Federal Courts update guidance on COVID-19

By Jordana Sanft, Allyson Whyte Nowak, Judith Robinson and Brian R. Daley on September 10, 2020 Posted in Uncategorized

The Federal Court of Appeal (FCA) provided updated guidance for resuming hearings starting September 1, 2020 and clarified the effect of the federal Time Limits and Other Periods Act (COVID-19) on timelines for commencing and conducting litigation in the FCA. Both the FCA and the Federal Court confirmed that all Practice Directions, judgments, orders and directions from both courts remain in full force and effect.

Resumption of in-person hearings

On September 1, 2020, the FCA issued a Notice to the Parties and Profession (Notice) confirming that three types of hearings will be held during the Court’s … Continue Reading

Data protection upheld for subsequently approved combination drugs containing new chemical entities: Federal Court finds Minister of Health’s decision to deny generic ANDS filing is reasonable

By Kristin Wall, Jordana Sanft and William Chalmers on August 6, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

Summary

On July 24, 2020, the Federal Court dismissed an application for judicial review brought by Natco Pharma (Canada) Inc. (Natco) in respect of a July 26, 2019 decision (Decision) by the Minister of Health (Minister). The Decision refused to accept Natco’s ANDS filing using Gilead Sciences Canada Inc.’s (Gilead) product DESCOVY as the Canadian Reference Product. DESCOVY contains a combination of tenofovir alafenamide (TAF) hemifumarate and emtricitabine. The Minister determined that TAF is a new chemical entity first approved in another Gilead drug product GENVOYA. GENVOYA is a designated … Continue Reading

Federal Court finds Minister’s CSP decision unreasonable on patent eligibility for fixed-dose combination drug product

By Morgan Westgate and Kristin Wall on July 28, 2020 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

On July 10, 2020, the Federal Court issued a decision in a judicial review under the Certificate of Supplementary Protection Regulations (CSP Regulations). The application was brought by ViiV Healthcare ULC (ViiV) regarding a decision by the Minister of Health (Minister) refusing to issue a CSP in respect of Canadian Patent No. 2,606,282 (282 Patent) and the drug JULUCA^®(Decision).

The Federal Court determined that the Decision was unreasonable, including for failing to interpret the CSP regime in a manner consistent with the Canada-European Union Comprehensive Economic and Trade … Continue Reading

PMPRB takes jurisdiction over medicine (again) following Federal Court of Appeal remand

By Colin Hyslop, Christopher A. Guerreiro and Kristin Wall on July 7, 2020 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Patented Medicine Prices Review Board (PMPRB or Board) has found that a patent can pertain to a medicine based on clinical similarities to the invention—even if the patent does not actually encompass the medicine.

Background

This case concerns Canadian Patent No. 2,478,237 (the 237 Patent), which relates to the use of adapalene to treat dermatological disorders. The patentee, Galderma Canada Inc. (Galderma), markets two adapalene products in Canada:

Differin^®, which contains 0.1% adapalene (DIFFERIN).
Differin XP^TM, which contains a higher concentration of adapalene: 0.3% (DIFFERIN XP).

Federal Court lifts Suspension Period

By Jordana Sanft, Allyson Whyte Nowak, Judith Robinson and Brian R. Daley on July 1, 2020 Posted in Intellectual property

On June 25, 2020, the Federal Court (FC) issued its latest Practice Direction and Order (FC Update) regarding Court operations during the pandemic, announcing that its Suspension Period will no longer be in force anywhere in Canada as of June 30, 2020. The FC Update also establishes guidelines for the transition toward more regular operations

Background

The FC Update is the fifth Practice Direction and Order issued by the FC in response to the Covid-19 pandemic. For ease of reference, the FC has published a consolidated version of these five notices, including those provisions of each … Continue Reading

Federal Courts begin to phase out the Suspension Period

By Jordana Sanft, Allyson Whyte Nowak, Judith Robinson and Brian R. Daley on June 23, 2020 Posted in Uncategorized

On June 11, 2020 the Federal Court (FC) and Federal Court of Appeal (FCA) published updated notices to gradually phase out the Suspension Period, which had previously been extended to June 15, 2020.

Federal Court

The FC’s June 11, 2020 Practice Direction and Order (Updated Order), amends its previous Practice Directions, which, subject to the amendments listed, continue to remain in force. The Updated Order provides for different procedures by region.

Ontario, Québec and the Territories

Suspension Period: Subject to the five exceptions listed in April 29^th practice direction, the Suspension Period is … Continue Reading

PMPRB launches consultation on revised Draft Guidelines

By Christopher A. Guerreiro, Kristin Wall and Brian R. Daley on June 21, 2020 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

On June 19, 2020, the Patented Medicine Prices Review Board (PMPRB) launched its consultation on revised Draft Guidelines to implement the amended Patented Medicines Regulations. The revised Guidelines outline new price tests for existing and new patented medicines, as well as a revised risk-based system for reporting and investigations. They will be available for public comment until July 20, 2020.

Background

Amendments to the Patented Medicines Regulations are scheduled to come into force on January 1, 2021. These amendments are intended to lower the prices of patented medicines in Canada. They include: (1) new factors for … Continue Reading

Ontario lifts recommendation to limit prescription dispensing to 30 days’ supply

By John Greiss and Randy Sutton on June 17, 2020 Posted in Uncategorized

We previously reported on the Ontario government’s efforts to manage the risk of drug shortages in the early days of the pandemic. Those efforts included a recommendation that pharmacies dispense no more than a 30-days’ supply of medication to patients under the Ontario Drug Benefit (ODB) program. Because the policy resulted in additional dispensing fees being charged to patients, the government took further regulatory action to ensure that patients would not be required to pay additional fees as a result of this policy.

On June 15th, 2020, the Drugs and Devices Division ended its recommendation that pharmacies dispense … Continue Reading

Federal Court determines that infringement action under PM(NOC) Regulations is not moot where trial proceeds after patent expiry

By Morgan Westgate, David Yi and Amy Grenon on June 8, 2020 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

On May 22, 2020, the Federal Court granted a motion seeking an order that the issue of infringement in an action brought pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations (Regulations) would not be moot notwithstanding that the trial was set to proceed after the expiry of the relevant patent.

Background

Sandoz served a Notice of Allegation on AstraZeneca alleging non-infringement, invalidity and ineligibility for listing of AstraZeneca’s patent for saxagliptin tablets (marketed as ONGLYZA), being Canadian Patent No. 2,402,894 (894 Patent). AstraZeneca commenced an action against Sandoz seeking a declaration that … Continue Reading

PMPRB update: Amendments delayed, new Guidelines consultation announced, and judicial review heard

By Christopher A. Guerreiro and Kristin Wall on June 4, 2020 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

This week has seen a number of developments relating to the Patented Medicine Prices Review Board (PMPRB), including a six-month delay to the implementation of amendments to the Patented Medicines Regulations and renewed consultation by the Board on revised Draft Guidelines to implement those amendments. Meanwhile, the Federal Court is now considering a judicial review of those amendments.