Topic: Life sciences and healthcare

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

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 … Continue reading

Competition Bureau issues statement regarding off-label use of vaccines

The Competition Bureau (Bureau) recently conducted a preliminary investigation into possible competition concerns arising from a proposal to include a clause in a procurement contract that would restrict off-label use of a vaccine.  The Bureau concluded that there was no abuse of dominance as the provision was not included in the procurement contract; however, it … Continue reading

Health Canada consulting on clinical trial requirements and “new class” of advanced therapeutic products

As we reported, the Budget Implementation Act, 2019 (BIA) paved the way for changes to the regulation of clinical trials and created a new class of “advanced therapeutic products” (ATPs) regulated by Health Canada. Health Canada is consulting on what it should consider in developing regulations for clinical trials and implementing the approval pathway for … Continue reading

Health Canada consulting on draft guidance distinguishing promotional and non-promotional activities for health products

Health Canada is consulting on a draft guidance document entitled The Distinction Between Promotional and Non-promotional Messages and Activities for Health Products (Draft Guidance), which is intended to replace the current 1996 policy entitled The Distinction Between Advertising and Other Activities (Current Policy). Copies of the Draft Guidance are available from Health Canada on request; … Continue reading

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

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 … Continue reading

Patent Act Infringement Actions Cannot be Joined to PM(NOC) Infringement Actions During NOC Prohibition Period

The Federal Court recently confirmed that an infringement action under the Patent Act cannot be joined with an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations) while the Regulations prohibit the Minister from granting a NOC. The Court stated that an infringement action under the Patent Act could instead be brought in … Continue reading

Health Canada proposes updates relating to sale of unapproved drugs for emergency treatment

Amendments have been proposed to the Food and Drug Regulations that relate to the sale of drugs that have not been approved in Canada for emergency treatment. These amendments update the Special Access Program (SAP) and create a mechanism whereby drugs can be purchased for immediate use or stockpiled for public health or Canadian Armed … Continue reading

CUSMA Implementation Bill Introduced

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 … Continue reading

Quebec Court of Appeal confirms CPA does not apply to the sale of prescription drugs

In a May 8 decision, the Quebec Court of Appeal confirmed that the Quebec Consumer Protection Act (CPA) does not apply to the sale of prescription drugs. The decision, Brousseau v Laboratoires Abbott limitée, 2019 QCCA 801 provides critical guidance on the liability regime in Quebec for manufacturers of pharmaceutical products facing product liability claims. … Continue reading

Federal Court of Appeal affirms cancellation of reconsideration of ANDS for Apo-omeprazole

The Federal Court of Appeal has dismissed an appeal by Apotex Inc. (Apotex) in its unsuccessful application for judicial review of a decision by the Minister of Health (the Minister) to cancel the reconsideration of approval for Apo-omeprazole. Background As we reported, the Minister revoked Apotex’s Notice of Compliance (NOC) for Apo-omeprazole and declined to … Continue reading

Proposed amendments to Food and Drugs Act introduced in omnibus budget bill

The federal government has proposed changes to the Food and Drugs Act (FDA) that would allow the Minister of Health (Minister) to classify products as foods, drugs, cosmetics, devices, or “advanced therapeutic products”; require authorizations to conduct clinical trials; and modify Health Canada’s inspection powers. These changes are included in an omnibus budget bill, the … Continue reading

Regulatory changes for generics proposed to clarify ANDS pathway eligibility

On March 30, 2019, the government published proposed amendments to the Food and Drug Regulations (FDR) intended to clarify whether a generic version of a drug can be approved using the abbreviated new drug submission (ANDS) pathway. These amendments affect how the FDR apply to a generic drug product if it contains a different medicinal … Continue reading

Federal Court grants application under the old PM(NOC) Regulations for a prohibition order regarding a metformin formulation

On March 8, 2019, the Federal Court issued a prohibition order against a generic version of GLUMETZA® (metformin hydrochloride extended-release tablets) proposed by Generic Partners Canada Inc. (Generic Partners) in an application under the pre-CETA Patented Medicines (Notice of Compliance) Regulations. GLUMETZA® is marketed in Canada by Valeant Canada LP/Valeant Canada SEC (Valeant), which asserted … Continue reading

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

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 … Continue reading

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

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 … Continue reading

Competition Bureau publishes Final IP Enforcement Guidelines

On March 13, the Competition Bureau published a revised version of its IP Enforcement Guidelines (IPEGs). The IPEGs clarify the Bureau’s approach to conducting investigations of alleged anti-competitive activities that involve IP, including settlement of pharmaceutical patent litigation under the Patented Medicines (Notice of Compliance) Regulations (Regulations). The revised IPEGs replace the earlier 2016 version. … Continue reading

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

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 … Continue reading

Ontario Introduces Legislation to Change Healthcare Administration

This week the Ontario government announced legislation that will overhaul the administration of healthcare delivery in Ontario. Bill 74 was introduced in the Ontario Legislature on February 26, 2019, and passed first reading.  The bill creates the Connecting Care Act (the “Act”). The province’s 14 existing Local Health Integration Networks (LHINs) and six other agencies … Continue reading

Health Canada rejects product-specific suffixes for biosimilars in favour of unique brand names

Health Canada has decided that all biologic drugs, including biosimilars, will be identified by both their unique brand name and non-proprietary (common) name — without the addition of a product-specific suffix. The ability to distinguish between biologics with the same non-proprietary name is important for pharmacovigilance and to minimize inadvertent substitution of drugs that have … Continue reading

FCA Confirms Entirety of Inventors’ Conduct is Relevant in Obviousness Analysis and Upholds Inventiveness of Crystal Form Patent

The Federal Court of Appeal (“FCA”) upheld the validity of Canadian Patent 2,436,668 (“668 Patent”) which covers Form I ODV succinate (marketed as PRISTIQ) in two separate appeals by Apotex Inc. (“Apotex”) and Teva Canada Ltd (“Teva”), finding that the claims were novel and inventive. Obviousness The FCA began be reiterating key points of the … Continue reading

Quebec Court of Appeal overturns minister’s decision to remove Remicade from Quebec’s List of Medications

The Quebec Court of Appeal has declared a decision by the Minister of Health and Social Services to “delist” Remicade from Quebec’s List of Medications (Quebec’s equivalent to a formulary) to be invalid and has ordered the minister to reinstate the drug on the list. Two takeaways from this decision: the minister’s decisions to list … Continue reading

Top Headlines of 2018

Last year ushered in a number of changes to the Canadian pharmaceutical and life sciences sector. 2018 also served as a year to explore the impacts of major intellectual property decisions and regulatory changes from 2017 including the impact of the Supreme Court’s decision in NEXIUM striking down the Promise Doctrine and the implementation of … Continue reading

FCA Confirms that Non-Infringing Alternative Must be Legal and Objectively Economically Viable

The Federal Court of Appeal (“FCA”) confirmed that in assessing the availability of a non-infringing alternative (“NIA”) defence, the NIA must be legal and cannot infringe any patent, and its economic viability must be considered objectively. The FCA upheld an award for damages for patent infringement by the Federal Court (“FC”) but remitted the issue … Continue reading

Bill C-86 receives Royal Assent, bringing amendments across Canada’s IP statutes

Canada’s core IP statutes have been amended by Bill C-86, which received Royal Assent as the Budget Implementation Act, 2018, No. 2, SC 2018, c 27 on December 14, 2018. The final version of the legislation includes amendments to the Patent Act that are substantially identical to the version that received first reading 46 days … Continue reading
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