Health Canada’s Ministerial Reliance Order: A New Era in Canadian Drug Regulation

Health Canada has introduced a new Ministerial Reliance Order (MRO) that represents a significant development in Canada’s drug regulatory framework. The MRO creates a new mechanism allowing Health Canada, in defined circumstances, to rely on decisions or documents produced by comparable foreign regulatory authorities (FRAs) when reviewing certain drug submissions. The initiative aims to improve the efficiency of regulatory review while maintaining Canada’s standards for safety, efficacy, and quality.

July 23, 2026

Spotless Testimony: Another Cycle of the Gemak Detergent Dispute Fails to Get Out the Stains

Patent trials are rarely just about the hard science of an underlying claim. They are human dramas with two competing storylines, where the Court must decide not only what the science shows, but whether the people explaining that science can be trusted.

Sana Halwani & Martin Brandsma | July 20, 2026

A Tale of Two Standards: Why Hikma May Have Had a Different Fate in Canada

On June 4, 2026, the US Supreme Court issued its decision in Hikma Pharmaceuticals USA Inc v Amarin Pharma Inc, a motion to dismiss against the backdrop of a claim for inducement of patent infringement in the pharmaceutical context. The Court held that the patentee, Amarin, had not pleaded more than a “sheer possibility” that Hikma actively induced infringement under the applicable US plausibility standard. Would a Canadian court have reached the same conclusion on identical facts? Possible, but not “plausible.”

Jordana Sanft, Martin Brandsma & Corey McClary | June 17, 2026

Class Dismissed: Copyright Reverse Class Action Fails to Get Passing Grade

On July 16, 2025, a long-running effort by several film studios to have claims of copyright infringement decided by way of reverse class action reached a further impasse. In Voltage Pictures v Robert Salna (Voltage FCA #2), the Federal Court of Appeal (FCA) dismissed – for a second time – the studios’ appeal for certification of a proposed class of unknown individual defendants.

Jordana Sanft, Paul-Erik Veel & Martin Brandsma | July 24, 2025

Policing Scope Creep: Relevance in Canadian Pharma Disputes for Section 8 Damages

In Canada, a generic pharmaceutical company can commence an action for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations (the “Regulations”), if it successfully defends a patentee’s claims in an earlier section 6 prohibition proceeding. Section 8 actions are often complex, requiring a determination of the alleged loss suffered by assessing a “but-for world” where the generic would have received regulatory approval and commenced sales at an earlier date, but for having been blocked by the operation of the Regulations. Depending on the drug(s) and patent(s) at issue, there may be several independent section 8 actions against a patentee, each started by a different generic plaintiff (see our previous post). When distinct section 8 actions are commenced pertaining to the same drug(s), patent(s), and patentee(s), issues as to relevance and scope of each action may arise. 

Jordana Sanft, Andrew Moeser & Martin Brandsma | April 12, 2024

Clarity on the Test for Inducing Infringement in Canadian Patent Law

Indirect infringement or “inducement” often arises in pharmaceutical patent infringement cases where a defendant generic manufacturer may not ultimately “use” the drug in question (i.e., directly infringe). Since 2011, the Federal Court of Appeal’s (“FCA”) Corlac Inc v Weatherford Canada Inc  decision has frequently been cited as the leading authority for the tripartate test for inducement. In 2020, the Federal Court suggested that Corlac had changed the law of inducement—particularly at the second step determining influence—thereby requiring “a higher threshold for establishing inducement than was applied in the earlier cases”. In the recent decision of Teva Canada Limited v Janssen Inc (“Paliperidone”), the FCA has rejected that interpretation of Corlac. The FCA held that Corlac incorporates the same principles of inducing infringement as had been established in cases dating back to 1906. In doing so, it overturned the lower Court’s inducement determination based on a supposed higher standard and found that the defendant was liable for inducement when the Corlac test was properly applied.

Jordana Sanft, Andrew Moeser & Martin Brandsma | April 13, 2023