Aitken Klee has an unrivalled track record successfully representing pharmaceutical manufacturers in litigation under both the Patent Act and the Patented Medicines (Notice of Compliance) Regulations, including at the Supreme Court of Canada. In small molecule drugs, we have taken on some of the most difficult cases, including successfully addressing numerous compound, formulation and use patents on blockbuster drugs. We have also been successful in a number of seminal cases, including defining the requirements of written description and clarifying the meaning of “inventive concept” that continue to shape Canadian patent law and have twice won a prestigious patent case of the year award.

Complementing its litigation experience, our team has the deep technical background required for biopharmaceutical and biosimilar products. Nearly one half of our lawyers have a life-sciences master’s or doctoral degree including those with first-hand experience in the expression and high-resolution characterization of recombinant protein products. While our team was counsel in the first biosimilar litigation in Canada involving filgrastim, our expertise is not limited to litigation.  We have also advised on biosimilar regulatory issues, provided early-stage advice on design-around opportunities, and negotiated partnership and licensing agreements.

Representative Cases