The European Patent Office recently released the Patent Index 2020, which provides an overview of Europe's filing activities. The index shows that Italy is one of the fastest-growing European countries in the healthcare innovation sector, achieving a significant increase in patent applications in the pharmaceutical and medical technology sectors. The recent positive trend of Italian innovation growth continued in 2020, particularly in the healthcare sector.
The Italian Medicines Agency recently adopted a resolution clarifying the criteria which must be met for generic medicines to be included on the Substitution List. The resolution clarifies the scope of Article 11(1bis) of Law Decree 158/2012 (known as the 'Balduzzi provision'), which contemplates a mechanism for linking the existence of patent protection for an originator drug, on the one hand, and the reimbursement classification of respective generics, on the other hand.
The current health emergency has highlighted the need to reconcile the urgency in offering a response to the spread of COVID-19 with the need to continue ensuring the effectiveness of patent protection. For this purpose, the Italian legal system offers a number of solutions based on legitimising the use of a pre-existing patent without the owner's consent on the one hand and guaranteeing the accessibility of patented inventions to the most people without having to deny the owner's exclusive rights on the other.