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COVID-19 and emergency inventions

As the spread of COVID-19 accelerates across the globe, everyone wants to find a way to tackle the pandemic, from Governments asking manufacturers to urgently make vital equipment to inventors creating innovative solutions. ...more

The EU and various member states measures on Personal Protective Equipment in response to the COVID-19 outbreak

In response to the global outbreak of the COVID-19 virus, the EU and various member states have taken measures to ensure continuity of supply of personal protective equipment (PPE) and address shortages of healthcare...more

AIFA provides guidance on critical aspects relating to the management of clinical trials in Italy during the COVID-19 emergency

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

Regulation of cannabis in Italy: use in food and cosmetics

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

New rules for expanded access in Italy

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

Italian time-machine : Limitation of the duration of an SPC may be decided by the Italian Patent Office

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

Purchase of expensive drugs from outside the EU: did AIFA open the Pandora’s box?

By Ministerial Circular of 23 March 2017, AIFA clarified the conditions under which unauthorized medicinal products may be purchased abroad further to the procedure laid down by the Ministerial Decree of 11 February 1997....more

Relocation of the EU Medicines Agency: Italy

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

Patentability of software in Italy & partial recovery of profits (infringement of patents on marginal aspects of a product)

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

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