In the fall of 2021, the Rx IP Update team celebrated its 20^thyear of monthly updates on Canadian life sciences IP and regulatory law. Below are highlights from our team’s 2021 updates (see also our Top 10 Rx IP Update Reads of 2021):

Contents

1. Patent decisions on the merits
2. Fourth anniversary of amended PMNOC Regulations
3. PMPRB: amendments further delayed to July 2022; validity challenge appeals pending; SOLIRIS pricing decision remitted to Board
4. Judicial consideration of Health Canada Certificate of Supplementary Protection decisions
5. Judicial consideration of Health Canada data protection, patent listing, NHP licence and access to information decisions
6. FCA upholds reconsideration decision maintaining damages award against Apotex for cefaclor patent infringement
7. Health Canada updates
8. Biosimilars update
9. Two Statutes of Monopolies claims summarily dismissed
10.  Litigation funding agreement for proposed class action against generic manufacturers approved
11.  Work ongoing on potential Pan-Canadian Formulary

1. Patent decisions on the merits

The Federal Courts issued many patent decisions in 2021, within (*) and outside the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations).

Federal Court (FC) decisions:

1. Teva v Pharmascience* ( glatiramer acetate, COPAXONE, GLATECT) – Claims to use of glatiramer acetate in treating patients who have had a single clinical attack suggestive of multiple sclerosis before confirmed diagnosis (437 patent) invalid (not anticipated but obvious); claims to use of 40 mg glatiramer acetate administered by subcutaneous injection three times per week for treatment of relapsing-remitting multiple sclerosis (802 patent) valid (not obvious, useful) and infringed. Appeals were heard in November, decisions are under reserve.
2. Bristol-Myers Squibb v Pharmascience, Sandoz* ( apixaban, ELIQUIS) – Claims to apixaban and use of apixaban in treatment of thromboembolic disorders (202 patent) valid (attacks included inutility of selection) and infringed; claims to formulation of 2.5 and 5 mg apixaban (dry granulation) tablets (171 patent) valid (attacks included obviousness) and infringed. Sandoz and Pharmascience’s appeals are pending.
3. Janssen v Hospira (infliximab, REMICADE, INFLECTRA) – On reconsideration of anticipation and obviousness, validity of claims to use of combination of infliximab with methotrexate (MTX) for treatment of rheumatoid arthritis maintained. Hospira’s appeal and the remedy portion of the action were discontinued in July 2021.
4. Janssen v Pharmascience* ( abiraterone acetate, ZYTIGA) – Claims to use of a combination of abiraterone acetate and prednisone for treatment of prostate cancer invalid (obvious). Janssen’s appeal is pending.
5. Merck v Wyeth (13-valent pneumococcal polysaccharide protein conjugate vaccine, PREVNAR 13) – In impeachment action (Merck filed NDS for 15-valent vaccine), claims to multivalent immunogenic composition comprising 13 distinct polysaccharide serotypes conjugated to CRM197 (363 patent) construed as limited to 13 serotypes, valid (not anticipated or obvious); claims to formulation (056, 111 patents) invalid (obvious, double patented). Wyeth’s appeal was discontinued.
6. 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) invalid (method of medical treatment and obvious). Roche’s appeal is pending.

Federal Court of Appeal (FCA) decisions:

1. Apotex v Janssen* ( abiraterone acetate, ZYTIGA) – Prohibition order under pre-amended PMNOC Regulations affirmed by FCA. Claims to use abiraterone acetate and prednisone for treatment of prostate cancer valid (patentable subject matter (synergy not required), not obvious, useful) and infringed.
2. Apotex v Shire* ( lisdexamfetamine, VYVANSE) – Prohibition order under pre-amended PMNOC Regulations/dismissal of impeachment action affirmed by FCA. Claims to lisdexamfetamine valid (not anticipated based on disclosure of genus, not obvious). The Supreme Court of Canada denied Apotex leave.
3. Viiv v Gilead (bictegravir/emtricitabine/tenofovir, BIKTARVY) – Dismissal of action following summary trial (claims to genus of compounds not infringed) upheld by FCA. Viiv has applied for leave to appeal.
4. Seedlings Life Science Ventures v Pfizer (next generation auto-injector EpiPen) – Dismissal of infringement action against Pfizer (auto-injection device claims invalid and not infringed) upheld by FCA. 

2. Fourth anniversary of amended PMNOC Regulations

In September, we provided a fourth anniversary update on the significant amendments to the PMNOC Regulations, which includes statistics on actions commenced, pending, decided, and appealed. Over the last four years, Sandoz was the most active patent challenger followed by Apotex and Teva. To date, no action under amended section 8 has gone to trial.

As reported in our mid-year update, procedural decisions under the PMNOC Regulations included:

• A defendant was permitted to amend its statement of defence to plead validity attacks beyond its notice of allegation; decision was upheld on appeal.
• Section 8.2, which permits an action on an unaddressed patent, e.g. 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 #1 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.

3. PMPRB: amendments further delayed to July 2022; validity challenge appeals pending; SOLIRIS pricing decision remitted to Board

Amendments – On December 23, the coming into force of the amended Patented Medicines Regulations and associated Guidelines, originally scheduled for July 1, 2020, was yet further delayed until July 1, 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. See our latest update on PMPRB.

Certificates of supplementary protection (CSPs) – On June 30, the jurisdiction of the Patented Medicine Prices Review Board (PMPRB) was extended to CSPs.

Excessive pricing decision remitted – On July 29, the FCA remitted the Board’s pricing decision regarding Alexion’s SOLIRIS back to the Board for redetermination. In doing so, the FCA found that the Board 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.

4. Judicial consideration of Health Canada Certificate of Supplementary Protection decisions

Since September 2017, CSPs have been available in Canada and provide additional patent-like protection of up to two years (see a general overview article on CSPs). To date, Health Canada decisions relating to three CSP applications have been the subject of court decisions.

On April 14, the FCA 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 September 29, the FC 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 new drug submission (NDS) before a CSP application can be filed, and that the NDS must be filed before the end of the twelve-month period beginning on the day on which the first application for a marketing approval in prescribed countries including the U.S. 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.

5. Judicial consideration of Health Canada data protection, patent listing, NHP licence and access to information decisions

Data protection – (1) Catalyst received an NOC for FIRDAPSE (amifampridine). Médunik later received an NOC for RUZURGI (also containing amifampridine) based on a new drug submission 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 May 31, 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.

(2) On July 12, the FCA dismissed Janssen’s appeal from a FC 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 November 10, 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 November 22, the FCA dismissed Merck’s appeal from a FC decision which 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. 

NHP licence – On November 2, the FCA dismissed C-RNA’s appeal from a FC decision which 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 September 24, the FCA allowed the Minister’s appeal of a FC decision finding that certain records relating to Elanco’s FORTEKOR were exempt from disclosure.

6. FCA upholds reconsideration decision maintaining damages award against Apotex for cefaclor patent infringement

On July 23, the FCA dismissed Apotex’s appeal of the FC reconsideration decision confirming its original decision fixing $31M in damages and $75M in prejudgment interest owed by Apotex for its infringement of eight Eli Lilly process patents related to the antibiotic cefaclor. Apotex has applied for leave to appeal.

7. Health Canada updates

Health Canada regulatory developments included:

• In January, the FDA 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, 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, proposed amendments to the PMNOC Regulations were published which would permit 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 new drug submission for a different salt form of the medicinal ingredient in the Canadian reference product.
• In June, proposed amendments to the Food and Drug Regulations were published that would extend drug establishment licensing and Good Manufacturing Practices (GMP) requirements to persons conducting licensable activities with drugs solely for export.
• Also in June, 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, 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 modernize the regulatory system for drugs and medical devices in four areas: imposing terms and conditions, risk management plans, rolling submissions, and modernizing requirements for biologic drugs. 
• In August, 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, Health Canada, the US Food and Drug Administration (FDA), and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) jointly published the Good Machine Learning Practice for Medical Device Development: Guiding Principles, paving the way for more AI/ML medical devices in Canada.
• Also in October, 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 also our COVID-19 page for updates on Health Canada, CIPO, and Federal Courts developments.

We also reported on Health Canada’s annual (April 1, 2020 to March 31, 2021) and second quarter 2021 performance reports.

8. Biosimilars update

In October, Urszula Wojtyra provided her latest biosimilars update on approvals, pending regulatory submissions, and litigation, regulatory, and market access developments.

9. 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 and similar claims against Pfizer regarding Apo-Sildenafil were summarily dismissed in September. Apotex’s appeals are pending.

10. Litigation funding agreement for proposed class action against generic manufacturers approved

On September 20, 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.

11. Work ongoing on potential Pan-Canadian Formulary

While progress on implementation of a national pharmacare program appeared slow in 2021, in December, the Canadian Agency for Drugs and Technologies in Health (CADTH) announced that on January 18, 2022, the Pan-Canadian Formulary Advisory Panel (established by CADTH) will be presenting an information session with their recommendations for the development of a framework for a potential pan-Canadian prescription drug list, or formulary.

[View source.]