Patent decisions on the merits
Fourth anniversary of amended PMNOC Regulations
PMPRB updates
Judicial consideration of Health Canada CSP decisions
Judicial consideration of Health Canada decisions
Court upholds decision maintaining damages award against Apotex for cefaclor patent infringement
Health Canada updates
Biosimilars update
Two Statutes of Monopolies claims summarily dismissed
Litigation funding agreement for proposed class action against generic manufacturers approved
Work ongoing on potential Pan-Canadian Formulary
This article provides an overview of the top Canadian life sciences IP and regulatory law developments in 2021.
Patent decisions on the merits
The federal courts issued many patent decisions in 2021, both within and outside the Patented Medicines (Notice of Compliance) Regulations (the PMNOC Regulations).
Federal Court decisions included the following:
- Teva v Pharmascience (glatiramer acetate, Copaxone, Glatect) – claims to the use of glatiramer acetate in treating patients who have had a single clinical attack suggestive of multiple sclerosis before a confirmed diagnosis (437 patent) were found to be invalid (not anticipated but obvious); claims to the use of 40 mg glatiramer acetate administered by a subcutaneous injection three times per week for the treatment of relapsing-remitting multiple sclerosis (802 patent) were found to be valid (not obvious, useful) and infringed. Appeals were heard in November; decisions are under reserve. This decision was made under the PMNOC Regulations;
- Bristol-Myers Squibb v Pharmascience, Sandoz (apixaban, Eliquis) – claims to apixaban and the use of apixaban in the treatment of thromboembolic disorders (202 patent) were found to be valid (attacks included inutility of selection) and infringed; claims to the formulation of 2.5 and 5 mg apixaban (dry granulation) tablets (171 patent) were found to be valid (attacks included obviousness) and infringed. Sandoz and Pharmascience's appeals are pending. This decision was made under the PMNOC Regulations;
- Janssen v Hospira (infliximab, Remicade, Inflectra) – on reconsideration of anticipation and obviousness; the validity of claims to the use of a combination of infliximab with methotrexate for the treatment of rheumatoid arthritis was maintained. Hospira's appeal and the remedy portion of the action were discontinued in July 2021;
- Janssen v Pharmascience (abiraterone acetate, Zytiga) – claims to the use of a combination of abiraterone acetate and prednisone for the treatment of prostate cancer were found to be invalid (obvious). Janssen's appeal is pending. This decision was made under the PMNOC Regulations;
- Merck v Wyeth (13-valent pneumococcal polysaccharide protein conjugate vaccine, Prevnar 13) – in an impeachment action (Merck filed a new drug submission (NDS) for 15-valent vaccine), claims to a multivalent immunogenic composition comprising 13 distinct polysaccharide serotypes conjugated to CRM197 (363 patent) were construed as limited to 13 serotypes and valid (not anticipated or obvious); claims to a formulation (056, 111 patents) were found to be invalid (obvious, double patented). Wyeth's appeal was discontinued; and
- Hoffmann-La Roche v Sandoz (pirfenidone, Esbriet) – pirfenidone for use in a specific dose escalation regimen (654 patent) and for use at a specific dose in a patient that experiences a specific liver abnormality (997 patent) was found to be invalid (method of medical treatment and obvious). Roche's appeal is pending. This decision was made under the PMNOC Regulations.
Federal Court of Appeal decisions included the following:
- Apotex v Janssen (abiraterone acetate, Zytiga) – a prohibition order under the pre-amended PMNOC Regulations was affirmed by the Federal Court of Appeal. Claims to the use of abiraterone acetate and prednisone for the treatment of prostate cancer were found to be valid (patentable subject matter (synergy not required), not obvious, useful) and infringed. This decision was made under the PMNOC Regulations;
- Apotex v Shire (lisdexamfetamine, Vyvanse) – a prohibition order under the pre-amended PMNOC Regulations and the dismissal of an impeachment action were affirmed by the Federal Court of Appeal. Claims to lisdexamfetamine were found to be valid (not anticipated based on disclosure of genus, not obvious). The Supreme Court of Canada denied Apotex leave. This decision was made under the PMNOC Regulations;
- Viiv v Gilead (bictegravir/emtricitabine/tenofovir, Biktarvy) – the dismissal of an action following the summary trial (claims to genus of compounds were found to be not infringed) was upheld by the Federal Court of Appeal. Viiv has applied for leave to appeal; and
- Seedlings Life Science Ventures v Pfizer (next generation auto-injector EpiPen) – the dismissal of an infringement action against Pfizer (auto-injection device claims were found to be invalid and not infringed) was upheld by the Federal Court of Appeal.
Fourth anniversary of amended PMNOC Regulations
September 2021 marked the fourth anniversary of the significant amendments to the PMNOC Regulations. Over the past four years, Sandoz was the most active patent challenger, followed by Apotex and Teva. To date, no action under the amended section 8 has gone to trial.
Procedural decisions under the PMNOC Regulations included the following (for further details, please see "2021 Mid-Year Highlights in Canadian Life Sciences IP and Regulatory Law"):
- A defendant was permitted to amend its statement of defence to plead validity attacks beyond its notice of allegation. The decision was upheld on appeal.
- Section 8.2, which permits an action on an unaddressed patent (eg, an unlisted patent) once a notice of allegation (NOA) is served, does not impose a deadline for commencing an action.
- A re-examination proceeding was stayed pending Pharmascience's appeal of a PMNOC judgment finding the patent valid and infringed (see the first bullet point under "Patent decisions on the merits" above).
- A plaintiff was denied leave to amend its statement of claim to plead infringement of further patents more than 45 days after receipt of NOAs.
Amendments further delayed to July 2022
On 23 December 2021, the coming into force of the amended Patented Medicines Regulations and associated guidelines, originally scheduled for 1 July 2020, was yet further delayed until 1 July 2022 (see statement from the minister of health). Appeals of Federal Court (hearing to be scheduled in 2022) and Quebec Superior Court (appeal heard in December) decisions regarding challenges to the amendments are pending. Both courts had struck out the provisions relating to confidential third-party rebates. A separate challenge to the guidelines is pending in the Federal Court. For further details, please see "PMPRB Update — Ringing in the New Year with New Regulations In-Force?".
CSPs
On 30 June 2021, the jurisdiction of the Patented Medicine Prices Review Board (PMPRB) was extended to certificates of supplementary protection (CSPs).
Excessive pricing decision remitted
On 29 July 2021, the Federal Court of Appeal remitted the PMPRB's pricing decision regarding Alexion's Soliris back to the PMPRB for redetermination. In doing so, the Federal Court of Appeal found that the PMPRB had misunderstood its mandate, which is directed at controlling patent abuse, not reasonable pricing, price-regulation or consumer protection at large. The attorney general of Canada has sought leave to appeal from the Supreme Court of Canada.
Judicial consideration of Health Canada CSP decisions
Since September 2017, CSPs have been available in Canada and provide additional patent-like protection of up to two years (see "Certificate of Supplementary Protection Regime: Second Anniversary Update" for a general overview of CSPs). To date, Health Canada decisions relating to three CSP applications have been the subject of court decisions.
On 14 April 2021, the Federal Court of Appeal found the minister of health was reasonable in her refusal to grant a CSP for Shingrix, including in her interpretation and application of the CSP provisions to exclude patent claims directed to a formulation, "particularly the one at issue".
On 29 September 2021, the Federal Court set aside the minister's decision rejecting Merck's CSP application for Belsomra and remitted it back to the minister for redetermination. The case relates to the requirements that a notice of compliance (NOC) must issue from the related NDS before a CSP application can be filed, and that the NDS must be filed before the end of the 12-month period beginning on the day on which the first application for a marketing approval in prescribed countries, including the United States, was submitted.
In 2020, a CSP application for Juluca was remitted to the minister of health for reconsideration. The minister had rejected the application as Juluca contains a combination of dolutegravir and rilpivirine, and the patent, while claiming dolutegravir, does not claim the combination. On reconsideration, the minister of health again refused the application and Viiv commenced but discontinued its second judicial review application.
Judicial consideration of Health Canada decisions
Data protection
Catalyst received an NOC for Firdapse (amifampridine). Médunik later received an NOC for Ruzurgi (also containing amifampridine) based on a NDS 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. On 31 May 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 a second judicial review application is pending.
On 12 July 2021, the Federal Court of Appeal dismissed Janssen's appeal from a Federal Court decision, finding that Spravato is not an "innovative drug" eligible for such protection as its medicinal ingredient esketamine hydrochloride is an enantiomer of a previously approved drug. On 10 November 2021, the minister rejected Janssen's second request for data protection for Spravato, submitted following the coming into force of the Canada-United States-Mexico Agreement. Janssen has sought judicial review.
Patent listing
On 22 November 2021, the Federal Court of Appeal dismissed Merck's appeal from a Federal Court decision that dismissed its application for judicial review of Health Canada's refusal to add a patent to the Patent Register against Keytruda, upholding the strict interpretation of patent listing deadlines.
Natural health product licence
On 2 November 2021, the Federal Court of Appeal dismissed C-RNA's appeal from a Federal Court decision that dismissed its application for judicial review of Health Canada's refusal to grant a Natural health product licence for Boluoke. C-RNA has sought leave to appeal.
Access to information
On 24 September 2021, the Federal Court of Appeal allowed the minister's appeal of a Federal Court decision finding that certain records relating to Elanco's Fortekor were exempt from disclosure.
Court upholds decision maintaining damages award against Apotex for cefaclor patent infringement
On 23 July 2021, the Federal Court of Appeal dismissed Apotex's appeal of the Federal Court reconsideration decision confirming its original decision fixing $31 million in damages and $75 million in prejudgment interest owed by Apotex for its infringement of eight Eli Lilly process patents relating to the antibiotic cefaclor. Apotex has applied for leave to appeal.
Health Canada regulatory developments included the following:
- In January 2021, the Food and Drug Administration published an overview of Project Orbis (a global collaborative review program) and the regulatory actions within the first year of its implementation, which included eight Health Canada approvals.
- In March 2021, Health Canada released for consultation its new draft guidance document on electronic media in prescription drug labelling, which sets out Health Canada's expectations for drug manufacturers distributing information about a prescription drug through an electronic platform linked to the drug's label.
- In April 2021, proposed amendments to the PMNOC Regulations were published that would permit the listing of patents that claim variations of the approved medicinal ingredient, including salts. Such amendments would come into force on the same day as proposed amendments to the Food and Drug Regulations, which remain pending and would allow a generic manufacturer to file an abbreviated NDS for a different salt form of the medicinal ingredient in the Canadian reference product.
- In June 2021, proposed amendments to the Food and Drug Regulations were published that would extend drug establishment licensing and good manufacturing practices requirements to persons conducting licensable activities with drugs solely for export.
- Also in June 2021, proposed amendments to the Natural Health Products Regulations were published that would make natural health product labels more clear, legible and easier to understand.
- In July 2021, proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations were published. The amendments are planned for Spring 2022 and are intended to modernise the regulatory system for drugs and medical devices in four areas:
- imposing terms and conditions;
- risk management plans;
- rolling submissions; and
- modernising requirements for biologic drugs.
- In August 2021, certain sections of the Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages), which provide Health Canada with permanent regulatory tools to address therapeutic product shortages, came into force. These regulations will maintain a number of the powers from interim orders made to address shortages since March 2020.
- In October 2021, Health Canada, the US Food and Drug Administration and the United Kingdom's Medicines and Healthcare Products Regulatory Agency jointly published the Good Machine Learning Practice for Medical Device Development: Guiding Principles, paving the way for more artificial intelligence/machine learning medical devices in Canada.
- Also in October 2021, Health Canada released its Mid-year update: Health products approved in 2021, which includes an update on Health Canada's covid-19 regulatory response. See updates on Health Canada, Canada Intellectual Property Office, and federal courts developments relating to covid-19 here.
Health Canada also released its annual (1 April 2020 to 31 March 2021) and second quarter 2021 performance reports.
For an update on approvals, pending regulatory submissions, and litigation, regulatory, and market access developments that took place in 2021, click here.
Two Statutes of Monopolies claims summarily dismissed
Apotex's claims against Eli Lilly under the Statutes of Monopolies, Trademarks Act and common law conspiracy relating to Apo-Olanzapine were summarily dismissed in March 2021 and similar claims against Pfizer regarding Apo-Sildenafil were summarily dismissed in September 2021. Apotex's appeals are pending.
Litigation funding agreement for proposed class action against generic manufacturers approved
On 20 September 2021, the Federal Court approved a litigation funding agreement in a proposed price-fixing/market allocation class action proceeding against over 50 generic drug manufacturers commenced in 2020.
Work ongoing on potential Pan-Canadian Formulary
While progress on implementation of a national pharmacare program appeared slow in 2021, in December 2021, the Canadian Agency for Drugs and Technologies in Health (CADTH) announced that the Pan-Canadian Formulary Advisory Panel (established by CADTH) would present an information session with its recommendations for the development of a framework for a potential pan-Canadian prescription drug list, or formulary. The information session took place on 18 January 2022.
For further information on this topic please contact Nancy Pei at Smart & Biggar by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar website can be accessed at www.smartbiggar.ca.