Powerful litigation. Unequaled in the courtroom
Navigating the increasingly complex global landscape of the pharmaceutical industry requires a focused and creative litigation strategy.
In Canada, the pharmaceutical industry has been dramatically impacted by amendments to the Patented Medicines (Notice of Compliance) Regulations which introduce significant opportunities and challenges for the enforcement of IP rights. Our litigators draw on more than 25 years of experience in pharmaceutical patent litigation to help clients chart their course over this new and complex landscape.
Unmatched technical depth in life sciences
Our highly specialized team of litigators has technical expertise in a wide range of life sciences including pharmacy, pharmacology, biophysics, molecular biology, immunology, biochemistry, genetics, organic chemistry, biochemistry and chemical engineering. All of our lawyers have graduate or undergraduate degrees in one or more of these areas.
Fearless defenders of pharmaceutical IP
We provide focused representation in pharmaceutical litigation, including infringement and validity actions under the Patented Medicines (Notice of Compliance) Regulations, including damages quantifications, s. 8 actions, and judicial reviews of Health Canada decisions involving patent listing, data protection, PMPRB jurisdiction, and access-to-information. We have represented patentees against generic manufacturers in nearly 250 proceedings under the Patented Medicines (Notice of Compliance) Regulations, including actions under the amended Regulations.
Understanding the big picture in life sciences
The life sciences industry operates in a complex and fluid regulatory environment including the new drug approval process, market access, Patented Medicines Pricing Review Board (PMPRB), patent listing, data protection and certificates of supplemental protection. Each of these elements are key components of an effective litigation strategy. We closely monitor the life sciences environment, updating our clients with our monthly newsletter Rx IP Update.
Strength in the global pharmaceutical arena
Given the global nature of pharmaceutical IP, the preparation of an action plan for litigation must reflect a global perspective. Using our experience in multi-jurisdictional cases, we provide coordinated domestic, cross-border and global litigation strategies to protect our clients in Canada as part of an integrated global strategy.
Strategic thinking is vital, in and out of the courtroom
All companies and situations are unique, and our lawyers identify what is central to each client’s business and product strategies. We align our litigation strategy with our clients’ overall business goals and objectives.
We understand that protecting our clients’ interests can require out of court resolutions, and favourable settlements. Our litigators draw on mediation, arbitration and other alternative dispute resolution strategies to protect our clients’ interests.
However, when litigation is necessary, we will fiercely pursue our clients’ objectives. Our team has handled precedent-setting pharmaceutical litigation for clients in Provincial Superior Courts, the Federal Courts of Canada and the Supreme Court of Canada.
Services we offer in this area:
- Infringement and validity opinions
- Pre-litigation strategic planning
- Infringement and validity litigation, including under the Patented Medicines (Notice of Compliance) Regulations
- Quantification of damages/profits
- Section 8 and related litigation
- Judicial reviews of decisions of regulatory bodies, including Health Canada
Key Contacts
Smart & Biggar is a dominant force in pharmaceutical patent enforcement and litigation. Our proven team is made up of highly capable trial and appellate counsel who routinely handle some of Canada’s most commercially important and technically complex pharmaceutical and life sciences cases.
Client Success
We have had unprecedented success representing innovative pharmaceutical and life science clients, including in the Federal Courts of Canada and the Supreme Court of Canada, resulting in many leading Canadian precedents.-
AstraZeneca Canada Inc. and AstraZeneca AB v Sandoz Canada Inc.
2020 FC 635 -
Celgene Inc et al v Natco Pharma (Canada) Inc
2019 FC 921Successfully represented the plaintiffs Celgene Inc. and Celgene Corporation defending a motion seeking to require production of deposition transcripts in other proceedings.Read More -
Apotex Inc v Sanofi-Aventis, et al
2018 ONCA 890 -
AstraZeneca AB v Apotex Inc
2018 FC 185 -
Apotex Inc v AstraZeneca Canada Inc
2018 FC 181 -
AstraZeneca Canada Inc v Apotex Inc
2017 FC 726 -
AstraZeneca Canada Inc v Apotex Inc (re NEXIUM)
2017 SCC 36In this precedent setting victory, the Supreme Court of Canada rejected the “promise doctrine”, upholding AstraZeneca’s NEXIUM patent (esomeprazole) as useful and clarifying requirements for “utility”...Read More -
Apotex Inc v AstraZeneca Canada Inc
2017 FCA 9
Unparalleled Expertise in Pharmaceutical Litigation
Recognized as Canada’s leading IP litigation firm, our team of pharmaceutical litigators are highly effective trial counsel. In addition to their courtroom victories, our litigators frequently receive international recognition from IP owners, clients and peers alike.-
Benchmark Litigation
Eleven leading IP litigators
2022Benchmark Canada -
Lexpert®-Ranked
13 lawyers in IP Litigation
2022The Canadian Legal LEXPERT® Directory -
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 -
Legal Media Group
Canadian Patent Strategy Firm of the Year
2013, 2014, 2018 & 2021LMG Life Sciences Awards -
Chambers & Partners
Band 3: Life Sciences
2019-2022Chambers Canada -
Who's Who Legal
17 leading IP experts
2021Who's Who Legal: IP -
Who's Who Legal
Five Life Sciences leaders
2018-2021Who's Who Legal: Life Sciences -
Who's Who Legal
Three Thought Leaders in Patents, Trademarks and Life Sciences
2019-2021WWL Thought Leaders: Global Elite -
Benchmark Litigation
Thirteen leading IP litigators
2020-2021Benchmark Canada
Related Publications & Articles
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Supreme Court of Canada denies leave to appeal SOLIRIS PMPRB decision
On March 24, 2022, the Supreme Court of Canada dismissed the Attorney General of Canada’s application for leave to appeal (Docket No. 39858).Read More -
COVID-19 Update: CIPO, Federal Courts, Health Canada
[Last updated on April 16, 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 -
B.C. Supreme Court declines to strike Province’s class action claims to recover healthcare costs and damages related to opioid epidemic
In August 2018, the Province of British Columbia commenced a class action on behalf of itself and other provincial and federal governments against approximately 50 pharmaceutical manufacturers, wholes...Read More -
10 things you need to know about life sciences patent linkage litigation in Canada
A vague queasiness may come over you when the envelope lands on your desk with an emphatic thump and you pull out the 100+ pages explaining why the patents on your key pharmaceutical or biologic produ...Read More -
Top 10 patent and regulatory things you need to know when bringing a biopharma product to Canada
Canada is an attractive market for pharmaceutical manufacturers. While universal healthcare does not currently extend to drugs in an outpatient setting, most Canadian consumers have some form of drug ...Read More -
2021 Highlights in Canadian Life Sciences IP and Regulatory Law
In the fall of 2021, the Rx IP Update team celebrated its 20th year of monthly updates on Canadian life sciences IP and regulatory law. Below are the team’s top stories from 2021.Read More -
Top 10 Rx IP Update Reads of 2021
We reviewed 2021’s top developments in Canadian life sciences IP and regulatory law in our highlights article.Read More -
Federal Court of Appeal dismisses appeal, upholds strict interpretation of patent listing deadline for KEYTRUDA formulation patent
The Federal Court of Appeal dismissed an appeal by Merck from a decision of the Federal Court dismissing Merck’s application for judicial review of Health Canada’s refusal to add Canadian Patent No. 2...Read More
Related News & Media
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Smart & Biggar earns top rank for Intellectual Property in Chambers Canada with seven lawyers ranked for IP Litigation, Life Sciences and Cannabis
Smart & Biggar, Canada’s leading firm for intellectual property law, has once again earned top rank as a Band 1 firm for Intellectual Property (IP) in the 2022 Chambers Canada Guide. In addition ...Read More -
Nine Smart & Biggar lawyers featured as industry leaders in Lexpert Special Edition: Health Sciences
Smart & Biggar is pleased to share that nine of our life-sciences practitioners are included among the leading lawyers listed in the Lexpert Special Edition: Health Sciences 2021.Read More -
Smart & Biggar “revered” for “landmark wins” in patents, trademarks and copyright in 2021 Benchmark Canada Guide
Smart & Biggar is pleased to share that Benchmark Litigation has honoured the firm once again as a leader in Intellectual Property (IP) Litigation.Read More -
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 -
5 Smart & Biggar lawyers listed in Lexpert Special Edition Litigation 2020
Smart & Biggar is pleased to share that Mark Evans, Gunars Gaikis, Steven Garland, François Guay and Sheldon Hamilton have been recognized once again in the annual Lexpert Special Edition on Litig...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 A...Read More