The Life Sciences sector is rapidly evolving as advances in medicine and scientific improvements in treatments collide with legal and ethical issues. Scrutiny by governments and advocacy groups, increased liability risks, enhanced needs to protect intellectual property assets and heightened consumer and shareholder demands set the stage for a fiercely-competitive global market.
Gardiner Roberts’ Life Sciences team is comprised of experienced professionals with significant academic knowledge, technical advice and in-depth industry expertise for a well-rounded understanding of the issues surrounding this progressive sector. This unique mix provides us with a comprehensive understanding of the industry while our multi-disciplinary, one-team approach delivers the big picture perspective. Your business benefits from Gardiner Roberts’ specialized expertise in financing, privacy, information management, commercial litigation, competition law, mergers and acquisitions, products liability and international trade, aligning with your business goals - for whatever stage of growth your business may be in.
From intellectual property litigation to understanding how patent strategies can affect your market position, Gardiner Roberts’ Life Sciences team’s depth of knowledge and breadth of experience is essential to the development of well-defined strategies and business-oriented solutions addressing the many far-ranging issues that challenge this sector.
Gardiner Roberts’ Life Sciences team represents public and private sector clients in the biopharmaceutical, biotechnology, prescription and over-the-counter pharmaceuticals, natural health products, medical devices and agriculture categories.
Successfully navigating through complex regulatory compliance issues through to cross-border transactions, we regularly advise clients with respect to their obligations and rights under applicable advertising and marketing laws and negotiate with Health Canada on necessary product approvals. Our diverse client base includes universities, research centres, hospitals, venture capitalists, multinational corporations, start-up and mid-sized companies.
Doing business within a highly-regulated and continuously-evolving industry demands exacting standards and proactive legal counsel targeted to solving your specific business issues. Gardiner Roberts’ Life Sciences team provides skilful advice and effective strategies you can rely on - because we understand the science and technology behind your business before engaging in the complexities of Canadian Federal and Provincial regulations and the accompanying issues you’re likely to encounter.
Lawyers in the Life Sciences Group provide expertise in the following areas:
- Clinical Trials
- Crisis management and recalls
- Direct-to-consumer communications
- Distribution, co-promotion, co-marketing and joint venture agreements
- Formulary listings and challenges to listings
- Freedom of information
- Good manufacturing practices
- Labeling, advertising, and promotion
- Non-competition and proprietary rights agreements
- Patent and trademark litigation, including litigation under the Patented Medicines (Notice of Compliance) Regulations
- Patent and trademark preparation, prosecution and maintenance
- Patentability, validity, infringement, and freedom to operate searches and opinions
- Patented Medicine Prices Review Board
- Privacy and personal information
- Product liability and class actions
- Regulatory approvals
- Regulatory change analysis
- Research and collaborative research agreements