In the first half of 2021, 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 here.
- PMPRB: amendments delayed to January 2022; jurisdiction extends to CSPs
- Judicial consideration of Health Canada CSP and data protection decisions
- Patent decisions on the merits
- Procedural decisions under PMNOC Regulations
- Statutes of Monopolies claim summarily dismissed
- Health Canada updates
- Biosimilar update
- COVID-19 Update: Federal Courts, Health Canada
1. PMPRB: amendments delayed to January 2022; jurisdiction extends to CSPs
The coming into force of the amended Patented Medicines Regulations and associated Guidelines (see articles here and here) was further delayed until January 1, 2022 (see our latest update here). Appeals of Federal Court and Quebec Superior Court decisions regarding challenges to the amendments are pending; both courts struck out the provisions relating to confidential third party rebates. On June 30, the jurisdiction of the Patented Medicine Prices Review Board (PMPRB) was extended to certificates of supplementary protection (CSPs).
2. Judicial consideration of Health Canada CSP and data protection decisions
The Federal Court of Appeal reversed a Federal Court decision and found the Minister of Health was reasonable in her refusal to grant a CSP for SHINGRIX, including the Minister’s interpretation and application of the CSP provisions to exclude patent claims directed to a formulation, “particularly the one at issue”.
Catalyst received an NOC for FIRDAPSE (amifampridine). Médunik later received an NOC for RUZURGI (also containing amifampridine) based on a regulatory submission 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. The Court quashed the RUZURGI NOC and returned the matter to the Minister for redetermination.
3. Patent decisions on the merits
In the first half of 2021, the Federal Courts issued a flurry of patent decisions within and outside the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations). Appeals / leaves to appeal of every decision below (to date, apart from #9) are pending.
- Teva v. Pharmascience (glatiramer acetate, COPAXONE, GLATECT) – In a PMNOC action, 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.
- Bristol-Myers Squibb v. Pharmascience, Sandoz (apixiban, ELIQUIS) – In a PMNOC action, claims to apixiban and use of apixiban in treatment of thromboembolic disorders (202 patent) valid (attacks included inutility of selection) and infringed; claims to formulation of 2.5 and 5 mg apixiban (dry granulation) tablets (171 patent) valid (attacks included obviousness) and infringed.
- Janssen v Hospira (infliximab, REMICADE, INFLECTRA) – Reconsideration on anticipation and obviousness; validity of claims to use of combination of infliximab with methotrexate (MTX) for treatment of rheumatoid arthritis maintained.
- Janssen v. Pharmascience (abiraterone acetate, ZYTIGA) – In a PMNOC action, claims to use of a combination of abiraterone acetate and prednisone for treatment of prostate cancer invalid (obvious). See #5.
- Apotex v Janssen (abiraterone acetate, ZYTIGA) – Prohibition Order under pre-amended PMNOC Regulations affirmed by FCA. Claims to use of abiraterone acetate and prednisone for treatment of prostate cancer valid (patentable subject matter (synergy not required), not obvious, useful) and infringed. See #4.
- 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).
- 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).
- Hoffmann-La Roche v. Sandoz (pirfenidone, ESBRIET) – In a PMNOC action, 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).
- Viiv v. Gilead (bictegravir/emtricitabine/tenofovir, BIKTARVY) – Dismissal of action following summary trial (claims to genus of compounds not infringed) upheld by FCA.
4. Procedural decisions under PMNOC Regulations
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 a claim 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.
5. Statutes of Monopolies claim 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. Apotex has appealed.
6. Health Canada updates
In addition to a number of COVID-19 developments (see #10 below), 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 clam 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 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 remain pending.
- 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.
7. Biosimilar update
Urszula Wojtyra provided a further biosimilar update on approvals, pending submissions, and regulatory, litigation and market access developments (see also a later article here on Quebec’s reimbursement policy).
8. COVID-19 Update: Federal Courts, Health Canada
See our COVID-19 update page for latest updates on the Federal Courts’ COVID-19 practice directions. The Court interpreted the Time Limits and Other Periods Act (COVID-19) as (i) suspending the 45-day time limit for commencing a s. 6(1) action under the PMNOC Regulations from March 13 to July 30, 2020 (see here) and (ii) not suspending the 30-day time limit under s. 4(6) for submitting a patent list (see here).
Our COVID-19 update page also summarizes Health Canada’s COVID-19 measures (see summary document here), including clinical trials relating to COVID-19. One of Health Canada’s Interim Orders (ISAD Interim Order) introduced a new pathway to expedite the authorization for COVID-19 drugs, including vaccines. The Food and Drug Regulations were amended on March 18, 2021 to allow continued sale of COVID-19 drugs so authorized, following expiry of the ISAD Interim Order.