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.-
Who's Who Legal
Four Life Sciences leaders
2023Who's Who Legal: Life Sciences -
Lexpert®-Ranked
12 lawyers in IP Litigation
2023The Canadian Legal LEXPERT® Directory -
Chambers & Partners
Band One Firm: IP Litigation
2020-2023Chambers Canada -
Who's Who Legal
Six Thought Leaders in Patents, Trademarks & Life Sciences
2023WWL Thought Leaders: Global Elite -
Chambers & Partners
Band 3: Life Sciences
2019-2023Chambers Canada -
Who's Who Legal
Five Life Sciences leaders
2018-2022Who's Who Legal: Life Sciences -
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
Related Publications & Articles
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COVID-19 Update: CIPO, Federal Courts, Health Canada
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 permits counterclaim as of right against non-asserted patent claims in s. 6(1) PMNOC actions
On February 17, 2023, the Federal Court ruled that Sandoz and Sun Pharma may counterclaim as of right against non-asserted patent claims in separate actions pursuant to the Patented Medicines (Notice ...Read More -
Federal Court concludes Minister of Health’s decision not to reassess data protection for SPRAVATO in view of CUSMA is reasonable
On January 5, 2023, Justice Manson found that the Minister’s decision was reasonable and dismissed Janssen’s application: Janssen Inc v Canada (Attorney General), 2023 FC 7.Read More -
Federal Court dismisses Takeda’s motion to consolidate two dexlansoprazole PMNOC actions against Apotex
On January 23, 2023, the Federal Court released a decision by Associate Judge Tabib denying Takeda’s motion to consolidate two actions commenced under the Patented Medicines (Notice of Compliance) Reg...Read More -
Lilly’s CIALIS patent claims extending to “physiologically acceptable salt” found invalid for overbreadth and insufficiency
On October 17, 2022, Justice St-Louis of the Federal Court granted a motion for summary trial brought by Teva, Pharmascience, Laboratoire Riva, Apotex and Mylan (the Defendants) and dismissed the unde...Read More -
10 things you need to know about life sciences patent 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 -
Federal Court of Appeal restores Minister of Health’s decision to grant RUZURGI NOC despite FIRDAPSE data protection
The Federal Court found that subsection C.08.004.1(3) of the Food and Drug Regulations applied to prevent the Minister from issuing an NOC in view of the data protection granted to FIRDAPSE, a drug co...Read More
Related News & Media
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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 -
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