PMPRB: amendments came into force on 1 July 2022
Health Canada's regulatory initiatives for 2022-2024
Final report from pan-Canadian formulary advisory panel released
Patent decisions on the merits
Federal Court issues decision on application of data protection when submissions are co-pending
Competition Bureau updates
Biosimilars update
Meta (Facebook) restricts targeted advertising for health-related topics
The first half of 2022 saw a number of developments in Canadian life sciences IP and regulatory law. This article summarises the top stories from January 2022 to July 2022.
PMPRB: amendments came into force on 1 July 2022
On 18 February 2022, the confidential rebate reporting and new price regulatory factors of the amended Patented Medicines Regulations were declared invalid by the Quebec Court of Appeal
(for further details, see "Court declares confidential rebate reporting and new price regulatory factors of amended Patented Medicines Regulations invalid"). Following this decision, the minister of health announced it would not proceed with those amendments (for further details, see "Slam dunk! New basket of countries for PMPRB reporting remain, controversial amendments to Patented Medicines Regulations dropped"), and the narrowed amended Patented Medicines Regulations, originally scheduled for 1 July 2020, came into force on 1 July 2022 (for further details, see "New PMPRB regulations in force"). The amendments:
- amended the basket of foreign reference countries for price benchmarking; and
- reduced reporting obligations for veterinary, over-the-counter (apart from non-prescription schedule D drugs such as vaccines and insulin) and generic medicines.
The appeal decision of the Federal Court decision on separate challenges to the amendments (for further details, see "Federal Court strikes price calculation provision of amendments to Patented Medicines Regulations") is pending. The Patented Medicine Prices Review Board (PMPRB) consulted on a proposed "status quo" approach to price reviews during the interim period between 1 July 2022 and the publication of revised guidelines, expected by year-end (for further details, see "New PMPRB regulations in force").
Health Canada's regulatory initiatives for 2022-2024
In June 2022, Health Canada updated its Forward Regulatory Plan: 2022-2024 (for further details, see "Updates to Health Canada's regulatory initiatives for 2022-2024 and amendments to Food and Drug Regulations (Exports and Transhipments of Drugs)", which included:
- reference to an advanced therapeutic products pathway for adaptive machine learning-enabled medical devices which had been planned to be pre-published in Spring 2022; and
- notice that in Autumn 2022, final amendments may be made to the Food and Drug Regulations, pre-published in 2019 (for further details, see "Proposed Amendments to Food and Drug Regulations: Generic drug equivalence, labeling, and related terminology") which would permit a generic manufacturer to file an abbreviated new drug submission for a drug that has a different salt form of the medicinal ingredient in the Canadian reference product.
Final report from pan-Canadian formulary advisory panel released
In June 2022, the advisory panel released its Final Report: Building Toward a Potential Pan-Canadian Formulary, together with summary highlights (for further details, "Final report from advisory panel on potential pan-Canadian formulary is released").
Patent decisions on the merits
The federal courts issued the following patent decisions in the first half of 2022, all relating to section 6(1) actions under the Patented Medicines (Notice of Compliance) Regulations.
Federal Court decisions:
- Janssen v Pharmascience, Janssen v Apotex (paliperidone palmitate, Invega Sustenna) – following summary trials, the trial judge concluded that Pharmascience and Apotex would induce infringement of claims for a dosing regimen (for further details, see "Federal Court holds summary trial appropriate, Apotex and Pharmascience will induce infringement of paliperidone palmitate patent"). Both have appealed; Pharmascience's defence of patent invalidity proceeded to trial;
- Allergan v Apotex (risedronate sodium, Actonel DR) – formulation claims "for use with or without food or beverage intake" valid (not anticipated, not obvious, useful, sufficient, not overbroad), but not infringed (product monograph stated should be taken with food) (for further details, see "Federal Court finds formulation patent relating to Actonel DR valid but not infringed");
- Merck Sharp & Dohme Corp v Pharmascience (sitagliptin, Januvia) – claim to R-enantiomer of the dihydrogen phosphate salt of sitagliptin in crystalline monohydrate form valid (not obvious in view of the prior genus, which included sitagliptin and its hydrochloride salt, not insufficient) (for further details, see "Merck's Januvia crystalline monohydrate DHP salt patent found valid"). Pharmascience appealed;
- Janssen v Sandoz (macitentan, Opsumit) – claims to macitentan in combination with a phosphodiesterase type-5 inhibitor to treat diseases where vasoconstriction is involved, including pulmonary arterial hypertension (770 patent) valid (not obvious, utility soundly predicted, not overbroad, not insufficient) (for further details, see "Federal Court finds Janssen's macitentan combination therapy patent valid"). Sandoz appealed; and
- Janssen v Apotex (macitentan, Opsumit) – Apotex would induce infringement of 770 patent claims (validity not challenged) (for further details, see "Janssen succeeds on infringement against Apotex in macitentan combination patent case"). Apotex appealed.
Federal Court of Appeal decisions:
- Pharmascience v Teva (glatiramer acetate, Copaxone, Glatect) – the Federal Court of Appeal upheld the finding that claims to use of 40 mg glatiramer acetate administered by subcutaneous injection three times per week for treatment of relapsing-remitting multiple sclerosis (802 patent) were valid (utility soundly predicted, not obvious) (for further details, see "Federal Court of Appeal upholds validity of glatiramer acetate patent"). The infringement finding was not challenged on appeal. Pharmascience sought leave to appeal.
Federal Court issues decision on application of data protection when submissions are co-pending
Catalyst received a notice of compliance (NOC) for Firdapse (amifampridine). Médunik later received an NOC for Ruzurgi (also containing amifampridine) based on a new drug submission filed about one month after Firdapse, referencing Firdapse data, and on the same day, Firdapse was found to be eligible for data protection. Data protection precludes the filing of a submission based on a direct or indirect comparison to Firdapse for six years after issuance of the NOC.
In 2021, the Court quashed the Ruzurgi NOC and returned the matter to the minister for redetermination (for further details, see "Federal Court quashes RUZURGI NOC and returns matter to the Minister of Health for redetermination"). On redetermination, Health Canada issued a new NOC for Ruzurgi and, in March 2022, the Court quashed the RUZURGI NOC for a second time, sending the matter back again for redetermination (for further details, see "Federal Court sets aside minister of health decision to issue Ruzurgi NOC for second time"). The minister of health's appeal remains pending.
In January 2022, the Competition Bureau demonstrated its continued interest in the health sector (for further details, see "Competition Bureau's interest in health sector continues"). In May 2022, the Competition Bureau announced it closed two investigations into pharmaceutical patent litigation settlement agreements as evidence gathered in the two investigations suggested the agreements did not contravene the Competition Act (for further details, see "Competition Bureau closes two investigations into pharmaceutical patent litigation settlements"). In June 2022, the Competition Bureau announced it completed a preliminary investigation into potential anti-competitive harm from "relabelled" biologic drugs (for further details, see "Update on biosimilars in Canada – June 2022").
For further details on approvals, pending regulatory submissions, and litigation, regulatory and market access developments, see "Update on biosimilars in Canada – June 2022".
Meta (Facebook) restricts targeted advertising for health-related topics
In January 2022, Meta Platforms, Inc (Meta) implemented changes to make it more difficult for advertisers using any of its platforms (including Facebook and Instagram) to use targeted advertising for certain sensitive topics (for further details, see "Two health advertising updates – PAAB and Meta (Facebook)").
For further information on this topic please contact Nancy Pei at Smart & Biggar by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar website can be accessed at www.smartbiggar.ca.