This article was last updated on December 23, 2020.
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 June 25 Consolidated Practice Direction and Update #5 amended July 9, 2020) implemented a suspension period that ended on June 15 (Western and Atlantic Canada, "WA") / June 29 (Ontario, Quebec, and the Territories, "OQT"). Many deadlines were suspended until June 29 (WA) / July 13 (OQT) and the Court indicated it would not hold in person hearings until July 13 (WA) / July 27 (OQT). According to the Practice Direction Update #6 (September 6, 2020), a number of practices from the Update #5 will continue until further notice, including that all applications for judicial review and all general sittings will be scheduled to be heard by videoconference; however, the Court will consider requests for in person hearings.
- The first patent infringement trial conducted by Zoom commenced on May 25 (see Order and remote trial protocol here). See also: General Policy Statement re: Virtual Hearings, the July 21 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 , March 19 , April 2 , May 12 , May 28 , and June 11 notices) adjourned most hearings and suspended many deadlines until initially April 17, now extended indefinitely for all files commenced before or after June 11, 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 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.
- 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).
- 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 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). While those provisions were repealed on October 1, 2020, without the making of any regulations, 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).
- 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
which introduces a new pathway to expedite the authorization for
importing, selling and advertising of COVID-19 drugs (see our
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". Health Canada granted an authorization under the Interim Order to
BioNTech for the Pfizer-BioNTech COVID-19 Vaccine
(December 9) and to Moderna for the Moderna COVID-19
Vaccine (December 23).
See our December 17, 2020 article for further Health Canada updates here.
- 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).
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.