All posts by Marco Blei

About Marco Blei

I am a counsel of the firm Gitti and Partner and in the part I worked with leading Italian and international law firms. I deal with industrial and intellectual property, information technology and contracts, with specific focus in the life sciences and high technology sectors. In my litigation activity I deal with disputes in patent and know-how matters, as well as in relation to trademarks, designs, copyrights, unfair competition and misleading advertising. I have also significant experience in the drafting and negotiation of agreements for the licensing, exploitation, valorization and acquisition of intellectual property rights, R&D and collaboration agreements as well as IT related contracts, also in the context of extraordinary corporate transactions and technology transactions. In the life sciences sector, I am regularly involved in drafting and negotiating agreements for the manufacturing, supply, distribution and co-marketing of pharmaceutical products and medical devices as well as of clinical trials agreements. I graduated in Law in 2003 from Università Cattolica del Sacro Cuore in Milan, and in 2008 I obtained a with distinction Master of Laws in Intellectual Property from the London King's College. I was admitted to the Milan Bar as avvocato in 2008.

Repeal of Patent Linkage in Italy is on the Horizon

The patent linkage is the practice of linking the marketing authorisation of medicinal products, their pricing or reimbursement, or any other generic drug approval, to the patent status of the original reference product.

On 4 November 2021 the Italian Council of Ministers approved the draft law for the market and competition for the year 2021 (the “Draft Law”), by means of which by the end of this year the Italian Government intends to modify, update and renovate the regulatory framework of several critical sectors of the economic life of the country, amongst which energy, transportation, entrepreneurship and healthcare.

With the aim of removing barriers to market entry for generic medicines, the Draft Law inter alia provides for the abolition of the patent linkage, finally bringing Italy, on this point, in line with the EU law and the other European countries.

Indeed, the Draft Law repeals article 11, paragraph 1, of Law no. 189/2012 (the “Balduzzi Decree”), pursuant to which generic drugs cannot be included in the list of the medicines reimbursed by the Italian National Health Service before the expiry date of the patent or of the supplementary protection certificate of the corresponding originator’s product.

Because it establishes a patent linkage, said provision of the Balduzzi Decree is generally held in breach of the EU law, according to which regulatory bodies, when granting a marketing authorisation for a medicine, setting its price, and determining its class of reimbursement, cannot consider the patent coverage, but only the quality, safety, and efficacy of medicines.

In the last decade the Italian association of generic drug manufacturers (Assogenerici), several patient advocacy groups and even the Italian Competition Authority had tried to push the Italian Government to repeal article 11, paragraph 1, of the Balduzzi Decree, but without success. Now, probably also under the EU Commission’s pressures to comply with the requirements it set in the framework of the aids given to Italy to face the economic and social consequences of the Covid-19 pandemic, the Italian Government decided to finally remove the patent linkage.

The purpose of the measure provided by the Draft Law is to allow manufacturers of generic medicines to carry out all the negotiation procedures for price and reimbursement to be ready to enter the market as soon as the patent expires, and so to increase the competition in the healthcare sector.

The Draft Law will be soon submitted to the Italian Parliament, where it will be discussed and where it might be subject to several and significant amendments. We will see whether the abolition of the patent linkage will be eventually approved and will therefore become law.