IN THIS ISSUE:
PMPRB amendments expected to come into force no earlier than Spring 2020
Health Canada News
Proposed Amendments to Food and Drug Regulations: Generic drug equivalence, labeling, and related terminology
Bill C-97: Proposed amendments to the Food and Drugs Act would establish framework for “Advanced Therapeutic Products”
Health Canada invites submissions containing high quality real world evidence
Biosimilar update: the Pan-Canadian Oncology Biosimilars Initiative; Health Canada announces collaboration on study of comparative effectiveness and safety of biosimilar drugs
Certificates of Supplementary Protection filing fee increase effective April 1, 2019
Procedural decisions in actions under the PMNOC Regulations: Common invalidity issues raised by different generics to be heard concurrently; only “second persons” can be named as defendants
Do Ontario regulatory laws apply to BC retailer’s online sales to Ontario residents? Ontario Court of Appeal overturns lower court ban on online sales of prescription eyewear to Ontario residents
New Court Proceedings
PMPRB amendments expected to come into force no earlier than Spring 2020
By Abigail Smith
On April 1, 2019, Health Canada released Forward Regulatory Plan 2019-2021: Regulations Amending the Patented Medicines Regulations. This brief document provides a high-level overview of the anticipated amendments which were released in draft on December 2, 2017 (see our article here), their expected impact, and the consultation process, including the results of an independent assessment which concluded that “there is no good economic or conceptual reason not to proceed with the proposed regulatory changes.” Of particular note, the amendments are expected to be published in Part II of the Canada Gazette in the Spring 2019 session, and are expected to come into force 12 months thereafter.
Health Canada News
Proposed Amendments to Food and Drug Regulations: Generic drug equivalence, labeling, and related terminology
By Urszula Wojtyra
Health Canada released proposed Regulations Amending the Food and Drug Regulations (Improving Access to Generics) (“proposed Regulations”) on March 30, 2019. Comments may be submitted until June 8, 2019.
The proposed Regulations clarify and codify Health Canada’s expectations and policies regarding differences in the form of the medicinal ingredient in a generic drug product eligible for submission under the abbreviated new drug submission (“ANDS”) pathway by introducing a regulatory definition for “therapeutically active component”. Most significantly, a generic drug having a different salt form of the medicinal ingredient in the Canadian reference product is eligible for submission as an ANDS under the proposed Regulations. Further, the proposed Regulations streamline identifying and labelling practices of the medicinal ingredient content in drug products, and make amendments to the definition of “innovative drug” in the data protection provisions of the Food and Drug Regulations (“FDR”).
Read more >>
Bill C-97: Proposed amendments to the Food and Drugs Act would establish framework for “Advanced Therapeutic Products”
By Katie Lee
Bill C-97, An Act to implement certain provisions of the budget tabled in Parliament on March 19, 2019 and other measures was introduced in the House of Commons on April 8, 2019, and includes proposed amendments to the Food and Drugs Act to introduce a new framework for “Advanced Therapeutic Products”, including a new licensing framework.
The proposed amendments define an “Advanced Therapeutic Product” as a product or class of products set out in Schedule G. Thus far, Schedule G does not contain any entries, but the proposed amendments allow the Minister to make additions to Schedule G if the Minister believes the product or class of products “represent an emerging or innovative technological, scientific or medical development”.
It is unclear what the full details and scope of this framework will encompass, however it is expected that advanced therapeutic products may include regulation of newer technologies such as cell and gene therapies, 3D printing and novel drug delivery methods. The proposed amendments align with the What we heard: A summary of scanning and consultations on what’s next for health product regulation report issued by Health Canada in March 2019. The report identifies various emerging technologies that Health Canada will be considering further and which Health Canada recognizes are challenging current regulatory classification schemes.
Health Canada invites submissions containing high quality real world evidence
By Brandon Heard
On April 16, 2019, Health Canada released a notice inviting drug submissions containing high quality real world evidence along with a document providing principles for the collection and evaluation of real world evidence.
Submissions containing real world evidence are encouraged in the following circumstances: to “expand evidence-based indications for populations often excluded from clinical trials”; “for drugs/diseases where clinical trials are unfeasible”; or “where clinical trials are unethical”. Sponsors must clearly identify that a submission contains real world evidence. When real world evidence is used as pivotal evidence, a sponsor must also (i) provide a rationale for its use; (ii) provide a detailed explanation of its collection/analysis; (iii) demonstrate how biases in data collection were mitigated; and (iv) contact Health Canada to determine whether a pre-submission meeting would be beneficial.
A further joint document regarding the use of real world evidence is in development by Health Canada, CADTH and INESSS with an anticipated release date of later this year.
Biosimilar update: the Pan-Canadian Oncology Biosimilars Initiative; Health Canada announces collaboration on study of comparative effectiveness and safety of biosimilar drugs
By Urszula Wojtyra
The pan-Canadian Pharmaceutical Alliance (pCPA) and Cancer Care Ontario have partnered to create a pan-Canadian Oncology Biosimilars Initiative, which aims to ensure appropriate implementation and cost-effective use of therapeutic oncology biosimilars across Canada. In November 2018, the Initiative held a Pan-Canadian Oncology Biosimilars Summit. The Initiative has released a Proceedings Report of the Summit, as well as a pan-Canadian Oncology Biosimilars Initiative Action Plan.
Separately, Health Canada announced that it is collaborating with the Drug Safety and Effectiveness Network on a project studying patients with inflammatory rheumatic diseases and inflammatory bowel disease who are taking biologic drugs, aiming to compare the safety and effectiveness of biosimilar drugs to the reference biologic drug. The protocol for the study can be found here.
Certificates of Supplementary Protection filing fee increase effective April 1, 2019
By Katie Lee
On April 1, 2019, in accordance with subsection 9(1) of the Certificate of Supplementary Protection Regulations, the fee for filing a Certificate of Supplementary Protection (CSP) increased from $9,192 to $9,376. For an overview and update of the CSP regime, please see our previously published article here.
As a reminder, a CSP does not require the payment of annuities or annual maintenance fees, and the annual maintenance fees to maintain the related patent end with the expiry of the 20-year patent term.
Procedural decisions in actions under the PMNOC Regulations: Common invalidity issues raised by different generics to be heard concurrently; only “second persons” can be named as defendants
By Tierney GB Deluzio and Urszula Wojtyra
In Bayer v Apotex; Bayer v Teva, 2019 FC 191, the Court ordered that common validity issues in actions relating to Bayer's rivaroxaban (XARELTO) against Apotex and Teva will be heard concurrently. Bayer objected to the concurrent hearing, arguing that consolidating the trials would constitute a joinder of actions and thus be prohibited by s. 6.02 of the PMNOC Regulations. Prothonotary Tabib concluded that the application of s. 6.02 is limited to the joinder of actions as a whole and did not prohibit the common trial of an action. Relying on Biogen v Taro, 2018 FC 1034 (see our article here), which arose in similar circumstances, she held that the common trial of issues in complex cases under the PMNOC Regulations “constitutes the most efficient use of the Court and the parties' time and resources.”
In Genentech v Celltrion Healthcare, 2019 FC 293, the Court refused to allow the plaintiffs to name additional Teva parties as further defendants in three actions relating to Celltrion’s HERZUMA, a trastuzumab biosimilar of Roche’s HERCEPTIN. The Court reasoned that only “second persons” may be named as defendants in actions under the PMNOC Regulations. The Court left open the possibility that a “second person” could include a person other than the person who filed the regulatory submission. However, the plaintiffs did not plead “sufficient material facts that if proven would enable the Court to make a finding that [Celltrion] was an agent, acting as a nominal second person, directed and controlled by the [Teva parties]”. The Court however allowed the plaintiffs to amend the pleadings to claim that Celltrion will infringe the patents at issue by common design or acting in concert with the Teva parties.
Do Ontario regulatory laws apply to BC retailer’s online sales to Ontario residents? Ontario Court of Appeal overturns lower court ban on online sales of prescription eyewear to Ontario residents
By Abigail Smith
On April 4, 2019, the Ontario Court of Appeal overturned the Ontario Superior Court of Justice’s finding that online sales of prescription eyewear by Essilor Group Canada Inc. (Essilor) to Ontario residents violated s. 27(1) of the Regulated Health Professions Act (RHPA). The lower Court had found that these sales involve a controlled act not performed by an optician or optometrist: College of Optometrists of Ontario and College of Opticians of Ontario v Essilor Group Canada Inc, 2019 ONCA 265.
Essilor conducts its online business in BC, but sells its products to the residents of other provinces, including Ontario. In BC, any entity may dispense prescription eyewear; in Ontario, only optometrists and opticians may do so. At the lower Court level, the College of Optometrists of Ontario and the College of Opticians of Ontario successfully sought a declaration that Essilor breached the RHPA and an injunction against Essilor on the basis that it was dispensing eyewear in Ontario without involving an Ontario-licensed health care provider.
The dispositive issue was whether Essilor’s sales to Ontario residents were sufficiently connected to Ontario such that Ontario legislation could be applied to a BC entity. The Court found that the sole act performed by Essilor in Ontario in the course of its online sales was the delivery of finished prescription eyewear. Although this act exists on the “continuum of activities” that constitute dispensing, the Court found that delivery is a commercial element of dispensing that requires no application of professional health care skills. The mere act of delivery therefore did not, by itself, establish a sufficient connection to Ontario so as to bring Essilor’s online transactions within the ambit of the RHPA. Accordingly, the Colleges’ applications were dismissed.
New Court Proceedings
For complete details about these proceedings, click here.
PMNOC Actions
apixaban (ELIQUIS): Bristol-Myers Squibb and Pfizer v Sandoz
daptomycin (CUBICIN): Cubist and Sunovion v Sandoz
Selected Rankings
Canadian IP Impact Case of the Year
AstraZeneca v Apotex (NEXIUM)
LMG Life Sciences
Read more »
Canada’s Intellectual Property Litigation Firm of the Year
Benchmark Canada
Read more »
