This article summarises the highlights in Canadian life sciences IP and regulatory law which took place in the first half of 2019.
Food and Drugs Act amendments
Bill C-97, which was published in April 2019, proposed amendments to the Food and Drugs Act, including a new framework for 'advanced therapeutic products' – a class of products that "represent an emerging or innovative technological, scientific or medical development". The bill received royal assent in June 2019 and will come into force on a day which has yet to be fixed (for further details please see "Bill C-97: amendments to Food and Drugs Act establish framework for advanced therapeutic products").
Food and Drug Regulations amendments
In March 2019 Health Canada proposed amendments which would:
- permit a generic drug having a different salt form from the Canadian reference product to be filed as an abbreviated new drug submission (ANDS);
- revise labelling practices for the medicinal ingredient in drug products; and
- amend the definition of 'innovative drug' in the data protection provision (for further details please see "Proposed amendments to Food and Drug Regulations").
Two proposed amendments from May 2019 would streamline the process for providing access to unauthorised drugs:
- for medical emergencies through the Special Access Programme for human drugs and the Emergency Drug Release Programme for veterinary products; and
- to a public health official, consistent with other jurisdictions, such as the United States, the European Union and Australia (for further details please see "Proposed regulations set to amend process for sale of drugs for medical emergencies").
The final regulations addressing the public release of clinical information came into force on 4 March 2019 (for further details please see "Final regulations addressing public release of clinical information now in force"). Health Canada intends to proactively publish clinical information for submissions that receive a final regulatory decision after this date (for further details please see "Update on Vanessa's Law")
Following the release of its December 2018 action plan, Health Canada commenced numerous initiatives, including as of 31 January 2019:
- publishing Regulatory Decision Summaries for Class III medical device licences (for further details please see "Health Canada releases further information alongside Action Plan on Medical Devices");
- launching an e-learning tool for understanding pre-market regulation (for further details please see "Health Canada launches e-learning tool for understanding pre-market regulatory requirements"); and
- proposing amendments to the Food and Drug Regulations and the Medical Devices Regulations in accordance with Vanessa's Law (for further details please see "Medical devices update").
Revised certificates of supplementary protection guidance
In May 2019 Health Canada released revised certificates of supplementary protection guidance (for further details please see "Certificate of supplementary protection regime: first anniversary update").
The Federal Court of Appeal affirmed the dismissal of Apotex's challenge of Health Canada's rejection of its ANDS for Apo-Omeprazole (omeprazole magnesium) tablets (for further details please see "Court upholds issuance of NON-W letter and cancellation of reconsideration process for Apotex"). The Supreme Court of Canada declined to grant Apotex leave to appeal regarding Health Canada's decision, which required Apotex to submit additional information concerning products manufactured or tested in Apotex's facilities in India (for further details please see "Supreme Court denies Apotex leave to appeal decision regarding India facilities").
While originally proposed to come into force on 1 January 2019, sweeping amendments to the Patented Medicines Regulations governing pricing criteria were still not released as of 30 June 2019 (for further details please see "Canada releases proposed amendments to patented medicines pricing regulations"). Assuming that they are released, they are expected to come into force 12 months thereafter. Therefore, the earliest expected in force date is July 2020 (for further details please see "Amendments to Patented Medicines Regulations expected to come into force no earlier than Spring 2020"). Work on guidelines modernisation to accompany these amendments continued through the first half of 2019, including the release of the steering committee's final report (for further details please see "Update on PMPRB guidelines modernisation").(1)
There were two court decisions issued in June 2019:
- First, the Federal Court upheld the Patented Medicine Prices Review Board's (PMPRB's) excessive pricing decision, which required a C$4.2 million payment regarding Alexion's Soliris (eculizumab) (for further details please see "Federal Court upholds PMPRB's pricing decision regarding Alexion's Soliris"). The court held that the PMPRB had not been unreasonable in:
- following its guidelines in one respect (in determining permitted increases); and
- not following its guidelines in another respect (in assessing the appropriate benchmark). Alexion has appealed.
- Second, in a closely watched case, the Federal Court of Appeal sent back to the PMPRB the question of whether an invention (in this case, the use of 0.3% adapalene) "pertains to" Differin (0.1% adapalene). While the determination of an invention is not an exercise of claim construction, the PMPRB must consider the patent as a whole, including the claims. In determining whether "an invention pertains to the medicine", the phrases "rational connection or nexus" or "merest slender thread" cannot supplant the statutory language, which requires that "the invention is intended or capable of being used for the medicine".
On 12 June 2019 the Advisory Council on the Implementation of National Pharmacare released its final report. The council has recommended that Canada implements a universal, single-payer, public pharmacare by enacting new legislation and proceeding in a stepwise approach to implementation (for further details please see "National pharmacare update: publication of advisory council's final report"). The 2019 Federal Budget announced funding for some of the steps, including the formation of an arms-length national drug agency. Whether the recommendations are implemented will turn in part on the results of the 21 October 2019 federal election (for further details please see "Pharmacare advisory council delivers initial recommendations").
The proposed changes to the OHIP+ programme aim to provide free prescription drug coverage for all children and youths 24 years of age or younger (for further information please see "Proposed changes to OHIP+ programme"). The changes came into force on 1 April 2019 such that only those children and youths who have no private plan will remain eligible for the OHIP+ benefits.
In February 2019 the Ontario 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 which violated the drug rebate prohibition (for further details please see "Costco Pharmacies receives C$7.25 million penalty for accepting drug rebates").
As of 30 June 2019 Health Canada had approved 16 biosimilars, based on 11 comparator products (three in 2019).
On 16 January 2019 the Quebec Court of Appeal overturned the minister's decision to delist Remicade from Quebec's List of Medications for violating procedural fairness (for further details please see "Quebec Court of Appeal overturns decision to delist Remicade from Quebec's List of Medications"). British Columbia announced in May 2019 that it will provide funding for further biosimilars and, as of 25 November 2019, it will no longer provide coverage for three original biologics for certain indications, except in exceptional cases, effectively requiring a change to the corresponding biosimilars.
On 14 February 2019 Health Canada released its policy statement on the naming of biologic drugs, which states that "biologic drugs, including biosimilars, will be identified by their unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix" (for further details please see "Health Canada announces decision on naming of biologic drugs").
Further, both brand and non-proprietary names should be used throughout the medication process to allow biologics that share the same non-proprietary name to be distinguished by their unique names.
The pan-Canadian Pharmaceutical Alliance and Cancer Care Ontario have partnered to create a pan-Canadian Oncology Biosimilars Initiative, which aims to ensure appropriate implementation and cost-effective use of therapeutic oncology biosimilars across Canada (for further details please see "New oncology initiative and Health Canada study on biosimilar drugs").
In February 2019 the PMPRB released its 2017 edition of Meds Entry Watch, which includes an analysis of the availability, pricing and uptake of biosimilars approved by the Food and Drug Administration (FDA), the European Medicines Agency or Health Canada between 2006 and 2017 (for further details please see "PMPRB publishes 2017 Meds Entry Watch"). In March 2019 Health Canada announced that it is collaborating with the Drug Safety and Effectiveness Network on a project to study patients with inflammatory rheumatic diseases and inflammatory bowel disease who are taking biologic drugs. The study aims to compare the safety and effectiveness of biosimilar drugs to the reference biologic drug (for further details please see "New oncology initiative and Health Canada study on biosimilar drugs").
Court decisions on merits (polymorph, salt and formulation patents)
There have been two Patented Medicines (Notice of Compliance) (PMNOC) Regulations decisions on the merits so far in 2019 and a pair of appeal decisions:
- Pfizer succeeded in Apotex and Teva's appeals regarding the validity of a patent claiming Form I o-desmethyl-venlafaxine (ODV) succinate (Pfizer's Pristiq) (for further details please see "Order of prohibition relating to polymorphic form patent for Pristiq upheld on appeal").
- Valeant succeeded against Generic Partners Canada, which alleged invalidity of Valeant's patent for a controlled-release dosage form of metformin (Valeant's Glumetza) (for further details please see "Federal Court finds invalidity allegations relating to patent for metformin formulations unjustified").
- Apotex succeeded 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) (for further details please see "Federal Court dismisses Servier's application for order of prohibition regarding salt patent").
Almost two years have passed since substantial amendments to the PMNOC Regulations came into force on 21 September 2017 (for further details please see "Publication of final regulations on patent linkage and term restoration relating to CETA"). As of 30 June 2019, 78 actions (relating to 26 drugs) had been commenced and 56 (relating to 17 drugs) were ongoing. The first trial, Janssen v Teva, is scheduled to start on 30 September 2019. It relates to paliperidone palmitate (Invega Sustenna).
The procedural decisions thus far have included as follows:
- Common invalidity issues raised by different generic manufacturers were ordered to be heard concurrently.
- Only 'second persons' can be named as defendants (although this could include a person other than the regulatory submission filer) (for further details please see "Procedural decisions under PMNOC Regulations: common validity issues and naming of defendants").
- An infringement claim based on making and selling under a notice of compliance for one strength was struck from an action triggered by a notice of allegation based on a different strength (for further details please see "Infringement based on making and selling under existing NOC struck from action").
On the eve of a Section 8 trial relating to lansoprazole (Abbott's Prevacid), the Ontario Superior Court granted Abbott and Takeda leave to amend their pleadings to assert that Apotex's purported non-infringing alternative was unlawful, as it would have infringed a third party's patent (for further details please see "Abbott and Takeda plead third party's patent would be infringed by non-infringing alternative"). Apotex discontinued the Section 8 action before trial.
The Supreme Court of Canada 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 which found certain claims of a patent invalid (for further details please see "Supreme Court of Canada denies Apotex leave to appeal in two cases"). The defendants were permitted to plead that the Supreme Court of Canada's decision in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36 – which rejected the promise doctrine as unsound – rendered the invalidity decision suspect. The first Statue of Monopolies trial (relating to atomoxetine; Eli Lilly's Strattera) was scheduled for May 2019 but was adjourned.
Damage award against CRO
The Ontario Court of Appeal upheld Apotex's award of more than C$11 million in damages from a contract research organisation (MDS Pharma Services) for losses resulting from delays in the FDA's approval of Apotex's amoxicillin-clavulanic acid and levodopa-carbidopa products (for further details please see "Court of Appeal dismisses appeal of judgement awarding Apotex damages").
Online prescription eyewear sales
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 so as to bring the transactions within the ambit of the Regulated Health Professions Act (for further details please see "Ontario Court of Appeal overturns ban on online sales of prescription eyewear to Ontario residents").
Cefaclor and non-infringing alternative defence
The Supreme Court of Canada 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 not available (for further details please see "Supreme Court of Canada denies Apotex leave to appeal in two cases"). The Federal Court of Appeal had remitted the Federal Court's decision (awarding Eli Lilly more than C$100 million and C$75 million in interest) for reconsideration solely on the issue of pre-judgment interest; the hearing is scheduled for September 2019 (for further details please see "Federal Court of Appeal overturns cefaclor damages decision on pre-judgment interest issue").
(1) The status of the steering committee's final report is available here.
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