ARTICLE
1 October 2020

Update On Amended Patented Medicines Regulations

SB
Smart & Biggar

Contributor

Smart & Biggar uncovers and maximizes intellectual property and technology assets for our clients. Today’s fast-paced innovation economy demands a higher level of expertise and attention to detail when it comes to IP strategy and protection. With over 125 lawyers, patent agents and trademark agents collaborating across five Canadian offices, Smart & Biggar is trusted by the world’s leading innovators to find value in their IP rights. As market leaders in IP, Smart & Biggar’s team is on the pulse when it comes to the latest developments and the wider industry changes that impact our clients. To stay informed, visit smartbiggar.ca/insights, including access to our RxIP Update (smartbiggar.ca/insights/rx-ip-updates), a monthly digest of the latest decisions and law surrounding the life sciences and pharmaceutical industries.
Both the applicants and the respondent have appealed the June 29, 2020 decision striking subsection 3(4) of the Regulations Amending the Patented Medicines Regulations...
Canada Food, Drugs, Healthcare, Life Sciences

Federal Court decision appealed

Both the applicants and the respondent have appealed the June 29, 2020 decision striking subsection 3(4) of the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements) (Amended Regulations) (see our article here). On September 10, 2020, Innovative Medicines Canada and the company applicants appealed Manson J.'s decision ( A-215-20). On September 21, 2020, the Attorney General of Canada cross-appealed ( A-215-20 Notice of Cross-Appeal).

Constitutional challenge scheduled to start Sept 28, 2020

The constitutional challenge to the Amended Regulations proceeding in the Quebec Superior Court has been scheduled to begin on September 28, 2020 (see our review of the challenge here).

PMPRB Guidelines to provide special consideration for COVID-19 drugs

On September 17, 2020, the Patented Medicine Prices Review Board (PMPRB) advised that the upcoming final PMPRB Guidelines will afford special consideration to drugs appearing on the List of Drugs for Exceptional Importation and Sale and on the list(s) published by Health Canada pursuant to the September 16, 2020 Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (see article here). Absent a pre-existing complaint, medicines appearing on these lists will only be subject to review or investigation by PMPRB Staff if a pricing complaint is received from the federal Minister of Health or any of her provincial or territorial counterparts. Upon expiry/repeal of the Interim Orders or removal from the applicable list, absent a pre-existing complaint, price reviews will be based on prevailing international and domestic list prices, and not on introductory discounted prices in Canada.

Should you have any questions, please do not hesitate to contact a member of the  Life Sciences Regulatory & Compliance group.

The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.

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