Kristin Wall

Firm/Organization: Norton Rose Fulbright

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

Latest Articles

Bill C-4: New CUSMA Implementation Act Introduced

By Caroline Henrie, Christopher A. Guerreiro & Kristin Wall

February 4, 2020

On January 29, 2020, the Government introduced Bill C-4 to implement the Canada-United States-Mexico Agreement (CUSMA). The Bill, sponsored by Deputy Prime Minister Freeland, was read for the first time the same day. As we reported, the previous Government’s CUSMA implementation bill (Bill C-100) died on the Order Paper as it was not passed into law before the federal election in October of 2019. Subsequently, the Intellectual Property Chapter of the CUSMA was amended…

Pharma in Brief

Pharma in Brief: The 2019 Year in Review

By Kristin Wall, Jordana Sanft, Christopher A. Guerreiro & Colin Hyslop

January 19, 2020

In this article, the Pharma in Brief team curated the most significant topics we covered during 2019. The Canadian pharma and life sciences space saw many developments in 2019. These included major policy initiatives and regulatory changes affecting the industry, driven in part by three high-profile federal objectives: lowering drug prices to move towards national pharmacare, replacing the North American Free Trade Agreement (NAFTA), and changes to drug approval pathways. There were few pharmaceutical patent…

Pharma in Brief

Ontario implements regulatory changes to streamline drug formulary listing and reduce government payments to pharmacies

By William Chalmers & Kristin Wall

December 19, 2019

The Ontario Ministry of Health and Long-Term Care (the Ministry) has amended Regulations made under the Ontario Drug Benefit Act (ODBA) and the Ontario Drug Interchangeability and Dispensing Fee Act (DIDFA). The new Regulations are substantially similar to those originally proposed (as we reported). The intended effect of the amendments is to reduce technical requirements for listing a product on the Ontario formulary and align policies with industry standards and other provinces. The amendments…

Pharma in Brief

Amended CUSMA no longer extends data protection for biologics

By Kassandra Shortt, Christopher A. Guerreiro & Kristin Wall

December 11, 2019

On December 10, 2019, Canada, the United States, and Mexico agreed to amend the Canada-United States-Mexico Agreement (CUSMA, also referred to as USMCA) as the trade agreement proceeds toward ratification in each country. Among other changes, the amended CUSMA no longer requires Canada to extend data protection for biologics to 10 years from the 8 years currently provided under Canadian law. Changes to the CUSMA As we reported, the previous version of CUSMA required two…

Pharma in Brief

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

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

December 10, 2019

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 Procedures. The changes are intended to implement the recent amendments to the Patented Medicines Regulations, which come into force…

Pharma in Brief

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…

Kristin Wall

Bill C-4: New CUSMA Implementation Act Introduced

Pharma in Brief: The 2019 Year in Review

Ontario implements regulatory changes to streamline drug formulary listing and reduce government payments to pharmacies

Amended CUSMA no longer extends data protection for biologics

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

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

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