This article reviews the first reported decision of the Federal Court on whether the Canadian Federal Government’s Time Limits and Other Periods Act (COVID-19) legislation (“TLOPA Act”) extends the time limits set out in the Patented Medicines (Notice of Compliance) Regulations (“NOC Regulations”).
The COVID-19 pandemic has derailed so much in 2020 – holiday plans, global travel, national and global economies – that it seems only natural it would derail litigation. In Canada, as the country entered lockdowns, and businesses that could asked their staff to work from home, the courts across the country attempted to adapt to the “new normal”, modifying the time periods under their Rules for certain steps in litigation, and conducting hearings online with platforms like Zoom.
The Federal Court Adapts to the Pandemic Lockdowns
The Federal Court of Canada was no exception, releasing several timely Practice Directions and Orders (the “Directions”) outlining changes to its practices in view of the pandemic. As part of the Directions, the Court initiated a suspension period effective as of March 17, 2020, suspending all timelines under previously made Orders and Directions, the Federal Courts Rules, and sections of the Federal Courts Act, Citizenship Act and Immigration and Refugee Protection Act. All other statutory filing deadlines continued to apply, because they could only be modified by the Federal government, but parties were permitted to request extensions of time for such deadlines from the Court. As of June 29, 2020, the Court’s Suspension Period was lifted across the country.
The Federal Government Suspends Limitation Periods
On July 27, 2020, the Canadian Federal government’s TLOPA Act came into force. Section 6 of the TLOPA Act suspended (a) any limitation or prescription period for commencing a proceeding before a court; (b) any time limit in relation to something that is to be done in a proceeding before a court; and (c) any time limit within which an application for leave to commence a proceeding or to do something in relation to a proceeding is to be made to a court, if the time limits are established by or under “an Act of Parliament”. The suspension period was made retroactive to cover all such deadlines that fell between March 13 and September 13, 2020.
Sandoz Sends a Notice of Allegation During Lockdown
ViiV Healthcare Company (“ViiV USA”) and Shionogi & Co. Ltd. co-own a patent for “Polycyclic Carbamoylpyridone Derivatives having HIV Integrase Inhibitory Activity” (the “Patent”) and have allowed ViiV Canada to list it on the Register maintained by the Health Minister for TIVICAY (dolutegravir sodium as a single medication). ViiV Canada has received notices of compliance for TIVICAY allowing it to market and sell the drug in Canada, and is the “first person” pursuant to the NOC Regulations. Its representative for service on the Drug Product Database is listed as “Legal Counsel” at GlaxoSmithKline in Mississauga, Ontario (“GSK”).
In November 2019, pursuant to the NOC Regulations, Sandoz Canada filed an Abbreviated New Drug Submission (“ANDS”) with Health Canada, seeking a Notice of Compliance (“NOC”) for dolutegravir sodium in film-coated tablets in a 50 mg strength for oral administration. In its ANDS, Sandoz compared its tablets to ViiV Canada’s 50 mg strength of TIVICAY (also in tablet form for oral administration). The data protection for TIVICAY ends on May 1, 2022, which means Sandoz cannot obtain its NOC until that date.
GSK Locks Down, and the Mail gets Misplaced
On March 15, 2020, Canada Post advised that as a result of the COVID-19 pandemic, it would no longer be requesting signatures for any deliveries made to the door to minimize points of close contact between people. For registered mail, it indicated a notice card would be delivered indicating the post office at which the recipient could pick up items by showing proof of identity and signing. On March 16, 2020, GSK began closing down its offices for a pandemic lockdown and its Counsel and General Counsel began working from home. On that same day, counsel for Sandoz sent a package by registered mail addressed to “Legal Counsel” at GSK. The letter was addressed directly to counsel at GSK and enclosed a copy of Sandoz’s Notice of Allegation (“NOA”) and password-protected documents on a USB key. The letter instructed the recipients to contact Sandoz’s counsel for access to those documents.
Sandoz’s package was delivered to the mailroom at GSK’s offices on March 17, which is operated by a third party who subcontracts the mailroom services to Xerox. Registered mail for GSK is signed for another third party, who then delivers it to Xerox for delivery to GSK. The Sandoz package was signed for by an employee of the third party, who then delivered it to Xerox. It was then delivered to the GSK Legal Department mailbox by March 19, but was not delivered to “Legal Counsel”, nor were GSK’s Counsel and General Counsel made aware of its existence. Until April 6, GSK’s Legal Department did not receive any mail or courier packages – rather, registered mail was to be opened, scanned and forwarded to the recipient, and if there was no name on the envelope it was to be opened, scanned and forwarded to the paralegal for handling.
On April 3, GSK’s Legal Department realized dolutegravir was listed on Health Canada’s Generic Drug Submissions Under Review list. On April 6, GSK’s paralegal asked Xerox to check whether anything had been received that was addressed to the Legal Department, but Xerox said nothing was in the mailroom and there were no courier packages in the shipping area. The paralegal told Xerox to be on heightened alert for any future correspondence addressed to the Legal Department, and asked to be contacted if anything was received.
Service of Sandoz’s NOA by registered mail was deemed effective March 21, and its proof of service was accepted by the Minister of Health in March 2020. Due to the deemed effective date, ViiV USA and Shionogi had until May 5, 2020 to commence an action pursuant to the NOC Regulations, but because they did not know about Sandoz’s NOA, they did not do so.
On June 11, counsel for Sandoz emailed counsel at GSK alleging service of the NOA by registered mail – this was the first notice Counsel and Legal Counsel at GSK received of the Sandoz package and NOA, and the first contact made by Sandoz’s counsel after sending the Sandoz package. On June 15, the Sandoz package was discovered in the mailbox of GSK’s Legal Department. The contents were scanned and forwarded to Counsel and Legal Counsel, who were still working at home, and ultimately forwarded to ViiV USA and Shionogi. Sandoz received no communication about the Sandoz package and its NOA from ViiV Canada, GSK, or the patent owners.
Despite Lapse of the 45 Days, the Plaintiffs start an Infringement Action
On July 24, 2020, ViiV US, ViiV Canada and Shionogi (the “Plaintiffs”) filed a Statement of Claim for Patent infringement through the Federal Court’s e-filing portal. The Claim issued on July 28, 2020 and was sent to counsel for Sandoz that day. Service was accepted on July 30. However, on July 6, the Minister of Health advised Sandoz that its submission for dolutegravir citing TIVICAY had been completed on July 3, 2020. Sandoz therefore takes the position that it has been determined that its NOC will issue once the Patent data protection expires on May 1, 2022.
Sandoz Brings a Motion, but the Federal Court Rejects the Limitation Argument
In response to the Plaintiffs’ Claim, Sandoz brought a motion for summary judgment, to strike the Claim without leave to amend, and for its dismissal, on the basis that it is time-barred or statute-barred because it was initiated after the 45 day period provided for in the NOC Regulations. Sandoz alleged that despite the “multiple failures” by GSK in processing receipt of the Sandoz package, service of its NOA was effective on March 21, and the Plaintiffs failed to exercise their right of action within the prescribed time period. It also argued that the right of action could not be saved by service of an allegedly deficient NOA. As a result, Sandoz alleged the relief sought by the Plaintiff was quia timet, and that the TLOPA Act could not save the right of action because to the extent there was any inconsistency between the TLOPA Act and the Patent Act, the Patent Act prevailed.
The Plaintiffs argued that section 6 of the TLOPA Act applied to the “within 45 days” time limit established under the NOC Regulations, which would mean their Claim issued during the suspension period. In the alternative, they argued that the time limit had not begun to run because Sandoz had served a deficient NOA because the password-protected documents were not searchable and unreadable. While section 6 of the TLOPA Act specified the suspension period would automatically expire in September, an Order in Council dated July 30, 2020 applicable to the NOC Regulations ended the suspension period as of that date.
The Court observed of Sandoz’s argument regarding the conflict between the TLOPA Act and the Patent Act, that there is a presumption of coherence between overlapping legislative provisions, and that conflicts should be avoided if possible. It held there was an overlap because the provisions of both Acts applied to the time limit for bringing an action following service of an NOA, but there was no conflict or inconsistency because the purpose of the TLOPA Act was to temporarily suspend certain time limits established by or under an Act of Parliament, of which the NOC Regulations was one.
The Court found that section 6 of the TLOPA Act and the NOC Regulations should be read together, and that this was also supported by the July 30 Order in Council that said the suspension of time limits under the NOC Regulations “is lifted”. The Court held the suspension period under the TLOPA Act applied to time limits under the NOC Regulations from March 13 through July 30, 2020.
The Court concluded that because the Plaintiffs’ Claim was issued on July 28, prior to the end of the suspension period on July 30, it was not statute-barred. Regarding the Plaintiffs’ alternative claim, the Court held that service of Sandoz’s NOA was effected on March 21, and that it was not materially incomplete due to the inclusion and incorporation of the password-protected USB key of documents, so the subsequent actions bar was not circumvented.
The Court dismissed Sandoz’s motion, and in view of the actions (and inactions) of both parties, refrained from ordering costs.
The TLOPA Act applies to time limits under the NOC Regulations, despite any perceived conflict between the two pieces of legislation. Further, because service was deemed effective March 21, 2020, the Plaintiffs’ Claim was only saved by the suspension period.