Martina Maffei
Martina specialises in intellectual property, particularly patent and regulatory law in the life sciences sector.
Martina is a leading life sciences lawyer combining deep regulatory expertise with robust litigation capability - a combination that gives clients a decisive advantage at every stage of the healthcare product life cycle. She advises a wide range of clients, from innovative start-ups to established multinational groups, across the pharmaceutical, biotechnology, medical technology, food, cosmetics and consumer health sectors. Her advice is grounded in real in-house experience, having spent two years embedded within the compliance function of a multinational pharmaceutical company.
Martina's work includes product classification, regulatory pathways, regulatory data and market protection, orphan and paediatric rewards, market access, pricing and reimbursement, promotional activities. She regularly assists clients with matters involving regulatory scrutiny and sensitive compliance issues, including compliance with the rules and codes governing interactions with healthcare professionals and healthcare organisations. She also advises on the regulatory and compliance aspects of strategic transactions, including due diligence exercises and commercial arrangements such as distribution agreements, R&D agreements, services agreements, consultancy arrangements and material transfer agreements.
She is also actively involved in advising on emerging areas such as AI-driven healthcare solutions, digital health, telemedicine models, Software as a Medical Device and navigating the medical device and EU AI regulatory frameworks.
Martina has significant experience in pre-litigation and IP litigation matters in the life sciences sector, with a particular focus on pharmaceutical and biotech patent disputes, patent and SPC enforcement, freedom-to-operate assessments and launch strategies. She is a Unified Patent Court representative.
Accolades
- 2026 IP Stars "Rising star"
- 2026 Chambers Europe "Associate to Watch", Life Sciences - Italy
- 2024-2026 Chambers Europe "Associate to Watch", Intellectual Property - Italy
- 2024 Rising Star - Italy, IP Stars Rankings by Managing IP
- 2024 Lawyer of the Year - Life Sciences & Pharma, Legalcommunity Forty under 40 Awards
- 2021 Lawyer of the Year – Life Sciences
- 2020 Rising Star at the 2020 TopLegal Awards
Experience & capabilities
Selected matters
- in-house experience through a two-year secondment to the Compliance Department of Santen Italy S.r.l. (day-to-day advice on pharmaceutical regulatory and compliance matters, including sponsorships, transfers of value, scientific events, interactions with healthcare professionals, promotion and marketing compliance, and Farmindustria-related processes)
- a global pharmaceutical company in a pan-European patent dispute relating to a blockbuster treatment for multiple sclerosis
- pharmaceutical and biotechnology companies on Italian and EU regulatory issues arising during the life cycle of medicinal products, including regulatory data protection, market protection, orphan and paediatric rewards, pricing and reimbursement, AIFA procedures and market access considerations
- CSL Behring on promotional compliance matters, including HCP-facing materials, patient-facing communications, disease awareness campaigns, websites, social media initiatives, digital campaigns and competitor challenges
- Managing regulatory and IP due diligence workstreams in life sciences transactions, including the assessment of product portfolios, regulatory status, marketing authorisations, medical device certifications, promotional materials, HCP/HCO arrangements, contractual structures, compliance procedures and healthcare-related risk areas.
Sectors
Background
Martina graduated from the University of Milan in 2012. She passed the Bar exam in 2014 and joined an international law firm, where she gained notable experience, particularly in the pharmaceutical and regulatory fields, before joining Herbert Smith Freehills Kramer.
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