Profile

Mrs. Marie Manley

Sidley Austin LLP

Contact Details

Sidley Austin LLP

Bio

Maria Isabel is a life sciences lawyer specialising in European and UK regulatory and competition law in the bio-pharmaceutical and medical devices sectors.

She advises on a broad spectrum of matters, both contentious and non-contentious, that arise in the conduct of a pharmaceutical or a biotechnology business. In particular, Maria Isabel holds extensive expertise in relation to the management of IP regulatory matters including: regulatory data protection (RDP); orphan products; supplementary protection certificates (SPCs); and the application of the Paediatric Regulation, including the maximisation of paediatric rewards.

Maria Isabel also has considerable experience of litigating before the national and European Court and has successfully represented a pharmaceutical company in a recent case concerning the application of the rewards under the Paediatric Regulation, and the refusal of the Commission to grant a marketing authorisation to an orphan drug under exceptional circumstances.

In addition, Maria Isabel also has specialist knowledge of the legal issues that arise in the context of clinical trials including clinical trial data disclosure and access to documents requests. Maria Isabel has significant expertise in this field and has represented the innovator industry in a case before the European Court concerning the redaction of commercially confidential information.