Brian R. Daley

Subscribe to all posts by Brian R. Daley

Federal Court extends Suspension Period and expands use of virtual hearings

Photo of Allyson Whyte NowakPhoto of Brian R. DaleyBy Allyson Whyte Nowak and Brian R. Daley on Posted in Intellectual property
On April 29, 2020, the Federal Court (FC) published a Practice Direction and Order (FC Update) extending its Suspension Period until May 29, 2020 and adjourning hearings until June 29, 2020—subject to certain exceptions. During this time, the Court has made provisions to hold certain hearings by phone or Zoom videoconference. The FC Update is … Continue reading

FCA to select cases that are ready to progress during pandemic

Photo of Allyson Whyte NowakPhoto of Brian R. DaleyBy Allyson Whyte Nowak and Brian R. Daley on Posted in Intellectual property
On April 15, 2020, the Federal Court of Appeal (FCA) published an updated Notice to the Parties and the Profession (FCA Update). As we previously reported, the FCA suspended the running of time under the Federal Courts Rules (the Rules) to May 15, 2020 (the Suspension Period). The FCA Update advises that circumstances permit the … Continue reading

Health Canada issues Interim Order to address shortages of health products

Photo of John GreissPhoto of Randy SuttonPhoto of Brian R. DaleyBy John Greiss, Randy Sutton and Brian R. Daley on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
Health Canada has published an Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (the Interim Order). This Interim Order allows Health Canada and the Canadian Food Inspection Agency to address critical supply issues in an expedited manner when shortages occur. It was signed by the Minister … Continue reading

Federal Courts Extend Suspension Period Until May 15

Photo of Allyson Whyte NowakPhoto of Brian R. DaleyBy Allyson Whyte Nowak and Brian R. Daley on Posted in Intellectual property
The Federal Court (FC) and the Federal Court of Appeal (FCA) have announced revised measures to facilitate limited court operations while providing relief to litigants and their counsel during the Covid-19 pandemic. As we reported, both courts introduced a first round of such measures in mid-March. Federal Court On April 4, 2020, the FC issued … Continue reading

Ontario and Quebec Introduce Changes to Pharmacy Practice and Highlight the Drug Supply Chain as an Essential Service

Photo of John GreissPhoto of Randy SuttonPhoto of Brian R. DaleyBy John Greiss, Randy Sutton and Brian R. Daley on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
Changes Affecting Ontario The Government of Ontario has made changes to the Ontario Drug Benefit (ODB) Program in an effort to reduce the risk of drug shortages in the province during the COVID-19 outbreak. Effective immediately, ODB eligible drugs are subject to the following changes to rules on dispensing and fees: The dispensing of medication … Continue reading

Patent owner files its own pleading in a PM(NOC) action

Photo of Daniel DanielePhoto of Brian R. DaleyPhoto of Pharma in Brief teamBy Daniel Daniele, Brian R. Daley and Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
The Federal Court granted leave to the United States of America (USA), in its capacity as co-owner of a patent, to file its own pleading in an action under s 6(1) of the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations). The USA was permitted to respond to the defendant’s (Apotex Inc.) allegations of invalidity, … Continue reading

PMPRB extends consultation on new Draft Guidelines implementing amendments to the Patented Medicines Regulations

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
The Patented Medicine Prices Review aboard (PMPRB) has extended the deadline for written submissions on new Draft Guidelines until January 31, 2020. Originally, the consultation was scheduled to run until January 20, 2020. Background As we reported, the Board proposed Draft Guidelines to replace its existing price-review practices, including the Compendium of Policies, Guidelines and … Continue reading

PMPRB launches 60-day consultation on new Draft Guidelines following amendments to the Patented Medicines Regulations

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
Today, the PMPRB launched a consultation on Draft Guidelines intended to implement recent amendments to the Patented Medicines Regulations. The PMPRB also released a Q&A-style Consultation Backgrounder. Interested parties have 60 days, until January 20, 2020, to make submissions on the Draft Guidelines. Background As we reported, the Government released final amendments to the Patented Medicines … Continue reading

Federal Court of Appeal applies holistic approach to the “palpable and overriding error” standard of review

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 of Appeal has provided a detailed review of the proper approach to identifying palpable and overriding errors of fact or mixed fact and law in an appeal concerning the obviousness of two patents. The Court of Appeal concluded that when viewed as a whole, there was no reviewable error in the judgment … Continue reading

Federal Court relies on foreign prosecution history in first application of file wrapper estoppel

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 CanMar Foods Ltd. v TA Foods Ltd., 2019 FC 1233, the Federal Court interpreted and applied the new file wrapper estoppel provision, section 53.1 of the Patent Act, RSC 1985, c P-4, for the first time. While CanMar is not a life sciences case, the application of Canada’s new file wrapper estoppel provision has implications for patentees generally. In CanMar, … Continue reading

Government releases final amendments to the PMPRB’s Patented Medicines Regulations to lower the prices of patented medicines

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
The Government is moving forward with changes to the PMPRB intended to lower the prices of patented medicines in Canada in order to lay the foundation for National Pharmacare. The changes are set out in final amendments to the Patented Medicines Regulations that were released on Friday, August 9, 2019. The amendments will come into … Continue reading

Federal Court of Appeal agrees that the PMPRB incorrectly applied the patent-pertaining analysis

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 Federal Court of Appeal has provided new guidance on the proper approach to the “patent pertaining” analysis used by the Patented Medicine Prices Review Board (PMPRB or Board), including on the identification of the medicine and the invention of the patent, in a case concerning Differin®. Having provided this guidance, the Court of Appeal set aside the … Continue reading

Competition Bureau publishes Final IP Enforcement Guidelines

Photo of David YiPhoto of Christopher A. GuerreiroPhoto of Brian R. DaleyBy David Yi, Christopher A. Guerreiro and Brian R. Daley on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
On March 13, the Competition Bureau published a revised version of its IP Enforcement Guidelines (IPEGs). The IPEGs clarify the Bureau’s approach to conducting investigations of alleged anti-competitive activities that involve IP, including settlement of pharmaceutical patent litigation under the Patented Medicines (Notice of Compliance) Regulations (Regulations). The revised IPEGs replace the earlier 2016 version. … Continue reading

Federal Court of Appeal upholds Health Canada’s requirement for additional information on testing data integrity

Photo of Brian R. DaleyPhoto of Pharma in Brief teamBy Brian R. Daley and Pharma in Brief team on Posted in Life sciences and healthcare
The Federal Court of Appeal (FCA) has dismissed Apotex’s appeal arising from its application to end Health Canada’s requirement for additional information establishing the integrity of data from Indian drug manufacturing facilities. The FCA found that the Federal Court (FC) properly considered the evidence and that it did not err in finding that the decision … Continue reading

Federal Court upholds patent validity and grants prohibition order against generic lisdexamfetamine in pre-CETA PM(NOC) application

Photo of Brian R. DaleyBy Brian R. Daley on Posted in Uncategorized
The Federal Court dismissed Apotex’s action to invalidate the claims of Canadian Patent No. 2,527,646 (the 646 Patent), which was consolidated with Shire’s application to prohibit the Minister of Health from issuing a Notice of Compliance for Apotex’s generic version of VYVANSE® (lisdexamfetamine). Shire’s counterclaim for infringement in the action was dismissed but the Court … Continue reading

Supreme Court dismisses leave to appeal on damages against Health Canada for Apo-Trazodone

Photo of Sofia Lopez BancalariPhoto of Kristin WallPhoto of Brian R. DaleyBy Sofia Lopez Bancalari, Kristin Wall and Brian R. Daley on Posted in Pharmaceuticals and life sciences
On December 14, 2017, the Supreme Court dismissed Apotex’s application for leave to appeal the decision finding that Health Canada does not owe a duty of care to drug manufacturers in reviewing drug submissions. Case: Apotex Inc v Canada (Minister of Health) (SCC Docket: 37593) Drug: Apo-Trazodone Nature of case: Application for leave to appeal … Continue reading

Federal Court of Appeal Provides Further Guidance on Inventive Concept

Photo of Brian R. DaleyPhoto of Pharma in Brief teamBy Brian R. Daley and Pharma in Brief team on Posted in Intellectual property
The Federal Court of Appeal has provided additional guidance on the framework for analyzing obviousness. In dismissing an appeal from the Federal Court, the Court of Appeal identified the search for an inventive concept as an “unnecessary satellite debate” and held that a more useful approach would be to construe the claims. Case:  CIBA Specialty … Continue reading

Federal Court upholds cancellation of reconsideration of Apotex’s ANDS for Apo-omeprazole

Photo of Brian R. DaleyPhoto of Pharma in Brief teamBy Brian R. Daley and Pharma in Brief team on Posted in Life sciences and healthcare
The Federal Court dismissed Apotex’s application for judicial review of the Minister of Health’s withdrawal of a notice of compliance (NOC) granted to Apotex Inc. for Apo-omeprazole. Health Canada withdrew the NOC because Apotex had not demonstrated bioequivalence. Health Canada also rejected Apotex’s request for reconsideration. The court found Apotex did not have legitimate expectations … Continue reading

Apotex files leave to appeal to SCC on damages against Health Canada for Apo-Trazodone

Photo of Kristin WallPhoto of Brian R. DaleyBy Kristin Wall and Brian R. Daley on Posted in Intellectual property, Pharmaceuticals and life sciences
Apotex filed an application for leave to appeal the decision allowing its claim for damages for misfeasance of public office, negligence and breach of contract against Health Canada based on its review of Apotex’s drug submission for Apo-Trazodone. Apotex has appealed the finding that Health Canada does not owe a duty of care to drug … Continue reading

Federal Court releases new trial management guidelines for actions and discusses impact of proposed regulations

Photo of Brian R. DaleyBy Brian R. Daley on Posted in Intellectual property, Pharmaceuticals and life sciences
On April 28 the Federal Court issued a Notice to the Parties and the Profession containing new guidelines for the trial management of actions. Among other things, they set new deadlines for various pre-trial steps and for the filing of motions, provide guidance regarding the scheduling and agenda of trial management conferences and streamline the … Continue reading

FCA finds no failure to mitigate Apotex damages claim against Health Canada for delayed Apo-Trazodone NOC

Photo of Kristin WallPhoto of Brian R. DaleyBy Kristin Wall and Brian R. Daley on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
Case: Apotex Inc v Her Majesty the Queen, 2017 FCA 73 (Court File No. A-553-14/A-554-14) Drug: Apo-Trazodone Nature of case: Appeal of action for damages in tort and breach of contract Successful party: Apotex Inc. (in part) Date of decision: April 6, 2017 Summary The Federal Court of Appeal allowed Apotex’s appeal, in part, from … Continue reading
LexBlog