Publication: Biotech Review of the Year

2023 is likely to be remembered as a year in which a number of highly anticipated developments in the biotech industry finally came to fruition.

Generative AI is being embraced by the biotech sector with a splash. Our article on how to integrate generative AI into the life sciences ecosystem highlights some of the key issues organisations in this field should consider when incorporating or leveraging generative AI into their products and processes. At the end of the year, we also saw a political deal reached on the EU AI Act, following a high-stakes trialogue negotiation. The final publication of the AI Act is likely to come in the coming months with the Act applying as law in stages between one and two years after publication, so there will be plenty for us to keep our eye on in 2024.

The Unified Patent Court, which for a long time looked like it might not take off, finally opened its doors on 1 June 2023. In this edition, we take a look at how the court is getting on as it approaches its first anniversary and in particular, how the first decisions relating to biotechnology from the United Patent Court have been decided.

In 2023 we saw some highly-anticipated breakthroughs in biotechnology, including the momentous global-first approval of CASGEVY®, a CRISPR therapy, by the MHRA earlier this year that we have covered in our article covering CRISPR updates in 2023. The arrival of cell and gene therapies in the market also brings new challenges in their manufacture. We explore this and the emerging role of CDMOs in another article in this edition.

As well as anticipated developments, 2023 has also seen a number of proposals for future legislative change being put forward. This edition includes articles looking at the Commission’s proposals to reform the EU pharmaceutical legislation and the package of proposals relating to changes on how Supplementary Protection Certificates are regulated. We will be tracking these changes closely in future editions and our On The Pulse microsite.

Finally, it is difficult to ignore that 2024 is being billed as the year of elections, with elections set to be held in a number of key jurisdictions for the biotech industry including the United States, the European Parliament, the United Kingdom and South Korea. In this edition, we take a look at the significant investment recently announced by the UK government, aimed at supporting the life sciences sector, but the outcomes of these elections may well shape the future of biotech investment globally.

We are pleased to share our insights on developments in the biotech industry in 2023, along with what lies ahead of us in 2024 and beyond, with you, which have been written by our lawyers who specialise in the life sciences sector and span a range of practice areas. We would also like to thank our external contributors to this year’s Biotech Review, namely Andrew Cossar from Syncona, Hsin Loke from OMass, and Brad Sitko and Nick Cole from XOMA Royalty.

We hope you enjoy reading this edition as much as we enjoyed pulling it together!