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.
Rebecca Crane
Rebecca is a drug regulatory and patent litigation lawyer who applies her legal and scientific expertise to strategically advise and support clients. Rebecca was called to the bar in 2006 and has spent her entire career working in national and global law firms working on pharmaceutical and biotechnology cases.
Emily Papsin
Emily received her JD from Osgoode Hall Law School in 2021, and was called to the bar in 2022. She also obtained her Bachelor of Science (Hons.) in Neuroscience from Dalhousie University. Emily has extensive laboratory and academic research experience…
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.
Elizabeth Ford
Elizabeth is a seasoned litigation law clerk with over 17 years of experience who recently assumed the dual role of Office Manager and Senior Law Clerk at Markwell Clarizio LLP. Throughout her career, Elizabeth has cultivated extensive knowledge in all aspects of litigation work.
Ayushman Kheterpal
Ayushman is an internationally trained lawyer who is currently an articling student with the Firm. He worked for three years in a large national law firm in India as a lawyer and patent agent on complex patent and technology-related legal matters across various industries, including pharmaceuticals, software, and automotives.