Life sciences is a foundational area of our practice—our firm was started on the idea that we could give advice to life sciences industries in a better way. We offer a comprehensive range of services to clients in pharmaceuticals, biotechnology, medical devices, and healthcare industries. Our team combines deep technical knowledge with unmatched legal expertise to help life sciences companies navigate the highly regulated and competitive landscape of their field.
We provide end-to-end support, from securing intellectual property rights and managing patent portfolios, to navigating regulatory approvals and representing clients in high-stakes litigation. Whether you’re developing cutting-edge therapies or facing complex challenges in regulatory approvals, market access, or patent litigation, we work closely with you to craft tailored strategic legal solutions that protect your interests and accelerate your path to market.
Regulatory Advice and Judicial Review
We help clients seeking approvals for pharmaceuticals, biologics and biosimilars, radiopharmaceuticals, medical devices, and natural health products. We offer advisory services during the regulatory process before Health Canada to address thorny legal obstacles to approval, and assess any risks for new product launches. We have experience in direct advocacy with Health Canada, as well as alternative means such as through engagement with policymakers and government officials to address more complex problems.
We also have expertise on IP and patent-related issues including patent listing issues, designation of innovative drugs (data protection), and dealing with the intersection between natural health products and drug regulation.
In the event that direct advocacy with Health Canada and other related agencies do not achieve the desired outcome, we also have a long track record of successful judicial reviews in the Federal Court. We can help you prepare a holistic strategy from the earliest stages of regulatory approval to build a successful record for court proceedings.
Patent Clearance and Market Landscape Analysis
We have assisted pharmaceutical companies in assessing the Canadian patent landscape for prospective new drug launches, including by providing freedom-to-operate opinions, risk assessment, due diligence, and market analysis. If you are a foreign market entrant seeking to break into the Canadian market, we can work with you and your prospective pharmaceutical partners to find market opportunities.
Pharmaceutical and Biosimilar Patent Litigation
Patent litigation in the life sciences field is one of our core areas of focus. For over 20 years, our firm has represented pharmaceutical clients on patent matters, including under the Patented Medicines (Notice of Compliance) Regulations and the Patent Act. We understand the need to develop holistic strategies early in the product lifecycle, and we can help you be prepared for the accelerated litigation timelines under the PMNOC Regulations.
We represent both innovator and generic companies, and we take on conflict referrals from other firms while protecting client relationships. While other firms may take sides, we believe that we provide value by giving you insight on both sides of the aisle, helping develop strategies that leverage our deep understanding of the industry players and to create opportunities for new approaches to resolving pharmaceutical disputes.
Why Choose Gilbert’s?
Our proven track record includes advising startups on protecting their intellectual property, defending established companies in multi-jurisdictional patent disputes, and advocating for regulatory reforms that promote fair competition and access to life-saving treatments. At Gilbert’s LLP, we understand the challenges and opportunities in the life sciences industry, and we are committed to helping our clients achieve long-term success through proactive, business-focused legal strategies.
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