From the Editor: Law and order

Listen to this article on the DDW Podcast: The Fall 2022 issue of the DDW is out now. DDW Editor Reece Armstrong comments. There’s no doubting that when the time came for the life sciences industry to step up during the Covid-19 pandemic, it delivered. From diagnostics to the launch of Covid-19 vaccines – within a never-before-seen timeframe – the life sciences industry was the beating heart behind getting the world back on track. However, with a few years having passed since the beginning of the pandemic, pharmaceutical companies are looking more closely at their respective intellectual property (IP) in the case of Covid-19 vaccines. Recently, biotechnology company Moderna filed a patent infringement lawsuit against Pfizer and BioNTech in relation to the use of its messenger RNA (mRNA) technology and Pfizer and BioNTech’s Covid-19 Comirnaty vaccine. Moderna states that Pfizer and BioNTech’s Covid-19 vaccine Comirnaty infringes on Moderna’s patents for its mRNA technology filed between 2010 and 2016. Moderna alleges that Pfizer and BioNTech copied this technology, without Moderna’s permission, to make Comirnaty. It’s major news and something which could have repercussions for many companies that have been involved with Covid-19 vaccine production. For Moderna, the importance of the potential infringement comes from the fact that the company developed its technology in the years preceding Covid-19, something which helped it launch its vaccine in record time. Patents are a tricky and often controversial business in the pharmaceutical industry, more-so when it comes to vaccines and Covid-19. On one hand, it’s understandable that companies should want to protect their IP which they’ve spent time and resources developing. In the case of vaccines however, these can be seen as vital components to people’s rights to human health and as such should be made readily available. Of course, the Covid-19 pandemic showed that equitable access to Covid-19 vaccines was something of a pipedream. We saw developing and low-to-middle-income countries struggle with access whilst wealthier countries ordered more doses than were necessary. The World Trade Organisation’s (WTO) TRIPS agreement set in place agreements so developing countries can authorise the use of patented materials for the manufacture of Covid-19 vaccines. Importantly, this can be done without the rights holder’s consent – though they will be compensated. The TRIPS agreement has its detractors and its supporters but there’s no doubt there are obvious concerns for IP sharing in pharma when it comes to access to vaccines. Back to Moderna, the company does not want to remove Comirnaty from the market or to prevent future sales, and it will not seek damages related to Pfizer’s sales to AMC 92 countries. With Pfizer reportedly being surprised by Moderna’s actions, and with BioNTech SE already facing a lawsuit from CureVac in relation to mRNA technology and Covid-19 vaccines, companies might want to ensure they’ve stayed within their legal boundaries. Even Moderna is facing a lawsuit from three companies over alleged infringement on the delivery technology used for mRNA Covid-19 vaccines. Going forward, the resulting lawsuits could set a precedent for companies operating in the same field. With the aforementioned companies making big profits throughout Covid-19, investment into new R&D approaches could be seen as a risky approach for companies who lose their lawsuits. As such is often the case in pharma, IP is the bedrock of a company, and any threat to it can be major catalysts for where companies invest their money. Hopefully the IP battle doesn’t act as a fall from grace for an industry which put so much effort into safeguarding human health throughout the Covid-19 pandemic. Volume 23 – Issue 4, Fall 2022