Chris BoyleSenior Managing Associate at Sidley Austin LLP
Chris is a life-sciences lawyer and qualified veterinarian who advises and litigates in the highly regulated fields of human and veterinary medicinal products and medical devices. In addition to his advisory and litigation work, Chris advises on due diligence issues for corporate transactions and private equity deals.
- For animal health clients, Chris advises across a broad range of issues including advertising and promotional campaigns, commercial agreements, telemedicine, IP regulatory exclusivities, routes to regulatory approval, off-label prescribing and compounding. He also advises clients preparing for the new EU Veterinary Medicines Regulations and EU Animal Health Regulations.
- Chris’s practice for biopharma and pharma clients includes advising on the complex regulatory frameworks and the availability of valuable IP regulatory rights such as orphan-drug market exclusivity, paediatric rewards, SPCs and regulatory data protection rights. Chris has successfully supported clients to both challenge unfavorable regulatory decisions and to enforce regulatory exclusivities.
- 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.
- Across these sectors, Chris counsels on COVID-19, Brexit, market access, advertising and transparency issues.
Chris is 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 between competition, regulatory and patent law. Chris recently acted in two appeals before the UK Supreme Court and a month-long trial before the High Court. Chris has also helped to successfully enforce orphan-drug market exclusivity before the General Court in Luxembourg.
Chris speaks regularly on hot topics in regulatory life-sciences including: IP regulatory rights, the orphan-drug regulatory framework, the regulatory framework for veterinary medicines and the legal opportunities/risks for animal health investors. He authored the orphan-drug chapter in the Oxford University Press textbook “Navigating European Pharmaceutical Law.”