Marco de Morpurgo

Marco’s experience includes advising:

• A leading UK biopharmaceutical company on regulatory exclusivity protection and patent term extensions for two HIV prodrugs in the EU and the UK
• A global biopharmaceutical company on cell and gene therapy (CGT) regulation in the EU, including in relation to compliance with the EU Tissue and Cells Directive, ATMP Regulation, and broader regulatory challenges arising from the company’s CGT business
• A US biotechnology company on all the regulatory and commercial aspects of one of its key clinical trials being conducted across numerous jurisdictions, including Europe, Australia, China, Hong Kong, Japan and Thailand
• A US pharmaceutical company on the planning, preparation and implementation of early access programs for its lead investigational medicine in 16 European jurisdictions (Belgium, Czech Republic, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden and the UK)
• A Japanese pharmaceutical company on defending its data exclusivity and market protection rights from two potential competitors preparing to enter the Italian market with generic versions of the client’s triple combination product, including proceedings against the Italian Medicines Agency (AIFA) to seek access to the competitors’ dossiers as well as broader regulatory strategies
• A US early-stage pharmaceutical company on regulatory and pricing issues related to its strategy to enter the EU market (Germany, Italy and Spain) with two biologic medicinal products – one of which received orphan designation from the EMA – containing the same active substance but with different therapeutic indications and dosages
• A US medical technology company across all aspects of medical device regulation including: (i) discontinuing a previous version of its medical device in 40 countries; (ii) rolling out a sampling program with HCPs all over Europe; and (iii) transparency obligations in the MedTech and national industry codes
• A UK medical device company on EU medical device regulation in relation to products without an intended medical purpose as listed in Annex XVI to the EU MDR
• A global contract research organization in relation to the provision of home nursing services in the context of decentralized clinical trials to be rendered at trial subjects’ homes in more than 50 jurisdictions worldwide
• A US-based biotech company in relation to a number of clinical trials sponsored across Europe (including in Belgium, Croatia, Czech Republic, France, Germany, Hungary, Italy, Poland, Portugal, Romania, Spain and Ukraine), including: (i) negotiating relevant clinical trial agreements with medical institutions, (ii) managing the relationship with the contract research organizations engaged for each trial, (iii) advising on applicable procedures to implement substantial and non-substantial amendments to the trial protocol, (iv) drafting agreements for the appointment of the sponsor’s EU Legal Representative, (v) drafting agreements for the provision of ancillary services and (vi) assisting on privacy-related issues, with a particular focus on applicable requirements for the transfer of personal data outside the EU
• A US pharmaceutical company on reviewing its internal compliance policies related to medicinal product promotion and HCP interactions in 31 jurisdictions worldwide
• A French/Swiss radiopharmaceutical company in relation to grants, interactions with HCPs and KOLs, and a review of its promotional initiatives and website in Europe
• A French multinational pharmaceutical company on the development and implementation of an internal compliance program relating to the digital promotion of consumer healthcare products on social media and other digital platforms under EU law, as well as under the national laws of France, Italy and Poland
• A leading French multinational pharmaceutical company on EU medical device regulatory, anti-kickback, privacy, and antitrust matters in relation to the assemblage of sample collection boxes, and their supply to healthcare professionals in the EU for the collection of patients’ biological samples for antibody testing and biomarker testing to be conducted in the US
• A world-leading US medical device company on the direct-to-consumer promotion, sale and supply of diabetes products, including through social media, across 29 jurisdictions

• Cortex – DLA Piper's Life Sciences Insights blog
• Medicinal product regulation and product liability in Italy: overview, Practical Law, 1 May 2021
• EU Medical Device Regulation May Spur Litigation Uptick, Law360, 14 May 2021
• EU SPC Manufacturing Waiver Becomes Effective: What Can Industry Expect?, European Pharmaceutical Law Review, Volume 3, Issue 3 (2019)
• The Sun Also Rises in Italy: New Statutory Transparency Requirements Expected under the Proposed Italian Sunshine Act, European Pharmaceutical Law Review, Volume 2, Issue 4 (2018)
• Italy Reforms Clinical Trial Rules, European Pharmaceutical Law Review, Volume 2, Issue 1 (2018)