Chris Boyle

Counsel at Sidley Austin LLP

Speaker

DR. CHRIS BOYLE is a life sciences lawyer and qualified veterinarian who advises and litigates in the highly regulated fields of human and veterinary medicinal products, medical devices, biocides, chemicals, food and feed. In addition to his advisory and litigation work, Chris coordinates multi-jurisdictional compliance projects, and supports complex life sciences corporate transactions and private equity deals by providing valuable legal and industry insights, and specialist due diligence.

For biopharma and pharma clients, Chris advises and litigates across a broad spectrum of regulatory frameworks. This includes advising on valuable IP regulatory rights such as orphan-drug market exclusivity, paediatric rewards, SPCs and regulatory data protection rights. On market access issues, Chris assists clients from pre-marketing authorisation through to commercialization phases. Chris has successfully supported clients to challenge unfavourable decisions of regulatory bodies such as the EMA and health technology authorities, such as NICE, and to enforce regulatory exclusivities in the courts. Chris is also actively involved in the development of the new EU Pharmaceutical Law Package, and advises clients on the potential impact of the proposals on the availability of medicines and the consequent impact on patients and the industry. In the MedTech sector, Chris helps clients to adapt to the evolving regulatory frameworks under the new medical device regulations (MDR and IVDR) and he advises on the many classification and borderline issues that arise as the legal frameworks try to keep pace with technology, including companion diagnostics, wearables, RWE and AI.

Chris is solicitor-advocate, experienced in representing clients before the UK and EU courts. He is acting for a pharmaceutical company in high-value, follow-on damages proceedings in the UK concerning the intersection of competition, regulatory and patent law. Chris acted in two appeals before the UK Supreme Court, winning the 2022 LMG Life Sciences “Impact Case of the Year” and the 2022 Managing IP awards “UK Impact Case of the Year.” Chris has also helped to successfully enforce orphan-drug market exclusivity before the General Court in Luxembourg.

Chris was named a “Rising Star” in the 2023 and 2024 edition of Legal 500 UK for Life Sciences and Healthcare.