This article was last updated on December 20, 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 Update #9 and Consolidated COVID-19 Practice Direction (October 24, 2022)) has confirmed that all Court offices are open; has provided guidance, including on electronic filing and service of documents; and advised that all matters scheduled to be heard in January 2023 and beyond, the presumptive mode for all hearings on the merits for actions, applications (apart from certain immigration matters), appeals of a final decision or order and all non-urgent motions in excess of two hours will be in-person. See also: General Policy Statement re: Virtual Hearings, the June 2022 updated COVID-19: Guidelines for Safe Court Facilities and Courtrooms operations during the COVID-19 pandemic: Guidelines for Safe Court Facilities and Courtrooms operations during the COVID-19 pandemic, and the November 6, 2021 COVID-19 Guide: In-person Hearings at the Federal Court.
- The Federal Court of Appeal - According to the June 14, 2022 notice, the Court expects to return to in-person hearings beginning in September 2022.
- 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, leave denied, 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 and our March 2022 Update here).
- Health Canada has taken a number of steps to facilitate the availability of COVID-19 health products, publish information relating to COVID-19 clinical trial applications, approvals and shortages, and 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, 2020, 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 introduced a new pathway to expedite the authorization for importing, selling and advertising COVID-19 drugs (see our article here). This Interim Order had a wide-reaching impact since it also allowed the Minister of Health to unilaterally expand the indication for non-COVID-19 drugs and also allowed generic and biosimilar applications for COVID-19 drugs with “insufficient supply”. Health Canada 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, the 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. See also Health Canada’s December 16, 2022 Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19.
- 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 the calculation of brand reference price with the rest of Canada (see our article here).