Laura OrlandoManaging Partner, Italy and EMEA Co-Lead Partner – Life Sciences at Herbert Smith Freehills
Specialising in contentious and non-contentious intellectual property, Laura has a focus on patent and regulatory law in the life sciences sector. She has acted in some of the highest profile multi-jurisdictional patent cases, including in the context of the SPC Regulation, and has assisted major pharmaceutical companies in connection with patent expiry of top selling drugs. She also advises on a range of regulatory issues including product life cycle management, routes for obtaining marketing authorisations, data exclusivity provisions, supplementary protection certificates, orphan designations, good manufacturing practice compliance certificates, pricing and reimbursement.
In addition to life sciences, Laura has experience in a broad cross-section of industries, notably food, chemicals, consumer products, TMT and electronics, fashion and industrial design.
Laura's experience includes:
- assisting Gilead on the Europe-wide dispute concerning the SPC for the HIV drug Truvada including the implementation of the CJEU decision on combination SPCs
- assisting Eli Lilly on a number of patent and regulatory matters, including most recently advising in relation to a blockbuster migraine drug
- assisting leading Italian vaccine-developer AchilleS Vaccines on IP and regulatory aspects relating to a new platform for streamlining the research and development of new vaccines and a research project for the development of human monoclonal antibodies against COVID-19
- assisting Elanco on a patent case against Italian competitor concerning a top selling animal health product
- assisting JC Bamford Excavators Limited on a multi-jurisdictional patent validity and infringement case concerning telescopic handlers
- advising Lundbeck on a variety of patent and regulatory law matters in relation to medicinal products for the central nervous system