Life Sciences

The Davis LLP Life Sciences Practice Group has in-depth knowledge of the Life Sciences industry and the complex legal challenges it faces.

We represent a variety of clients in the pharmaceutical (human and veterinarian), biotechnology, medical device, natural health product, pesticide and cosmetic sectors, ranging from individuals and start-ups to large multinational corporations, industry associations and governmental organizations.

From product conceptualization and development, to manufacturing, sale, marketing, distribution and licensing, members of Davis LLP’s Life Sciences Practice Group have extensive experience assisting both domestic and foreign clients at every stage of the product life cycle. In addition, as a leading full-service firm, the Davis LLP Life Sciences Group has the support of a wide diversity of legal expertise in various other specialties.

Members of our Life Sciences Practice Group write and lecture extensively and have additional technical training, including at a graduate level. They have also been recognized as leading lawyers by notable publications, such as The Canadian Legal Lexpert® Directory, Best Lawyers in Canada, Benchmark Canada, Who’s Who Legal, and LMG Life Sciences.

Life Sciences – Intellectual Property

The Davis LLP Life Sciences Practice Group has extensive experience in assisting the Life Sciences industry obtain, protect and commercialize intellectual property. We offer a significant advantage through a unique combination of technical expertise and innovative approaches.

With respect to the Life Sciences industry, our IP Group’s activities include the following:

  • Strategic development of and management of IP portfolios
  • Preparing, filing, prosecuting and advising on applications for patents, trade-marks, copyrights and industrial designs
  • Advising on IP-related matters for due diligence in mergers and acquisitions, licensing and other agreements
  • Drafting and filing assignments, licenses, security agreements and liens
  • Advising on validity, invalidity, freedom-to-practice and infringement of patents
  • Litigation relating to patent and trade-mark infringement/impeachment and applications under the Patented Medicines (Notice of Compliance) Regulations before the Federal Courts and Supreme Court of Canada

We have acquired a high level of expertise over many years of handling a variety of challenging and sophisticated cases. Members of the Davis LLP Life Sciences Practice Group have scientific training, including advanced degrees in chemical engineering and pharmacology, and are registered patent and trade-mark agents.

Life Sciences – Regulatory

The Davis LLP Life Sciences Practice Group has extensive experience in assisting the Life Sciences industry navigate the regulatory requirements imposed at both the federal and provincial levels.

We work with clients in advancing products from concept to market, and have experience advising clients on the following:

  • Product classification
  • Strategic development of and management of regulatory approval, drug establishment and product licensing and compliance strategies for pharmaceuticals, medical devices, natural health products and functional food
  • Drug pricing, including representation before the Patented Medicines Prices Review Board and provincial drug formularies
  • Drug interchangeability and reimbursement strategies, and listing agreements
  • Advertising, labelling and marketing
  • Adverse event reporting and recalls
  • Clinical trial approval and related agreements between CRO, institution and investigator
  • Canada’s Special Access Program
  • Importation, manufacturing, distribution and quality agreements
  • Regulatory compliance in corporate transactions
  • Data protection for pharmaceutical products
  • Privacy and access to information
  • Competition law
  • Corporate governance and anti-corruption
  • Government relations

Members of our Life Sciences Practice Group have advocated on behalf of clients before various Directorates, Inspectorates, Offices and Bureaux of Health Canada, including the Therapeutic Products Directorate, Medical Devices Bureau, Office of Clinical Trials, Natural Health Products Directorate, Food Directorate and the Canadian Food Inspection Agency. In addition, we have extensive experience in judicial review of decisions of these agencies.

Members of our team have been specifically acknowledged for excellence in life sciences regulatory by LMG Life Sciences, and write and speak extensively on regulatory matters touching the Life Sciences industry.

Life Sciences – Corporate / Commercial

The Davis LLP Life Sciences Practice Group has extensive experience in providing corporate and commercial advice to the Life Sciences industry, including the following. We have advised clients on:

  • Financing and corporate organization
  • Capital raising
  • Mergers and acquisitions
  • Joint venture and licensing agreements
  • Corporate governance
  • Transactions, including contested corporate transactions
  • Initial public offerings (IPOs)