Canada’s Intellectual Property Firm

Pharmaceutical Litigation

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.

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.