2024 highlights in Canadian life sciences IP and regulatory law

In 2024, the Rx IP Update team at Smart & Biggar reported on a number of developments in Canadian life sciences IP and regulatory law. Highlights from 2024 are below; see also our top ten Rx IP Update reads of 2024.

Table of contents

1. Patent decisions on the merits
2. PMNOC Regulations: seventh anniversary of major amendments, court decisions, updated Federal Court Guidelines
3. Patent term adjustment now in force
4. PMPRB: FCA rules in Galderma’s favour on nexus requirement, new draft guidelines released for comment
5. Regulatory: Florida’s import plan not commenced, increased transparency for GSUR list, agile licensing amendments registered
6. Market access: Pharmacare Act in force, CDA initiatives including Target Zero, pCPA launches Temporary Access Process, “patient steering” update
7. Biosimilars: BYOOVIZ/BEOVU trademarks found confusing, biosimilars update
8. FCA dismisses appeal of SPRAVATO data protection decision
9. Class actions relating to opioid use disorder continue across Canada

1. Patent decisions on the merits

Below are the patent infringement/validity decisions on the merits released in 2024. A case to follow in 2025 is Pharmascience’s Supreme Court of Canada appeal relating to methods of medical treatment, tentatively scheduled to be heard in May 2025.

Federal Court (FC):

• 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.

• Boehringer Ingelheim (Canada) Ltd v JAMP Pharma Corporation (nintedanib, OFEV) – The FC granted Boehringer’s s. 6(1) PMNOC action on a patent claiming the use of nintedanib and its esylate salt in the prevention or treatment of idiopathic pulmonary fibrosis. The claims were found valid (not obvious, soundly predicted and not invalid for double patenting) and directly infringed (JAMP had conceded it would induce infringement). The action was dismissed regarding a formulation patent for non-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 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). The SCC granted Pharmascience leave to appeal.

• Eli Lilly v Apotex 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: seventh anniversary of major amendments, court decisions, updated Federal Court Guidelines

In August, Health Canada released its Statistical Report 2023/2024 for the Patented Medicines (Notice of Compliance) Regulations, Data Protection and Certificates of Supplementary Protection. In September, we provided a seven-year anniversary update of cases under the amended PMNOC Regulations, including various statistics on actions commenced since September 2017, the majority of which are resolved before trial. In the anniversary year ending September 2024, JAMP was the most active patent challenger, followed by Apotex.

Decisions relating to the PMNOC Regulations (other than the decisions on the merits listed under #1 above) included:

• The FCA held that it was an abuse of process for Apotex to raise invalidity in defending s. 6(1) actions regarding paliperidone palmitate after unsuccessfully asserting only non-infringement in a 2021 action involving the same parties and the same patent.

• The FCA affirmed the reasonableness of the Minister of Health’s determination that Biosimilar Collaborations Ireland Limited was entitled to the benefit of section 5 of the PMNOC Regulations, including prior service of a Notice of Allegation by the previous owner of the new drug submission for YESAFILI (an aflibercept biosimilar).

• The FC dismissed EMD Serono’s judicial review challenge to the Minister of Health’s finding that Apotex was not required to address a patent on a patent list submitted by EMD Serono before Apotex’s ANDS filing for cladribine (EMD Serono’s MAVENCLAD) but that was listed by the Minister after such filing. EMD Serono has appealed.

• The FC granted Amgen’s motion finding that a patent listed against Bayer’s aflibercept (EYLEA) did not meet the product specificity requirement for listing against a supplemental new drug submission.  Bayer’s application for leave to appeal to the FCA is pending.

In November, the Federal Court updated its Case and Trial Management Guidelines for Complex Proceedings and Proceedings under the PMNOC Regulations, which now requires pre-trial conferences and sets target dates for completion of first round examinations and service of expert reports.

3. Patent term adjustment now in force

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. Regulations implementing PTA came into force on January 1, 2025. Only patents filed on or after December 1, 2020, and issuing after December 1, 2025, may qualify. See our practical guide to the new PTA system.

4. PMPRB: FCA rules in Galderma’s favour on nexus requirement, new draft guidelines released for comment

In a closely-watched case, the FCA overturned the Patented Medicine Prices Review Board’s decision that the patent at issue—claiming the use of 0.3% adapalene for the treatment of dermatological disorders—pertained to and therefore gave it jurisdiction over Galderma’s 0.1% adapalene product, DIFFERIN. The FCA confirmed that the Board does not regulate the pricing of unpatented medicines.

In December, the PMPRB released new draft Guidelines for comment by March 19, 2025. The Draft Guidelines propose a 2-step pricing review process:

1. first reviews (screening) based on whether the price is higher than the highest international price in the PMPRB11 countries, conducted (i) when the drug is first sold in Canada, (ii) annually, also considering inflation using the Consumer Price Index, and (iii) following a complaint, and, if the screening price could be too high,
2. in-depth review, comparing the drug to similar drugs and treatments available for similar medical conditions.  

New medicines will be reviewed immediately after the Guidelines come into effect. Existing medicines (those first sold before July 1, 2022) would be subject to the same annual review process starting one year after the Guidelines go into effect.

The PMPRB’s 2023 Annual Report was also released in December.

5. Regulatory: Florida’s import plan authorized but not implemented, increased transparency for GSUR list, agile licensing amendments registered

While in January, the FDA authorized Florida’s plan to import drugs in bulk from Canada, to date, the program has not yet been implemented. Florida must meet further statutory requirements before drugs can be imported, including testing and relabeling of the prescription drugs. Florida’s proposal is authorized for two years from the date the FDA is notified of the first shipment of drugs to be imported. Health Canada responded in January emphasizing “[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…”

Health Canada proposed regulatory amendments to address health product shortages (to be released) and provided a fiscal year 2023-2024 review on drug shortages: 3,098 drug shortages were reported, with an average length of 93.5 days.

In February, 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 (MOU) 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. Unrelated to this MOU, the Competition Tribunal dismissed JAMP’s application for leave to bring an abuse of dominance case against Janssen relating to ustekinumab (STELARA). 

In November, agile licensing amendments to the Food and Drug Regulations and Medical Devices Regulations were registered. Amendments include enabling the use of terms and conditions on the drug identification number of any drug, requiring risk management plans for certain human drugs and modernizing requirements for biologics. Some amendments are now in force, others will follow in 2025-2027.

6. Market access: Pharmacare Act in force, CDA initiatives including Target Zero, pCPA launches Temporary Access Process, “patient steering” update

The Pharmacare Act came into force in October. For the first phase, the Minister of Health will work with provinces and territories to reach bilateral agreements to provide universal access to certain contraception and diabetes medications. The Act sets out a number of requirements for the Minister of Health and Canada’s Drug Agency. In November, the Minister established a committee of experts to make recommendations on options for the operation and financing of national, universal, single-payer pharmacare.

Canada’s Drug Agency (CDA, formerly CADTH) 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 by accepting submissions 180 days before Health Canada’s anticipated regulatory approval. In November, Health Canada announced that the option for aligned reviews with CDA and INESSS is available to all biological and pharmaceutical new drug submissions. In December, CDA announced the Appropriate Use Coalition to improve the appropriate prescribing and use of medications in Canada.

In April, the pan-Canadian Pharmaceutical Alliance (pCPA) announced that it was ready to accept drugs through the pCPA Temporary Access Process (pTAP) which applies to drugs that follow CDA’s time-limited reimbursement recommendation pathway and allows patients temporary access to drugs with promising early results while further clinical evidence is collected. The pCPA released its 2023-2024 impact report in December.

In October, we provided an update on increased regulatory scrutiny of “patient steering”, the practice of directing patients to certain preferred pharmacies.

7. Biosimilars: BYOOVIZ/BEOVU trademarks found confusing, biosimilars update

Novartis obtained a permanent injunction preventing Biogen and Samsung Bioepis from using the trademark BYOOVIZ for its ranibizumab biosimilar of Novartis’ 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 decision was stayed pending the issuance of an appeal decision, which remains under reserve.

Our March 2024 biosimilars update provides a further update on biosimilars in Canada (approvals, pending submissions, litigation, regulatory and market access).  

Effective August 1, 2024, Manitoba became the last province to implement a Biosimilars Initiative.

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. Health Canada’s Statistical Report 2023/2024 extends to data protection.

9. Class actions relating to opioid use disorder continue across Canada

In December, we provided an update on the ongoing class actions against pharmaceutical companies regarding Opioid Use Disorder and its effects.

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.