Pharmaceuticals and Life Sciences
The advent of the 4.0 industrial revolution is having a significant impact likewise within the life sciences sector, both as far drugs and medical devices are concerned.
The evolution of scientific studies, placing focus on patients’ needs which are not only clinical, along with the implementation of robotized automation processes, require extremely high levels of specialization and expertise; furthermore, manufacturers need to collect and manage big flows of data, which entail dealing with ever increasing material issues.
On top, (i) the expiration of patent protection for traditional blockbuster medicines, which allows generics and biosimilars to widely step into the market, (ii) the urgency of research for new molecules aimed at treating severe and orphan diseases or to step over increasing cases of drug-resistance, (iii) the opinion movements that strongly oppose drugs and vaccinations, (iv) the continuous increase of life expectancy and the exponentially growing number of elderly patients suffering from complex conditions involving log or permanent treatments, with increasingly heavy consequences on healthcare spend, and (v) the correspondingly ever increasing expansion of pharmaceutical spend are, amongst others, some of the major challenges that this delicate sector is actually facing in Italy at the beginning of the third millennium, where primary manufacturers have since a long time deployed a role of excellence in the domestic and international landscape.
OUR SERVICES
Right from its foundation, the Firm became pivotal and is presently rated as a key-played in the life sciences sector, providing a wide-range assistance and advice, and being always responsive to the changes and challenges of the market.
Our multi-disciplinary team gained through the years a highly qualified expertise in the sector and is proactively present in addressing all features of pharmaceutical products’ lives: from research and development up to access to market, continuously monitoring compliance with the domestic and EU regulatory scenario, marketing authorizations, patent defence and enforcement, compliance with antitrust laws and advertising rules.
We pay special attention to the continuous evolution of technology and the protection of intellectual property: new molecules’ registration and protection, license and sale of patents, countering infringements, patent exploitation, patent box.
We take specific care of manufacturers involved in litigations filed by consumers because of alleged adverse reactions to drugs and/or vaccines, as well as protecting manufacturers’ reputation, which is often under attack by stakeholders groups challenging pharmaceuticals or alleging they are dangerous for human health.
We furthermore provide assistance and advice to devise efficient governance and delegation structures, monitoring in particular mergers and acquisitions, negotiating strategic partnership and joint ventures, with a peculiar focus on compliance with antitrust rules.
We, finally, developed broad experience and competence in dealing with the regulatory authorities (European Commission, EMA, Italian Medicines Agency, Ministry of Health, awarding entities of the public tenders for procurements of medicines and medical devices) and any related matter-specific administrative and ordinary litigation.
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21 Jan
IL TRIBUNALE DELL’UNIONE SI ESPRIME SUGLI ACCORDI PAY-FOR-DELAY E SULLA DEFINIZIONE DEL MERCATO RILEVANTE NEL CASO DEL PERINDOPRIL. L’ORIGINATORE TITOLARE DEL BREVETTO E I GENERICISTICI SONO CONCORRENTI, QUANTO MENO POTENZIALI
Society, EU and Competition, Intellectual Property, Pharmaceuticals and Life Sciences -
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19 Dec
LA CORTE DI GIUSTIZIA SI ESPRIME SULLA NOZIONE DI PROCEDURA DI AUTORIZZAZIONE AMMINISTRATIVA AI FINI DEL RILASCIO DI UN CPC PER UNA SOSTANZA INCORPORATA IN UN DISPOSITIVO MEDICO
Society, Intellectual Property, Pharmaceuticals and Life Sciences -
26 Nov
AVASTIN/LUCENTIS. LA CORTE DI GIUSTIZIA GIUDICA CONFORME AL DIRITTO EUROPEO LA PRESA IN CARICO DA PARTE DEL SERVIZIO SANITARIO NAZIONALE DELL’UTILIZZO OFF-LABEL DELL’AVASTIN
Society, EU and Competition, Pharmaceuticals and Life Sciences -
18 Oct
IL TRIBUNALE DELL’UE NEGA LA RIAPERTURA DELLE INDAGINI SUL SISTEMA DI DUAL PRICING DI GSK PER LA DISTRIBUZIONE DI MEDICINALI, CONFERMANDO GLI AMPI POTERI DISCREZIONALI DELLA COMMISSIONE E DELLE AUTORITÀ DI CONCORRENZA NELLA GESTIONE DELLE DENUNCE
Society, EU and Competition, Pharmaceuticals and Life Sciences -
09 Oct
IMPORTAZIONE PARALLELA DI MEDICINALI E DIRITTO DI MARCHIO. IL TAR DEL LAZIO CHIARISCE I REQUISITI PER IL CAMBIO DI DENOMINAZIONE DI UN FARMACO
Society, Intellectual Property, Pharmaceuticals and Life Sciences -
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14 Jan
DE BERTI JACCHIA FRANCHINI FORLANI RAFFORZA LA SEDE DI ROMA CON DAVID MARIA SANTORO
De Berti Jacchia Franchini Forlani ha assistito con successo Tirana International Airport SHPK (TIA), gestore dello scalo aeroportuale della capitale della Repubblica di Albania contro Compagnia Aerea Italiana S.p.A. (CAI), davanti al Tribunale di Civitavecchia. Lo studio ha agito con un team guidato dal partner David Maria Santoro. -
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06 Feb
DE BERTI JACCHIA FRANCHINI FORLANI NOMINA ARMANDO AMBROSIO RESIDENT PARTNER DELLO STUDIO DI MOSCA
L'avv. Armando Ambrosio è il nuovo resident partner della sede di Mosca dello Studio Legale De Berti Jacchia Franchini Forlani. -
27 Feb
DE BERTI JACCHIA FRANCHINI FORLANI ANNUNCIA LA NOMINA A SOCIO DELL'AVVOCATO CLAUDIO CORBA COLOMBO DELLA SEDE DI MILANO
Lo Studio legale De Berti Jacchia Franchini Forlani annuncia la nomina a Partner del Senior Associate Claudio Corba Colombo. -
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12 Mar
RECENT DEVELOPMENTS IN PHARMACEUTICALS LAW - Pague, March 12th - 14th, 2009
Prague
March 12th - 14th, 2009
Michelangelo Cicogna -
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18 Oct
GESTIONE DEGLI INFORMATORI SCIENTIFICI DEL FARMACO - Milan, October 18th, 2007
Milan
October 18th, 2007
Guido Callegari -
18 Sep
IL VIRUS RESPIRATORIO SINCIZIALE DAL LABORATORIO ALLA PRATICA CLINICA QUOTIDIANA - Brescia, September 18th - 19th, 2007
Brescia
September 18th - 19th, 2007
Antonella Terranova -
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13 Oct
LA GESTIONE DEL PAZIENTE IN TERAPIA HAART - Monteriggioni (SI), October 13th, 2005
Monteriggioni (SI)
October 13th, 2005
Antonella Terranova