Overview
Miller Thomson’s Life Sciences Group is intimately familiar with the highly specialized and complex regulatory environment in which life sciences companies operate. Our team brings together a broad depth of experience in the pharmaceutical product (prescription and non-prescription), biotechnology, medical device and natural health product businesses. Our team provides practical, efficient and creative solutions for the legal challenges encountered by life sciences companies. Our services span Regulatory Affairs, Intellectual Property, Litigation, and Corporate.
Our clients range from startups to multi-national companies operating at every level of the supply chain, including manufacturers, fabricators, importers, exporters, distributors, and wholesalers, as well as service providers to those companies.
Many of our group members are registered patent agents and have scientific technical training, such as in chemistry, microbiology, genetics, neuroscience and pharmacology. In addition, several of our group members have worked together for over a decade.
Our expertise encompasses the most critical issues encountered by life sciences companies bringing products to market, and keeping them on the market, including:
Regulatory Affairs:
- Product classification, and developing strategies for regulatory approval of life sciences products
- Interactions with healthcare professionals
- Marketing to healthcare professionals, and direct to consumer advertising
- Pricing advice in respect of the Patented Medicines Prices Review Board
- Drug interchangeability and reimbursement strategies, as well as product listing agreements
- Misleading comparative advertising by competitors
- Protection of confidential information from access to information and freedom of information requests
- Product recalls
- Judicial reviews of Health Canada decisions
- Privacy matters in the context of patient programs
- Federal and Provincial regulatory inspections and investigations.
Intellectual Property:
- Litigation pursuant to the Patented Medicines (Notice of Compliance) Regulations, including section 8 proceedings
- Patent infringement and impeachment proceedings
- Patented Medicines Prices Review Board litigation
- Preparing, filing and prosecuting applications for patents and managing patent portfolios
- Validity and freedom to operate opinions.
Corporate:
- Importation, fabrication, supply, distribution and quality agreements
- Acquisition of rights and products
- Competition matters
- Mergers and acquisitions
- Capital raising
- Partnerships, joint ventures and licensing agreements
- Cross-border and international commercial transactions
- Corporate governance
- Product liability.
