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Martina Maffei

Martina Maffei

Associate

Martina specialises in intellectual property, particularly patent and regulatory law in the life sciences sector.

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Experience

Martina is an IP litigator, with particular experience in life sciences, and has extensive experience of advising on multi-jurisdictional cases. Martina assists clients with strategic regulatory issues in the life sciences area, such as routes for obtaining marketing authorisations, pricing and reimbursement, the promotion of medicinal products and medical devices, the limits of the Bolar clause and the interpretation of the SPC Regulation.  She also assists Italian and international clients on non-contentious matters, such as advising on patents, trademarks and e-commerce. 

Martina has experience assisting coordinating counsel in patent litigation cases across Europe. In addition to extensive patent litigation experience, Martina has also worked for many of the largest pharma and biotech companies on a range of regulatory issues, including marketing authorisations, data exclusivity and pricing and reimbursement as well as: 

  • compliance with national and international standards on interactions with healthcare professionals (HCPs) and healthcare organisations (HCOs), transparency and disclosure obligations at industry level and under the law
  • legal and regulatory aspects of digital health solutions
  • borderline qualification cases (between food, medical devices, cosmetics, medicinal products)

Martina's experience includes:

  • assisting a world leading pharmaceutical company in patent litigation and Supplementary Protection Certificate validity, including providing regulatory assistance  
  • assisting a market leading animal health provider in relation to patent enforcement in Italy. 
  • advising a leading pharmaceutical company in a multi-jurisdictional revocation and non-infringement action concerning key patents in the ophthalmic field 
  • advising a Japanese pharmaceutical company in relation to pricing and reimbursement issues and the preparation for patent litigation in view of the expiry of patent rights
  • assisting a global pharmaceutical company in the preparation of patent litigation and providing strategic regulatory advice in relation to a blockbuster product

 

 

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.