Kristin Wall

Health Canada releases updated Certificate of Supplementary Protection guidance

By Sarah Pennington, Paul Jorgensen and Kristin Wall on May 29, 2023 Posted in Pharmaceuticals and life sciences

On May 12, 2023, Health Canada announced the release of an updated version of the Guidance Document: Certificates of Supplementary Protection (CSP Guidance). The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations (CSP Regulations) and to reflect changes to Health Canada’s administrative … Continue reading

PMPRB Update: Federal Standing Committee on Health begins review of the Board

By Christopher A. Guerreiro and Kristin Wall on May 2, 2023 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

The Standing Committee on Health (HESA) has begun a study on the Patented Medicine Prices Review Board (PMPRB). HESA is made up of 12 Members of Parliament representing the four main parties in the House of Commons. In connection with this study, HESA has conducted two meetings to ask questions of witnesses regarding the PMPRB: The events … Continue reading

Bill C-47 introduces patent term adjustment: Proposed term to run concurrently with term of Certificate of Supplementary Protection

By Kristin Wall, Anna Wilkinson and Paul Jorgensen on May 1, 2023 Posted in Intellectual property, Pharmaceuticals and life sciences

On April 20, 2023, the federal government tabled legislation (Bill C-47) that would amend the Patent Act to bring, for the first time, a system of general patent term adjustment (PTA) into Canada. Canada is required under the Canada-United States-Mexico Agreement (CUSMA) to adopt a PTA system by 2025. The PTA system is intended to … Continue reading

U.S. Trade Representative cites Canada’s “IP problems” including pharmaceutical patent protection

By Paul Jorgensen and Kristin Wall on April 27, 2023 Posted in Intellectual property, Pharmaceuticals and life sciences

On April 26, 2023, the Office of the United States Trade Representative (USTR) released its 2023 Special 301 Report on intellectual property. The report keeps Canada on a Watch List of 29 U.S. trading partners that “merit bilateral attention to address underlying IP problems”. The report is the USTR’s annual review of the global state of … Continue reading

Federal Court of Appeal rejects elevated standard of proof for induced infringement in paliperidone case

By Fortunat Nadima Nadima, Christopher A. Guerreiro and Kristin Wall on April 21, 2023 Posted in Intellectual property, Pharmaceuticals and life sciences

The Federal Court of Appeal (FCA) has allowed an appeal concerning induced infringement in an action under the Patented Medicines (Notice of Compliance) Regulations (Regulations). The FCA found that the Federal Court (FC) had erred by applying an elevated causation requirement. The FCA also rejected an appeal by the generic from the finding that the patent was … Continue reading

Canada announces its first-ever national strategy for drugs for rare diseases

By Sarah Pennington, Paul Jorgensen and Kristin Wall on March 27, 2023 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

On March 22, 2023, Canada’s federal government announced its first-ever National Strategy for Drugs for Rare Diseases, including an investment of up to $1.5 billion over three years to help increase drug access and affordability. Investments made as part of the National Strategy The lion’s share of the federal government’s investment – up to $1.4 … Continue reading

Federal Court launches IP Chamber pilot project

By Christopher A. Guerreiro and Kristin Wall on March 6, 2023 Posted in Intellectual property

The Federal Court has created a new, specialized Chamber of judges to be used for assigning intellectual property and competition law hearings. The Chamber formalizes the Court’s existing practice of endeavouring to assign judges with relevant IP expertise to preside over IP matters. It is intended to increase transparency and provide greater certainty regarding the … Continue reading

Higher costs awards coming to the Federal Court, including for pharma regulatory and IP disputes

By Chelsea Nimmo, Paul Jorgensen and Kristin Wall on February 26, 2023 Posted in Damages, Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

Higher costs awards for Federal Court litigation are on the horizon, with the Canadian government consulting on proposed amendments to the costs structure in the Federal Courts Rules (the Rules). The proposed amendments are intended to increase costs awards by approximately 25%. The current costs regime Under the Rules, the Federal Courts can fix a … Continue reading

PMPRB Update: New Chairperson Appointed

By Christopher A. Guerreiro and Kristin Wall on February 8, 2023 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Governor in Council has appointed Thomas J. Digby as the new Chairperson of the Patented Medicine Prices Review Board (PMPRB). According to the Government’s news release, “Mr. Digby is a lawyer with expertise in intellectual property and has an extensive educational background in the Biological Sciences” and has been appointed for a term of five … Continue reading

Pharma in Brief: The 2022 Year in Review

By William Chalmers, Christopher A. Guerreiro, Paul Jorgensen and Kristin Wall on January 25, 2023 Posted in Damages, Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

Does 2022 already seem like a blur? The Pharma in Brief team is here for you with a summary of some of 2022’s most significant legal and regulatory developments in the Canadian pharmaceutical space. We also flag what to watch out for in 2023. The most significant legislative changes concerned the Patent Act and … Continue reading

Health Canada consulting on wide-ranging regulatory amendments for drugs and medical devices

By John Greiss, Paul Jorgensen and Kristin Wall on January 19, 2023 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

Health Canada has launched a consultation on proposed amendments to the Food and Drug Regulations and Medical Devices Regulations (the Regulatory Amendments). Consultation on the Regulatory Amendments, which have been published in the Canada Gazette, Part 1, is open until March 27, 2023. The Regulatory Amendments build upon the regulatory flexibilities introduced in the Interim … Continue reading

Federal Court of Appeal overturns judicial review decision in data protection dispute

By William Chalmers, Christopher A. Guerreiro and Kristin Wall on January 12, 2023 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court of Appeal (FCA) has overturned a decision of the Federal Court (FC) that found the Minister of Health’s (Minister) analysis of the data protection provisions of the Food and Drug Regulations unreasonable. The FCA restored the Minister’s decision granting an NOC to Médunik Canada (Médunik) for its amifampridine product, RUZURGI. Background Catalyst … Continue reading

Ontario introduces biosimilar transition policy

By Sarah Pennington, Paul Jorgensen and Kristin Wall on January 11, 2023 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

On December 20, 2022, the government of Ontario announced a new policy to expand the use of biosimilar drugs in the province. Patients receiving coverage under the Ontario Drug Benefit (ODB) program for eight originator biologic drugs will be required to transition to the biosimilar version by December 29, 2023. During the transition period from … Continue reading

Federal Court of Appeal issues decision in industry challenge to the PMPRB Patented Medicines Regulations

By Orestes Pasparakis, Kristin Wall, Rowan Weaver and Christopher A. Guerreiro on December 8, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

On December 5, 2022, the Federal Court of Appeal (FCA) upheld the validity of changes to the list of countries used for international reference pricing by the Patented Medicine Prices Review Board (PMPRB). This new schedule of countries, known as the PMPRB11, removes the United States and Switzerland while adding six lower-price jurisdictions.[i] The FCA … Continue reading

PMPRB issues excessive price order on rare disease drug

By Christopher A. Guerreiro and Kristin Wall on October 5, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Patented Medicine Prices Review Board (PMPRB) has issued a decision that Procysbi (cysteamine bitartrate) is being sold at an “excessive” price. The PMPRB ordered the manufacturer, Horizon Pharma PLC (Horizon), to reduce its price and pay excess revenues to the Crown. In its decision, the Board applied the Guidelines to determine the price ceiling … Continue reading

24-month stay extended under the PM(NOC) Regulations for late pleadings amendment

By Christopher A. Guerreiro and Kristin Wall on October 3, 2022 Posted in Intellectual property, Pharmaceuticals and life sciences

In a recent pleadings amendment motion under the Patented Medicines (Notice of Compliance) Regulations (the Regulations), the Federal Court gave the generic a choice: either (a) abandon proposed new grounds of invalidity or (b) accept that the scheduled trial date will be adjourned, with a commensurate extension of the 24-month statutory stay preventing approval of … Continue reading

Generic not required to address Patent Register when reference innovator drug is no longer marketed in Canada

By Sarah Pennington, Christopher A. Guerreiro and Kristin Wall on September 7, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

On August 17, 2022, the Federal Court dismissed applications for judicial review regarding the product-specificity requirements for addressing patents listed on the Patent Register under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). Background This case concerns biosimilar presentations of an AbbVie Corporation and AbbVie Biotechnology Ltd. (collectively, AbbVie) product, HUMIRA (adalimumab), sought to … Continue reading

PMPRB round-up: report on current reforms

By Kristin Wall and Christopher A. Guerreiro on August 31, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

In this post, we summarize the current status of reforms to the Patented Medicine Prices Review Board (PMPRB). These reforms commenced with August 2019 amendments to the Patented Medicines Regulations (the Amendments) and accompanying changes to the Board’s Guidelines. Background of the proposed reforms The Amendments were intended to lower the prices of patented medicines … Continue reading

Federal Court of Appeal upholds decision invalidating claims to multiple sclerosis treatment regimen

By Paul Jorgensen, Christopher A. Guerreiro and Kristin Wall on August 23, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court of Appeal (FCA) has dismissed appeals concerning two actions brought under the Patented Medicines (Notice of Compliance) Regulations (Regulations), confirming the Federal Court (FC) holding that claims to uses of the molecule fampridine were invalid. The FCA’s decision provides guidance on claims construction and analyzing obviousness, while pointedly refusing to endorse the FC’s … Continue reading

FCA upholds selection patent protecting apixaban and rejects that a second patented invention was obvious to try

By Pardeep Heir, Christopher A. Guerreiro and Kristin Wall on August 15, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court of Appeal (FCA) has dismissed an appeal concerning four actions related to the molecule apixaban under the Patented Medicines (Notice of Compliance) Regulations (Regulations). The Federal Court (FC) found the patents at issue to be valid. Background Bristol-Myers Squibb Canada Co. (BMS) markets ELIQUIS® (apixaban) in Canada for the treatment of thrombosis. … Continue reading

2022 Guide to Canada’s Pharmaceutical Intellectual Property Regime

By William Chalmers and Kristin Wall on July 25, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

Our 2022 Guide to Canada’s Pharmaceutical Intellectual Property Regime is a convenient all-in-one reference to the important legal and regulatory regimes governing pharmaceuticals in Canada. The Guide provides a detailed review of the key regimes, including: Data protection market exclusivity; The Patented Medicines (Notice of Compliance) Regulations (PMNOC), linking generic market access to patent rights; … Continue reading

Federal Court finds generic would induce infringement of combination therapy patent

By Colin Hyslop, Christopher A. Guerreiro and Kristin Wall on July 18, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court has allowed a second infringement action concerning a macitentan product under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court found that the defendant would induce infringement of claims relating to combination treatment if it were allowed to market its macitentan product. Background Janssen Inc. markets OPSUMIT® (macitentan) to treat patients … Continue reading

Government of Canada invests in clinical trial development in Canada through the Clinical Trials Fund

By Sarah Pennington, Christopher A. Guerreiro and Kristin Wall on June 26, 2022 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

On June 22, 2022, the Canadian Institutes of Health Research (CIHR) announced the launch of the Clinical Trials Fund (CTF), which will inject funding into Canada’s clinical trials environment. The government’s goals include reinforcing Canada’s clinical trials infrastructure so as to improve the health and safety of all Canadians while also ensuring that Canada is … Continue reading

Federal Court finds a combination therapy patent valid and infringed

By Colin Hyslop, Christopher A. Guerreiro and Kristin Wall on June 14, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court has allowed an infringement action concerning a macitentan product under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court dismissed allegations that the asserted patent claims were invalid for obviousness, lack of utility, overbreadth, and insufficiency of disclosure. Background Janssen Inc. (Janssen) markets OPSUMIT® in Canada for the treatment of pulmonary arterial … Continue reading