Life Sciences & Pharmaceuticals

All industries

The pharmaceutical and life sciences sectors are among the areas in which LGV Avvocati has developed particular depth of expertise. In these highly regulated and innovation-driven industries, intellectual property rights are central to market strategy, the timing of product launches and the protection of significant investments in research and development.

LGV Avvocati acts for originator pharmaceutical companies, manufacturers of generic and biosimilar medicines, and biotechnology companies in patent and supplementary protection certificate (SPC) litigation, including disputes concerning validity and infringement. The Firm handles both domestic proceedings and complex pan-European disputes. In cross-border matters, LGV Avvocati works closely with legal teams in the relevant jurisdictions, contributing to the development and implementation of the overall litigation strategy.

A substantial part of the Firm’s practice concerns disputes between originators and generic manufacturers, particularly in the period leading up to and following the expiry of patent protection. LGV Avvocati advises on and conducts urgent interim proceedings, applications for search orders and substantive proceedings, including negative declaratory actions for non-infringement designed to provide legal certainty ahead of market entry. The Firm also advises on the Bolar exemption, “at-risk” launches, and issues concerning the term and validity of SPCs.

Since the Unified Patent Court (UPC) became operational, LGV Avvocati has assisted clients in assessing the opportunities and risks arising from the new system. This includes advising on the strategic choice between national courts and the UPC, potential centralised revocation proceedings, and the protection and enforcement of strategically important patent portfolios.

LGV Avvocati also provides strategic advice on the negotiation of licensing and collaboration agreements, as well as on pharmaceutical trade mark matters. This includes the protection and enforcement of established medicinal product brands, parallel imports and the repackaging of pharmaceutical products.

 

Significant experience

• Representing a leading international pharmaceutical group before the Enterprise Court Division of the Venice Court in proceedings concerning a well-known medicinal product for the treatment of hypercholesterolaemia. The client company was subsequently acquired by another major pharmaceutical group.
• Advising the owner of patents relating to components of COVID-19 vaccines in preparation for international litigation. LGV Avvocati advised on the Italian aspects of the proposed proceedings, including jurisdiction, available procedural mechanisms and patent validity issues, working closely with the UK legal team.
• Providing strategic advice in relation to licensing agreements concerning EGFR inhibitor medicines, in anticipation of challenges to the validity of the relevant patents. LGV Avvocati assessed the potential courses of action available to the counterparties, including proceedings before the UPC, and developed defence strategies across both the Italian national system and the new unitary patent framework.
• Advising one of the world’s leading generic pharmaceutical manufacturers on the strategy for launching a new anti-inflammatory medicine for the treatment of psoriasis in Italy ahead of its competitors. LGV Avvocati assessed the strategic advantages and limitations of interim relief and substantive proceedings under the Italian procedural framework.