Kristin Wall

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

By Gunars Gaikis, Orestes Pasparakis, Brian R. Daley, Allyson Whyte Nowak and Kristin Wall on December 3, 2023 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

What is a natural health product? Health Canada’s findings upheld by Federal Courts

By Paul Jorgensen and Kristin Wall on November 20, 2023 Posted in Life sciences and healthcare

In recent months, the Federal Courts have twice upheld Health Canada’s findings as to what is, and is not, a natural health product. The Courts’ decisions provide insight into how natural health products are distinguished, under federal law, from cosmetics and from drugs subject to the Food and Drug Regulations. These distinctions are important as … Continue reading

Drug pricing: PMPRB releases scoping paper to consult on new Guidelines

By Christopher A. Guerreiro and Kristin Wall on November 12, 2023 Posted in Pharmaceuticals and life sciences

The Patented Medicine Prices Review Board (PMPRB) has released a scoping paper on themes and questions to develop new price review Guidelines. The scoping paper also includes information on how stakeholders can participate in the consultation. The deadline for written submissions addressing the scoping paper is December 20, 2023. Background The PMPRB has not had a … Continue reading

Ontario proposes removing barrier to listing “well-established drugs” on its public formulary

By Julia Won, Paul Jorgensen and Kristin Wall on November 5, 2023 Posted in Pharmaceuticals and life sciences

On October 19, 2023, the Ontario government proposed regulatory amendments that may eliminate the need to submit certain clinical studies and evidence when requesting that a “well-established drug” be (i) listed or (ii) designated as interchangeable on Ontario’s publicly-funded formulary. The government is seeking feedback on the proposed amendments. Background A manufacturer can apply to … Continue reading

Drug pricing: PMPRB announces framework for new guidelines consultation

By Christopher A. Guerreiro and Kristin Wall on October 26, 2023 Posted in Pharmaceuticals and life sciences

The Patented Medicine Prices Review Board (PMPRB) has announced a framework for the launch of its consultation on new guidelines, beginning with a scoping paper to be published in advance of Policy Roundtable sessions to be held December 5 (English) and December 6 (French), 2023. The PMPRB has not had a full set of guidelines … Continue reading

Drug reimbursement: CADTH publishes procedures on time-limited reimbursement

By Sarah Pennington, Christopher A. Guerreiro and Kristin Wall on October 24, 2023 Posted in Pharmaceuticals and life sciences

Canada’s Drug and Health Technology Agency (CADTH) has published its procedures for a new time-limited reimbursement recommendation category. This recommendation category is intended to help provide earlier access to new therapies for severe, rare, or debilitating conditions where there is an unmet medical need. The pathway includes mechanisms to revisit the clinical and economic evidence … Continue reading

Federal Court: Transferring drug submission does not require re-serving Notice of Allegation

By Pardeep Heir, Paul Jorgensen and Kristin Wall on October 22, 2023 Posted in Pharmaceuticals and life sciences

The Federal Court has upheld a decision of the Minister of Health (Minister) that the new owner of a biosimilar new drug submission (NDS) could adopt the notice of allegation (NOA) served by its predecessor. Consequently, the new owner was properly added as a defendant to an on-going action under subsection 6(1) of the Patented … Continue reading

Drug pricing: PMPRB finalizes Interim Guidance amendments

By Christopher A. Guerreiro and Kristin Wall on September 28, 2023 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

The Patented Medicine Prices Review Board (PMPRB) has amended its Interim Guidance to address prices of “New Medicines”, implementing a review threshold based on “below the median” of the PMPRB11 countries (Median International Price, MIP). “New Medicines” are defined as patented medicines that did not receive a PMPRB ceiling price as of July 1, 2022. … Continue reading

Guidance on inventor discovery and “invention story” evidence in Canadian patent actions: Federal Court rules in favour of patentee

By Pardeep Heir, Paul Jorgensen and Kristin Wall on September 19, 2023 Posted in Intellectual property

In three recent decisions, released in July and August, the Federal Court addressed questions concerning inventors and the “invention story” during Canadian patent litigation. The Court found that: (i) a patentee has no duty to facilitate inventor discovery; (ii) patentee’s counsel can object to questions during an inventor examination; and (iii) a patent challenger must … Continue reading

Federal Court finds that Health Canada breached procedural fairness by relying on an undisclosed internal guidance document

By John Greiss, Paul Jorgensen and Kristin Wall on September 5, 2023 Posted in Life sciences and healthcare

On August 8, 2023, the Federal Court overturned Health Canada’s decision that a cannabis product, Edison Jolts, was to be classified as edible cannabis and not cannabis extract. The Court found that Health Canada had breached the duty of procedural fairness by relying on a product classification factor in an internal guidance document that Health … Continue reading

Patent term adjustment: Canada consults on proposed regulatory framework

By William Chalmers, Christopher A. Guerreiro, Anna Wilkinson and Kristin Wall on August 7, 2023 Posted in Intellectual property

On August 7, 2023, the Canadian Intellectual Property Office (CIPO) launched a consultation on proposed features of regulations on patent term adjustment (PTA) in Canada (the Consultation). The PTA system is intended to compensate patentees for “unreasonable delays” by CIPO in issuing a patent. The Consultation seeks feedback on proposals that would impact the length of … Continue reading

Drug advertising: Updated guidance from Health Canada on the distinction between advertising and other activities for health products

By Sarah Pennington, John Greiss and Kristin Wall on August 3, 2023 Posted in Pharmaceuticals and life sciences

On July 31, 2023, Health Canada published its updated Guidance on distinction between advertising and other activities for health products (the Distinction Guidance). The Distinction Guidance outlines the factors that contribute to rendering a message or activity promotional in nature. Promotional messages and activities are subject to the advertising provisions of the Food and Drugs … Continue reading

Drug price negotiations: pCPA consulting on a Temporary Access Process (pTAP)

By Sarah Pennington and Kristin Wall on July 19, 2023 Posted in Pharmaceuticals and life sciences

The pan-Canadian Pharmaceutical Alliance (pCPA) has recently published a set of principles and conditions for a pCPA Temporary Access Process (pTAP) which will inform the negotiation process and potential product listing agreements (PLAs) for drug products following the Canada Drug and Health Technology Agency (CADTH) time-limited recommendation pathway. CADTH Time-Limited Reimbursement Recommendations Starting in the … Continue reading

Canada implements patent term adjustment as Bill C-47 becomes law

By Kristin Wall, Anna Wilkinson and Paul Jorgensen on June 26, 2023 Posted in Intellectual property, Pharmaceuticals and life sciences

On June 22, 2023, Canada’s federal government passed legislation (Bill C-47) introducing a system of general patent term adjustment (PTA). The provisions amending the Patent Act to introduce PTA passed without substantive amendment and are scheduled to come into force no later than January 1, 2025. Canada’s new PTA system is intended to compensate patentees … Continue reading

PMPRB Update: Consultation on Amendment to the Interim Guidance re New Medicines

By Christopher A. Guerreiro and Kristin Wall on June 20, 2023 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Patented Medicine Prices Review Board (PMPRB) has launched a 60-day consultation on proposed changes to the price-review process set out in its Interim Guidance of August 18, 2022 (Interim Guidance). The proposed changes would affect products classified as “New Medicines” with list prices that are below the median of prices in the basket of … Continue reading

Health Canada releases updated Certificate of Supplementary Protection guidance

By Sarah Pennington, Paul Jorgensen and Kristin Wall on May 29, 2023 Posted in Pharmaceuticals and life sciences

On May 12, 2023, Health Canada announced the release of an updated version of the Guidance Document: Certificates of Supplementary Protection (CSP Guidance). The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations (CSP Regulations) and to reflect changes to Health Canada’s administrative … Continue reading

PMPRB Update: Federal Standing Committee on Health begins review of the Board

By Christopher A. Guerreiro and Kristin Wall on May 2, 2023 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

The Standing Committee on Health (HESA) has begun a study on the Patented Medicine Prices Review Board (PMPRB). HESA is made up of 12 Members of Parliament representing the four main parties in the House of Commons. In connection with this study, HESA has conducted two meetings to ask questions of witnesses regarding the PMPRB: The events … Continue reading

Bill C-47 introduces patent term adjustment: Proposed term to run concurrently with term of Certificate of Supplementary Protection

By Kristin Wall, Anna Wilkinson and Paul Jorgensen on May 1, 2023 Posted in Intellectual property, Pharmaceuticals and life sciences

On April 20, 2023, the federal government tabled legislation (Bill C-47) that would amend the Patent Act to bring, for the first time, a system of general patent term adjustment (PTA) into Canada. Canada is required under the Canada-United States-Mexico Agreement (CUSMA) to adopt a PTA system by 2025. The PTA system is intended to … Continue reading

U.S. Trade Representative cites Canada’s “IP problems” including pharmaceutical patent protection

By Paul Jorgensen and Kristin Wall on April 27, 2023 Posted in Intellectual property, Pharmaceuticals and life sciences

On April 26, 2023, the Office of the United States Trade Representative (USTR) released its 2023 Special 301 Report on intellectual property. The report keeps Canada on a Watch List of 29 U.S. trading partners that “merit bilateral attention to address underlying IP problems”. The report is the USTR’s annual review of the global state of … Continue reading

Federal Court of Appeal rejects elevated standard of proof for induced infringement in paliperidone case

By Christopher A. Guerreiro, Kristin Wall and Pharma in Brief team on April 21, 2023 Posted in Intellectual property, Pharmaceuticals and life sciences

The Federal Court of Appeal (FCA) has allowed an appeal concerning induced infringement in an action under the Patented Medicines (Notice of Compliance) Regulations (Regulations). The FCA found that the Federal Court (FC) had erred by applying an elevated causation requirement. The FCA also rejected an appeal by the generic from the finding that the patent was … Continue reading

Canada announces its first-ever national strategy for drugs for rare diseases

By Sarah Pennington, Paul Jorgensen and Kristin Wall on March 27, 2023 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

On March 22, 2023, Canada’s federal government announced its first-ever National Strategy for Drugs for Rare Diseases, including an investment of up to $1.5 billion over three years to help increase drug access and affordability. Investments made as part of the National Strategy The lion’s share of the federal government’s investment – up to $1.4 … Continue reading

Federal Court launches IP Chamber pilot project

By Christopher A. Guerreiro and Kristin Wall on March 6, 2023 Posted in Intellectual property

The Federal Court has created a new, specialized Chamber of judges to be used for assigning intellectual property and competition law hearings. The Chamber formalizes the Court’s existing practice of endeavouring to assign judges with relevant IP expertise to preside over IP matters. It is intended to increase transparency and provide greater certainty regarding the … Continue reading

Higher costs awards coming to the Federal Court, including for pharma regulatory and IP disputes

By Chelsea Nimmo, Paul Jorgensen and Kristin Wall on February 26, 2023 Posted in Damages, Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

Higher costs awards for Federal Court litigation are on the horizon, with the Canadian government consulting on proposed amendments to the costs structure in the Federal Courts Rules (the Rules). The proposed amendments are intended to increase costs awards by approximately 25%. The current costs regime Under the Rules, the Federal Courts can fix a … Continue reading

PMPRB Update: New Chairperson Appointed

By Christopher A. Guerreiro and Kristin Wall on February 8, 2023 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Governor in Council has appointed Thomas J. Digby as the new Chairperson of the Patented Medicine Prices Review Board (PMPRB). According to the Government’s news release, “Mr. Digby is a lawyer with expertise in intellectual property and has an extensive educational background in the Biological Sciences” and has been appointed for a term of five … Continue reading