On December 10, 2019, Canada, the United States, and Mexico agreed to amend the Canada-United States-Mexico Agreement (CUSMA, also referred to as USMCA) as the trade agreement proceeds toward ratification in each country. Among other changes, the amended CUSMA no longer requires Canada to extend data protection for biologics to 10 years from the 8 years currently provided under Canadian law.

Changes to the CUSMA

As we reported, the previous version of CUSMA required two notable changes to Canadian law concerning pharmaceuticals and biologics:

• Extended data protection for biologics. CUSMA previously required Canada to provide a

The Federal Court has denied a motion by Dr. Reddy’s Laboratories’ (Dr. Reddy’s) seeking to participate in a common validity issues trial in actions concerning four other generic versions of the same drug under the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations).

Background

As we reported, the Federal Court has made a number of orders concerning common validity trials in actions commenced by Bayer Inc. (Bayer) under the PM(NOC) Regulations in respect of generic versions of XARELTO (rivaroxaban). The common validity issues in these earlier actions against Apotex Inc., Teva Canada Limited, … Continue Reading

The Federal Court has granted an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. for a generic version of ZYTIGA (abiraterone acetate). It held that the use of the combination of abiraterone acetate and prednisone claimed by Janssen Inc.’s patent was patentable subject matter, and that the patent’s claims were non-obvious and possessed at least a scintilla of demonstrated utility. The Court also held that Apotex would induce infringement of Janssen’s patent with the product monograph for its proposed generic. This will likely be one of the last cases decided under the pre-September … Continue Reading

The Federal Court has ordered that two additional generic defendants (Taro Pharmaceuticals Inc., Sandoz Canada Inc.) be added to a trial of common issues currently set for Bayer Inc.’s claims against Teva Canada Limited and Apotex Inc. concerning generic versions of XARELTO^® (rivaroxaban) under the Patented Medicines (Notice of Compliance) Regulations (the Regulations).

All four proceedings are patent infringement actions brought by Bayer under the Regulations. The actions were launched in response to each defendant’s Notice of Allegation (NOA) for their respective generic versions of XARELTO^® and one or more Bayer patents.

Earlier this … Continue Reading

On a motion for leave to file reply expert reports, the Federal Court has reinforced the rule against case splitting and outlined the circumstances under which reply expert reports are permissible under the Federal Courts Rules. The Court concluded that none of the proposed reply reports put forward by Teva Canada Limited (Teva) in respect of patent validity issues were proper and dismissed the motion.

Background

This motion arose in the context of an action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations, relating to the drug INVEGA SUSTENNA (paliperidone). The plaintiffs, … Continue Reading

The Government is moving forward with changes to the PMPRB intended to lower the prices of patented medicines in Canada in order to lay the foundation for National Pharmacare. The changes are set out in final amendments to the Patented Medicines Regulations that were released on Friday, August 9, 2019. The amendments will come into force on July 1, 2020.

Once the amendments come into force, the PMPRB will use a different basket of price comparator countries. Significantly, the new basket excludes the US. The PMPRB will also consider new pharmacoeconomic market size, and gross domestic product (GDP)-based … Continue Reading

The Federal Court recently confirmed that an infringement action under the Patent Act cannot be joined with an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations) while the Regulations prohibit the Minister from granting a NOC. The Court stated that an infringement action under the Patent Act could instead be brought in a separate proceeding.

With cooperation between the parties and simultaneous scheduling of the trial of common issues, separate Patent Act and Regulations infringement proceedings could proceed efficiently without formal joinder. The Court’s position is consistent with its recent decision in Bayer Inc. v … Continue Reading

On May 29, 2019, the federal government introduced Bill C‑100 to implement the new trilateral trade deal known as the Canada-United States-Mexico Agreement (CUSMA, also referred to as USMCA), making Canada the first of the three member countries to introduce legislation that would ratify the treaty.

CUSMA provides more protections for biologic and innovative pharmaceuticals under Canadian law. However, the treaty does not require the immediate adoption of these new protections and none of them are directly implemented by Bill C‑100.

As we reported, full implementation of CUSMA will require Canadian law to include:

• Extended data protection

On March 30, 2019, the government published proposed amendments to the Food and Drug Regulations (FDR) intended to clarify whether a generic version of a drug can be approved using the abbreviated new drug submission (ANDS) pathway. These amendments affect how the FDR apply to a generic drug product if it contains a different medicinal ingredient than the Canadian reference product (CRP), but the same therapeutically active component. They also include changes to (i) labelling requirements and (ii) data protection eligibility for variations of previously-approved medicinal ingredients.

The proposed amendments follow a consultation on … Continue Reading

On March 13, the Competition Bureau published a revised version of its IP Enforcement Guidelines (IPEGs). The IPEGs clarify the Bureau’s approach to conducting investigations of alleged anti-competitive activities that involve IP, including settlement of pharmaceutical patent litigation under the Patented Medicines (Notice of Compliance) Regulations (Regulations).

The revised IPEGs replace the earlier 2016 version. Sections 7.2 and 7.3 include a detailed explanation of the Bureau’s approach to litigation settlements under the Regulations, which can be summarized as follows:

1. Entry-split agreements.  An entry-split settlement pursuant to which the generic firm enters the market on or