A successful intellectual property strategy always complies with regulatory rules and laws
We are experts in navigating the complex Canadian regulatory environment.
In the strict and constantly changing regulatory environment for pharmaceuticals and biologics in Canada, expert regulatory and compliance advice and counselling is essential to maximize commercial opportunities while minimizing unnecessary risk.
Drawing on our extensive legal and litigation expertise in regulatory areas, we provide an integrated team approach and a level of technical depth and support for our Canadian and international clients that is unmatched in Canada.
Our lawyers have deep expertise in managing issues that arise at the pharmaceutical/biologic patent-regulatory interface. We offer our clients expert assistance and targeted advice, helping to develop and implement policies to ensure best practices. We also have extensive experience drafting submissions on proposed regulatory amendments. In addition, if necessary, our experienced litigators will pursue judicial reviews before federal, provincial and appellate courts.
We recognize the importance of coordinating patent prosecution and enforcement with regulatory and market status of pharmaceutical and biologic drug products, throughout a product’s life cycle, from early clinical development to regulatory approval to litigation and beyond.
In our regulatory and compliance practice we work with and advise clients on matters that extend to and include pharmaceuticals (small molecules), biologics, Advanced Therapeutic Products, controlled drugs and substances, medical devices, natural health products and veterinary products.
Our regulatory and compliance services include:
- Regulatory (Health Canada and provincial) and health care compliance advice
- Reimbursement, interchangeability, rebate and procurement advice
- Marketing and advertising, including programs with HCPs and patients, disease awareness initiatives, collaboration agreements, PR communications, Direct-to-Consumer advertising campaigns, and Innovative Medicines Canada (IMC) and Pharmaceutical Advertising Advisory Board (PAAB) matters
- Brand name assessments including Look-alike Sound-alike (LA/SA) Assessments of product names
- Access to Information Act and Freedom of Information and Protection of Privacy Act matters
- Regulatory due diligence
- Data protection advice and responding to eligibility rejections by the Office of Patented Medicines and Liaison (OPML)
- Patent listing under the Patented Medicines (Notice of Compliance) Regulations, including preparation of forms and responding to objections by the OPML
- Certificates of supplementary protection, including preparation of applications
- Patented Medicine Prices Review Board (PMPRB) advice
- Submissions on draft statutory and regulatory amendments
- Applications for judicial review
We assist our clients with all relevant government agencies, including:
- Health Canada
- Patented Medicine Prices Review Board
- Provincial insurers
- Regulatory colleges for health care professionals
- The Office of Patented Medicines and Liaison
We advise on all applicable legislation, including:
- The Food and Drugs Act
- Provincial reimbursement (e.g. Ontario Drug Benefit Act, Drug Interchangeability and Dispensing Fee Act)
- Laws governing health care professionals (e.g. Medicine Act, Drug and Pharmacies Regulation Act)
- Access to Information Act
- Freedom of Information and Protection of Privacy Act
Key Contacts
Unparalleled Expertise in Life Sciences Regulatory & Compliance
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Lexpert®-Ranked
8 lawyers in Biotechnology
2020The Canadian Legal LEXPERT® Directory -
Lexpert®-Ranked
24 Lexpert®-ranked lawyers
2020The Canadian Legal LEXPERT® Directory -
Who's Who Legal
Five Life Sciences leaders
2020Who's Who Legal: Life Sciences -
Who's Who Legal
Five Life Sciences leaders
2019Who's Who Legal: Life Sciences -
Euromoney LMG
10 leading Life Sciences experts
2019Expert Guides: Life Sciences -
Who's Who Legal
Three Thought Leaders in Patents, Trademarks and Life Sciences
2019Who's Who Legal: Thought Leaders -
Who's Who Legal
17 leading IP experts
2019Who's Who Legal: Canada -
Euromoney LMG
One top Life Sciences lawyer
2019Expert Guides: Best of the Best -
Euromoney LMG
Six leading women in business law
2018Expert Guides: Women in Business Law -
Who's Who Legal
17 leading IP experts
2018Who's Who Legal: Canada
Related Publications & Articles
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COVID-19 Update: CIPO, Federal Courts, Health Canada
[Last updated on February 26, 2021] In view of COVID-19, we have compiled a list of important updates as it relates to the pandemic and its impact on Life Sciences.Read More -
Federal Court holds section 8.2 of the PMNOC Regulations does not impose a limitation period
On December 22, 2020, the Federal Court issued its decision holding that section 8.2 of the PMNOC Regulations does not impose a limitation period either the same as or comparable to the 45-day limitat...Read More -
Janssen’s abiraterone acetate and prednisone combination therapy patent found invalid
On January 14, 2020, the Federal Court released a decision by Phelan J. in patent infringement actions pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (PMNOC R...Read More -
PMPRB proposes to modify Guidelines definition of "gap medicine" to include medicines sold by July 1, 2021
As previously reported, regulations further amending the coming into force date of the Amended Regulations were registered on December 24, 2021 and push back the coming into force date of the Amended ...Read More -
Brexit prompts amendment to CSP Regulations
On December 21, 2020, the CSP Regulations were amended to add the U.K. as a “prescribed country” for the purpose of determining the timeliness of the CSP applicant’s New Drug Submission.Read More -
Federal Court decision regarding glatiramer acetate finds one patent obvious and another valid and infringed
On January 6, 2021, the Federal Court issued its decision in two patent infringement actions pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations involving Teva’s p...Read More -
First year of Project Orbis leads to 38 approvals of cancer therapies, including 8 by Health Canada
The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence recently published an overview of Project Orbis and the regulatory actions within the first year of its implementation (June 2...Read More -
2020 Highlights in Canadian Life Sciences IP and Regulatory Law
In 2020, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law.Read More
Related News & Media
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Urszula Wojtyra moderates panel on biosimilar patent disputes for LSPN Connect
On Thursday, February 25, 2021, partner Urszula Wojtyra will moderate “Biosimilar Patent Disputes: What the Early Wave of Litigation Signals for the Future”, a virtual panel as part of LSPN Connect.Read More -
5 Smart & Biggar practitioners recognized as leading lawyers by Who's Who Legal: Life Sciences Global Guide 2021
Smart & Biggar is pleased to share that Who’s Who Legal: Life Sciences 2021 Global Guide has honoured five lawyers as leaders in life sciences law.Read More -
Graham Hood and Abigail Smith chosen as Rising Stars in IP at 2020 Rising Stars Awards Americas
Smart & Biggar is pleased to share that partner Graham Hood and senior associate Abigail Smith have been honoured at the Expert Guides Rising Stars Awards Presentation on January 28th, 2021.Read More -
Alice Tseng and Kwan T. Loh join faculty of Osgoode Certificate in Cannabis Law and Regulation
Toronto partner Alice Tseng and Vancouver council Kwan T. Loh participate as instructors for the Osgoode Certificate in Cannabis Law and Regulation—a five-day, intensive Osgoode Professional Developme...Read More -
Daphne Lainson presents ‘Preparing for PMPRB Final Guidelines’ at the Pathways to Access & Reimbursement virtual conference
Ottawa partner Daphne Lainson will present the at the Pathways to Access & Reimbursement virtual conference, presented by the Canadian Institute, on Thursday, January 21, 2021.Read More -
Graham Hood and Abigail Smith shortlisted by IFLR for the 2020 Rising Stars Awards Americas
Smart & Biggar is pleased to announce that partner Graham Hood and senior associate Abigale Smith have been shortlisted for the 2020 Rising Star Award Americas in Trademarks and Life Sciences, respect...Read More -
Smart & Biggar partners examine biologics and biosimilars in Canada on LSPN Connect
Smart & Biggar partners David Schwartz and Urszula Wojtyra will present a webinar update on biologics and biosimilars through LSPN Connect.Read More -
Smart & Biggar boasts 17 lawyers and agents recognized in Who's Who Legal Canada 2020
Smart & Biggar has been honoured across all IP practice areas in the Who’s Who Legal Canada 2020 National Guide with 17 of the firm’s lawyers and agents recognized in Patent (Litigation), Patent Agent...Read More