Life sciences

The life sciences industry is highly innovative but also one that is legally complex and highly regulated. Whether it’s a strategic relationship, a patent dispute, a technology licence or R&D collaboration, a clinical trial, a regulatory issue, a strategic recruitment or the launch of a new corporate vehicle, we understand the environment you are operating in and will work with you to achieve your objectives.

Supporting you on the journey to achieving your ambitions

We understand the pathway from laboratory bench to the end user. Our clients include global organisations, as well as many small and mid-sized companies, universities, research institutes, charities and government organisations. We have extensive multi-disciplinary experience across all areas of the industry including pharma and biotech, medical devices, diagnostics, digital health and specialist service provision. We partner our clients on all stages of the journey.

The pharmaceutical and medical device product lifecycles present particular challenges. Our wide range of expertise and experience ensures we understand the issues you face. We will work closely with you to manage your risks and maximise opportunities on all stages of your journey. We will help you negotiate early-stage agreements to develop and protect your innovative technology - vital to ensuring you have a firm base for growth. We will support you with securing timely funding on favourable terms. We work with both early stage and established companies and organisations, supporting the development of a product or technology through clinical trials, commercialisation and post-marketing activity, and on a corporate sale or listing.

Our experience of dispute resolution means that our expert intellectual property teams can act in a swift and decisive manner, which is key in the competitive life sciences and disputes sector. We will support you on product liability and recall issues, regulatory investigations, enforcement of your rights and in defensive action where others may accuse you of infringing activity.

The breadth of our sector expertise marks us out. We have clients across the higher education and charitable sectors, helping them to promote early stage research and move it towards the market. We advise a broad range of health and care regulators and public and private health and care providers supporting them both within the UK and elsewhere. With our broad experience of working for innovative companies, education institutions, charities, investors, regulators and healthcare providers, we understand the sector from all perspectives and can make deals and connections that work for you.

And given the importance of international markets to life sciences clients, we can offer you a network of business contacts and law firms across the globe (including SCG Legal, a worldwide network of leading law firms) to support your international requirements.

Our lawyers

Our life sciences experts include specialists in all the key areas below. Many of our legal advisors are former scientists or have experience of working in-house for life science organisations, building on legal knowledge to provide our clients with advice that is commercially focused.

Our lawyers are available near you, wherever you are. We have offices close to the UK’s major life science hubs, including in Cambridge, Birmingham, Leeds, Manchester and London. Our team has extensive experience of advising clients within the sector on:

  • acquisitions, disposals and joint ventures; funding and venture capital transactions; capital market work; spin-out transactions; tax, corporate governance and advisory; company secretarial support
  • IP advisory work, strategy and litigation; trade mark filing; anti-counterfeiting and falsified medicines; licensing and technology/IP transfer; R&D; freedom to operate work; use of social media
  • Industry regulatory work including regulatory compliance (e.g. conduct of clinical trials, human tissue and pharmacovigilance); advising on borderline products and product classification; data exclusivity; labelling, marketing and advertising; pricing and reimbursement; product liability and recall 
  • Privacy and anti-corruption compliance, including policy work and regulatory investigations 
  • Commercial contracting, including collaborative arrangements; marketing and promotion agreements; distribution, supply and manufacturing agreements; outsourcing agreements; procurement; IT and technology agreements
  • HR, pensions and immigration law, including executive and employee contracts; disputes; policies and processes; reorganisations 
  • Real estate transactions and strategy 
  • Competition law advice including dawn raids and parallel importing 
  • NHS commissioning and contracting 
  • The impact of the UK’s exit from the EU

Our experience

  • Advising a global pharmaceutical company on its international distribution arrangements for two drug candidates, patent issues and supply chain structures, including advising on a range of distribution and licensing transactions and manufacturing, pharmacovigilance, market access, logistics, packaging and labelling, and serialisation agreements.
  • Advising the Wellcome Trust Sanger Institute on a number of commercial transactions, including negotiating the funding and licence terms for its investment / spin out of Microbiotica, a start up specialising in the therapeutic use of live naturally occurring symbiotic human bacteria for the treatment of human disorders, based on research at the Institute, including licensing and access to cell lines, analytical software, patents and know how.
  • Advising a listed global healthcare company on the branch sponsorship structure for its UK operations and its obligations relating to the transfer under TUPE of sponsored migrants.
  • Ongoing participation in the MedImmune Annual Learning and Development Programme where we work closely with this client to deliver training directly to its managers, from experienced senior managers through to talented scientists who are progressing through the ranks and taking on increasing amounts of line management responsibility.
  • Licensing and IP advice for Imperial College Healthcare NHS Trust on setting up the UK’s first Academic Healthcare Centre, selected as one of the UK's 11 Biomedical Research Centres with five years guaranteed research funding.
  • Acting for Bicycle Therapeutics, on its syndicated fundraisings of more than £30 million from investors Atlas Ventures, Novartis Venture Fund, SR One (GSK's corporate healthcare fund), SV Life Sciences and Astellas Venture, and on a commercial dispute with a key supplier.
  • Advising on the establishment and estates strategy in relation to the Stevenage Bioscience Hub, Babraham Research Campus and Cambridge Biomedical Campus.
  • Advising The National Institute for Biological Standards and Control (a division of the MHRA) on a range of commercial transactions in IP licensing agreements, grant funding (including EU funding) and material transfer arrangements, and in particular cell line licensing arrangements. Members of our team have also undertaken secondments into this organisation and we have dedicated lawyers providing support on commercial agreements largely on an extended in-house counsel basis.

What our clients and others say about us

  • James Fry is noted for his capabilities as a commercial and transactional IP adviser. He is "approachable and extremely knowledgeable" say clients - Chambers. The Legal 500 says that he provides “excellent pragmatic support”.
  • Alasdair Poore continues to command the respect of market commentators. Clients say he is "very practical in his approach, very responsive and able to cut through legal jargon"- Chambers
  • Listed nationally for pharmaceuticals and biotechnology expertise by Legal 500 
  • Clients note the ‘excellent service at reasonable rates’ from the team at Mills & Reeve LLP, which provides the full range of commercial, regulatory and IP advice to the biotechnology sector.

Legal resources you may find useful

Visit the Life Science Law blog for legal updates, opinions and the latest news in a blog by our life science lawyers. We also issue regular updates and run regular events for life science organisations. Please contact us for more details. Other relevant and useful online resource can be found below: