Below are the major highlights in Canadian life sciences intellectual property and regulatory law that we have reported on in the first half of 2019.
1) Health Canada: Statutory and regulatory amendments, medical devices updates, court decisions, revised CSP guidance
Food and Drugs Act amendments: Bill C-97, tabled in April, 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 and will come into force on a day to be fixed.
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.
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 EU or Australia.
On March 4, the final regulations addressing the public release of clinical information came into force; Health Canada intends to proactively publish clinical information for submissions that receive a final regulatory decision after this date (see our live chart, tracking the progress of Vanessa’s Law regulatory amendments and associated guidance).
Medical devices: Following the release of its December 2018 action plan, Health Canada commenced a number of initiatives including: as of January 31, publishing 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 in accordance with Vanessa’s Law.
Court decisions: The Federal Court of Appeal (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 Supreme Court of Canada (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 Apotex’s facilities in India.
2) PMPRB News: Amendments still not released; Alexion/SOLIRIS, Galderma/DIFFERIN decisions
While originally proposed to come into force on January 1, 2019, sweeping amendments to the Patented Medicines Regulations governing pricing criteria were still not released as of June 30. Assuming they are released, they are expected to come into force 12 months thereafter; the earliest expected in force date is therefore July 2020. Work on guidelines modernization to accompany the amendments continued through the first half of the year, including release of the Steering Committee’s final report (see latest status here).
Two Court decisions issued in June. First, the Federal Court (FC) upheld the Patented Medicine Prices Review Board’s (PMPRB) excessive pricing decision requiring a $4.2M payment regarding Alexion’s SOLIRIS (eculizumab). The Court held that the PMPRB was not unreasonable in following its Guidelines in one respect (in determining permitted increases) and in not following its Guidelines in another respect (in assessing the appropriate benchmark). Alexion has appealed.
Second, in a closely watched case, the FCA sent back to the PMPRB the question of whether the invention (in this case use of 0.3% adapalene) “pertains to” DIFFERIN (0.1% adapalene). While the determination of the 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.”
3) Market Access: National Pharmacare, OHIP+, Costco rebates
On June 12, 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. Whether the recommendations are implemented will turn in part on the results of the October 21 federal election.
We reported on proposed changes to the OHIP+ program, under which Ontario provided free prescription drug coverage for all children/youth 24 years of age or younger. The changes came into force on April 1 such that only those children/youth that do not have a private plan will remain eligible for OHIP+ benefits.
In February, the Ontario Ministry of Health and Long-Term Care ordered a subsidiary of Costco to pay a $7.25M penalty for accepting generic manufacturer payments, violating the drug rebate prohibition.
4) Biosimilars: Market Access, Naming, Studying Usage
As of June 30, Health Canada had approved 16 biosimilars, based on 11 comparator products (3 in 2019).
Market Access: On January 16, the Quebec Court of Appeal overturned the Minister's decision to delist REMICADE from Quebec's Liste des médicaments for violating procedural fairness. British Columbia announced in May that it will provide funding for further biosimilars and, as of November 25, will no longer provide coverage for three original biologics for certain indications, except in exceptional cases, effectively requiring a change to the corresponding biosimilar(s).
Naming: On February 14, 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.” Further, both the brand and non-proprietary names should be used throughout the medication use process so that brand names can distinguish amongst biologics having the same non-proprietary names.
Studying Usage: 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. In February, 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), European Medicines Agency and/or Health Canada between 2006 and 2017. In March, Health Canada announced that it is collaborating with the Drug Safety and Effectiveness Network on a project studying patients with inflammatory rheumatic diseases and inflammatory bowel disease who are taking biologic drugs to compare the safety and effectiveness of biosimilar drugs to the reference biologic drug.
5) Pre-amended PMNOC Regulations: Court decisions on the merits (polymorph, salt, formulation patents)
There have been two Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) decisions on the merits so far in 2019 and a pair of appeal decisions: (i) Pfizer was successful in Apotex and Teva’s appeals regarding the validity of a patent claiming Form I o-desmethyl-venlafaxine (ODV) succinate (Pfizer’s PRISTIQ); (ii) 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); and (iii) 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).
6) Amended PMNOC Regulations: Statistics, procedural decisions
Almost two years have passed since substantial amendments to the PMNOC Regulations came into force on September 21, 2017. As of June 30, 78 actions (relating to 26 drugs) had been commenced; 56 (relating to 17 drugs) were ongoing. The first trial is scheduled to start on September 30: Janssen v Teva, relating to paliperidone palmitate (INVEGA SUSTENNA).
Procedural decisions include: (i) common invalidity issues raised by different generic manufacturers were ordered to be heard concurrently; (ii) only “second persons” can be named as defendants (although this could include a person other than the regulatory submission filer); and (iii) an infringement claim based on making/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.
7) Section 8 and Statute of Monopolies claims: Pleading amendments
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 (NIA) was unlawful, as it would have infringed a third party’s patent. Apotex discontinued the section 8 action prior to trial. The 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 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.
8) Further Court Decisions: Damage award against CRO, online prescription eyewear sales, cefaclor/NIA defence
The Ontario Court of Appeal upheld Apotex’s award of over $11M in damages from a contract research organization (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 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, $75 million in interest) for reconsideration solely on the issue of prejudgment interest; the hearing is scheduled for September 2019.
9) Also: Final Competition Bureau IPEGs, CUSMA Implementation Bill, new Patent Rules
In March, the Competition Bureau released its final updated Intellectual Property Enforcement Guidelines (with modest updates). In May, Bill C-100, to implement the Canada-US-Mexico Agreement (CUSMA), which would extend data protection for biologics from eight years to ten years, was tabled and is presently before the Standing Committee on International Trade. The new Patent Rules (see our article on the draft) will be in force on October 30.