01 July 2019
The Regulation (EU) No 2019/933, published in the Official Journal of the European Union on June 11, 2019, will enter into force on July 1st, 2019.The Regulation, which amends Regulation (EC) No 469/2009 concerning the supplementary protection certificate (SPC) for medicinal products, seeks to strike a balance between the rights of producers of generics and biosimilars established in the Union and those of producers based outside the Union.The Regulation (EC) No 469/2009 provides for extension of the term of a patent relating to protection of medicinal products subject to Marketing Authorization by five years (there is a further 6-month extension of patent protection for pediatric pharmaceuticals).The absence in Regulation (EC) No 469/2009 of any exception to the protection conferred by an SCP has had the unintended consequence of preventing producers of generics and biosimilars established in the Union from manufacturing generics and biosimilars in the Union, even for the purpose of export to third-country markets in which protection does not exist or has expired. Likewise, producers are prevented from manufacturing generics and biosimilars for the purpose of storing them for a limited period before expiry of an SPC.The aim of the new Regulation is to promote the competitiveness of the Union, preventing relocation of pharmaceutical research outside the Union, thereby enhancing growth and job creation in the internal market and contributing to a wider supply of products under uniform conditions, by allowing producers of generics and biosimilars established in the Union to compete, on the one hand, in rapidly developing global markets in which protection does not exist or has expired and, on the other, in the Union market upon expiry of the SPC.To that end the new art. 5 of Regulation (EU) No 2019/933 provides for an exception to the protection conferred by an SPC so as to allow the manufacturing of a product, or a medicinal product containing that active principle, for the purpose of export to third countries in which protection of the original product does not exist or has expired, or of storing (i.e. for supply immediately after expiry of the patent protection), and any related acts including: possessing; offering to supply; supplying; importing; using or synthesizing an active ingredient for the purpose of making a medicinal product; or temporary storing or advertising for the exclusive purpose of export to third-country destinations.
22 March 2019
The CJEU has just issued the judgement in the C-443/17 case (Abraxane).
08 February 2019
With a decision dated May 1, 2017, the CAFC ruled that a commercial agreement concerning a specific pharmaceutical composition and the related dosages, in combination with a press release announcing the existence of the agreement without disclosing the technical details thereof, is an obstacle to the patentability of the pharmaceutical composition, although the claimed characteristics were not disclosed in the agreement.
08 January 2019
AVVERTENZE PRELIMINARI IN ATTESA DEL VOTO DEL PARLAMENTO UK
07 December 2018
Il Ministero dello Sviluppo Economico, ha reso noto che è stato rifinanziato il programma di agevolazioni alle imprese per favorire la registrazione di marchi dell'Unione europea ed internazionali Marchi+3.
Disclosures that are alleged to be “prior art” may sometimes have uncertain status.
05 October 2015
Mr. Gianfranco Dragotti, president and founder of Dragotti & Associati, has been appointed co-chair of AIPPI's Standing Committee on PCT.
08 July 2015
We inform you that the Italian Government officially confirmedItaly's adherence to the unitary patent.
05 June 2015
the Specialized Section of the Turin Court confirmed that the Italian portion of AstraZeneca’s European patent EP907364B1 is invalid since it lacks inventive step.
16 April 2015
Dragotti & Associati is proud and honored to announce that, during FICPI’s executive committee meeting held in Cape Town on last April 13, its partner and CEO, RobertoPistolesi, has been elected as Secretary General of FICPI.
13 April 2015
With an order issued on April 1, 2015, the Specialized Section of the Turin Court confirmed that no preliminary injunctions can be granted against Accord, since AstraZeneca’s European patent EP907364B1 would prima facie lack inventive step.
11 November 2019
In this section are collected papers, articles and pubblications by our professionals together with other public material of interest to IP professionals.
11 November 2019
In this section is available a selection of key Italian, European and International laws and treaties on intellectual and industrial property protection.
11 November 2019
In this section are available forms for download.