Below are highlights from the Rx IP’s team’s 2023 updates (see also our Top 10 Rx IP Update Reads of 2023):
- Patent decisions on the merits
- PMNOC Regulations: Sixth anniversary of major amendments, court decisions
- Section 8 of the PMNOC Regulations: Pending cases, Ontario Superior Court dismisses Apo-Atomoxetine section 8 action; SCC denies leave from Apo-Olanzapine Statute of Monopolies decision
- Patent Act amendments to introduce patent term adjustment will be in force no later than January 1, 2025
- PMPRB: New chair and vice-chair, amended Interim Guidance, consultation ongoing on amended guidelines expected in 2024
- National Strategy for Rare Diseases, Health Canada regulatory initiatives
- Market access: CADTH announces upcoming improvements to reimbursement reviews, time-limited reimbursement recommendations; revised generic Tiered Pricing Framework; Pharmacare cost estimate
- Biosimilars update, Ontario biosimilars transition policy
- Data protection court decisions
- Quebec’s “IP Box” explained
1. Patent decisions on the merits
We reported on the following patent decisions on the merits in 2023.
Federal Court (FC) decisions:
- Eli Lilly v Teva, Pharmascience, Riva, Apotex, Mylan (tadalafil, CIALIS) – Following a summary trial, Lilly’s infringement actions were dismissed: composition claims directed to “a physiologically acceptable salt” of tadalafil were found invalid for overbreadth (broader than what was invented) and for insufficient disclosure. Lilly’s appeal is pending.
- AbbVie Corporation v JAMP Pharma Corporation (adalimumab, HUMIRA) – JAMP launched three high concentration, citrate-free SIMLANDI biosimilars in presentations not marketed by AbbVie. The FC found two adalimumab dosing regime patents (for treating inflammatory bowel disease and for treating hidradenitis suppurativa) invalid for obviousness. The FC found the third patent claiming an aqueous formulation of adalimumab valid, with infringement conceded, but declined to grant a permanent injunction in view of the public interest as switching to other biosimilars could cause increased injection site pain. AbbVie has appealed.
- Allergan Inc v Juno Pharmaceuticals Corp (bimatoprost, LUMIGAN RC) – The FC granted Allergan’s s. 6(1) action under the Regulations; infringement was conceded, formulation claims were valid (not obvious, disclosure not insufficient). The patent relates to a formulation with a lower percentage of bimatoprost and a higher percentage of benzalkonium chloride, a preservative, than an older LUMIGAN formulation. Juno may appeal as of right.
Federal Court of Appeal (FCA) decisions:
- Teva Canada Limited v Janssen Inc (paliperidone palmitate, INVEGA SUSTENNA) – The FCA dismissed Teva’s appeal on direct infringement and obviousness of claims relating to dosing regimens in a s. 6(1) action and allowed Janssen’s cross-appeal on inducing infringement. On the latter, the FC’s test was too stringent; its finding that the capable, approved and intended use for the Teva product incorporated all the dosing and administration elements of the product claims inevitably leads to the conclusion that Teva would induce infringement.
- Apotex Inc v Janssen Inc (macitentan, OPSUMIT) – The FCA dismissed Apotex’s appeal, finding Apotex would induce infringement of the 770 patent claims relating to macitentan in combination with a phosphodiesterase type-5 inhibitor (PDE5-I) to treat pulmonary arterial hypertension including based on references in its product monograph to the SERAPHIN study, the pivotal trial regarding monotherapy and combination therapy with a PDE5-I.
- Sandoz Canada Inc v Janssen Inc (macitentan, OPSUMIT) – The FCA dismissed Sandoz’s appeal, finding that the 770 claims were not invalid based on lack of sound prediction, confirming that the threshold for sound prediction is not high.
2. PMNOC Regulations: Sixth anniversary of major amendments, court decisions
In June, Health Canada released its Statistical Report 2022/2023 for the Patented Medicines (Notice of Compliance) Regulations, Data Protection, and Certificates of Supplementary Protection.
In September, we provided a six-year anniversary update of cases under the significantly amended PMNOC Regulations,
which includes statistics on actions commenced since September 2017: pending, decided and appealed. In the year ending September 2023, Pharmascience was the most active patent challenger, followed by Apotex.
Decisions relating to the PMNOC Regulations (other than s. 6(1) decisions on the merits, which are listed above) included:
- The FC dismissed Takeda’s motion to consolidate two s. 6(1) actions against Apotex based on two notices of allegation served approximately eight months apart regarding different patents and one abbreviated new drug submission for dexlansoprazole (Takeda’s DEXILANT). The trial of the first s. 6(1) action was heard in October and November 2023, and a decision is under reserve.
- The FC held that Sandoz and Sun Pharma could counterclaim as of right regarding non-asserted claims in a s. 6(1) action relating to empagliflozin (Boehringer Ingelheim’s JARDIANCE). The FCA’s decision in BI’s appeal is pending.
- The FC dismissed Janssen’s motion for summary judgment in actions relating to paliperidone palmitate (INVEGA SUSTENNA). Janssen had argued that Apotex’s invalidity defence was res judicata, an abuse of process and precluded by the doctrine of election having regard to Apotex’s prior notice of allegation and decisions based on infringement. Janssen’s appeal was allowed, with public reasons to follow. Update: The FCA held that Apotex’s invalidity defences are an abuse of process as Apotex could and should have raised invalidity in the first action.
- The FC decided that the Minister of Health’s decision that Biosimilar Collaborations Ireland Limited was entitled to the benefit of a notice of allegation served by the previous owner of a new drug submission for YESAFILI, an aflibercept biosimilar of Bayer’s EYLEA, was reasonable; an appeal is pending.
- The FCA dismissed Janssen’s appeal regarding the eligibility of a patent for listing on the Patent Register against two supplementary new drug submissions for Janssen’s STELARA (ustekinumab).
3. Section 8 of the PMNOC Regulations: Pending cases, Ontario Superior Court dismisses Apo-Atomoxetine section 8 action; SCC denies leave from Apo-Olanzapine Statute of Monopolies decision
To date, no amended section 8 damages cases have proceeded to trial. A trial relating to Pharmascience’s section 8 claim re: abiraterone (Janssen’s ZYTIGA) is scheduled for May 2025. Two other section 8 claims
relating to fampridine (Biogen’s FAMPYRA) remain pending, but trials have not been scheduled.
In March, the Ontario Superior Court of Justice dismissed Apotex’s pre-amended section 8 claim relating to Apo-Atomoxetine (Eli Lilly’s STRATTERA),
including finding that Apotex would not have launched any earlier in the hypothetical world than it did in the real world.
In April, the Supreme Court of Canada dismissed Apotex’s application for leave to appeal regarding its Statute of Monopolies claim relating to a patent for olanzapine. The Ontario Court of Appeal held that the Patent Act and PMNOC Regulations form a complete code.
4. Patent Act amendments to introduce patent term adjustment will be in force no later than January 1, 2025
On June 22, 2023, Bill C-47 amended the Patent Act to introduce patent term adjustment (PTA) to compensate patentees for Patent Office delays in granting a patent (see, A first look at Canada’s proposed patent term adjustment system; the amendments passed as originally proposed). Once in force, no later than January 1, 2025, the PTA provisions will apply to Canadian patent applications filed on or after December 1, 2020. The term for a certificate of supplementary protection (CSP) will run concurrently with the term for the PTA.
5. PMPRB: New chair and vice-chair, amended Interim Guidance, consultation ongoing on amended guidelines expected in 2024
In February, the Minister of Health announced the appointment of Thomas J. Digby, a lawyer with over 25 years
of experience working with the pharmaceutical sector, as the new Chairperson for the PMPRB; Anie Perrault was appointed Vice Chairperson in August.
Amended Guidance under the July 1, 2022 amendments to the Patented Medicines Regulations remain pending. In September, the PMPRB adopted Amended Interim Guidance. In November, as part of the first phase of consultations, the PMPRB published its Scoping Paper, indicating it anticipates finalizing the new guidelines in 2024. Policy roundtables with stakeholders were held in December.
6. National Strategy for Rare Diseases, Health Canada regulatory initiatives
In March, the Minister of Health announced the first-ever National Strategy for Drugs for Rare Diseases,
which includes $1.5 billion invested to “increase access to, and affordability of, effective drugs for rare diseases to improve the health of patients across Canada, including children” and in October, announced the creation of the Implementation Advisory Group (IAG). The IAG’s mandate is to provide advice to Health Canada and healthcare providers on implementation of the National Strategy and to be a forum to exchange
information and best practices on drugs for rare diseases.
Health Canada’s regulatory initiatives
Health Canada consultations included:
- Proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations and related guidance to modernize the regulatory system to permit agile licensing of drugs and medical devices, including rolling review of submissions and expansion of the ability to impose terms and conditions on market authorizations (consultation ended April 26, 2023);
- A proposed application of the definition of Canadian reference product based on “Dormant status” (consultation ended May 12, 2023);
- Proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations to modernize the frameworks for establishment licences and recalls of therapeutic products (consultation ended June 29, 2023);
- A consultation on improving access to drugs and other health products (consultation ended August 4, 2023);
- A consultation on draft pre-market guidance for machine learning-enabled medical devices (consultation ended October 29, 2023); and
- A consultation on draft guidance for determining medical device application type (consultation ended November 10, 2023).
Health Canada’s new or newly revised Guidance Documents included:
- Guidance on factors that contribute to a determination of whether a message or activity in respect of a health product is promotional (i.e., considered advertising): Guidance on distinction between advertising and other activities for health products;
- Updated guidance on the regulatory requirements for medical device establishment licences; and
- Guiding Principles for Predetermined Change Control Plans for machine learning-enabled medical devices.
Relating to public health emergencies:
- Amendments to the Food and Drug Regulations to add a new Division 11, titled “Public or Canadian Armed Forces Health Emergencies — Drugs for Immediate Use or Stockpiling” came into force in February;
- In February, amendments to the Medical Devices Regulations came into force that created a permanent regulatory framework for COVID-19 medical devices; and
- In March, proposed amendments to the Medical Devices Regulations that would expand the regulatory framework for COVID-19 medical devices to apply to future public health emergencies were published (consultation ended April 13, 2023).
7. Market access: CADTH announces upcoming improvements to reimbursement reviews, time-limited reimbursement recommendations; revised generic Tiered Pricing Framework; Pharmacare cost estimate
In June, the Canadian Agency for Drugs and Technologies in Health (CADTH) announced upcoming improvements to its Reimbursement Review process over the coming year, including the addition of presubmission pipeline meetings with drug sponsors. CADTH also announced a 1-year pilot program
of a new Formulary Management Expert Committee to support decision-making across the drug life cycle.
CADTH’s annual report was released in August.
Following a spring consultation, in September, CADTH
introduced the time-limited reimbursement recommendation category, which
aims to provide early access to promising new drugs that target unmet needs of people with severe, rare, or debilitating illnesses by allowing a recommendation to publicly funded drugs for a certain period of time based on the condition that the manufacturer
will conduct ongoing clinical studies to address any uncertainty in evidence. Any new evidence will be assessed by CADTH, leading to a final reimbursement recommendation. In anticipation, the pan-Canadian Pharmaceutical Alliance (pCPA) introduced its Temporary Access Process (pTAP) in July 2023.
A new three-year agreement between the pCPA and the Canadian Generic Pharmaceutical Association (CGPA) now includes new
generic drugs funded in Quebec and through the Ontario Exceptional Access Program (in addition to regular formulary benefits). Pursuant to this new agreement, single-source generic products entering the Tiered Pricing Framework as of October 1, 2023
will be priced at 75% of the brand reference price for the first three months and 55% thereafter if a product listing or pricing agreement exists or existed, and if no agreement exists or existed, 85% of the brand reference price.
The Ontario Ministry of Health sought feedback regarding its proposal to remove certain requirements for funding and interchangeability submissions for well-established drugs.
In October, the Office of the Parliamentary Budget Officer (PBO) published a report, the Cost Estimate of a Single-payer Universal Drug Plan based on the 2016 House of Commons Standing Committee on Health’s proposed framework for Pharmacare. An October announcement stated the “Government of Canada remains committed to introducing a Pharmacare Bill”.
In December, the Minister of Health announced the creation of the Canadian Drug Agency which will build and expand on CADTH’s mandate and functions, including improving appropriate prescribing and use of medications, increasing pan-Canadian data collection and expanding access to drug and treatment data, including real-world evidence data.
8. Biosimilars update, Ontario biosimilars transition policy
Our March 2023 biosimilars update provided a further update on biosimilars in Canada (approvals, pending submissions, litigation, regulatory, and market access). Effective December 29, 2023, the Ontario Drug Benefit program no longer funds seven specific innovator biologics or COPAXONE, unless an exception applies.
9. Data protection court decisions
In January, the Federal Court held the Minister of Health was reasonable not to reassess data protection for SPRAVATO despite the implementation of the Canada-United States-Mexico Agreement (CUSMA) after its first denial of data protection – the Minister reasonably concluded that the definition of “innovative drug” is compliant with CUSMA. SPRAVATO
contains esketamine hydrochloride, an enantiomer of ketamine hydrochloride, a medicinal ingredient in previously approved drugs.
Also in January, the FCA restored the Minister’s decision to grant an NOC to Médunik for RUZURGI, despite data protection for FIRDAPSE (both amifampridine), and references to FIRDAPSE carcinogenicity and reproductive and development toxicity studies in the RUZURGI product monograph. The Minister reasoned that the Therapeutic Products Directorate had not relied upon those studies to establish the safety and efficacy of RUZURGI; Médunik therefore did not seek an NOC “on the basis of a direct or indirect comparison” with FIRDAPSE, and subsection C.08.004.1(3) was therefore not engaged.
10. Quebec’s “IP Box” explained
Sanro Zlobec summarized the key features of the Quebec IP Box which provides a tax incentive to conduct research and development in Quebec, by permitting a qualified corporation to reduce its Quebec tax rate on eligible income attributable to a qualified intellectual property asset.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.
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