This article was last updated on March 22, 2022.
In view of COVID-19, we have compiled a list of important updates as it relates to the pandemic and its impact on Life Sciences.
We will continue to update this page as new updates come in:
CIPO COVID-19 updates
- Patent, trademark and industrial design deadlines through Friday August 28, 2020 were extended until Monday August 31, 2020 (see here, our article here, and FAQs regarding the initial extension).
- The Patent Act was amended on March 25 to expand the powers of the Commissioner of Patents to authorize use of patented inventions in specified circumstances to respond to public health emergencies (see our article here).
- Effective December 14, 2020, the Canadian Trademarks Office began accepting requests for expedited examination of trademark applications associated with medical goods or services related to COVID-19 (see our article here).
How Canadian courts have changed operations due to COVID-19
- The Federal Court of Canada (see Practice Direction Update #7 (January 18, 2021) has closed its Court’s facilities in Ontario and Quebec until further notice (there will be no in-person hearings until February 12, 2021), but will continue its operations by video conference, teleconference and in writing. The Court has also provided further guidance, including on electronic filing and service. The Court’s previous suspension period expired on June 15 (Western and Atlantic Canada / June 29 (Ontario, Quebec, and the Territories).
- The first patent infringement trial conducted by Zoom commenced on May 25, 2020 (see Order and remote trial protocol here). See also: General Policy Statement re: Virtual Hearings, the July 21, 2020 guide COVID-19: Recommended Preventive Measures as the Court resumes certain in-person operations, and the November 6 COVID-19 Guide: In-person Hearings at the Federal Court which outlines safety measures for in-person hearings.
- The Federal Court of Appeal (see March 16, May 28 and June 11 notices) adjourned most hearings and suspended many deadlines until initially April 17, 2020 now extended indefinitely for all files commenced before or after June 11, 2020 except for (i) Selected Files (designated primarily based on age; files will be posted on the Court’s website, see for example here) and (ii) files already released from the suspension. According to the September 1, 2020 notice, as of the start of the fall session on September 1, 2020, hearings will proceed with: (i) all counsel appearing in person, (ii) all counsel appearing remotely, or (iii) some counsel appearing in person, with others appearing remotely. While, according to the April 21, 2021 notice, the Court restored the suspension period by “deselecting” a number of files, per the June 17, 2021 notice, these files will appear on the Selected Files List and deadlines began to run on June 28, 2021.
- Deadlines affecting intellectual property matters governed by statutes and regulations (other than the Federal Courts Act and the Federal Courts Rules), including statutory stays under the Patented Medicines (Notice of Compliance) Regulations, were not extended by the Federal Court/Federal Court of Appeal’s notices/Orders. However, the 45-day time limit for commencing a s. 6 (1) action under the PMNOC Regulations was suspended under the Time Limits and Other Periods Act (COVID-19) from March 13 to July 30, 2020 (Viiv v. Sandoz, 2020 FC 1040, see article here). The Federal Court dismissed Merck’s judicial review application of the Minister’s decision that the 30-day time limit under s. 4(6) for submitting a patent list was not suspended by the Time Limits and Other Periods Act (COVID-19) (Merck v. Canada (Health), 2021 FC 345, aff’d 2001 FCA 224, see article here).
- An Action Committee on Court Operations in Response to COVID-19 has been established.
Health Canada's response to COVID-19
- The Food and Drugs Act was amended on March 25, 2020 to provide the power to make regulations: (i) requiring the provision of information to the Minister of Health and (ii) considered necessary “for the purpose of preventing shortages of therapeutic products in Canada or alleviating those shortages or their effects, in order to protect human health” (see our article here). On October 16, 2020, Health Canada approved an Interim Order which allows for information to be requested from anyone who sells a drug and for terms and conditions to be imposed on authorizations to sell drugs in order to address drug shortages related to COVID-19 (see our article here). Amendments to the Food and Drug Regulations and Medical Devices Regulations to address therapeutic product shortages were registered on August 12, 2021 (see our article here).
- Health Canada has taken a number of steps to facilitate availability of COVID-19 health products, to publish information relating to COVID-19 clinical trial applications, approvals and shortages, and to provide guidance on the conduct of ongoing clinical trials in light of COVID-19 (see our articles here, here, and here). Health Canada has also contacted Health Product Licence Holders to advise how they may be able to contribute (e.g., by identifying production capacity that could be used for manufacturing personal protective equipment) and issued requests for information for alternative suppliers of certain pharmaceuticals (see our article here). See Health Canada’s summary document regarding its various measures here. On July 28, Health Canada granted a notice of compliance with conditions to Gilead for remdesivir (VEKLURY) for the treatment of certain patients with severe symptoms of COVID-19.
- On September 16, 2020, Health Canada approved an Interim Order (ISAD Interim Order) which introduces a new pathway to expedite the authorization for importing, selling and advertising of COVID-19 drugs (see our article here).
This Interim Order has wide-reaching impact, since it also allows the Minister of Health to unilaterally expand the indication for non-COVID-19 drugs and also allows generic and biosimilar applications for COVID-19 drugs with “insufficient
supply”. To date, Health Canada has granted authorizations under the Interim Order for the Pfizer-BioNTech COVID-19 Vaccine (December 9, 2020), the Moderna COVID-19 Vaccine (December 23, 2020), the AstraZeneca COVID-19 Vaccine (February 26, 2021), and the Janssen COVID-19 Vaccine (March 5, 2021), among others. As the ISAD Interim Order expired on September 16, 2021, the Food and Drug Regulations were amended on March 18, 2021 to allow, among other things, continued sale of COVID-19 drugs authorized under
the ISAD Interim Order (see our article here). Pfizer’s PAXLOVID (nirmatrelvir and ritonavir) was authorized under the amended FDR provisions on January 17, 2022, and Novavax’s NUVAXOVID COVID-19 Vaccine (February 17, 2022) and Medicago’s COVIFENZ COVID-19 Vaccine (February 24, 2022) were also authorized under the amended FDR provisions.
- Health Canada and the Competition Bureau have taken action against manufacturers and retailers making impermissible COVID-19 related claims (see our article here).
Other COVID-19 regulatory developments
- There have been a number of pharmacy developments including broadening the scope of pharmacists’ practice in view of COVID-19 (see our article here).
- Reimbursement-related developments include interim funding measures by Cancer Care Ontario, guidance by the Ontario Ministry of Health recommending a maximum 30-day supply of medication, as well as amendments in Ontario to better align calculation of brand reference price with the rest of Canada (see our article here).