Topic: Life sciences and healthcare

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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

By Shantelle LaFayette, Jonathan Chong and Brian R. Daley on January 26, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

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

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

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

By Christopher A. Guerreiro, Brian R. Daley and Kristin Wall on December 23, 2021 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

By Christopher A. Guerreiro, Brian R. Daley and Kristin Wall on December 20, 2021 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

By Caroline Henrie, Christopher A. Guerreiro and Kristin Wall on October 28, 2021 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

Federal Court finds Minister of Health’s refusal to grant CSP based on the “Timely Submission Requirement” unreasonable

By Kristin Wall, Corey McClary and Colin Hyslop on October 20, 2021 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences, Uncategorized

SUMMARY The Federal Court has granted Merck Canada Inc.’s (Merck) application for judicial review of a decision of the Minister of Health (Minister) denying a Certificate of Supplementary Protection (CSP) for Canadian Patent No. 2,670,892 (892 Patent) and the drug BELSOMRA (suvorexant). BACKGROUND A CSP provides patent-like rights and is intended to compensate patentees for … Continue reading

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

By Kristin Wall and Christopher A. Guerreiro on October 7, 2021 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

ONSC dismisses Apotex’s second monopolies action

By Orestes Pasparakis, Daniel Daniele, David Yi and Morgan Westgate on October 6, 2021 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Ontario Superior Court of Justice has released the second decision in a series of summary judgment motions relating to Apotex’s claims against innovative drug companies under various causes of action pursued above and beyond the section 8 damages regime in the Patented Medicines (Notice of Compliance) Regulations. In Apotex Inc. v. Pfizer Ireland Pharmaceuticals, … Continue reading

Health Canada reports on a national strategy for rare disease drugs

By John Greiss, Christopher A. Guerreiro and Kristin Wall on August 11, 2021 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

Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations

By Sarah Pennington and Kristin Wall on August 9, 2021 Posted in Life sciences and healthcare

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations (FDR) and the Medical Devices Regulations in the spring of 2022. The proposed amendments are intended to modernize the Canadian therapeutic product regulatory system at every stage of products’ lifecycles from authorization to post-market. … Continue reading

PMPRB excessive price decision quashed by Federal Court of Appeal

By Christopher A. Guerreiro and Kristin Wall on August 3, 2021 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

CADTH convenes Advisory Panel on a pan-Canadian prescription drug list

By Kassandra Shortt and Kristin Wall on July 28, 2021 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

CADTH has convened a pan-Canadian Advisory Panel on a Framework for a Prescription Drug List (the Panel). The Panel will provide recommendations on developing a potential pan-Canadian prescription drug list (or formulary). Stakeholder consultations are scheduled to take place in the fall and winter of 2021, leading to a final public report setting out the … Continue reading

PMPRB Guidelines update: consultation on changes re delayed implementation

By Christopher A. Guerreiro, Brian R. Daley and Kristin Wall on July 25, 2021 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

Certain COVID-19 medical devices no longer hold urgent public health need status under Interim Order No. 2

By Sarah Pennington, John Greiss and Kristin Wall on July 22, 2021 Posted in Life sciences and healthcare

Health Canada has issued a notice explaining a policy change to the review of applications for COVID-19 medical devices. As of July 16, 2021, Health Canada is no longer accepting applications for certain categories of medical devices under Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (IO … Continue reading

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

By Christopher A. Guerreiro, Brian R. Daley and Kristin Wall on July 7, 2021 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

Generic allowed to plead new grounds of invalidity not raised in the Notice of Allegation

By Morgan Westgate and Brian R. Daley on July 5, 2021 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court of Appeal (FCA) has confirmed that in an infringement action under the Patented Medicines (Notice of Compliance) Regulations, the “second person” (i.e., generic/biosimilar) is not precluded from pleading invalidity allegations in its Statement of Defence beyond those that were raised in its notice of allegation (NOA). While new allegations may not be … Continue reading

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

By Corey McClary, Christopher A. Guerreiro and Kristin Wall on June 22, 2021 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

By William Chalmers, Christopher A. Guerreiro and Kristin Wall on June 9, 2021 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

Quebec Prohibits Financial Assistance by Drug Manufacturer for Patients’ Drug Costs

By Gregory Bordan and Kimberly Jeffers on April 29, 2021 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

At the end of 2016, the previous Quebec government prohibited a number of common commercial practices by drug manufacturers and pharmacists with the aim of fostering greater price competition between drug manufacturers and reducing the cost of the public drug insurance scheme.[1] Among the new prohibitions was one that would prohibit a manufacturer from offering … Continue reading

Proposed amendments to the PM(NOC) Regulations: Patents claiming different salt forms of medicinal ingredients eligible for inclusion on the Patent Register

By Corey McClary, David Yi and Kristin Wall on April 25, 2021 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

On April 23, 2021, Proposed PM(NOC) Amendments [1] were published in the Canada Gazette, Part I. These amendments permit patents claiming different forms of a medicinal ingredient (e.g., salt forms) to be listed on the patent register and are intended to balance Proposed FDR Amendments [2] published on March 30, 2019 which allow generic manufacturers … Continue reading

PMPRB Update: New periods for compliance with the new Guidelines

By Christopher A. Guerreiro, Brian R. Daley and Kristin Wall on April 20, 2021 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

Food and Drug Regulations amended: COVID-19 drugs and vaccines transitioned out of interim order framework

By John Greiss, Sarah Pennington and Kristin Wall on April 13, 2021 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Food and Drug Regulations (FDR) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance (NOC) under the FDR. Certain provisions of the amendments came into force on March 18, 2021, while others will come into force on … Continue reading