicholas Jones, partner and patent attorney at Withers & Rogers, discusses what the pharma industry can learn from its experiences of working collaboratively during the COVID-19 pandemic by establishing best practice and minimising the risk of legal disputes in the future.
Key insights:
- Pharma industry experts are calling for greater preparedness and a framework for pandemic-related licence agreements to avoid future disputes.
- Moderna is seeking to impose a ‘commercially reasonable licence’ on third parties that have profited from vaccines developed using its proprietary mRNA technology.
- A legal framework for sharing patented technologies under licence during a pandemic could help to speed up decision making and facilitate better and fairer outcomes in the future.
News that Moderna is suing Pfizer-BioNTech for infringement of its patent rights when producing a vaccine for use during the COVID-19 pandemic has shocked some industry commentators. Legal disputes of this kind are quite rare between pharma innovators, with most tussles in the industry normally involving at least one generics producer. So, what went wrong here?
Patent rights
The legal claims brought by Moderna hinge on Pfizer-BioNTech’s use of its proprietary messenger RNA (mRNA) platform technology, for which Moderna held patents dating back to 2010. Pfizer-BioNTech’s vaccine, Cominarty, proved to be highly effective in preventing people from catching COVID-19 or minimising the risk of serious illness or death, and it was sold in large volumes to governments around the world.
Not long after the pandemic had been declared, Moderna pledged not to enforce its patent rights for the mRNA technology during the pandemic, with the aim of speeding up the development of more vaccines to protect populations around the world. Other pharma companies took similar decisions not to enforce their intellectual property rights at around this time, and all efforts were focused on finding a solution.
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On 8th March 2022, Moderna decided to make the meaning of its COVID-19 patent pledge clearer for all, whilst confirming that it would never enforce its patent rights in low- and middle-income countries. However, it is now seeking to impose a ‘commercially reasonable licence’ on third parties that have profited from vaccines developed using its proprietary mRNA technology, which were sold in other more affluent markets.
With legal action pending in both Germany and the US, the industry may not know for some time whether Moderna’s post-pandemic legal claims will be successful. However, big pharma will be keeping a close eye on the situation, as the outcome could provide a precedent for future post-pandemic litigation.
Looking to the future
Whilst no one knows when the next pandemic will come, many industry experts are already calling for greater preparedness.
The COVID-19 pandemic has cost many lives and establishing best practice to accelerate the development of vaccines and treatments could reduce this number next time round. For example, a framework for pandemic-related licence agreements could make it clear when and where patent rights could be enforced, and encourage stakeholders to engage in discussion at an earlier stage. This approach could help to mitigate the risk of disputes arising in the future. Importantly, these licence agreements would also protect the interests of patent owners that want to ‘do the right thing’, whilst retaining an option to leverage their rights in situations where third parties go on to generate significant profits through the use of their technologies.
As seen during the COVID-19 pandemic, when the chips are down big pharma companies are more than willing to sacrifice commercial intent to help save lives – this was evident in the widespread commitment to collaboration. However, establishing a legal framework for sharing patented technologies under licence during a pandemic could help to speed up decision making and facilitate better and fairer outcomes in the future.