Paul Jorgensen

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Pharmacare Update: Budget 2024

Canada’s federal 2024 budget has set aside $1.5 billion over five years to launch pharmacare, which will introduce national universal drug coverage to Canada. Background As we reported, on February 29, 2024, the federal government tabled Bill C-64, An Act respecting pharmacare (the Pharmacare Act). The Pharmacare Act outlines the first phase of a national … Continue reading

Drug price negotiations: pCPA Temporary Access Process launched

The pan-Canadian Pharmaceutical Alliance (pCPA) has launched its Temporary Access Process (pTAP) to facilitate early market access to new drugs that were assessed under the time-limited reimbursement recommendation (TLR) pathway at the Canada Drug and Health Technology Agency (CADTH). The pCPA has published principles and conditions for the pTAP as well as information on its … Continue reading

National Pharmacare bill tabled

On February 29, 2024, the federal government tabled Bill C-64, An Act respecting pharmacare (the Pharmacare Act). The Pharmacare Act outlines the “foundational principles” for the first phase of a national universal drug coverage plan in Canada. The legislation includes a commitment to first launch diabetes medication and contraceptives coverage for Canadians through a universal, … Continue reading

Health Canada disclosing more information on pending generic drug submissions

On February 23, 2024, Health Canada published a Notice advising that it was making its review process for generic drug submissions more transparent.  Specifically, for generic drug submissions accepted into review on or after April 1, 2024, Health Canada will start disclosing: (i) the year and month that the submission was accepted for review; and … Continue reading

Dormant drug status can trigger generic access to an alternate Canadian Reference Product

On January 26, 2024, Health Canada published a Notice concerning its application of the definition of Canadian Reference Product (CRP) in the Food and Drug Regulations (Regulations). The Notice advises that if an innovative drug is categorized as “Dormant” in Health Canada’s Drug Product Database, then a generic manufacturer can compare its drug against an … Continue reading

Pharma in Brief’s 2023 Year in Review and Trends for 2024

As you start the new year, allow us to recap 2023’s important legal and regulatory developments for Canadian pharma. We also flag what to watch out for in 2024.  The most significant legal development in 2023 was the introduction of a system of patent term adjustment (PTA). On the regulatory front, seemingly all of Canada’s … Continue reading

Florida approved to import Canadian prescription drugs

On January 5, 2024, the US Food and Drug Administration (FDA) approved Florida’s proposal to import prescription drugs from Canada. This is the first approval of a Section 804 Importation Program (SIP) by the FDA. Whether Florida is able to import drugs from Canada, including in light of Canadian regulations controlling drug exports, remains to … Continue reading

New Canadian Drug Agency formed, while National Pharmacare bill is delayed into 2024

The Government of Canada has announced the creation of the Canadian Drug Agency (CDA). According to the government, the CDA “will provide the dedicated leadership and coordination needed to make Canada’s drug system more sustainable and better prepared for the future, helping Canadians achieve better health outcomes.” As we reported, the genesis of the CDA … Continue reading

Federal Court refuses to issue injunction on infringed antibody formulation patent

On December 4, 2023, the Federal Court held that a patent claiming a formulation of adalimumab, a monoclonal antibody used to treat autoimmune diseases, is valid and is being infringed by a biosimilar product. However, the Court refused to issue an injunction removing the infringing product from the Canadian market, finding that it was not … Continue reading

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

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

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

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

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

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

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

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

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

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

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

Health Canada releases updated Certificate of Supplementary Protection guidance

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

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

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

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

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

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

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

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

Pharma in Brief: The 2022 Year in Review

Does 2022 already seem like a blur? The Pharma in Brief team is here for you with a summary of some of 2022’s most significant legal and regulatory developments in the Canadian pharmaceutical space. We also flag what to watch out for in 2023.    The most significant legislative changes concerned the Patent Act and … Continue reading

Health Canada consulting on wide-ranging regulatory amendments for drugs and medical devices

Health Canada has launched a consultation on proposed amendments to the Food and Drug Regulations and Medical Devices Regulations (the Regulatory Amendments). Consultation on the Regulatory Amendments, which have been published in the Canada Gazette, Part 1, is open until March 27, 2023. The Regulatory Amendments build upon the regulatory flexibilities introduced in the Interim … Continue reading

Ontario introduces biosimilar transition policy

On December 20, 2022, the government of Ontario announced a new policy to expand the use of biosimilar drugs in the province. Patients receiving coverage under the Ontario Drug Benefit (ODB) program for eight originator biologic drugs will be required to transition to the biosimilar version by December 29, 2023.  During the transition period from … Continue reading

Federal Court of Appeal upholds decision invalidating claims to multiple sclerosis treatment regimen

The Federal Court of Appeal (FCA) has dismissed appeals concerning two actions brought under the Patented Medicines (Notice of Compliance) Regulations (Regulations), confirming the Federal Court (FC) holding that claims to uses of the molecule fampridine were invalid. The FCA’s decision provides guidance on claims construction and analyzing obviousness, while pointedly refusing to endorse the FC’s … Continue reading
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