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20 Jul 20
Supplementary protection certificates and Court of Justice: clarifications on the conditions for obtaining a supplementary protection certificate
On July 9, 2020, the Court of Justice (the “Court”) ruled on supplementary protection certificates (“SPCs”) in case C-673/18.
5 Jun 19
Breaking news on the supplementary protective certificate for medicinal products
On June 11, 2019, Regulation (EU) 2019/933 (“Regulation 2019/933”), amending Regulation (EC) No 2009/469 (“Regulation 2009/469”) concerning the supplementary protection certificate (“SPC”) for medicinal products, was published in the Official Journal of the European Union.
7 Apr 19
Supplementary protection certificates: clarifications from the EU Court of Justice
In its judgment on Case C-443/17 of March 21, 2019, the European Court of Justice ruled on a significant patent issue following a preliminary ruling under Article 267 of the Treaty on the Functioning of the European Union (TFEU) from the High Court of Justice (England & Wales).
1 Feb 19
The European Parliament legal affairs committee votes in favor of a comprehensive SPC manufacturing waiver
In May 2016, the European Parliament, in its Resolution on the Single Market Strategy, endorsed the need for changes to the EU supplementary protection certificate (“SPC”) and urged the Commission to introduce and implement an SPC manufacturing waiver before 2019, without undermining the market exclusivity granted under the SPC in the protected markets.
3 Dec 17
CJEU and SPCs: a never-ending story
The work of the Court of Justice of the European Union (CJEU) on Regulation (EC) No. 469/2009 (Regulation), on supplementary protection certificates for medicinal products (SPCs), has been quite intense in the last few years, and it still is, given that in the pharmaceutical sector even one more day of exclusivity can be worth millions of euros, so fighting for it is certainly worth the investment of time and money.
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the Life Sciences-Healthcare industry.
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Our highly-ranked team of professionals will provide news, insights 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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October 6, 2023
CBD products: the Administrative Court suspended until October 24 the recent Decree of the Italian Ministry of Health listing cannabidiol for oral use among narcotic drugs, due to the lack o...
October 4, 2023
The Guidelines for regulating contractual relations between universities and research institutes and private sponsors were adopted by the relevant Italian Ministries following the amendment ...
September 21, 2023
CBS products: from September 20th, compositions for oral administration of cannabidiol obtained from Cannabis sativa extracts shall be considered as narcotic drugs in Italy, as they have bee...
July 27, 2023
Payback on medical devices: Italian government announces extension of payment deadline to October 30, 2023
July 21, 2023
On July 21, 2023, the Italian Ministry of Health published new guidelines on health advertising of self-medication drugs (OTC) and non-prescription drugs (SOP), including advertising on new ...
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