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Portolano Cavallo Life Sciences Blog
8 Feb 19
Using medicinal product trademarks in clinical trials prior to marketing authorization does not amount to genuine use, states advocate general szpunar
On January 9, 2019, Advocate General (AG) of the Court of Justice of the European Union (CJEU) Maciej Szpunar gave his opinion on case C-668/17 (“Opinion”), a trademark dispute that, while focusing on medicinal products, raised two other far-reaching issues concerning the scope and definition of the requirement of genuine use within the provisions of Article 58 of Regulation (EU) 2017/1001 of the European Parliament and of the Council of June 14, 2017 on the European Union trade mark (“EUTMR”).
7 Feb 19
New law to settle the long-lasting dispute on the pharmaceutical payback for 2013-2017
On February 11, 2019, Italian Law no. 12/2019 was published in the Official Gazette of Italy, converting into law, with amendments, Italian Law Decree no. 135 of December 14, 2018 (also called the Simplifications Decree) aimed at simplifying certain administrative responsibilities for both private and public entities.
6 Feb 19
No deal brexit’s impact on the pharmaceutical and medical devices industries: guidance from the ema and the european commission
On January 15, 2019, the UK House of Commons rejected the withdrawal agreement reached by Theresa May and the EU after a long and exhausting negotiation period of almost 2 years.
5 Feb 19
Benefit companies: an overview from a corporate perspective
Italy was the first European country to issue a regulation on benefit companies (in Italian “società benefit”), importing the model from the US.
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
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Our highly-ranked team of professionals will provide newsinsights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

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September 21, 2022
Payback for medical devices: Decree quantifying the exceeding of the expenditure ceiling for medical devices at national and regional level for the years 2015, 2016, 2017 and 2018 published ...
September 1, 2022
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of p...
July 19, 2022
Guidelines for the implementation of the Electronic Health Record (EHR) to ensure dissemination, uniformity and accessibility of the EHR at national level now published in the Official Gazet...
June 6, 2022
The National Coordination Centre for Ethics Committees published new draft agreements for conducting clinical trials on drugs and medical devices
April 27, 2022
EU Medical Device Coordination Group (MDCG) approves “Guidance” on the borderline between medical devices and medicinal products in order to support the uniform application of Regulation...
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