Our practice provides both contentious and non-contentious advice focusing on regulatory, patent, major contract 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.
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, and data protection and privacy.
Key services include:
– Advice on obtaining marketing authorisations and acting in cases relating to regulatory decisions
– Advice on manufacturing, labelling, distribution and advertising of medicinal products
– Advice on direct and indirect promotional aspects of pharmaceutical products
– Advice on procurement through public competitions
– Regulatory and contractual issues relating to clinical trials agreements
– Regulation of novel foods and food supplements
– Pharmacovigilance issues, including (a) monitoring of post-market mechanisms which are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted, and (b) data protection issues that should be considered when conducting pharmacovigilance activities
– Pricing issues, including national legislation on pricing and reimbursement of medicinal products
– Advice in relation to paediatric drugs.
• Patents & Supplementary Protection Certificates (SPCs)
– Managing complex disputes relating to validity and/or infringement of patents and SPCs, and issues of patentability
– Freedom to operate advice in the light of third party rights and clearing the way to market strategies
– Strategic advice to pharmaceutical companies on the implications of the Unitary Patent and Unified Patent Court and opting out of the proposed regime
• Intellectual Property (non-patents)
– Protection, exploitation and enforcement of IP rights across the Life Sciences industry, including advising on complex clearance issues and portfolio management relating to pharmaceutical brands and trade marks
– Anti-counterfeiting strategies including innovative use of civil and criminal remedies and border detentions
– Trade secrets protection
• Dispute Resolution
– Resolution of IP, competition, regulatory and contractual disputes.
– Product liability, including liability for defective medicinal products
– Reputation management
– Advising on relevant market definition applicable to the pharmaceutical sector
– Advising on the interplay between competition law and intellectual property, including patent settlement, 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.