11 February 2021
Dear Sirs, we would like to give you the main insights into what will happen to your European/Community rights when Brexit comes into effect.
18 March 2020
Following recommendations from the Italian Government, we have decided to implement home office: to urgently contact us, we suggest to use this list of cellular phones.
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.