Kristin Wall

Firm/Organization: Norton Rose Fulbright

Blogs: Health Law Pulse, Pharma in Brief, The Brand Protection Blog

Latest Articles

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

By Christopher A. Guerreiro, Kristin Wall & Brian R. Daley

November 21, 2019

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 Regulations on August 9, 2019. These amendments are scheduled to come into force on July 1, 2020…

Pharma in Brief

Apotex held to induce infringement in one of the last applications under the old PM(NOC) Regulations

By Sarah Pennington & Kristin Wall

November 17, 2019

The Federal Court has granted an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. for a generic version of ZYTIGA (abiraterone acetate). It held that the use of the combination of abiraterone acetate and prednisone claimed by Janssen Inc.’s patent was patentable subject matter, and that the patent’s claims were non-obvious and possessed at least a scintilla of demonstrated utility. The Court also held that Apotex would induce…

Pharma in Brief

Ontario consults on changes to streamline drug formulary listing and reduce government payments to pharmacies

By William Chalmers & Kristin Wall

November 10, 2019

The Ontario Ministry of Health and Long-Term Care (the Ministry) has proposed draft amendments to Regulations made under the Ontario Drug Benefit Act (ODBA) and the Ontario Drug Interchangeability and Dispensing Fee Act. The proposed changes are intended to reduce technical requirements for listing a product on the Ontario formulary and align policies with industry standards and other provinces. The consultation period will close on November 27, 2019. The proposed changes Key changes to the…

Pharma in Brief

Federal Court refuses to permit reply evidence on validity issues in action under the PM(NOC) Regulations

By Colin Hyslop, Christopher A. Guerreiro & Kristin Wall

November 7, 2019

On a motion for leave to file reply expert reports, the Federal Court has reinforced the rule against case splitting and outlined the circumstances under which reply expert reports are permissible under the Federal Courts Rules. The Court concluded that none of the proposed reply reports put forward by Teva Canada Limited (Teva) in respect of patent validity issues were proper and dismissed the motion. Background This motion arose in the context of an…

Pharma in Brief

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

By Christopher A. Guerreiro, Kristin Wall & Brian R. Daley

August 13, 2019

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 force on July 1, 2020. Once the amendments come into force, the PMPRB will use a different basket of price…

Pharma in Brief

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

By Christopher A. Guerreiro, Brian R. Daley & Kristin Wall

July 9, 2019

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 judgment under appeal and remanded the final determination of whether or not the patent in question pertains to Differin® to the Board.…

Pharma in Brief

CUSMA Implementation Bill Introduced

By Kassandra Shortt, Christopher A. Guerreiro & Kristin Wall

June 4, 2019

On May 29, 2019, the federal government introduced Bill C‑100 to implement the new trilateral trade deal known as the Canada-United States-Mexico Agreement (CUSMA, also referred to as USMCA), making Canada the first of the three member countries to introduce legislation that would ratify the treaty. CUSMA provides more protections for biologic and innovative pharmaceuticals under Canadian law. However, the treaty does not require the immediate adoption of these new protections and none of them…

Pharma in Brief

Health Canada publishes new amendments to the Food and Drug Regulations and Medical Devices Regulations allowing for public release of clinical information in regulatory submissions

By Morgan Westgate, Daniel Daniele & Kristin Wall

March 25, 2019

On March 20, 2019, new amendments to both the Food and Drug Regulations (the Regulations) and the Medical Devices Regulations regarding the disclosure of clinical data were published in the Canada Gazette. These changes follow from the May 2017 release of Health Canada’s white paper – Public Release of Clinical Information in Drug Submissions and Medical Device Applications (which we have previously reported on here and here), and confirm Health Canada’s decision to…

Pharma in Brief

Budget 2019: Federal government announces intention to implement recommendations on national pharmacare

By Christopher A. Guerreiro, Kristin Wall & Pharma in Brief team

March 20, 2019

As we reported the Advisory Council on the Implementation of National Pharmacare recently released an interim report calling for the creation of a national drug agency. Yesterday, the federal government announced funding to implement this recommendation. Specifically, the government intends to work with partners to implement the following: Create the Canadian Drug Agency — to provide a coordinated approach on prescription drugs. Budget 2019 proposes to provide Health Canada with $35 million over four years,…

Pharma in Brief

Interim Report on Implementation of National Pharmacare calls for creation of a National Drug Agency

By Kristin Wall

March 11, 2019

The Advisory Council on the Implementation of National Pharmacare (“Council”) presented an interim report following consultation with Canadians. The report outlines work done to date by the Council, core principles the Council believes should underpin national pharmacare, and initial foundational recommendations. As we reported, the Council consulted with Canadians on the implementation of a national program to fund prescription drugs. The Council engaged with patients and caregivers, healthcare providers, representatives of Indigenous organizations, government…

Kristin Wall

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

Apotex held to induce infringement in one of the last applications under the old PM(NOC) Regulations

Ontario consults on changes to streamline drug formulary listing and reduce government payments to pharmacies

Federal Court refuses to permit reply evidence on validity issues in action under the PM(NOC) Regulations

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

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

CUSMA Implementation Bill Introduced

Health Canada publishes new amendments to the Food and Drug Regulations and Medical Devices Regulations allowing for public release of clinical information in regulatory submissions

Budget 2019: Federal government announces intention to implement recommendations on national pharmacare

Interim Report on Implementation of National Pharmacare calls for creation of a National Drug Agency

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