
Herbert Smith Freehills Kramer Studio Legale
Italy
Lawyers

Martina Maffei
- Phone+39 02 3602 1371
- Email[email protected]
- Social
Work Department
Intellectual property
Position
Of Counsel, Milan
Career
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 pediatric 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.
Languages
Italian, English