Our full-service group of Life Sciences specialists comprises lawyers who are passionate and knowledgeable about this dynamic yet highly regulated sector. They are regarded as leaders in their field and many have scientific and technical backgrounds. The group focuses on patent, regulatory, major contract and competition law disputes across the life sciences sector.
We understand that having the right regulatory advice is critical to your success and we advise our clients 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. The Life Sciences Group also works with academic institutions and non-profits, tailoring legal solutions in recognition of their institutional needs and risk preferences.
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.
- Managing complex multi-jurisdictional disputes relating to validity and infringement of patents and SPCs
- Freedom to operate advice in the light of third party rights and clearing the way to market
- Strategic advice to pharmaceutical companies on the implications of the Unitary Patent and Unified Patent Court and opting out of the proposed regime.
- 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.
- 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.
- Resolution of IP, competition, regulatory and contractual disputes, including through mediation and arbitration
- Product liability
- Reputation management
- Conducting internal investigations (benefitting from the potential retention of legal professional privilege for the client in UK as opposed to the use of in-house professional legal advisers)
- Advising in respect of bribery and corruption legislation/exposure in the UK (for example, Bribery Act, ISO 37001) and wider transnational jurisdictional aspects
- Conducting private prosecutions (including fraud, IP breaches and counterfeiting offences)
- Directing and guiding criminal investigations
- Insurance coverage disputes.
- 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.
- 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.
- 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.
- 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
- Fund structuring and establishment, including tax and regulatory advice.
- 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.
- Acting for Lupin in proceedings against Gilead Sciences Inc over the validity of Gilead's Supplementary Protection Certificate for Truvada.
- Representing Dr Reddy's Laboratories in patent infringement and validity proceedings against Warner-Lambert relating to its second medical use patent for pregabalin.
- Acting for Advanta Netherlands B.V. in revoking Cargill, Inc's patent for a high stearic, high oleic sunflower oil.
- Advising Dermal Laboratories and Sixtem Life Srl in defending patent infringement proceedings brought by Orasure Inc relating to Dermal's 'Bazuka Sub-Zero' cryogenic wart treatment.
- Advising Shionogi Limited in relation to its contract research organisation (CRO) managed clinical trial programmes, in over 140 sites and in 20 countries. In addition to creating country specific template clinical trial agreements, based on local regulations of clinical trials, this included preparing confidential disclosure agreements and local representation agreements, and subsequently negotiating each of the site specific clinical trial agreements.
- Representing Perrigo in defending a trade mark infringement and passing off claim by Reckitt Benckiser relating to certain trade marks and packaging for Nurofen Express.
- 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.
- Advising Woodford Management LLP on a number of investments in life science, bioscience and pharmaceutical companies.