1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court challenges pending, draft Guidelines released; Alexion/SOLIRIS, Galderma/DIFFERIN decisions
Significant amendments to the Patented Medicines Regulations — which provide the framework under which the Patented Medicine Prices Review Board (PMPRB) regulates the prices of patented medicines — were released in August (see our articles here and here) and will be in force on July 1, 2020. Changes include a revised list of reference countries (which excludes the United States and Switzerland) and new price regulatory factors: pharmacoeconomic value, market size, and GDP and GDP per capita in Canada (see list of key resources, including an unofficial consolidated version of the amended Regulations here). Court challenges to the validity of the amendments are pending in the Quebec Superior Court and the Federal Court (FC) (the latter scheduled for April 2020). Submissions on draft guidelines, which include a proposed price review process under the amended Regulations, are due by January 31, 2020.
We highlighted two Court decisions in our mid-year update relating to: SOLIRIS (eculizumab) (appeal pending) and DIFFERIN (0.1% adapalene) (now before the PMPRB for re-determination).
2) Biologics: Biosimilars update; Canada compared to U.S. and Europe; USMCA will not extend data protection for biologics
In October, we provided an update on biosimilars in Canada (approvals, pending submissions, regulatory news including Health Canada’s new Fact Sheet on biosimilars, naming, litigation and market access). We also provided a chart comparing relevant considerations for biosimilars in Canada, the U.S., and Europe, including regulatory pathways, data protection and patent linkage. On December 10, CUSMA (or USMCA) was amended to remove the requirement that biologics receive at least ten years of data protection (see our article on what the amendments mean for Canadian IP Law here).
3) Amended PMNOC Regulations: Statistics, procedural decisions
In September, we provided a second anniversary update regarding substantial amendments to the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations), which came into force on September 21, 2017 (status of actions; procedural decisions, including relating to common hearings – see also later briefs here and here; appeals; and timing/length of trials). Among other changes, the amendments ended dual litigation and provided the innovator a right of appeal. The Federal Court of Appeal (FCA) confirmed that Amgen, although unsuccessful regarding one generic manufacturer’s invalidity allegation under the pre-amended Regulations, could litigate that patent against another generic manufacturer under the amended Regulations. Currently, the first trial is scheduled to start in January 2020: Amgen v Pfizer, relating to filgrastim.
4) Pre-amended PMNOC Regulations: Last decisions on the merits
In the final decisions on the merits under the pre-amended PMNOC Regulations:
- Pfizer was successful in Apotex’s and Teva’s appeals regarding the validity of a patent claiming Form I o-desmethyl-venlafaxine (ODV) succinate (Pfizer’s PRISTIQ);
- Valeant was successful against Generic Partners Canada, which alleged invalidity of Valeant’s patent for a controlled-release dosage form of metformin (Valeant’s GLUMETZA);
- Apotex was successful in its obviousness and claim overbreadth allegations relating to Servier’s patent claiming the arginine salt of perindopril and its hydrates in connection with Apotex’s perindopril arginine/amlodipine product (Servier’s VIACORAM);
- Janssen was successful against Apotex, which alleged invalidity of Janssen’s patent claiming the use of abiraterone acetate (Janssen’s ZYTIGA) and prednisone for the treatment of prostate cancer (appeal pending).
5) Section 8 and Statute of Monopolies claims
The Supreme Court of Canada (SCC) declined to grant Apotex’s request to hear an appeal of a decision permitting Sanofi and Schering to amend their defences to Apotex’s claims, including under the Ontario Statute of Monopolies, grounded on a decision finding certain claims of a patent invalid. The defendants were permitted to plead that the SCC’s decision AstraZeneca v Apotex, 2017 SCC 36 – which rejected the promise doctrine as “unsound” – rendered the invalidity decision suspect.
In October, the FC found that Pfizer’s defence of ex turpi causa based on infringement was not a legally viable defence to Pharmascience’s claim under section 8 of the PMNOC Regulations for its pregabalin product (Pfizer’s LYRICA) because Pfizer did not bring an infringement action against Pharmascience in the real world (appeal pending).
In November, the FCA upheld the finding of obviousness and therefore upheld Teva’s section 8 claim regarding its bortezomib product (Janssen’s VELCADE).
6) Market Access: National Pharmacare; Ontario: Costco rebates, and ODBA/DIDFA amendments
In June, the Advisory Council on the Implementation of National Pharmacare released its final report, which recommends that Canada implement a universal, single-payer, public pharmacare by enacting new legislation and proceeding in a stepwise approach to implementation. The 2019 Federal Budget announced funding for some of the steps, including the formation of an arms-length national drug agency. Following the October federal election, which saw the Liberals return with a minority government, the new Government indicated in its December 5 Speech from the Throne that it will “take steps to introduce and implement national pharmacare so that Canadians have the drug coverage they need”.
Ontario: In February, the Ministry of Health and Long-Term Care (Ministry) ordered a subsidiary of Costco to pay a $7.25M penalty for accepting generic manufacturer payments, violating the drug rebate prohibition. In October, the Ministry published proposed changes to Regulations made under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee Act (DIDFA) to adjust the cap on ordinary commercial terms, reduce the administrative burden to drug manufacturers and pharmacies, and to reduce the Ministry’s payments to pharmacies. The proposed changes came into effect on January 1, 2020.
7) Health Canada: Statutory and regulatory amendments, medical devices updates, court decisions
Food and Drugs Act amendments: Bill C-97, tabled in April, included a new framework for Advanced Therapeutic Products (in force June 21, other provisions coming into force on a date to be fixed), a class of products that “represent an emerging or innovative technological, scientific or medical development”.
Food and Drug Regulations amendments: March proposed amendments would (i) permit a generic drug having a different salt form of the Canadian reference product to be filed as an abbreviated new drug submission, (ii) revise labelling practices for the medicinal ingredient in drug products, and (iii) make related amendments to the definition of “innovative drug” in the data protection provision.
On March 4, the final regulations addressing the public release of clinical information came into force (see database here). See also our live chart, tracking the progress of Vanessa’s Law regulatory amendments and associated guidance.
A pair of May proposed amendments would streamline the process for providing access to unauthorized drugs (i) for medical emergencies through the Special Access Program (for human drugs) / the Emergency Drug Release Program (for veterinary products), and (ii) to a public health official, consistent with other jurisdictions such as the U.S., the E.U. or Australia.
Amendments in force December 16 require hospitals to provide specific information relating to serious adverse drug reactions and medical device incidents.
Draft guidance distinguishing between promotional and non-promotional activities: In July, Health Canada opened a consultation on its draft Distinction Between Promotional and Non-promotional Messages and Activities for Health Products policy.
Annual Reports: In June, Health Canada published an annual highlights report for 2018 and the Therapeutic Products Directorate (TPD) and Biologics and Genetic Therapies Directorate (BGTD) drug submission performance annual reports.
Project Orbis - Concurrent regulatory approval in Canada, U.S. and Australia: In September, the combination therapy of Eisai’s LENVIMA (lenvatinib) and Merck’s KEYTRUDA (pembrolizumab) for the treatment of advanced endometrial carcinoma received simultaneous approvals by Health Canada, the U.S. FDA, and the Australian Therapeutic Goods Administration under Project Orbis.
Medical devices: Following the release of its December 2018 action plan, Health Canada commenced a number of initiatives including: publishing (as of January 31) Regulatory Decision Summaries for Class III medical device licences; launching an e-Learning Tool for understanding premarket regulation; and proposing amendments to the Food and Drug Regulations and the Medical Devices Regulations for post-market surveillance in accordance with Vanessa’s Law.
Court decisions: The FCA affirmed the dismissal of Apotex’s challenge of Health Canada’s rejection of its abbreviated new drug submission for Apo-Omeprazole (omeprazole magnesium) tablets. The SCC declined to grant Apotex leave to appeal regarding Health Canada’s decision requiring Apotex to submit additional information for products manufactured or tested in its facilities in India.
8) Certificates of supplementary protection
In September, we provided a second anniversary update on the certificate of supplementary protection (CSP) regime in Canada. CSPs provide an additional term of patent-like protection of up to two years. We provided (i) an updated summary of approvals, rejections, and pending applications and (ii) further reminders and tips, including relevant deadlines.
9) Further court decisions: Damage award against CRO, online prescription eyewear sales, cefaclor/NIA defence, file wrapper estoppel
The Ontario Court of Appeal upheld Apotex’s award of over $11M in damages from a contract research organization (CRO) — MDS Pharma Services — for losses flowing from delays in the FDA approval of Apotex’s amoxicillin-clavulanic acid and levodopa-carbidopa.
The Ontario Court of Appeal overturned a finding that online sales of prescription eyewear to Ontario residents without involving an Ontario-licensed health care provider violated the Regulated Health Professions Act (RHPA), which permits only optometrists and opticians to dispense prescription eyewear. The Court of Appeal found that the mere act of delivery did not, by itself, establish a sufficient connection to Ontario to bring the transactions within the ambit of the RHPA.
The SCC denied Apotex leave to appeal a FCA decision which concluded that a non-infringing alternative (NIA) defence to Eli Lilly’s damages claim relating to cefaclor was not available. The FCA had remitted the FC’s decision (awarding Eli Lilly over $100 million, including $75 million in interest) for reconsideration solely on the issue of prejudgment interest; in December, the FC maintained its original decision and Apotex has appealed.
A 2018 amendment to the Patent Act permits the admission into evidence of written communications between the patentee and the Canadian Patent Office to “rebut any representation made by the patentee in the action” related to claims construction. The first decision under this provision held that in “extraordinary circumstances” a corresponding U.S. application history could be admitted (under appeal).
10) New rules and practice guidance: Final Competition Bureau IPEGs, new Patent Rules, IMC revised Code of Ethical Practices
In March, the Competition Bureau released its final updated Intellectual Property Enforcement Guidelines (IPEGs) with modest updates. The new Patent Rules came into force on October 30 (see our article here and on the updated Manual of Patent Office Practice, here). In December, Innovative Medicines Canada (IMC) announced changes to its Code of Ethical Practices.