We are committed to protecting innovation in the life sciences
We have long recognized the importance of protecting the intellectual property (IP) of innovative companies in their quest to develop novel therapies that have an immeasurable impact on patients in Canada and elsewhere.
The life sciences industry has seen radical change over the last two decades with dramatic advances in medicine, including the advent of precision and personalized medicines and other novel and advanced therapies that are challenging regulatory authorities the world over. We have kept abreast of these changes, developing an experienced team of practitioners that work with our clients to protect and defend their innovations, maximize commercial opportunities, and provide patients with access to their cutting edge technologies.
We are experts in IP law and policy and understand the role that IP protection plays in driving value and funding the discovery of new life-saving and life-changing drugs. We are also experts in the related regulatory framework that governs market access and exclusivity, allowing us to offer sophisticated advice in managing the life-cycle of a therapeutic product.
In partnership with our clients, we work to develop IP and regulatory strategies with the flexibility and foresight to meet changing business needs, the demands of the regulatory authorities and evolving market conditions.
The Smart & Biggar difference
Our lawyers and agents work as a team to assist our clients in securing the most effective protection for innovative medicines. The legal and regulatory landscape governing new drugs, biologics, medical devices and specialized medicines is complex. It often requires input from a combination of our technical experts, patent agents, legal and regulatory counsel, and litigators, each of whom have a sophisticated understanding of the Canadian market.
Smart & Biggar is the largest firm in Canada focusing on IP law and related areas. As such, we have deep bench strength across multiple disciplines in order to protect and fully commercialize any new technology in the life sciences, as well as a team of experienced trial lawyers to defend against subsequent entrant challengers. Our combined technical and legal expertise allows us to provide a holistic approach to protecting exclusivity and maximizing commercial opportunities.
We are subject-matter experts in the life sciences
All of our life sciences practitioners have graduate or undergraduate degrees in relevant scientific disciplines, including chemistry, molecular and cellular biology, biochemistry, physiology, microbiology, immunology, neuroscience, genetics, molecular and cellular physiology, pharmacology or pharmacy. Many also hold PhDs and have relevant post-doctoral and industry experience. Thus, whether the invention is a new chemical or biologic entity—or a combination thereof, or is at the cutting edge of gene therapy, we have the expertise to assist.
When necessary, we also draw on our expert colleagues in the other scientific and engineering disciplines. Whether the invention is a new connected medical device or system to address Risk Evaluation and Mitigation Strategies (REMS), our technical experts in areas such as computer implemented inventions, engineering, the internet of things (IoT), blockchain and artificial intelligence are ready to help.
We are experts in life sciences law and policy
Our lawyers have decades of experience in the various regulatory regimes that govern the life sciences sector. We have been advising clients on how to navigate and manage the various regimes since the introduction of patent linkage under the Patented Medicines (Notice of Compliance) Regulations, regulatory data exclusivity (“data protection”) under the Food and Drug Regulations, supplementary protection under the Certificate of Supplementary Protection Regulations and pricing issues under the Patented Medicines Regulations.
Our team of legal experts work closely with our patent prosecution professionals to provide a sophisticated approach to managing exclusivity and developing a life-cycle plan that takes into account the complex and evolving legal landscape for drugs, biologics, medical devices and other advanced therapies.
Our integrated approach allows us to advise clients at an early stage of product development through to enforcement and potential loss of exclusivity and beyond, and in the licensing, acquisition or divestiture of technology. Therefore, whether your IP strategy calls for patent procurement, litigation proceedings, regulatory, market access, health care compliance or advertising advice, due diligence for mergers and acquisitions, or licensing and partnership negotiations, the Smart & Biggar team is ready to provide unparalleled IP counsel to safeguard your competitive position.
Fearless defenders of pharmaceutical IP
Our lawyers have unparalleled experience as counsel and have earned a reputation for being fearless advocates in the courtroom. Our decades of litigation experience and subject-matter expertise keep us at the forefront of pharmaceutical litigation in Canada.
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.
A local presence with global reach
The Smart & Biggar team collaborates with life sciences IP practitioners around the world to obtain protection for Canadian inventions abroad, as well as protection for foreign inventions in Canada. As a result, while our offices extend across the country, our practice and experience covers the globe.
Our global client base includes ground-breaking start-ups as well as some of the largest life sciences companies in the world. We work with pharmaceutical and biotech companies, medical device companies, well-known research institutions and universities, health services organizations, and venture capital firms.
Staying abreast of the changing landscape
Smart & Biggar understands that protecting your products from early clinical development to regulatory approval to litigation and beyond is critical. For more than a century, we have worked with innovators to help them meet the unique challenges of the Canadian marketplace, where our depth of experience remains unrivalled.
We have also remained at the forefront of developments in Canadian law and policy. To further serve the needs of our clients, we are actively involved in the evolution of Canadian IP policy and legislation and play an active part in major organizations to develop and promote the pharmaceutical and biologics industry in Canada. Our monthly newsletter, Rx IP Update, helps our clients keep abreast of the latest developments.
Our service offerings are unmatched
The combination of technical knowledge, experience, and insight within our life sciences IP, regulatory and litigation group is unmatched in Canada.
Smart & Biggar provides exceptional IP counsel with respect to:
- 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
- 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
- Submissions on draft statutory and regulatory amendments
- Applications for judicial review