Studio Legale De Berti Jacchia Franchini Forlani

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.