Biologics: Definition, Legislation and Litigation

Biologics are a new and very promising category of pharmaceuticals, whose development and use in Canada is increasing rapidly. A number of cutting-edge biologics are already on the market, with more planned for the coming years.

Due to scientific and manufacturing differences between biologics and traditional pharmaceuticals, the regulatory approval regime for biologics is unique. In other ways, biologics are treated like traditional pharmaceuticals by Health Canada and the courts.

The growing importance of biologics to Canadians and the Canadian healthcare system has led to significant litigation over biologics, including patent infringement lawsuits and proceedings under the Patented Medicines (Notice of Compliance) regulations.

This article provides an accessible survey of biologics and the law in Canada, including:

• The science behind biologic drugs, including an explanation of how they differ from traditional pharmaceuticals.
• The applicable legislation and regulatory regimes for biologics, including Health Canada marketing approval and protections available for innovator drug companies who develop biologics.
• A review of past and current litigation which involves biologic drugs and gene patents.