Topic: Intellectual property

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Drug pricing: PMPRB releases “What We Learned” Report on guidelines consultation

The Patented Medicine Prices Review Board (PMPRB or Board) has released a “What We Learned” Report (the Report), marking the next step along the path to new Guidelines. The Report was prepared by Phoenix Strategic Perspectives Inc., which was commissioned to facilitate consultation with stakeholders and report on the presentations and discussions. Overview As we … Continue reading

Federal Court finds trademark confusion between the names of two approved biologics

The Federal Court (FC) has found the brand name of a biologic drug to be confusingly similar to the brand name of a drug used to treat the same disorder, but with a different active ingredient. The application of the ordinary test for trademark confusion was not affected by the fact that the names of … Continue reading

Federal Court of Appeal clarifies scope of implied licence on sale of patented medicine

The Federal Court of Appeal (FCA) has held that the sale of a single dose of a patented multi-dose regimen does not provide an implied license to use the entire patented dosing regimen. As a result, it is possible to infringe a dosing regimen patent by combining a first dose sourced from the patentee with … Continue reading

Federal Court of Appeal Decides Case Splitting through NOAs is an Abuse of Process

The Federal Court of Appeal (FCA) held that it is abuse of process for a generic or biosimilar manufacturer to split its case across multiple notices of allegation (NOAs) under the Patented Medicines (Notice of Compliance) Regulations (Regulations). Reversing the Federal Court (FC), the FCA found that the generic or biosimilar manufacturer should raise all … Continue reading

Federal Court upholds PMPRB jurisdiction based on “clinical similarities”

The Federal Court (FC) has refused to overturn a decision of the Patented Medicine Prices Review Board (PMPRB or Board) that found that a patent can pertain to a medicine based on “clinical similarities” to the invention—even if the patent does not actually encompass the medicine. The FC concluded that the Board’s decision was reasonable. Background This case … 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

Federal Court Notice on Use of Artificial Intelligence in Court Proceedings

On December 20, 2023, the Federal Court (Court) published a notice on the use of artificial intelligence (AI) in proceedings (Notice) and interim principles and guidelines on the Court’s own use of AI (Policy). Notice mandates AI Declaration from litigants Declaration requirement. The Court now expects parties to proceedings before the Court to inform it, … 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

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

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

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

Canada increases patent office fees for 2024

Beginning January 1, 2024, the Canadian Intellectual Property Office (CIPO) will implement the first substantial increases to its service fees since 2004. Many fees will increase by 25% of more, though some “low materiality fees” will remain capped at $150. Meanwhile, an increase to the employee cap for “small entity” status will increase the number … Continue reading

Patent term adjustment: Canada consults on proposed regulatory framework

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

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

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

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

The Ontario Superior Court dismisses a generic manufacturer’s claim for damages under section 8 of the PM(NOC) Regulations

The Ontario Superior Court (ONSC) has dismissed a claim for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations (the Regulations) brought by Apotex Inc. (Apotex) for lost sales of its Apo-Atomoxetine product. The Court conducted a purposive interpretation of the Regulations and found that Apotex did not meet the statutory requirements … Continue reading

Supreme Court denies leave to appeal in generic Statute of Monopolies case

On April 27, 2023, the Supreme Court of Canada dismissed an application by Apotex Inc. and Apotex Pharmachem Inc. (Apotex) for leave to appeal from a decision of the Ontario Court of Appeal (ONCA), dismissing its claim for damages in the Ontario courts under the Statutes of Monopolies and other novel causes of action. In the Courts below, Apotex … 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

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

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

Federal Court launches IP Chamber pilot project

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

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

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

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

Federal Court of Appeal overturns judicial review decision in data protection dispute

The Federal Court of Appeal (FCA) has overturned a decision of the Federal Court (FC) that found the Minister of Health’s (Minister) analysis of the data protection provisions of the Food and Drug Regulations unreasonable. The FCA restored the Minister’s decision granting an NOC to Médunik Canada (Médunik) for its amifampridine product, RUZURGI. Background Catalyst … Continue reading
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