Christopher A. Guerreiro

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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

PMPRB excessive price decision quashed by Federal Court of Appeal

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 Federal Court of Appeal has quashed an excessive-price decision of the Patented Medicine Prices Review Board (PMPRB) in a proceeding concerning the drug SOLIRIS. The matter has been remitted to the PMPRB for redetermination. Procedural background The PMPRB issued a decision in 2017 finding that Alexion Pharmaceuticals Inc. sold SOLIRIS (eculizumab) at an excessive … Continue reading

PMPRB Guidelines update: consultation on changes re delayed implementation

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 launched a consultation on proposed changes to its new Guidelines (the New Guidelines). These changes include revisions to the price tests for some medicines marketed prior to the anticipated coming-into-force date of the New Guidelines. The PMPRB has indicated that these changes are intended to account for … Continue reading

PMPRB Update: 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 January 1, 2022. These amendments form the basis for new PMPRB Guidelines, which are scheduled to come into force at the same time as the amendments. The amendments contain a number of … Continue reading

CSP Amendments to the PMPRB Regime: Jurisdiction of Patented Medicine Prices Review Board to Include Medicines Protected by Certificates of Supplementary Protection

Photo of Christopher A. GuerreiroPhoto of Kristin WallPhoto of Pharma in Brief teamBy Christopher A. Guerreiro, Kristin Wall and Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
A suite of amendments to the Patent Act and the Patented Medicines Regulations (the Regulations) will soon require holders of Certificates of Supplementary Protection (CSPs) to report information to the Patented Medicine Prices Review Board (PMPRB) on substantially the same terms and conditions as would be reported by patentees. Regulations amending the Regulations, which will … Continue reading

Federal Court quashes NOC in dispute over Data Protection Provisions

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 has quashed a notice of compliance (NOC) issued to Médunik Canada (Médunik) for its amifampridine product, RUZURGI, over an issue concerning data protection for another amifampridine product. The Minister provided no reasons for its issuance of the NOC, and the Court found that the Certified Tribunal Record (CTR) outlining the decision-making process … Continue reading

PMPRB Update: New periods for compliance with the 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 PMPRB has confirmed that patentees of “Grandfathered” and “Gap” medicines will have two reporting periods to comply with new price ceilings to be set under its new Guidelines, replacing previous guidance that only one reporting period would be permitted. Updates to the Guidelines As we reported, the Guidelines were released by the PMPRB on … Continue reading

Federal Court of Appeal provides guidance on the “inventive concept”

Photo of Paul JorgensenPhoto of Christopher A. GuerreiroBy Paul Jorgensen and Christopher A. Guerreiro on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
The Federal Court of Appeal (FCA) has held that the “inventive concept” can go beyond the essential elements of the claim and may include advantageous properties stated in the patent’s description. The FCA confirmed that the inventive concept is the end-point in the obviousness analysis: for a claimed invention to be obvious, the gap between … Continue reading

Bill C-213, An Act to enact the Canada Pharmacare Act: rejected by Parliament

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 February 24, 2021, Parliament voted down Bill C-213, which would have enacted the Canada Pharmacare Act. The Private Member’s Bill was first introduced a year ago, re-introduced in September 2020 after Parliament’s prorogation, and defeated at Second Reading. The Canada Pharmacare Act set out a series of criteria and conditions that would have been … Continue reading

Federal Court upholds patent validity and issues declarations of infringement against two generic apixaban tablets

Photo of Christopher A. GuerreiroPhoto of Pharma in Brief teamBy Christopher A. Guerreiro and Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
In one of its first patent decisions of 2021, the Federal Court tackled arguments regarding the relevant date for insufficiency allegations and the level of disclosure required for demonstrated utility. The Court resolved these and other issues in the patentees’ favour, granting declarations of infringement against two proposed apixaban generics. Background ELIQUISTM (an blood thinner) … Continue reading

PM(NOC) Regulations do not preclude defendants from amending the statement of defence

Photo of Christopher A. GuerreiroPhoto of Brian R. DaleyBy Christopher A. Guerreiro and Brian R. Daley on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
A defendant in a patent infringement action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations was allowed to amend its defence to include invalidity allegations not found in the Notice of Allegation. Background In an action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (Regulations) concerning three patents, the … Continue reading

Pharma in Brief: The 2020 Year in Review

Photo of Christopher A. GuerreiroPhoto of Kristin WallPhoto of Pharma in Brief teamBy Christopher A. Guerreiro, Kristin Wall and Pharma in Brief team 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 2020. Introduction The Canadian pharma and life sciences space saw many developments in 2020, despite and in some cases because of the COVID-19 pandemic. The industry was among the heroes of 2020, developing, commercializing … Continue reading

Divided success in PM(NOC) actions regarding glatiramer acetate

Photo of Sarah PenningtonPhoto of Christopher A. GuerreiroPhoto of Pharma in Brief teamBy Sarah Pennington, Christopher A. Guerreiro and Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
The Federal Court has decided two infringement actions concerning glatiramer acetate products under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court dismissed allegations of anticipation based upon “speculative” prior art and rejected an argument that there was insufficient disclosure to satisfy the test for sound prediction. However, the Court found one of … Continue reading

Prosecution history cannot be invoked against patent licensees

Photo of Christopher A. GuerreiroPhoto of Brian R. DaleyPhoto of Pharma in Brief teamBy Christopher A. Guerreiro, Brian R. Daley and Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
The Federal Court has found that prosecution history evidence is inadmissible to rebut representations made by a patent licensee (as opposed to the patentee) on claims construction. The Court also considered the issues of “essential elements”, infringement, and obviousness in the context of a formulation patent. Background The Court’s decision concerns Canadian Patent No. 2,507,002 … Continue reading

NOC issued after Federal Court overturns Minister’s decision on effective date of consent letter under the PM(NOC) Regulations

Photo of Christopher A. GuerreiroPhoto of Pharma in Brief teamBy Christopher A. Guerreiro and Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
On October 29, 2020, the Federal Court ordered the Minister of Health to immediately issue a notice of compliance (NOC) for a biosimilar drug following a dispute about the effective date of a consent letter under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court held the Minister acted unreasonably in refusing to … Continue reading

Federal Court issues new consolidated guidelines on complex proceedings

Photo of Caroline HenriePhoto of Christopher A. GuerreiroPhoto of Kristin WallBy Caroline Henrie, Christopher A. Guerreiro and Kristin Wall on Posted in Intellectual property
On October 22, 2020, the Federal Court (FC) issued new Case and Trial Management Guidelines for Complex Proceedings (the FC Guidelines). These new consolidated FC Guidelines address many of the topics raised in the following earlier FC Notices to the Profession: Case management: Increased Proportionality in Complex Litigation before the Federal Court (June 24, 2015); … Continue reading

PMPRB Update: Final Guidelines Released

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
On Friday, October 23, the Patented Medicine Prices Review Board (PMPRB) released final Guidelines that are intended to take effect on January 1, 2021, together with the scheduled coming-into-force of amendments to the Patented Medicines Regulations (the Amendments). According to the PMPRB: The Guidelines provide information on the PMPRB’s general approach to the price review … Continue reading

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

Photo of Christopher A. GuerreiroPhoto of Kristin WallPhoto of Pharma in Brief teamBy Christopher A. Guerreiro, Kristin Wall and Pharma in Brief team on 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 … Continue reading
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