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
19 Lexpert®-ranked lawyers
2022-2023Lexpert Special Edition: Technology and Health Sciences -
Who's Who Legal
Four Life Sciences leaders
2023Who's Who Legal: Life Sciences -
Who's Who Legal
Six Thought Leaders in Patents, Trademarks & Life Sciences
2023WWL Thought Leaders: Global Elite -
Who's Who Legal
16 leading IP experts
2022Who's Who Legal: Canada -
Who's Who Legal
17 leading IP experts
2022Who's Who Legal: IP -
Who's Who Legal
Five Life Sciences leaders
2018-2022Who's Who Legal: Life Sciences -
Who's Who Legal
Four Thought Leaders in Patents and Trademarks
2022WWL Thought Leaders: Global Elite -
Who's Who Legal
17 leading IP experts
2020-2021Who's Who Legal: Canada -
Who's Who Legal
17 leading IP experts
2021Who's Who Legal: IP -
Lexpert
Nine Lexpert®-ranked lawyers
2021Lexpert Special Edition: Health Sciences
Related Publications & Articles
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PM(NOC) Regulations: seven-year anniversary of major amendments
September 21, 2024, marked the seventh anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activiti...Read More -
CADTH officially becomes Canada’s Drug Agency
On September 5, 2024, the Canadian Agency for Drugs and Technologies in Health (CADTH) officially became Canada’s Drug Agency (CDA).Read More -
Supreme Court of Canada to hear method of medical treatment appeal
On September 19, 2024, the Supreme Court of Canada granted Pharmascience leave to appeal a Federal Court of Appeal decision affirming a trial decision that upheld the validity of Janssen’s patent rela...Read More -
Boehringer Ingelheim succeeds in nintedanib PMNOC action against JAMP
In a public decision dated August 8, 2024, Justice Furlanetto of the Federal Court found Boehringer Ingelheim’s Canadian Patent No. 2,591,083 (the 083 patent) valid and infringed by JAMP in an action ...Read More -
Release of Statistical Report 2023/2024 for PMNOC Regulations, data protection and CSPs
On August 12, 2024, the Office of Patented Medicines and Liaison of Health Canada released its Statistical Report 2023/2024 for the Patented Medicines (Notice of Compliance) Regulations, Data Protecti...Read More -
Manitoba last province to introduce Biosimilars Initiative, while Ontario adds four drugs to its Biosimilar Policy
Manitoba has implemented a Biosimilars Initiative effective August 1, 2024.Read More -
CIPO expected to resume patent granting on August 20
According to CIPO’s updated roadmap, patent granting should resume on August 20, 2024.Read More -
Health Canada’s proposed regulatory amendments to address health product shortages
On June 25, 2024, Health Canada published a notice of intent and Building resilience: Health Canada’s plan to address health product shortages, 2024 to 2028, relating to Health Canada’s plan over the ...Read More
Related News & Media
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Smart & Biggar boasts 21 lawyers and agents recognized as leaders for IP in Who’s Who Legal: Canada Guide 2023
Smart & Biggar is proud to be featured as a leader in IP in the recent edition of Who’s Who Legal (WWL) Canada Guide 2023. In total, 21 of our lawyers and patent agents have been recognized across...Read More -
BIO 2023: Connect with Smart & Biggar’s leading Canadian Life Sciences team
Smart & Biggar's leading Life Sciences team will be attending this year’s Bio International Convention in Boston, and look forward to reconnecting with colleagues and clients from around the world...Read More -
Smart & Biggar sees four lawyers recognized in Who’s Who Legal: Life Sciences 2023
Smart & Biggar is proud to announce that four lawyers have been named in the recent Who’s Who Legal: Life Sciences 2023 Global Guide as leaders in life sciences law.Read More -
Smart & Biggar boasts 16 lawyers and agents recognized as leaders for IP in Who’s Who Legal: Canada Guide 2022
Smart & Biggar is proud to be featured once again as a leader in IP in the recent edition of Who’s Who Legal (WWL) Canada Guide 2022. In total, 16 of our lawyers and patent agents have been recogn...Read More -
Smart & Biggar partners recognized in the 2022 edition of IAM Strategy 300: The World’s Leading IP Strategists
Smart & Biggar is proud to share that Ottawa partner and Chair of the firm Daphne Lainson and Montréal partner Sanjay Goorachurn have been recognized once again in the 2022 edition of IAM Strategy...Read More -
Smart & Biggar partners recognized at the 10th annual LMG Life Sciences Awards Americas 2022
Smart & Biggar is proud to share that Ottawa partner and Chair of the firm Daphne Lainson and Vancouver partner Mark Pidkowich have been recognized in the 10th annual LMG Life Sciences Awards Amer...Read More -
Smart & Biggar receives six shortlist nominations for the 2022 LMG Life Sciences Americas Awards
Smart & Biggar is proud to announce that we have been shortlisted for six LMG Life Sciences Awards 2022. Each award nomination recognizes Smart & Biggar’s exceptional leadership in life scien...Read More -
Smart & Biggar leads the Canadian patent rankings with 23 lawyers and agents listed in IAM Patent 1000
Smart & Biggar is pleased to announce our continued standing as a ‘gold tier' firm in Canada for patent prosecution and litigation, in the 2022 IAM Patent 1000: The World’s Leading Patent Professi...Read More