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.-
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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 -
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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 requirem...Read More
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.-
Legal Media Group
Canadian IP Impact Case of the Year
2017 & 2020LMG Life Sciences Awards -
Chambers & Partners
Band 3: Life Sciences
2019-2021Chambers Canada -
Lexpert®-Ranked
8 lawyers in Biotechnology
2020The Canadian Legal LEXPERT® Directory -
Lexpert®-Ranked
9 lawyers in IP Litigation
2020The Canadian Legal LEXPERT® Directory -
Lexpert®-Ranked
24 Lexpert®-ranked lawyers
2020The Canadian Legal LEXPERT® Directory -
Benchmark Litigation
Thirteen leading IP litigators
2020Benchmark Canada -
Who's Who Legal
Five Life Sciences leaders
2020Who's Who Legal: Life Sciences -
Chambers & Partners
Band One Firm: IP Litigation
2020Chambers Canada -
Who's Who Legal
Five Life Sciences leaders
2019Who's Who Legal: Life Sciences -
Who's Who Legal
Two Thought Leaders
2019Who’s Who Legal: Thought Leaders Global Elite
Related Publications & Articles
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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 -
COVID-19 Update: CIPO, Federal Courts, Health Canada
[Last updated on December 23, 2020] 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 -
Supreme Court denies leave of interlocutory decision in pregabalin section 8 case
On December 10, 2020, the Supreme Court of Canada dismissed Pfizer’s application for leave to appeal (Docket No. 39150) a decision upholding an interlocutory decision on a question relevant to the ass...Read More -
FCA provides guidance on standard for leave to appeal interlocutory PMNOC decisions
On December 3, 2020, the Federal Court of Appeal released its first decision providing guidance on the standard for obtaining leave to appeal interlocutory decisions under section 6.11(1) of the Paten...Read More -
Innovators challenge final PMPRB Guidelines in new Federal Court application
On November 23, 2020, Innovative Medicines Canada (IMC) and a number of research-based pharmaceutical companies commenced an application for judicial review of the final PMPRB Guidelines.Read More -
Federal Court of Appeal dismisses appeal of first trial decision under the amended PMNOC Regulations
On November 3, 2020, the Federal Court of Appeal heard and dismissed the appeal of the first trial decision under the amended Patented Medicines (Notice of Compliance) Regulations: Amgen v Pfizer, 202...Read More -
Effectively using experts in IP Litigation – Part 2: Practise
In intellectual property litigation, the outcome of many high stakes cases has turned on expert testimony.Read More -
Federal Court orders Minister of Health to issue NOC to Fresenius Kabi for its biosimilar IDACIO following filing of consent letter
On October 29, 2020, Justice Manson of the Federal Court ordered the Minister of Health to issue a notice of compliance (NOC) to Fresenius Kabi for IDACIO (adalimumab), a biosimilar of AbbVie’s HUMIRA...Read More
Related News & Media
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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 Litigatio...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 -
Smart & Biggar boasts seven “Life Sciences Stars” in the 2020 edition of LMG Life Sciences
Smart & Biggar is pleased to announce that seven partners have been named “Life Sciences Stars” across IP and Regulatory practice areas in the 2020 edition of LMG Life Sciences.Read More -
Smart & Biggar hailed at the 8th annual LMG Life Sciences Awards
Smart & Biggar is proud to claim three major practitioner awards, as well as recognition for our involvement in one of the Patent Impact Cases of the Year at the 8th annual LMG Life Sciences Awards fo...Read More -
Smart & Biggar shortlisted for five LMG Life Sciences Awards in 2020
Smart & Biggar is proud to share that we have been shortlisted for five LMG Life Sciences awards, each a recognition of the firm’s leadership in the Life Sciences law space.Read More -
Abigail Smith re-elected to the Ontario Bar Association’s IT & IP section
Smart & Biggar congratulates Toronto senior associate Abigail Smith on her re-election to the Ontario Bar Association’s (OBA) Information Technology (IT) and Intellectual Property (IP) section as an e...Read More -
Yoon Kang named in the 'Top 250 Women in IP' by Managing Intellectual Property
Smart & Biggar is pleased to share that partner Yoon Kang has been featured among the top female IP lawyers in the world in MIP ‘Top 250 Women in IP'.Read More