Marco de Morpurgo

Partner

Global Co-Chair, Life Sciences Sector

Marco de Morpurgo is definitely the cream of the crop.

— Client, Healthcare and Life Sciences, The Legal 500 EMEA 2022

Emailmarco.demorpurgo@dlapiper.com

Call+39 06 68 880 1

Brussels Rome

About

Areas of FocusLife Sciences Regulatory and Government Affairs

Professional QualificationsAvvocato admitted to the Rome BarAvocat admitted to the Paris BarAbogado registered with Ilustre Colegio de Abogados de MadridAttorney-at-law admitted with the Supreme Court of New York

Highlights

EXPERIENCE

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

Languages

Education

University of Milan, Ph.D., Comparative Law

Harvard Law School, LL.M.

University of Trieste, Law degree

IUC Turin, M.Sc., Comparative Law, Economics & Finance

Awards and recognitions

Pro Bono

Marco performs a significant amount of pro bono work for clients in the Life Sciences industry. He recently assisted EURORDIS, the European alliance of patient organisations for rare diseases, with the drafting and execution of the Charter for Collaboration in Clinical Research in Rare Diseases, as well as with other projects aiming to foster patient engagement in clinical research into rare diseases.

Publications