Nancy Pei practises exclusively in the field of life sciences (pharmaceuticals, biologics, medical devices, natural health products). She has over fifteen years of experience with pharmaceutical patent and related litigation and in providing regulatory advice to clients operating in the life sciences industry.
Nancy represents innovative life sciences companies in litigation relating to the Patented Medicines (Notice of Compliance) Regulations and in patent infringement actions. She has represented clients before the Federal Court of Canada, the Federal Court of Appeal, the Supreme Court of Canada, the Ontario Superior Court of Justice and in opposition proceedings before the Canadian Intellectual Property Office. Most recently, Nancy was a member of the Smart & Biggar team that successfully represented AstraZeneca in its patent infringement action against Apotex: AstraZeneca Canada Inc v Apotex Inc, 2015 FC 322 (LOSEC, omeprazole).
She also provides advice and assistance on matters relating to life cycle management (including strategic advice regarding patents 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.
Nancy has been the editor of Rx IP Update, the firm's monthly pharmaceutical intellectual property and regulatory newsletter, since its inception in 2001. She is also an editor of IP Update — Canada, the firm's intellectual property law bulletin.