Christopher A. Guerreiro

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Supreme Court denies leave to appeal in generic Statute of Monopolies case

On April 27, 2023, the Supreme Court of Canada dismissed an application by Apotex Inc. and Apotex Pharmachem Inc. (Apotex) for leave to appeal from a decision of the Ontario Court of Appeal (ONCA), dismissing its claim for damages in the Ontario courts under the Statutes of Monopolies and other novel causes of action. In the Courts below, Apotex … 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

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

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

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

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

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

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

By Allyson Whyte Nowak, David Yi and Christopher A. Guerreiro on August 25, 2022 Posted in Damages, Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

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

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

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

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

By Colin Hyslop, Christopher A. Guerreiro and Brian R. Daley on April 19, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

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

By Colin Hyslop, Christopher A. Guerreiro and Kristin Wall on March 23, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

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

Federal Court rejects motion for summary judgment in Canadian patent infringement case following voluntary dismissal of parallel US litigation

By Colin Hyslop, Christopher A. Guerreiro and Brian R. Daley on March 17, 2022 Posted in Intellectual property

In a recently released decision, the Federal Court (FC) considered what happens when a patent infringement plaintiff agrees to resolve a dispute in a foreign jurisdiction, but continues to press parallel litigation against the same defendant in Canada. In this case, the defendant sought summary judgment based on the terms of a voluntary dismissal between the … Continue reading

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

By Sarah Pennington, Christopher A. Guerreiro and Kristin Wall on March 9, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

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

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

By Sarah Pennington, Christopher A. Guerreiro, Brian R. Daley and Kristin Wall on January 10, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

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

By Kristin Wall, William Chalmers, Christopher A. Guerreiro and David Yi on January 9, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

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