In the first half of 2024, 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.
Table of content
- Patent decisions on the merits
- PMNOC Regulations: Second notice of allegation may be abusive; successor second person permitted to rely on predecessor’s NOA
- Proposed regulations for new patent term adjustment system released
- PMPRB’s DIFFERIN decision upheld; Discussion Guide released for new guidelines consultation
- Regulatory: US FDA authorizes Florida import plan; CRP ‘dormant’ status; increased transparency for GSUR list
- Market access: Pharmacare Bill introduced; CDA initiatives including Target Zero; pCPA launches Temporary Access Process
- Biosimilars: BYOOVIZ / BEOVU trademarks found confusing; biosimilars update
- FCA dismisses appeal of SPRAVATO data protection decision
1. Patent decisions on the merits
Federal Court (FC):
- Allergan v Juno (bimatoprost, LUMIGAN RC) – The FC granted Allergan/AbbVie’s s. 6(1) Patented Medicines (Notice of Compliance) Regulations (PMNOC) action. The asserted formulation claims were found valid (not obvious, not insufficient); Juno conceded infringement.
- Takeda v Apotex (dexlansoprazole, DEXILANT) – Takeda’s s. 6(1) PMNOC action was dismissed. The claims relating to a pulsatile release formulation of dexlansoprazole were found not infringed and invalid for lack of sound prediction of utility and insufficiency.
- Medexus Pharmaceuticals v Accord Healthcare (methotrexate 50 mg/ml pre-filled syringes, METOJECT) – Medexus and Medac’s infringement action was dismissed. The claims relating to a use of methotrexate for the production of a subcutaneously administered medicament in a ready-made syringe for the treatment of rheumatoid arthritis at a concentration of about 50 mg/ml were found invalid as obvious; Accord conceded infringement.
Federal Court of Appeal (FCA):
- Apotex v Janssen (paliperidone palmitate, INVEGA SUSTENNA) – The FCA dismissed Apotex’s appeal of a decision in a s. 6(1) PMNOC action finding that Apotex would induce infringement of claims to a dosing regime. Apotex’s non-infringement position was premised on not seeking approval for the 75 mg strength syringe, which corresponded to an essential element of the claims, and specifically, that prescribing practices would not change. Apotex’s SCC leave application was dismissed.
- Pharmascience v Janssen (paliperidone palmitate, INVEGA SUSTENNA) – The FCA dismissed Pharmascience’s appeal of a decision in a s. 6(1) PMNOC action finding that Pharmascience would induce infringement of claims to a dosing regime. Pharmascience’s non-infringement position was premised on not seeking approval for the 75 mg strength syringe, and specifically, that any activities using Pharmascience’s product that would fall within the scope of the claims would be licensed by Janssen, as it provides the 75 mg-eq dose. Pharmascience’s SCC leave application was dismissed.
- Pharmascience v Janssen (paliperidone palmitate, INVEGA SUSTENNA) – The FCA dismissed Pharmascience’s appeal of a decision in a s. 6(1) PMNOC action finding that claims to a dosing regime were not invalid as a method of medical treatment (non-obviousness finding was not pursued on appeal). Pharmascience’s SCC leave application is pending.
- Eli Lilly v Teva and others (tadalafil, CIALIS) – The FCA dismissed Eli Lilly’s appeal of a decision finding that the claims were invalid for claim overbreadth and insufficiency of disclosure, declining to interfere with the FC’s construction of “physiologically acceptable” salt of tadalafil.
2. PMNOC Regulations: Second notice of allegation may be abusive; successor second person permitted to rely on predecessor’s NOA
In December 2023, the FCA reversed an FC decision and held that it was an abuse of process for Apotex to raise invalidity in defending s. 6(1) PMNOC actions relating to paliperidone palmitate (INVEGA SUSTENNA) after unsuccessfully asserting only non-infringement in a 2021 action involving the same parties and the same patent: Janssen v Apotex, 2023 FCA 253. According to the FCA, had Apotex wished to allege invalidity, it could and should have done so in the 2021 action.
In February, the FCA affirmed an FC decision, which found that the Minister of Health’s determination that Biosimilar Collaborations Ireland Limited was entitled to the benefit of prior service of a Notice of Allegation by the previous owner of the new drug submission for YESAFILI (an aflibercept biosimilar) was reasonable: Bayer v BGP Pharma (Viatris Canada), 2024 FCA 29.
3. Proposed regulations for new patent term adjustment system released
In June 2023, the Patent Act was amended to introduce patent term adjustment (PTA) to compensate patentees for Patent Office delays in granting a patent. 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. Proposed regulations implementing the PTA system were published for comment on May 18, 2024.
4. PMPRB’s DIFFERIN decision upheld; Discussion Guide released for new guidelines consultation
In January, the FC held that the PMPRB was reasonable in its redetermination that the patent at issue—claiming the use of 0.3% adapalene for the treatment of dermatological disorders—pertained to, or could be used for, Galderma’s 0.1% adapalene product, DIFFERIN: Galderma Canada Inc v Canada, 2024 FC 46. The FC held that the Board reasonably found that the significant clinical similarities between DIFFERIN XP (0.3 % adapalene) and DIFFERIN supported the conclusion that the patent pertains to DIFFERIN. The PMPRB ordered Galderma to file prescribed sales information for DIFFERIN. Galderma has appealed.
The PMPRB released its 2022 Annual Report in February.
In June, the PMPRB released a Discussion Guide for its Phase 2 Consultations on its New Guidelines. Comments are due September 11, 2024. Draft Guidelines are anticipated by the end of 2024 for comment, with implementation anticipated in 2025.
5. Regulatory: US FDA authorizes Florida import plan; CRP ‘dormant’ status; increased transparency for GSUR list
In January, the U.S. FDA authorized Florida’s plan to import drugs in bulk from Canada. Florida must meet further statutory requirements before drugs can be imported, including testing and relabeling of the prescription drugs. Health Canada responded with a Bulletin and Statement emphasizing that “[t]he Government of Canada is taking all necessary action to safeguard the drug supply and ensure Canadians have access to the prescription drugs they need and has been clear in its position: bulk importation will not provide an effective solution to the problem of high drug prices in the U.S.”
Also in January, Health Canada confirmed that if a drug that would otherwise have been identified as the Canadian reference product (CRP, the comparator product for an abbreviated new drug submission) is listed as ‘Dormant’ in the Drug Product Database, such status can be considered to be evidence that the drug is “no longer marketed”, as used in subsection C.08.001.1(b) of the Food and Drug Regulations. Pursuant to subsection C.08.001.1(b), where a drug that would otherwise have been a CRP is no longer marketed in Canada, another drug acceptable to the Minister can be used as the CRP for demonstrating bioequivalence.
In February, Health Canada announced that the Generic Submissions Under Review (GSUR) list was expanded to include the year and month in which each abbreviated new drug submission (ANDS) was accepted into review and the sponsor name for ANDSs accepted into review on or after April 1, 2024.
In March, Health Canada published a Memorandum of Understanding with the Competition Bureau which includes a commitment to share information on complaints or inquiries related to false, misleading or deceptive health claims, subject to confidentiality obligations and applicable legislation.
6. Market access: Pharmacare Bill introduced; CDA initiatives including Target Zero; pCPA launches Temporary Access Process
On February 29, 2024, Bill C-64, An Act respecting pharmacare (Pharmacare Act), was introduced. According to Health Canada’s news release, the Bill “proposes the foundational principles for first phase of national universal pharmacare in Canada and describes the Government of Canada’s intent to work with provinces and territories (PTs) to provide universal, single-payer coverage for a number of contraception and diabetes medications.” Bill C-64 also provides that Canada’s Drug Agency (CDA; formerly, CADTH) will develop a national formulary and a national bulk purchasing strategy and will also support the publication of a pan-Canadian strategy regarding the appropriate use of prescription medications. Finally, the Minister would establish an expert committee to make recommendations on operations and financing of the national universal pharmacare. The Bill was referred to committee by the Senate on June 18, 2024.
CDA announced several major initiatives, including, in April, the Target Zero initiative which aims to achieve zero days between Health Canada’s regulatory approval of a drug and CDA’s reimbursement recommendation to participating drug plans. CDA accepts submissions 180 days before Health Canada’s anticipated regulatory decision, which enables a parallel review process.
In April, the pan-Canadian Pharmaceutical Alliance (pCPA) announced that it was ready to accept drugs through the pCPA Temporary Access Process (pTAP). This process applies to drug products that follow the CDA’s time-limited reimbursement recommendation pathway and allows patients temporary access to drugs with promising early results while further clinical evidence is collected.
7. Biosimilars: BYOOVIZ / BEOVU trademarks found confusing; biosimilars update
In February 2024, Novartis obtained a permanent injunction preventing Biogen and Samsung Bioepis from using the trademark BYOOVIZ for its ranibizumab biosimilar of Novartis’s LUCENTIS, holding that it was confusing to Novartis’ BEOVU trademark used in association with brolucizumab; all three drugs are used to treat age-related macular degeneration. The FCA stayed the injunction and expedited the appeal, which was heard on May 28, 2024.
Our March 2024 biosimilars update provides a further update on biosimilars in Canada (approvals, pending submissions, litigation, regulatory, and market access).
8. FCA dismisses appeal of SPRAVATO data protection decision
In April, the FCA upheld the FC’s decision which 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.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group or the Pharmaceutical Litigation Group.
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.