Topic: Life sciences and healthcare

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

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

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

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

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

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

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

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

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

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

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

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

ONCA Confirms Generics Limited to Section 8 Damages in the Face of an Innovator’s Legitimate Exercise of Rights under the PM(NOC) Regulations

On August 16, 2022, the Ontario Court of Appeal (ONCA) released its decision in Apotex Inc. v. Eli Lilly Canada Inc., 2022 ONCA 587.  The ONCA denied Apotex’s appeal of a lower court summary judgement decision that dismissed Apotex’s novel claims under the UK and Ontario Statutes of Monopolies, the Trademarks Act, and at common law (see … Continue reading

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

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

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

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

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

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

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

Federal Court finds salt patent valid in a PM(NOC) action regarding sitagliptin

The Federal Court has allowed an infringement action concerning sitagliptin phosphate monohydrate products under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court dismissed allegations of obviousness and insufficiency, and it found the asserted claims to be valid and infringed. In reaching its decision, the Court provided substantive guidance on hearsay evidence in infringement … Continue reading

Federal Court sends NOC dispute concerning data protection provisions back to the Minister for a second redetermination

The Federal Court (FC) has granted an application for judicial review involving the data protection provisions in section C.08.004.1 of the Food and Drug Regulations in a case involving new drug submissions (NDSs) for two different amifampridine products. This is the second time that the FC has set aside a decision to issue a notice … Continue reading

New interim order continues expedited authorization pathway for COVID-19 medical devices

The Minister of Health has issued a new interim order regarding expedited authorizations for COVID-19-related medical devices. Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (IO No. 3) maintains all of the flexibilities of its predecessor, including the consideration of urgent public health needs (UPHN). … Continue reading

Federal Court finds patent valid, but rejects infringement claims in a PM(NOC) action regarding risedronate

The Federal Court has decided an infringement action concerning risedronate products under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court dismissed allegations of anticipation based on prior art, as well as arguments that the asserted claims were invalid due to lack of demonstrated utility, insufficiency of disclosure, and/or overbreadth. However, the Court … Continue reading

Federal Court finds inducement of infringement at summary trial under the PM(NOC) Regulations

The Federal Court has confirmed that issues of infringement, including by inducement, may be decided by summary trial in an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court rejected the Defendant’s attempt to avoid infringement based on the scope of its abbreviated new drug submission and product monograph (PM). … Continue reading

FCA upholds patent validity, rejects argument that a soundly predicted invention must be obvious

The Federal Court of Appeal (FCA) has affirmed a decision of the Federal Court (FC) finding that a patent concerning glatiramer acetate (GA) is valid and would be infringed under the Patented Medicines (Notice of Compliance) Regulations. Background As we previously reported, the FC decision concerned allegations by Teva Canada Innovation and Teva Canada Limited … Continue reading

Pharma in Brief: The 2021 Year in Review

In this article, the Pharma in Brief team has curated and provided updates on the most significant topics we covered in 2021. Introduction In 2021, governments advanced major policy initiatives aimed at the COVID-19 pandemic and broader health priorities. These policy initiatives included reforms to the Patented Medicine Prices Review Board (PMPRB), the Patented Medicines … Continue reading
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