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Life Sciences

Our full-service group of specialist Life Sciences lawyers brings knowledge and passion to this dynamic but highly regulated sector. We focus on patent, regulatory, major contract, insurance and competition law disputes across the life sciences sector.

Known for our nimble and creative approach, we pursue every avenue to protect our clients' interests. For example, our regular use of civil search and asset freezing orders in counterfeit pharmaceutical and agrochemical cases sets us apart from our competitors.

We understand that having the right regulatory advice is critical to your success and we advise on the full range of commercial agreements including licences, research and development agreements, large-scale clinical trial programmes and technology transfer.

Our clients range from multi-nationals to start-ups, operating in the pharmaceutical, medical device, biotechnology, agrochemical, crop science and veterinary medicine fields. We also work with academic institutions and non-profits, tailoring legal solutions to match their institutional needs and risk preferences.

As new developments arise we provide our clients with clarity, recently advising several clients on the regulatory landscape affecting medical cannabis and CBD products. Tenacious problem-solvers, our Life Sciences group relish the commercial challenges of a sector disrupted by technology but rooted in regulation.

Key Services

Patents and Supplementary Protection Certificates

Managing complex multi-jurisdictional disputes relating to validity and infringement of patents, SPCs, and entitlement issues
Freedom to operate advice in the light of third party rights and clearing the way to market

Intellectual Property (non-patents)

Protection, exploitation and enforcement of IP rights across the life sciences industry, advising on complex clearance issues and portfolio management relating to pharmaceutical brands
Anti-counterfeiting strategies including innovative use of civil and criminal remedies (including actions for fraud and for recovery of proceeds of crime) and Border detentions
Trade secrets protection

Regulatory

Advice on obtaining marketing authorisations and acting in cases relating to regulatory decisions
Regulatory and contractual issues relating to clinical trials agreements
Regulation of novel foods and food supplements
Pharmacovigilance issues
Reimbursement and pricing issues
Advice in relation to paediatric and orphan drugs

Dispute Resolution

Resolution of IP, competition, regulatory and contractual disputes, including through mediation and arbitration
Product liability
Reputation management
Conducting internal investigations
Advising in respect of bribery and corruption legislation/exposure in the UK
Directing and guiding criminal investigations, and conducting private prosecutions (including for fraud, IP breaches, and counterfeiting offences)
Insurance coverage disputes

Competition

Advising on relevant market definition applicable to the pharmaceutical sector
Advising on the interplay between competition law and intellectual property, including patent settlement, FRAND issues in relation to regulatory data and potential misuse of the patent system/SPCs
Advising various drug manufacturers and wholesalers on various issues associated with the application of EU competition law to the pharmaceutical sector

Drug ∕ product development and clinical trials

Negotiating the full range of research, development and collaboration agreements for new therapies and medical devices
Advising both pharma companies (as Sponsors) and contract research organisations on the largest multicentre study arrangements, covering interventional, extended use, paediatric and observational studies

Insurance

Advising on insurance programmes relevant to the pharmaceutical sector and potential gaps in coverage, including product liability policies, bespoke clinical trial policies, D&O insurance
Representing life sciences companies in high-value insurance coverage disputes against their insurers, such as product liability Bermuda Form arbitrations, employment practices liability, directors' and officers' liability
Representing life science companies in claims against insurance brokers for breach of contract/negligence
Insurance coverage advice

Commercial issues and exploitation

Advising on and negotiating the full suite of commercial transactions across the Life Sciences industry
Data protection, data privacy and cyber-security advice
Advising in relation to advertising and marketing issues.

Corporate, Tax and Employment

Purchases and sales of companies or their assets. Accessing capital markets and IPO
Advising financial institutions and other investors on investments in the Life Sciences sectors and related due diligence
Private equity transactions, including buy outs and buy ins, corporate business acquisitions and disposals, public-to-private transactions, growth/development capital investments
Transactions involving re-organisations and demergers, including advice on TUPE
Fund structuring and establishment, including tax and regulatory advice
Managing the full spectrum of contentious and non-contentious employment law, from HR advisory and contractual agreements to advising on team moves, data theft and restrictive covenants
Expertise in business immigration and incentives

Meet the team

The Unitary Patent and Unified Patent Court

With an ambitious eye on its place in the UK patent market, the well-positioned patent practice at Mishcon de Reya continues to develop its visibility…
Juve Patent, UK Rankings – 2023

Great team with a great diversity, excellent collaboration and responsiveness. it is a pleasure working with them. They also have an innovative way of working which guarantees to get value for money.
Legal 500 2023

A diverse and very professional team, with a breadth of experience across the IP field.
Legal 500 2023

They are knowledgeable beyond the borders of their specialty and can also reach a large pool of experts to further leverage knowledge.
Legal 500 2022

They are highly competent and take a pragmatic approach. They are present when needed and supporting the business needs in the best possible way.
Legal 500 2022

Mishcon de Reya provides an excellent full-range IP service, including life sciences and healthcare within the support framework of a full-service firm.
Legal 500 2022

National Security and Investment Act checkerIs your deal caught by the National Security and Investment Act? – find out here.

Leading firm

Sprawling, multi-jurisdictional patent cases are Mishcon de Reya’s bread and butter. Offering sterling IP litigation, the full-service outfit has significantly expanded its capabilities in recent years.
IAM Patent 1000 2019

Intellectual Property disputes and regulatory issues are the key areas of focus for Mishcon de Reya LLP
Legal 500 2019

Work highlights

Work highlight

Lupin

Acting for Lupin in proceedings against Gilead Sciences Inc before the Court of Justice of the European Union and the English Court of Appeal over the validity of Gilead's Supplementary Protection Certificate for Truvada, recognised as Impact Patent Case of the Year at MIP's 2019 EMEA Awards.

Work highlight

Dr Reddy's Laboratories

Acting for Dr Reddy's Laboratories in an enquiry as to damages against Warner-Lambert relating to its second medical use patent for pregabalin following the finding of invalidity

Work highlight

Shionogi Limited

Advising Shionogi Limited in relation to its contract research organisation (CRO) managed clinical trial programmes, in over 140 sites and in 20 countries.

Work highlight

United Phosphorus Limited

Successfully representing United Phosphorus Limited in High Court proceedings relating to unauthorised copies of its Metafol herbicide sold under parallel trade permits in Germany, including obtaining what is believed to be the first ever civil search and asset freezing order in respect of counterfeit agrochemicals.

Work highlight

Generic pharmaceutical company

Advising a generic pharmaceutical company in relation to the European Commission's abuse of dominance investigation into Servier's patent settlement agreements relating to perindopril.