Christopher A. Guerreiro

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Pharma in Brief: The 2022 Year in Review

Photo of William ChalmersPhoto of Christopher A. GuerreiroPhoto of Paul JorgensenPhoto of Kristin WallBy William Chalmers, Christopher A. Guerreiro, Paul Jorgensen and Kristin Wall on 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

Photo of William ChalmersPhoto of Christopher A. GuerreiroPhoto of Kristin WallBy William Chalmers, Christopher A. Guerreiro and Kristin Wall on 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

Photo of Orestes PasparakisPhoto of Kristin WallPhoto of Rowan WeaverPhoto of Christopher A. GuerreiroBy Orestes Pasparakis, Kristin Wall, Rowan Weaver and Christopher A. Guerreiro on 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

Photo of Christopher A. GuerreiroPhoto of Kristin WallBy Christopher A. Guerreiro and Kristin Wall on 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

Photo of Christopher A. GuerreiroPhoto of Kristin WallBy Christopher A. Guerreiro and Kristin Wall on 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

Photo of Sarah PenningtonPhoto of Christopher A. GuerreiroPhoto of Kristin WallBy Sarah Pennington, Christopher A. Guerreiro and Kristin Wall on 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

Photo of Kristin WallPhoto of Christopher A. GuerreiroBy Kristin Wall and Christopher A. Guerreiro on 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

Photo of Allyson Whyte NowakPhoto of David YiPhoto of Christopher A. GuerreiroBy Allyson Whyte Nowak, David Yi and Christopher A. Guerreiro on 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

Photo of Paul JorgensenPhoto of Christopher A. GuerreiroPhoto of Kristin WallBy Paul Jorgensen, Christopher A. Guerreiro and Kristin Wall on 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

Photo of Pardeep HeirPhoto of Christopher A. GuerreiroPhoto of Kristin WallBy Pardeep Heir, Christopher A. Guerreiro and Kristin Wall on 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

Photo of Colin HyslopPhoto of Christopher A. GuerreiroPhoto of Kristin WallBy Colin Hyslop, Christopher A. Guerreiro and Kristin Wall on 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

Photo of Sarah PenningtonPhoto of Christopher A. GuerreiroPhoto of Kristin WallBy Sarah Pennington, Christopher A. Guerreiro and Kristin Wall on 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

Photo of Colin HyslopPhoto of Christopher A. GuerreiroPhoto of Kristin WallBy Colin Hyslop, Christopher A. Guerreiro and Kristin Wall on 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

Photo of Colin HyslopPhoto of Christopher A. GuerreiroPhoto of Brian R. DaleyBy Colin Hyslop, Christopher A. Guerreiro and Brian R. Daley on 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

Photo of Colin HyslopPhoto of Christopher A. GuerreiroPhoto of Kristin WallBy Colin Hyslop, Christopher A. Guerreiro and Kristin Wall on 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

Photo of Colin HyslopPhoto of Christopher A. GuerreiroPhoto of Brian R. DaleyBy Colin Hyslop, Christopher A. Guerreiro and Brian R. Daley on 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

Photo of Sarah PenningtonPhoto of Christopher A. GuerreiroPhoto of Kristin WallBy Sarah Pennington, Christopher A. Guerreiro and Kristin Wall on 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

Photo of Sarah PenningtonPhoto of Christopher A. GuerreiroPhoto of Brian R. DaleyPhoto of Kristin WallBy Sarah Pennington, Christopher A. Guerreiro, Brian R. Daley and Kristin Wall on 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

Photo of Kristin WallPhoto of William ChalmersPhoto of Christopher A. GuerreiroPhoto of David YiBy Kristin Wall, William Chalmers, Christopher A. Guerreiro and David Yi on 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

PMPRB Update: further-delayed implementation of Patented Medicines Regulations amendments and new Guidelines

Photo of Christopher A. GuerreiroPhoto of Brian R. DaleyPhoto of Kristin WallBy Christopher A. Guerreiro, Brian R. Daley and Kristin Wall on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
Changes to the Patented Medicine Prices Review Board (PMPRB) regime, contained in pending amendments to the Patented Medicines Regulations, have been delayed until July 1, 2022. These amendments form the basis for new PMPRB Guidelines. The PMPRB has updated its website to indicate that the new Guidelines will be in place as of the coming-into-force … Continue reading

PMPRB will not proceed with proposed July 15, 2021 changes to its new Guidelines

Photo of Christopher A. GuerreiroPhoto of Brian R. DaleyPhoto of Kristin WallBy Christopher A. Guerreiro, Brian R. Daley and Kristin Wall on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
The Patented Medicine Prices Review Board (PMPRB) has announced that it will not proceed with changes to its new Guidelines that were proposed in a July 15, 2021 Notice and Comment. As we reported, these changes would have affected the definition of “Gap” medicine, references to the PMPRB11 basket of comparator countries, and the price … Continue reading

Federal Court of Appeal provides guidance on disclosure exemptions in ATI requests

Photo of Caroline HenriePhoto of Christopher A. GuerreiroPhoto of Kristin WallBy Caroline Henrie, Christopher A. Guerreiro and Kristin Wall on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
The Federal Court of Appeal (FCA) has set aside a decision of the Federal Court (FC), which had invalidated Health Canada’s decision to disclose records in response to a request (ATI Request) made pursuant to the Access to Information Act (the Act). The FCA remitted the matter to the FC for redetermination. Procedural Background As … Continue reading

Canada seeks leave to appeal to the Supreme Court in PMPRB excessive-pricing case

Photo of Kristin WallPhoto of Christopher A. GuerreiroBy Kristin Wall and Christopher A. Guerreiro on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
The Attorney General of Canada has sought leave to appeal to the Supreme Court in an excessive-pricing case regarding the drug SOLIRIS. As we reported, Alexion Pharmaceuticals Inc. was successful before the Federal Court of Appeal in an application for judicial review of a 2017 PMPRB decision finding that Alexion had sold SOLIRIS at an … Continue reading

Health Canada reports on a national strategy for rare disease drugs

Photo of John GreissPhoto of Christopher A. GuerreiroPhoto of Kristin WallBy John Greiss, Christopher A. Guerreiro and Kristin Wall on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
Health Canada has published a report on its public consultation on building a national strategy to address access to drugs for rare diseases. This report follows the Government of Canada’s commitment to create a national strategy for drugs for rare diseases based on recommendations made by the Advisory Council on the Implementation of National Pharmacare. … Continue reading
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