Life Sciences & Healthcare
The life sciences and healthcare sector encompasses one of the most dynamic and vital industries in the global economy, spanning pharmaceuticals, biotechnology, medical devices, healthcare services, and digital health solutions. This sector operates within an exceptionally complex regulatory framework, with companies facing stringent oversight from multiple regulatory authorities at national and international levels. The heavily regulated nature of this industry demands that organisations navigate intricate compliance requirements whilst driving innovation and maintaining commercial viability.
Our Expertise
In the life sciences and healthcare sector, legal counsel must be more than technically proficient – they must understand the science, the business imperatives, and the regulatory landscape that defines your industry. We believe that companies operating in this sector need a firm that speaks their language, understands the commercial realities of their business, and recognises how legal and regulatory decisions can have far-reaching implications for their entire commercial strategy.
We provide comprehensive legal support to life sciences and healthcare clients across the full spectrum of regulatory, commercial, and contentious challenges. Our deep industry immersion – built through years of advising pharmaceutical companies, medical device manufacturers, healthcare providers, biotech innovators, universities and government agencies – enables us to deliver practical, business-focused advice that addresses the unique demands of this highly regulated sector. We don’t just understand the law; we understand your industry, your challenges, and what’s at stake.
Regulatory Excellence
Our regulatory practice covers the entire life sciences and healthcare ecosystem. We guide clients through the complex regulatory requirements governing pharmaceuticals – from marketing authorisations and clinical trials to marketing, pricing and reimbursement. Our work extends to medical devices, where we advise on regulatory requirements and marketing. We also support healthcare service providers with licensing and operational compliance matters. Throughout all of this work, data protection and privacy considerations are paramount, and we provide comprehensive advice on managing clinical data, patient privacy, and the regulatory frameworks governing digital health innovations.
Our team maintains close relationships with regulatory authorities and stays at the forefront of regulatory developments, ensuring our clients receive timely, strategic guidance on compliance matters and regulatory strategy.
Strategic Commercial Partnerships and Complex Contracting
We have extensive experience advising on the complex contractual arrangements that underpin the life sciences industry. Our commercial practice encompasses:
- R&D Collaboration and Joint Venture Agreements: Structuring strategic partnerships for research and development, including risk allocation, intellectual property ownership, and governance frameworks
- Licensing Agreements: Negotiating and drafting technology transfers, patent licences, know-how agreements, and commercialisation arrangements
- Clinical Trial Agreements: Advising sponsors, contract research organisations, and clinical sites on trial agreements, including liability provisions and data ownership
- Service Agreements Between Life Science Companies and Contract Manufacturers: Drafting and negotiating manufacturing, supply, and technology transfer arrangements
- Other Commercial Agreements for the Pharmaceutical Industry: Supporting distribution agreements, supply arrangements, and other commercial contracts
Our commercial team understands the technical, regulatory, and business considerations that shape these agreements, enabling us to deliver contracts that protect our clients’ interests whilst facilitating successful collaborations.
Client highlights
- Borenius represented Teva Pharmaceuticals in a patent and supplementary protection certificate dispute
- Borenius secures win for Teva in a patent dispute over blockbuster anticoagulant drug
- Borenius advised Heraeus in a complex trade secret dispute in the Market Court
- Borenius Secures Victory for Teva and Mylan in SPC Dispute over Blockbuster Drug
- Borenius successfully represented Mylan before the Supreme Court in a landmark case concerning the presumption of validity
- Borenius successfully represented Orifarm Generics at The Court of Appeal
- Borenius advised Valio Ltd on the sale of its starter culture ingredients business to Chr. Hansen A/S and its related supply, licence and IPR arrangements
Award-Winning Litigation and Dispute Resolution
We have established a formidable reputation in life sciences litigation, recognised by all major legal ranking houses, consistently ranked at the top of our field, and award-winning in our practice. We appear before courts and tribunals at all levels – from the Market Court through to the Supreme Court, the Court of Justice of the European Union, and administrative courts of the highest instance. Our litigation expertise includes:
- Complex Pharmaceutical Patent Litigation: Acting in sophisticated patent disputes involving innovative medicines, biosimilars, and generic pharmaceuticals, including preliminary injunction proceedings, infringement proceedings, validity challenges, and supplementary protection certificate matters
- Administrative Proceedings Against Regulatory Authorities: Representing clients in administrative appeals concerning regulatory decisions related to pharmaceuticals, medical devices, and pharmacy business operations
- Commercial Disputes: Resolving contractual disputes, licensing disagreements, and supply chain conflicts specific to the life sciences sector
Our litigation team combines technical expertise with strategic acumen, delivering robust advocacy that protects our clients’ commercial interests and intellectual property rights in this competitive and highly regulated marketplace.
Data, Privacy and Digital Health
Data protection is fundamental to the life sciences and healthcare sector, where organisations handle sensitive personal health data and valuable research information. Our dedicated data and privacy practice provides comprehensive advice on:
- GDPR and national data protection law compliance for clinical trials, patient registries, and healthcare services
- Cross-border health data transfers and international data sharing arrangements
- Clinical data management and electronic health record systems
- Patient consent frameworks and privacy impact assessments
- Data security incident response and breach notification
- Digital health applications and health technology platforms
- Anonymisation and pseudonymisation of health data for research purposes
- Compliance with sector-specific regulations governing health data
We help clients develop robust data governance frameworks that enable innovation whilst ensuring full compliance with data protection obligations and maintaining patient trust. Whether you are navigating regulatory challenges, negotiating critical commercial agreements, or facing high-stakes litigation, our Life Sciences & Healthcare team is ready to deliver the expert guidance you need. Contact us to learn more.
Our experts are always ready to assist you. See all our Life Sciences and Healthcare references here.
Additional information
Team
Latest references & news
- The Court of Justice’s New Ruling – Interpretation of Conditions for Obtaining a Supplementary Protection Certificate under Article 3(a) and 3(c) of the Regulation (EC) 469/2009
- A Victory for Clarity: The Turku Administrative Court Decision Ensures Transparent Labelling for Plant-Based Foods
- The Court of Justice’s New Ruling – Finnish Strict Liability Regime regarding Unfounded Preliminary Injunctions Compatible with the EU Enforcement Directive
- EU Commission Proposes New Rules on Green Claims and Right to Repair
