Nancy Pei is a partner in Smart & Biggar's Toronto office. She practises exclusively in the field of life sciences (including pharmaceuticals and biologics). Nancy has over 20 years of experience with pharmaceutical patent and related litigation and in providing regulatory advice to clients operating in this industry.
Nancy represents innovative life sciences companies in patent litigation, including under the Patented Medicines (Notice of Compliance) Regulations. She has represented clients before the Federal Court of Canada, the Federal Court of Appeal, the Supreme Court of Canada, and the Ontario Superior Court of Justice. Most recently, Nancy was a member of the Smart & Biggar team that successfully represented AstraZeneca in its patent infringement action against Apotex relating to omeprazole: AstraZeneca v Apotex, 2015 FC 322, aff'd in part 2017 FCA 9, SCC leave denied and was the lead in the subsequent quantification reference: AstraZeneca a v Apotex, 2017 FC 726.
She also provides advice and assistance on matters relating to life cycle management (including strategic advice regarding patents, certificates of supplementary protection, and data protection), patent listing under the Patented Medicines (Notice of Compliance) Regulations, pricing and reimbursement (including Patented Medicine Prices Review Board matters), federal (AIA) and provincial (FIPPA) access to information requests, regulatory due diligence, regulatory compliance issues (under the Food and Drugs Act and associated regulations), and submissions regarding draft statutory and regulatory amendments in these areas. She has also represented clients in related judicial review applications.
Nancy's hands-on experience as a pharmacist coupled with the expertise gained through her highly focussed yet diverse practice afford her a unique position in examining broader patenting and regulatory issues of importance to innovative life sciences clients.
Since 2016 Nancy has been recognized in Who's Who Legal: Canada under Life Sciences. In 2017 she was listed as one of the leading Life Sciences legal practitioner in the world in Euromoney's Expert Guides: Women in Business Law. Among others, she has also been named in The Best Lawyers in Canada and Managing Intellectual Property's IP Stars Handbook: Patents. Nancy is a Fellow of IPIC, a registered patent and trademark agent and a registered pharmacist (Ontario College of Pharmacists).