Drug Regulatory Disputes
Drug Regulatory Disputes
The manufacture, packaging, labelling, storage, importation, distribution, advertising and sale of drug products in Canada is regulated by federal and provincial governments and industry associations.
- The federal government is responsible for clinical trials, new drug approvals, data protection, patent linkage (PMNOC), certificates of supplemental protection, advertising, and reviewing the prices of patented medicines (PMPRB), among other things.
- Provincial governments are responsible for product interchangeability, reimbursement and the maintenance of public drug benefit formularies.
- Industry associations regulate ethical conduct among member companies and some forms of advertising.
We work with innovative pharmaceutical and biotechnology companies to navigate this complex regulatory framework and to help them achieve their commercial goals. We attend meetings with public agencies (e.g., Health Canada), provide counsel at administrative hearings (e.g., PMPRB), and provide representation on judicial review applications.
Team Members
Jason Markwell
Jason is a leading patent and drug regulatory litigation lawyer in Canada. Jason draws on twenty-five years of experience in global and national law firms to provide clients with practical advice to meet their commercial goals.
Dino Clarizio
Dino is a leading intellectual property litigation lawyer in Canada. Dino has practised exclusively in the field of intellectual property law for more than thirty years. He has represented clients in high stakes cases and is the co-author of several leading IP textbooks.
Adam Haller
Adam is lawyer with over a decade of experience in complex intellectual property litigation in Canada. He has represented clients across industry sectors including pharmaceutical & life sciences, energy, financial services, consumer brands and hi-tech.
David Park
David received his JD from Osgoode Hall Law School in 2022 and was called to the bar in 2023. He also obtained his Bachelor of Science degree from McMaster University in 2018 as a biochemistry major. During law school, David was actively engaged with the IP faculty.
Emily Johnston
Emily received her JD from Queen’s University in 2024 and was called to the bar in 2025. She obtained her Bachelor of Health Science (Biomedical Discovery and Commercialization) and her Master of Biomedical Discovery and Commercialization from McMaster University in 2019 and 2020, respectively.
Marc Mitri
Marc is a drug regulatory and intellectual property litigator in Toronto.
Marc received his JD from Queen’s University in 2024 and was called to the bar in 2025. While in law school, Marc was an active member of the Intellectual Property Society..
Delara Emtyazi
Delara is a recent graduate of Osgoode Hall Law School, where she actively participated in the mooting program and completed a full-semester placement as a caseworker at Parkdale Community Legal Services (PCLS). She was awarded the Hennick Business Law Interns.
Alexa Mahabir
Alexa is a second-year JD student at Osgoode Hall Law School. She holds an Honours Bachelor of Science with Distinction from the University of Toronto, where she majored in Human Biology and Biology with a minor in Physiology.
Sara Duaibes
Sara is a 2L summer student at Markwell Clarizio LLP. Sara attends Queen’s University Faculty of Law and serves on the Senior Board of the Queen’s Law Journal. Sara has worked as a Student Caseworker with Queen’s Legal Aid, where she assisted low-income clients with criminal, civil, and administrative law matters, and has volunteered with Pro Bono Students Canada.