Welcome to the 12th edition of our Biotech Review of the Year. As with previous years, 2024 did not disappoint in terms of developments in the biotech sphere and we have enjoyed reviewing these and preparing this edition for you. 

Our tour of the developments from 2024 begins with a look at how AI is making its impact on biotech companies. In August 2024 the EU AI Act entered into force and its impact is beginning to be felt across the industry. Our article on how AI affects biotech companies looks at some of the regulation of biotech activities in Europe under the AI Act but also looks at activities outside of the Act which could help accelerate innovation. 2024 also saw a number of further collaborations between biopharma companies and AI-focused companies demonstrating the strength of focus on AI as a path for future innovation in the sector.

Outside of the AI arena, a spotlight has been put on mRNA technologies. The mRNA vaccine and therapeutics market almost doubled in value in the last 4 years and is set to increase further in this decade. mRNA vaccines are publicly pushing the boundary particularly with personalised vaccines. There are some ongoing mRNA vaccines in Phase I and Phase I/II trials targeting conditions such as pancreatic cancer. Many of these rely on collaborations between competitors to drive innovation and meet patient need. Driving innovation in this area has also resulted in increased patent applications as well as the high-profile patent disputes surrounding the Covid-19 vaccines.

With collaborations key to many aspects of innovation, companies continue to consider how best to structure agreements and meet the needs of their businesses. The structure of the collaborations with AI companies and the implications of this on business models is evolving at pace and is of utmost importance to any company considering entering into such collaborations. Further, during 2024 the new UK tax relief rules for R&D came into force giving pause for thought to those who contract out research (and those who conduct it) when it comes to the terms of agreements between organisations. Several of our articles in this edition look at the implications of legislative changes and rules relating to collaborations.

We updated readers last year on key proposals in relation to Supplementary Protection Certificate legislation in Europe. These proposals have taken some procedural steps through the EU Parliament but still have some way to go before they come into force. It will be interesting to monitor developments through 2025. With the spotlight off the legislative changes to SPCs for the bulk of the year, those with an interest in these rights were given an early Christmas present in December 2024 with a decision from the CJEU on the validity of combination SPCs in Europe. The implications of this decision are still being considered.

We are fortunate to share the insights from our external collaborators, Serena ter Kuile from Genmab and Robert Jenny at Amgen. We thank them for their very interesting contributions. We hope you enjoy reading them together with the articles from our lawyers at Bristows who specialise in the life sciences sector from different practice areas.