Patent Infringement Actions

Non-infringing Alternative is Relevant to Damages, but Not made out on Facts
Apotex Inc. v. Merck & Co. Inc., 2015 FCA 171
Drug: lovastatin

Merck was successful in a patent infringement action. A separate damages reference was held where the Judge awarded lost profits and a reasonable royalty, for a total of $119,054,327 plus interest (decision here; summary here). Apotex’s appeal of that damages decision was dismissed.

At the reference, Apotex had argued that it had a non- infringing alternative process available, and thus the “but for” causation test should apply to all of the lovastatin it sold. Apotex thus argued that Merck had not demonstrated that its loss was caused by Apotex’s wrongful use of the patented process. The Court held that the existence of a non-infringing alternative was not relevant to an assessment of damages for patent infringement. The FCA held that the Court had erred in this finding, and at law, a non-infringing alternative is legally relevant. However, the FCA held that Apotex had failed to establish that they could and would have sold the non-infringing alternative. Thus, the appeal was dismissed.

Other Industry News

Health Canada has started publishing a list of new drug submissions (NDSs) for new active substances that are accepted into review. The Submissions Under Review List is here.

Health Canada has released a revised Post-Notice of Compliance (NOC) Changes: Level III Form. Health Canada has released a Post-Notice of Compliance (NOC) Changes: Quality Document.

Health Canada has released a Natural and Non-prescription Health Products Directorate Guidance Document and Information on Homeopathic Products.


Chantal Saunders

Beverley Moore

Adrian J. Howard


Intellectual Property