In the first half of 2022, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to July and summarized them for you.
- PMPRB: Amendments came into force on July 1
- Health Canada’s regulatory initiatives for 2022-2024, including pathway for adaptive machine learning-enabled medical devices, approvability of different salt forms of generic drugs
- 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
1. PMPRB: Amendments came into force on July 1
On February 18, the confidential rebate reporting and new price regulatory factors of the amended Patented Medicines Regulations were declared invalid by the Quebec Court of Appeal. Following this decision, the Minister of Health announced it would not proceed with those amendments, and the narrowed amended Patented Medicines Regulations, originally scheduled for July 1, 2020, came into force on July 1, 2022. The amendments:
(i) amended the basket of foreign reference countries for price benchmarking and
(ii) 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 is pending. The PMPRB consulted on a proposed “status quo” approach to price reviews during the interim period between July 1 and the publication of revised Guidelines, expected by year-end.
2. Health Canada’s regulatory initiatives for 2022-2024, including pathway for adaptive machine learning-enabled medical devices, approvability of different salt forms of generic drugs
In June, we reported on Health Canada’s Forward Regulatory Plan: 2022-2024 which included:
(i) 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
(ii) notice that in Fall 2022, we may see final amendments to the Food and Drug Regulations pre-published in 2019 (see our previous article from 2019) which would permit a generic manufacturer to file an abbreviated new drug submission for a drug having a different salt form of the medicinal ingredient in the Canadian reference product.
3. Final report from pan-Canadian formulary advisory panel released
In June, the advisory panel released its Final Report: Building Toward a Potential Pan-Canadian Formulary, together with summary highlights.
4. Patent decisions on the merits
The Federal Courts issued the following patent decisions in the first half of 2022, all relating to s. 6(1) actions under the Patented Medicines (Notice of Compliance) Regulations.
Federal Court (FC) decisions:
Janssen v Pharmascience, Janssen v Apotex (paliperidone palmitate, INVEGA SUSTENNA) – Following summary trials, the trial Judge concluded Pharmascience and Apotex would induce infringement of claims for a dosing regimen. 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).
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). 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). Sandoz appealed.
Janssen v Apotex (macitentan, OPSUMIT) – Apotex would induce infringement of 770 patent claims (validity not challenged). Apotex appealed.
Federal Court of Appeal (FCA) decisions:
Pharmascience v Teva (glatiramer acetate, COPAXONE, GLATECT) – FCA 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). Infringement finding not challenged on appeal. Pharmascience sought leave to appeal.
5. Federal Court issues decision on application of data protection when submissions are co-pending
Catalyst received an 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. On redetermination, Health Canada issued a new NOC for RUZURGI and in March, the Court quashed the RUZURGI NOC for a second time, sending the matter back again for redetermination. The Minister of Health’s appeal remains pending.
6. Competition Bureau updates
In January, Alice Tseng provided an update on the Competition Bureau’s continued interest in the health sector. In May, 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. In June, the Competition Bureau announced it completed a preliminary investigation into potential anti-competitive harm from “relabelled” biologic drugs.
7. Biosimilars update
In June, Urszula Wojtyra provided her latest biosimilars update on approvals, pending regulatory submissions, and litigation, regulatory, and market access developments.
8. Meta (Facebook) restricts targeted advertising for health-related topics
In January, 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.