Brian R. Daley

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Thirty years of the Patented Medicines (Notice of Compliance) Regulations

Photo of Gunars GaikisPhoto of Orestes PasparakisPhoto of Brian R. DaleyPhoto of Allyson Whyte NowakPhoto of Kristin WallBy Gunars Gaikis, Orestes Pasparakis, Brian R. Daley, Allyson Whyte Nowak and Kristin Wall on Posted in Intellectual property, Life sciences and healthcare
This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations (Regulations), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators.  Since their genesis, the Regulations have been the focal point of most of the pharmaceutical patent litigation … Continue reading

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

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

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

Photo of Brian R. DaleyBy Brian R. Daley on 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

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

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

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

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

Photo of Brian R. DaleyPhoto of Pharma in Brief teamBy Brian R. Daley and Pharma in Brief team on 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

Federal Court of Appeal Gradually Phases Out Suspension Period

Photo of Allyson Whyte NowakPhoto of Kristin WallPhoto of Brian R. DaleyBy Allyson Whyte Nowak, Kristin Wall and Brian R. Daley on Posted in Intellectual property
The Federal Court of Appeal (FCA) has begun to gradually restore filing deadlines in appeals before the Court that were subject to the Court’s Suspension Period. Under the Suspension Period system, the progress of individual appeals has been managed by “selecting” and “deselecting” them from a Selected Files list. As we previously reported, the FCA … Continue reading

Federal Court of Appeal Restores Suspension Period

Photo of Allyson Whyte NowakPhoto of Kristin WallPhoto of Brian R. DaleyBy Allyson Whyte Nowak, Kristin Wall and Brian R. Daley on Posted in Uncategorized
On April 21, 2021, the Federal Court of Appeal (FCA) announced that it will restore the Suspension Period by default for all new matters and begin reinstating the Suspension Period on existing matters by removing them from its Selected Files List. Selected Files As previously reported in June 2020 (June 2020 Update), the FCA began … 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

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

Federal Court updates guidance on COVID-19

Photo of Caroline HenriePhoto of Brian R. DaleyBy Caroline Henrie and Brian R. Daley on Posted in Intellectual property
On January 18, 2021, the Federal Court (FC) issued its latest COVID-19 Practice Direction, which supersedes all its prior COVID-19 practice directions. The FC’s facilities in Ontario and Quebec have been closed in light of the recent public health measures to combat the pandemic. The FC will continue its operations remotely in these two provinces … 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

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

Federal Courts update guidance on COVID-19

Photo of Allyson Whyte NowakPhoto of Brian R. DaleyBy Allyson Whyte Nowak and Brian R. Daley on Posted in Uncategorized
The Federal Court of Appeal (FCA) provided updated guidance for resuming hearings starting September 1, 2020 and clarified the effect of the federal Time Limits and Other Periods Act (COVID-19) on timelines for commencing and conducting litigation in the FCA. Both the FCA and the Federal Court confirmed that all Practice Directions, judgments, orders and … Continue reading

Federal Courts begin to phase out the Suspension Period

Photo of Allyson Whyte NowakPhoto of Brian R. DaleyBy Allyson Whyte Nowak and Brian R. Daley on Posted in Uncategorized
On June 11, 2020 the Federal Court (FC) and Federal Court of Appeal (FCA) published updated notices to gradually phase out the Suspension Period, which had previously been extended to June 15, 2020. Federal Court The FC’s June 11, 2020 Practice Direction and Order (Updated Order), amends its previous Practice Directions, which, subject to the … Continue reading

PMPRB launches consultation on revised Draft Guidelines

Photo of Christopher A. GuerreiroPhoto of Kristin WallPhoto of Brian R. DaleyBy Christopher A. Guerreiro, Kristin Wall and Brian R. Daley on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
On June 19, 2020, the Patented Medicine Prices Review Board (PMPRB) launched its consultation on revised Draft Guidelines to implement the amended Patented Medicines Regulations. The revised Guidelines outline new price tests for existing and new patented medicines, as well as a revised risk-based system for reporting and investigations. They will be available for public … Continue reading

Federal Court supports virtual trials for intellectual property actions

Photo of Brian R. DaleyPhoto of Pharma in Brief teamBy Brian R. Daley and Pharma in Brief team on Posted in Intellectual property, Pharmaceuticals and life sciences
The Federal Court of Canada has embraced virtual hearings as the best solution to the prolonged Covid-19 shutdown. While acknowledging some litigants’ concerns pertaining to procedural fairness and information security in recent rulings, the Court is more concerned that justice delayed can become justice denied. Videoconferencing will not impede the Court’s ability to assess the … Continue reading

Dosing regimen patent found valid and infringed in the second decision under the new PM(NOC) Regulations

Photo of Brian R. DaleyBy Brian R. Daley on Posted in Intellectual property, Pharmaceuticals and life sciences
In the second trial judgment under the new Patented Medicine (Notice of Compliance) Regulations, the Federal Court (FC) found for the Plaintiffs, Janssen Inc. and Janssen Pharmaceutica N.V., and enjoined Teva Canada Limited (Teva) from making, constructing, using or selling paliperidone palmitate (paliperidone) in accordance with its abbreviated new drug submission. The Court rejected Teva’s … Continue reading
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