In the first half of 2023, 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 June and summarized them for you.
- Patent decisions on the merits
- PMNOC Regulations: Pending amended section 8 cases, SCC denies leave from Apo-Olanzapine Statute of Monopolies decision, Ontario Superior Court dismisses Apo-Atomoxetine section 8 action
- Patent Act amendments to introduce patent term adjustment will be in force no later than January 1, 2025
- PMPRB: New chair, amended guidelines expected in 2024 and updates to Interim Guidance
- National Strategy for Rare Diseases, Health Canada’s regulatory initiatives
- Market access: IMC proposes framework for innovative agreements for drug reimbursement, CADTH announces upcoming improvements to reimbursement reviews
- Biosimilars update, Ontario biosimilars transition policy
- Data protection court decisions
1. Patent decisions on the merits
Federal Court (FC):
- Eli Lilly v Teva, Pharmascience, Riva, Apotex, Mylan (tadalafil, CIALIS) – Following a summary trial, 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 insufficiency of disclosure. Lilly’s appeal is pending.
Federal Court of Appeal (FCA):
- Teva v Janssen (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) PMNOC 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.
- Eli Lilly v Apotex, Pharmascience, Riva, Mylan, Teva (tadalafil, CIALIS) – The FCA dismissed Eli Lilly’s appeal on obviousness of claims relating to oral pharmaceutical unit dosage forms containing specific strengths and ranges of strengths of tadalafil for the treatment of erectile dysfunction. The FCA did not address anticipation, as unnecessary.
2. PMNOC Regulations: Pending amended section 8 cases, SCC denies leave from Apo-Olanzapine Statute of Monopolies decision, Ontario Superior Court dismisses Apo-OlanzapineApo-Atomoxetine section 8 action
Section 8 damage cases brought by Dr. Reddy’s and Apotex against Janssen regarding their abiraterone acetate products (Janssen’s ZYTIGA) were scheduled for consecutive trials in June 2023, but the proceedings have been discontinued. The trial relating to Pharmascience’s section 8 claim re: abiraterone has not yet been scheduled. Two other section 8 claims, relating to fampridine (Biogen’s FAMPYRA) remain pending, but trials have not been scheduled.
In April, the Supreme Court of Canada dismissed Apotex’s application for leave to appeal regarding the Ontario Court of Appeal’s Statute of Monopolies decision relating to the patent for olanzapine. While Eli Lilly was successful in the PMNOC proceeding against Apotex (and therefore Apotex could not claim section 8 damages), the patent was later found invalid in a separate case against Novopharm. In 2021, the Ontario Superior Court of Justice dismissed Apotex’s claims for damages against Eli Lilly under the Statute of Monopolies, Trademarks Act, and common law conspiracy. In 2022, the Ontario Court of Appeal dismissed Apotex’s appeal, based in part on its finding that the Patent Act and PMNOC Regulations form a complete code.
In March, the Ontario Superior Court of Justice dismissed Apotex’s section 8 claim relating to Apo-Atomoxetine (Eli Lilly’s STRATTERA). Teva invalidated the atomoxetine patent in a separate action while the prohibition application against Apotex was pending. The FC dismissed the application as moot, but reasoned that it would have granted it but-for the patent being invalid. The Superior Court held that Apotex was not entitled to section 8 damages in these circumstances, and additionally held that Apotex did not suffer any damages as it would not have launched any earlier in the hypothetical world than it did in the real world.
3. Patent Act amendments to introduce patent term adjustment will be in force no later than January 1, 2025
On June 22, 2023, the Budget Implementation Act, 2023, No. 1 (Bill C-47) received royal assent and amended the Patent Act to introduce patent term adjustment (PTA) to compensate patentees for Patent Office delays in granting a patent. Our article, “A first look at Canada’s proposed patent term adjustment system”, discusses the amendments, which 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.
4. PMPRB: New chair, amended guidelines expected in 2024 and updates to Interim Guidance
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.
In April, the House of Commons Standing Committee on Health began meetings on its study of the PMPRB.
Amended Guidance under the July 1, 2022 amendments to the Patented Medicines Regulations remain pending. In a June Notice and Comment, the PMPRB proposed an update to interim price reviews for comment by August 21, and advised that the new guidelines “are anticipated to be finalized in 2024.”
5. National Strategy for Rare Diseases, Health Canada’s regulatory initiatives
On March 22, 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.”
Health Canada consultations included:
Relating to public health emergencies:
6. Market access: IMC proposes framework for innovative agreements for drug reimbursement, CADTH announces upcoming improvements to reimbursement reviews
In November 2022, Innovative Medicines Canada (IMC) published the Innovative Agreements Framework, describing various innovative reimbursement models that have already been piloted or implemented globally to facilitate new approaches for reimbursement in negotiations between the pan-Canadian Pharmaceutical Alliance (pCPA) and pharmaceutical manufacturers for formulary listing by public payors. In March, IMC released a further report, Innovative Access Arrangements and Managed Entry—What Canada Can Learn From Europe, which outlines various arrangements made for reimbursement of drugs in Italy, England and Spain, and what lessons Canada could take from such arrangements.
In March, the Canadian Agency for Drugs and Technologies in Health (CADTH) released a consultation document for a Proposed Process for Time-limited Reimbursement Recommendations, which would be contingent on a future reassessment with further evidence about the comparative clinical benefit and cost-effectiveness of the drug or drug regimen under review.
In June, 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.
7. Biosimilars update, Ontario biosimilars transition policy
Our March 2023 biosimilars update provides a further update on biosimilars in Canada (approvals, pending submissions, litigation, regulatory, and market access). By December 29, 2023, the Ontario Drug Benefit program will not fund eight specific innovator biologics subjects to exemptions.
8. 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, including as 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, and reference 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.
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