Italy was the first and among the hardest-hit countries in Europe by the COVID-19 pandemic. Emergency regulation for COVID-19 clinical trials and compassionate uses...more
The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more
3/17/2020
/ Biopharmaceutical ,
Biotechnology ,
Centers for Disease Control and Prevention (CDC) ,
China ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Crisis Management ,
Emergency Management Plans ,
Food and Drug Administration (FDA) ,
Good Clinical Practices ,
Infectious Diseases ,
Institutional Review Board (IRB) ,
Italy ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Netherlands ,
Public Health ,
Reimbursements ,
Research and Development ,
Supply Chain ,
Travel Restrictions ,
Trump Administration ,
UK ,
Vaccinations ,
Vendors ,
World Health Organization
Due to the COVID-19 emergency and the consequent lockdown that is affecting non-essential services in Italy, including some health care services, on March 12, 2020 the Italian Medicines Agency ("AIFA") issued a Guidance,...more
3/16/2020
/ China ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Crisis Management ,
EU ,
Good Clinical Practices ,
Infectious Diseases ,
Italy ,
Life Sciences ,
Pharmaceutical Industry ,
Public Health
The use of hemp for the production of foodstuffs is contemplated by the Law No. 242 of 02 December 2016 (Law 242/2016), bearing provisions for the promotion of the hemp cultivation and of the agro-industrial hemp chain in...more
1/23/2020
/ Agribusiness ,
Cannabis Products ,
Dietary Supplements ,
Hemp ,
Hemp Cultivation ,
Italy ,
Marijuana ,
Medical Foods ,
Plant Based Products ,
Regulatory Oversight ,
Regulatory Standards ,
Retail Market ,
Supply Chain
In Italy, the cultivation and the industrial use of hemp has a long tradition and recent changes in the law have led to a revival. While a law enacted in 2016 promotes the cultivation of hemp as a means to preserve...more
7/31/2019
/ Agribusiness ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Cosmetics ,
Decriminalization of Marijuana ,
EU ,
Hemp ,
Italy ,
Marijuana ,
Medical Foods ,
Plant Based Products ,
Regulatory Oversight ,
Regulatory Requirements
In the aftermath of this year investigation against business operators not complying with the requirement of Italian law on label notification (see here), the Italian Competition Authority ("Authority") - in charge of...more
By decision No. 10892 published on 7 May 2018, the Italian Supreme Court ruled on an appeal brought by the Ministry of Health against a decision of the appellate Court of Padua in a case concerning the administrative...more
The possibility for the patent owner to prevent the reimbursement of medicinal products before expiry of patent protection is still an open issue. While the law covers prohibition of reimbursement for medicinal generic...more
On December 14th, 2017, the Italian Senate passed a long-awaited bill (DDL no 2801) governing the informed consent to medical treatments, which also allows individuals to express their wishes on medical treatments in the...more
Fast track for orphan diseases and rare forms of cancers -
By Ministerial Decree of 7 September 2017 (DM 7 September 2017), published in the Italian Official Journal on 2nd November2017, the Ministry of Health enacted new...more
The Court of Milan held in a Judgment recently handed down in the proceedings brought by Bayer S.p.a. against the generic manufacturer DOC Generici S.r.l. that online publication of over-the-counter (OTC) medicinal products...more
By Law passed today, August 2nd, 2017 (Law for the improvement of the competition on the market), further to a recommendation of the Italian Competition Authority (“ICA“), the Italian legislature enacted provisions for the...more
The Board of Appeal of the Italian Patent Office (Commissione dei Ricorsi), by decision published on June 26, 2017, acknowledged the right of the patent holder to ask the Italian Patent Office for the limitation of the...more
7/10/2017
/ Appeals ,
Direct Marketing Association ,
EU ,
European Court of Justice (ECJ) ,
European Medicines Agency (EMA) ,
Generic Drugs ,
Intellectual Property Protection ,
Italy ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supplementary Protection Certificate
By order issued on June 18, 2017, in summary proceedings brought by Teva against Mylan and Synthon for the alleged infringement of EP 2 361 924 (covering a manufacturing process for the active ingredient glatiramer acetate),...more
6/23/2017
/ Drug Pricing ,
Generic Drugs ,
Italy ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Reimbursements ,
Teva Pharmaceuticals
The EU Medicines Agency (EMA), the most sought after EU regulator, is looking for a new home. 900 jobs will move from London to an EU Member State when Brexit is complete. In a series of blog posts, our European life science...more
By judgement of January 3rd, 2017, the Turin Court of Appeal delivered a monumental decision in a longstanding patent dispute concerning the validity and infringement of patents relating to an Electronic Program Guide (EPG)...more
2/6/2017
/ Appeals ,
Digital Goods ,
Digital Services ,
EU ,
Infringement ,
Intellectual Property Protection ,
Italy ,
Patent Infringement ,
Patent-Eligible Subject Matter ,
Patents ,
Satellites ,
Software Patents ,
Technology ,
Technology Sector ,
Television Programming
Transfer of a MA, its subsequent revocation and compensation for damages -
What happens if you purchase a marketing authorisation and that is then revoked for serious non-compliances with the Good Clinical Practice...more
By decision of December 2nd, 2016, No 24658, Industriale Chimica S.r.l. vs Bayer Pharma AG, the Italian Supreme Court ruled on the infringement by equivalence and on the patentability of intermediates.
...more