Libby Amos-Stone acts for life sciences companies in product liability and public law litigation before the UK and EU Courts and advises clients on the pharmaceutical, medical device, food, cosmetic and cannabis regulatory framework in the UK and EU.
Ms. Amos-Stone assists companies on strategic issues arising during the life cycle of pharmaceutical products including regulatory data protection, supplementary protection certificates, paediatric rewards, and orphan market exclusivity. She also advises companies on the boundaries of the ABPI and EFPIA codes of practice, and UK and EU legislation, regarding the promotion of medicinal products, including use of social media, packaging and labelling, presence at conferences, use of consultants, and marketing materials.
Additionally, Ms. Amos-Stone works on product liability matters on behalf of pharmaceutical and medical device companies, defending large multiparty actions, and individual personal injury and product liability claims.
Ms. Amos-Stone also assists life sciences and technology companies on mHealth and related issues, including classification of digital technologies, and navigation of the Medical Device regulatory framework.
Experience
- Bayer, representation in relation to product liability claims relating to a legacy product, Primodos, used as a hormone pregnancy test.
- Assisting a global pharmaceutical company in a public inquiry (product liability).
- Bayer, representation in Judicial Review before the High Court, Appeal Court and application to the UK Supreme Court regarding the regulatory framework for off-label use.
- Orion Corp, on its pan-EU strategy to protect the regulatory data protection for its product, including in the General Court (Case T-223/20), preliminary reference in the Court of Justice (Case C-165/21), acting in the English administrative law action, and managing coordinating similar actions across the EU.
- Biogen, as an interested party in support of the MHRA and EMA, who refused to validate applications for generic marketing authorisations due to the data protection for Biogen’s product, in the English Court and in the General Court (Cases T-611/18 and T-703/20).
- Cases before the EU General Court cases in relation to transparency of clinical trial data and access to documents held by the EMA.
- Application to the EU General Court for annulment of a Commission Decision as to the eligibility of an orphan medicinal product to receive a paediatric extension on the basis of a paediatric investigation plan conducted voluntarily.
- Reference to the CJEU regarding the correct date for use in the calculation of duration of a supplementary protection certificate.
- Action for annulment of a Commission Decision condemning a large pharmaceutical company for breach of Articles 101 and 102 TFEU.
- Defending an action for declaratory relief that a marketing authorisation first authorised in East Germany prior to reunification constituted a valid reference medicinal product in accordance with Directive 2001/83/EC.
- Judicial review of the grant of marketing authorisations by the MHRA of a generic product authorised under Article 10(3) of Directive 2001/83/EC by reference to data contained in the dossier of a previously authorised Article 10(3) medicinal product where the Global MA concept does not apply.
- An individual in the inquest into the death of their young children, including representations regarding Article 2 of the European Convention on Human Rights.
Perspectives
Recognition
"Recommended" Life Sciences: Regulatory (2022)
Credentials
Education
- Solicitor Advocate, BPP Law School, 2016
- Post-Graduate Diploma in European Union Law, King's College London, 2015, with distinction
- LL.B., The College of Law, 2011, First Class Honours
- B.Sc., Physiological Sciences, University of Bristol, 2006, First Class Honours
Admissions
- England and Wales
- Ireland