Our regulatory practice advises clients across the sector including pharmaceuticals and biotechnology, cell and gene therapies, veterinary medicine, medical devices, in vitro-diagnostics and digital health. Our team has a variety of backgrounds, within the fields of bioscience, genetics and neuroscience.

As most of our lawyers have spent some time in-house, we understand the priorities faced by our clients in the day-to-day running of their business and navigating the national and EU framework.

We advise leading international companies on the full range of strategic issues arising during the life cycle of a product, from its development to its commercialisation. This encompasses advising, amongst other things, on clinical trials, marketing authorisations, CE Marking, recalls, the legal implications of parallel trade and market access.

“Regulatory IP” rights are a vital issue for our clients and we help clients analyse their products in development together with the IP regulatory rights available under the regulatory legal framework (such as regulatory data protection, orphan exclusivities, SPC and paediatric rewards).

We have a deep understanding of the challenges that medical device and IVD companies face in light of the MDR (and IVDR) revolution.

Our team represents clients before the national and European courts as well as before the competent authorities, including the European Commission, the European and UK medicines authorities (EMA and MHRA), Notified Bodies, the National Institute for Health and Care Excellence (NICE), the Department of Health, NHS England, the HFEA and the HTA.

We have a particular specialisation in more challenging issues such as cell and gene therapies, synthetic biology, genomics, borderline products and the use of AI.

Our team has conducted regulatory due diligence on behalf of clients acquiring or investing in businesses across the sector. We draw upon a deep sector knowledge to identify legal and regulatory risks as well as assessing them, whilst maintaining a commercial focus to resolve these potential issues.

Key contact

Alex Denoon

Contact

Publications

Biotech Review of the Year

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Experience

Our client is trialling its approved medicine in two novel indications which will significantly expand the market. We analysed the “regulatory IP” opportunities for the expanded markets, which involved considerations of regulatory data protection, biosimilars and SPCs. We worked with our competition team to finalise the advice.

For some years, we have helped our client navigate multiple regulatory hurdles to develop an innovative system to deliver medicines directly into the brain. The therapy poses multiple challenges for regulators, but promises to revolutionise conditions ranging from Parkinson’s to glioma.

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What others say

“Bristows’ compact competition team has established itself as one of the market leaders in the pharmaceutical sector and for cases involving a crossover between antitrust and intellectual property.”

Global Competition Review 2021

“Strong UK-based practice offering expertise in pan-European IP matters, with a solid reputation in cross-border matters of both a transactional and contentious nature.”

Chambers and Partners Europe 2021

Bristows is “an important international adviser for many companies involved at the intersection of health and technology.”

Chambers and Partners Global 2021

“Bristows has great knowledge and skill in coordinating pan-European patent litigation, especially in the area of pharmaceuticals.”

Chambers and Partners Global 2021

“Superb patent litigation and IP practice.”

Chambers and Partners Global 2021

Recent rankings and awards

Life Sciences and Healthcare - Tier 1
Legal 500 2021

Life Sciences - Band 1
Chambers and Partners UK 2021

Life Sciences: Transactional - Band 2
Chambers and Partners UK 2021

Life Sciences - Band 4
Chambers and Partners Global 2021

Life Sciences - Band 4
Chambers and Partners Europe 2021