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03 February 2020
PMPRB amendments to regulations
Amended PMNOC Regulations
Pre-amended PMNOC Regulations
Section 8 and Statute of Monopolies claims
Certificate of supplementary protection regime
Further court decisions
New rules and practice guidance
This article examines the key developments in life sciences IP and regulatory law which took place in 2019.
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 2019 (for further details please see "Canada releases final amendments to patented medicines pricing regulations" and "Countdown begins: getting ready for new patented medicines pricing regime") and will come into force on 1 July 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.(1) Court challenges to the validity of the amendments are pending in the Quebec Superior Court and the Federal Court (the latter scheduled for April 2020). Submissions on draft guidelines, which include a proposed price review process under the amended regulations, are due by 31 January 2020.
Notably, there were two court decisions relating to Soliris (eculizumab) (appeal pending) (for further details please see "Federal Court upholds PMPRB's pricing decision regarding Alexion's Soliris") and Differin (0.1% adapalene) (for further details please see "Federal Court of Appeal requires PMPRB to redetermine whether patent pertains to Galderma's Differin").(2)
A number of biosimilar developments (including with regard to approvals, pending submissions, regulatory developments including Health Canada's new Fact Sheet on biosimilars, naming, litigation and market access) took place in Canada in 2019 (for further details please see "Update on biosimilars").(3)
On 10 December 2019 the US-Mexico-Canada Agreement (USMCA) was amended to remove the requirement that biologics receive at least 10 years of data protection (for further details please see "Amendments to USMCA remove 10-year data protection requirement for biologics").
The amended Patented Medicines (Notice of Compliance) (PMNOC) Regulations came into force on 21 September 2017 and, as such, celebrated their second anniversary last year (for further details please see "Amended PMNOC Regulations: second anniversary update").(4)
Among other changes, the amendments ended dual litigation and provided the innovator a right of appeal. The Federal Court of Appeal 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. The first trial is scheduled to start in January 2020 (ie, Amgen v Pfizer, relating to filgrastim).
In the final decisions on the merits under the pre-amended PMNOC Regulations:
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 in AstraZeneca v Apotex (2017 SCC 36), which rejected the promise doctrine as "unsound", rendered the invalidity decision suspect (for further details please see "Supreme Court of Canada denies Apotex leave to appeal in two cases").
In October 2019 the Federal Court 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) (for further details please see "Federal Court issues two interlocutory decisions in Section 8 pregabalin case").
In November 2019 the Federal Court of Appeal upheld the finding of obviousness and therefore upheld Teva's Section 8 claim regarding its bortezomib product (Janssen's Velcade) (for further details please see "Federal Court of Appeal confirms obviousness finding in Section 8 bortezomib action against Teva").
In June 2019 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 (for further details please see "Pharmacare advisory council delivers initial recommendations").
Following the October 2019 federal election, which saw the Liberals return with a minority government, the new government indicated in its speech from the throne of 5 December 2019 that it will "take steps to introduce and implement national pharmacare so that Canadians have the drug coverage they need".
In February 2019 the Ministry of Health and Long-Term Care ordered a subsidiary of Costco to pay a C$7.25 million penalty for accepting generic manufacturer payments, violating the drug rebate prohibition (for further details please see "Costco Pharmacies receives C$7.25 million penalty for accepting drug rebates"). In October 2019 the ministry published proposed changes to regulations made under the Ontario Drug Benefit Act and the Drug Interchangeability and Dispensing Fee Act to:
The proposed changes came into effect on 1 January 2020.
Food and Drugs Act amendments
Bill C-97, which was tabled in April 2019, included a new framework for advanced therapeutic products (in force from 21 June 2019, while other provisions will come into force on a date to be fixed), a class of products that "represent an emerging or innovative technological, scientific or medical development" (for further details please see "Bill C-97: amendments to Food and Drugs Act establish framework for advanced therapeutic products").
Food and drug regulation amendments
Amendments to the Food and Drug Regulations proposed in March 2019 would:
A pair of amendments to the Food and Drug Regulations proposed in May 2019 streamlined the process for providing access to unauthorised drugs:
Amendments in force as of 16 December 2019 require hospitals to provide specific information relating to serious adverse drug reactions and medical device incidents (for further details please see "Regulations will require hospitals to report adverse drug reactions and medical device incidents").
Draft guidance distinguishing between promotional and non-promotional activities
In July 2019 Health Canada opened a consultation on its draft Distinction Between Promotional and Non-promotional Messages and Activities for Health Products policy (for further details please see "Health Canada consults on promotional and non-promotional activities for health products").
In June 2019 Health Canada published an annual highlights report for 2018 and the Therapeutic Products Directorate and the Biologics and Genetic Therapies Directorate drug submission performance annual reports (for further details please see "Drug and medical device highlights").
Project Orbis: concurrent regulatory approval in Canada, the United States and Australia
In September 2019 the combination therapy of Eisai's Lenvima (lenvatinib) and Merck's Keytruda (pembrolizumab) for the treatment of advanced endometrial carcinoma received simultaneous approval from Health Canada, the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration under Project Orbis.
Following the release of its December 2018 action plan, Health Canada commenced a number of initiatives, including:
The Federal Court of Appeal 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 (for further details please see "Supreme Court denies Apotex leave to appeal decision regarding India facilities").
The second anniversary of the certificate of supplementary protection regime was 21 September 2019. CSPs provide an additional term of patent-like protection of up to two years (for further details please see "Certificate of supplementary protection regime: second anniversary update").
On 16 January 2019 the Ontario Court of Appeal upheld Apotex's award of over C$11M in damages from a contract research organisation – MDS Pharma Services – for losses flowing from delays in the FDA approval of Apotex's amoxicillin-clavulanic acid and levodopa-carbidopa (for further details please see "Court of Appeal dismisses appeal of judgment awarding Apotex damages").
On 4 April 2019 the Ontario Court of Appeal overturned a finding that online sales of prescription eyewear to Ontario residents without involving an Ontario-licensed healthcare provider violated the Regulated Health Professions Act, 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 act (for further details please see "Ontario Court of Appeal overturns ban on online sales of prescription eyewear to Ontario residents").
The SCC denied Apotex leave to appeal a Federal Court of Appeal decision which concluded that a non-infringing alternative defence to Eli Lilly's damages claim relating to cefaclor was unavailable (for further details please see "Apotex seeks leave from Supreme Court of Canada in cefaclor damages action"). The Federal Court of Appeal had remitted the Federal Court's decision (awarding Eli Lilly over C$100 million, including C$75 million in interest) for reconsideration solely on the issue of prejudgment interest. In December 2019 the Federal Court maintained its original decision and Apotex has appealed.
A 2018 amendment to the Patent Act permits the admission into evidence of written communications between a 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 US application history could be admitted (under appeal).
In March 2019 the Competition Bureau released its final updated Intellectual Property Enforcement Guidelines with modest updates.
On 30 October 2019 the new Patent Rules came into force (for further details please see "New Patent Rules in force" and "Updated Manual of Patent Office Practice explains 'due care' standard and more"). Further, in December 2019 Innovative Medicines Canada announced changes to its Code of Ethical Practices.
For further information on this topic please contact Nancy Pei at Smart & Biggar by telephone (+1 416 593 5514) or email (email@example.com). The Smart & Biggar website can be accessed at www.smart-biggar.ca.
(3) See here for a chart comparing relevant considerations for biosimilars in Canada, the United States and the European Union, including regulatory pathways, data protection and patent linkage.
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