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Top 10 patent and regulatory things you need to know when bringing a biopharma product to Canada

Canada is an attractive market for pharmaceutical manufacturers. While universal healthcare does not currently extend to drugs in an outpatient setting, most Canadian consumers have some form of drug coverage through...more

New PMPRB Guidelines will not be implemented January 1, 2023

The Patented Medicine Prices Review Board (PMPRB) has advised that the new Guidelines will not be implemented on January 1, 2023, and that the Interim Guidance issued by the Board on August 18, 2022 will remain in place until...more

Federal Court of Appeal dismisses appeal challenging amended basket of comparator countries in PMPRB Regulations

On December 5, 2022, the Federal Court of Appeal (FCA) dismissed Innovative Medicines Canada (IMC) and sixteen innovative pharmaceutical companies’ appeal regarding the validity of the amended basket of comparator countries...more

Draft revised PMPRB Guidelines released for comment by December 5, 2022

On October 6, 2022, the Patented Medicine Prices Review Board (PMPRB) released its revised draft Guidelines to give effect to the July 1, 2022 amendments to the Patented Medicines Regulations. Submissions are due by December...more

Patented medicines pricing – “status quo” during the interim period

The amended PMPRB regulations came into force on July 1, 2022, and at that time an interim approach to pricing was proposed. The interim approach proposed a “status quo” to pricing until Guidelines could be established...more

New PMPRB regulations registered, in force July 1, 2022, interim approach to pricing announced

As previously announced, the amended Patented Medicines Regulations will be coming into force on July 1, 2022 in substantially revised form. As we previously reported, the new basket of countries for Patented Medicine Prices...more

Slam dunk! New basket of countries for PMPRB reporting remain, controversial amendments to Patented Medicines Regulations dropped

On April 14, 2022, the Minister of Health announced that the amendments to the Patented Medicines Regulations (the “Regulations”), originally released on August 18, 2019, would come into force on July 1, 2022 in a...more

Confidential rebate reporting and new price regulatory factors of the amended Patented Medicines Regulations declared invalid by...

On February 18, 2022, the Court of Appeal of Quebec released its decision in Merck Canada Inc c Procureur général du Canada (2022 QCCA 240). This is the appeal of the Quebec Superior Court decision declaring price and revenue...more

PMPRB update: New regulations now coming into force July 1, 2022

The coming into force date of the amended Patented Medicines Regulations governing the Patented Medicine Prices Review Board (PMPRB) has been deferred for the fourth time, now until July 1, 2022. The news was announced on...more

PMPRB Update — Ringing in the New Year with New Regulations In-Force?

Update: The coming into force date of the amended Patented Medicines Regulations governing the Patented Medicine Prices Review Board (PMPRB) has been deferred, once again, until July 1, 2022. Read more on the statement from...more

Federal Court of Appeal finds Minister of Health’s refusal to grant a CSP for SHINGRIX is reasonable

In the first appellate decision relating to Certificates of Supplementary Protection (CSPs), the Federal Court of Appeal has allowed the appeal of the Minister of Health (the Minister), setting aside the lower court...more

Amendments to PMPRB Regulations will now be in force July 1, 2021

Update: See our January 26, 2021 article, which links to the Canada Gazette copy of the further amendments and discusses proposed consequential modifications to the Guidelines definition of “gap medicine” and compliance...more

Quebec Court finds price and revenue calculation provisions of amended PMPRB Regulations unconstitutional

Update: The decision has been appealed. On December 18, 2020, the Quebec Superior Court issued its decision from a constitutional challenge to the Patented Medicine Prices Review Board (PMPRB) provisions of the Patent Act...more

Few significant changes made in final PMPRB Guidelines

Update: On November 23, Innovative Medicines Canada and a number of pharmaceutical companies commenced an application for judicial review of the final Guidelines. See also the PMPRB’s November 20, 2020 webinar slides here....more

Final PMPRB Guidelines Released

UPDATE: See our article here highlighting changes relative to the June 2020 draft Guidelines. This morning, the PMPRB released the final Guidelines operationalizing the amended Patented Medicines Regulations (Amended...more

JULUCA CSP application remitted to Minister of Health for reconsideration

UPDATE: On January 13, 2021, the Minister of Health refused the application on reconsideration. Viiv sought but later discontinued a second application for judicial review (T-258-21). In a decision dated July 10, 2020,...more

Consultation on Draft PMPRB Guidelines extended to August 4

The PMPRB has extended the deadline for comments on the revised draft Guidelines to August 4, 2020. ...more

Federal Court releases decision on validity of the Amending Regulations of the Patented Medicines Regulations

UPDATE: See July 15, 2020 article here describing the decision in more detail. On September 10, 2020, the applicants (Innovative Medicines Canada and the company applicants) appealed Justice Manson’s decision (A-215-20). On...more

Revised draft Guidelines operationalizing the Patented Medicines Regulations: notable changes

Update: See our article here regarding the final October 2020 Guidelines. On November 23, Innovative Medicines Canada and a number of pharmaceutical companies commenced an application for judicial review of the final...more

PMPRB releases revised draft Guidelines

UPDATE: See June 23, 2020 article here describing the notable changes. See our article here regarding the final October 2020 Guidelines. On November 23, Innovative Medicines Canada and a number of research-based...more

New amendments to PMPRB pricing regulations push back deadlines by six months

Update: See December 30, 2020 and January 26, 2021 articles discussing the further amendments which defer the coming into force date of the Amended Regulations until July 1, 2021. Further to our June 1, 2020 update,...more

Amendments to PMPRB Regulations will now be in force January 1, 2021

Update: See our June 10, 2020 article here describing the amendments extending the deadline, and our articles here and here regarding the amendments further deferring the coming into force date until July 1, 2021, and our...more

First decision on CSPs: SHINGRIX refusal remanded to Health Canada

The first decision considering the scope and meaning of the provisions in the Patent Act relating to Certificates of Supplementary Protection (CSPs) has now been released.  Justice Barnes of the Federal Court in...more

PMPRB releases draft Guidelines operationalizing amended Patented Medicines Regulations

On November 21, 2019, the Patented Medicines Prices Review Board (“PMPRB”) released draft new Guidelines for consultation, together with a backgrounder. The new Guidelines are intended to operationalize the amended Patented...more

Certificate of Supplementary Protection Regime: Second Anniversary Update

September 21, 2019 marked the second anniversary of the certificate of supplementary protection (CSP) regime in Canada. CSPs provide an additional term of patent-like protection of up to two years. In our first anniversary...more

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