In this article, the Pharma in Brief team curated the most significant topics we covered during 2019.
The Canadian pharma and life sciences space saw many developments in 2019. These included major policy initiatives and regulatory changes affecting the industry, driven in part by three high-profile federal objectives: lowering drug prices to move towards national pharmacare, replacing the North American Free Trade Agreement (NAFTA), and changes to drug approval pathways.
There were few pharmaceutical patent decisions released in 2019 but plenty of activity in the Courts, as the first actions under the new Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) wound their way to the first trials—currently scheduled for 2020. Meanwhile, the era of prohibition applications neared its end as some of the last of these cases from the pre-CETA regime were decided.
1. Major policy initiatives
Throughout 2019, there was activity across a range of federal portfolios affecting health and IP policy. This included ongoing work to ratify a replacement for the NAFTA, as well as development of an evolving set of policies intended to lay the foundation for national pharmacare. One such change—reforms to the Patented Medicine Prices Review Board (PMPRB)—has already passed into law via new regulations scheduled to come into force on July 1, 2020. Consultations on guidelines to implement these reforms are now underway.
The federal government also made a range of amendments, both proposed and enacted, that affect drug approval pathways and the use of clinical information under the Food and Drugs Act and the Food and Drug Regulations. Advertising Standards Canada and the Competition Bureau released policies and guidance to regulate this sector as well.
(a) Changes to the PMPRB
In August 2019, the government finalized amendments to the PMPRB’s Patented Medicines Regulations. These amendments aim to lower prices of patented medicines by changing how the PMPRB assesses whether these prices are excessive. These amendments have been positioned by the government as a step toward making national pharmacare affordable. In pursuit of this goal, the amendments introduce new price tests based on market-size and pharmacoeconomic factors, as well as a revised and enlarged “basket” of 11 comparator countries that—for the first time—omits the United States.
In preparation for the amendments coming into force on July 1, 2020, the PMPRB has been consulting since November 2019 on a new set of price-review and reporting guidelines to accompany these amendments. The PMPRB is accepting feedback until February 14, 2020 and expects to finalize both the guidelines and a revised set of reporting forms before the amendments come into force. The PMPRB has indicated that patentees will be expected to comply with the revised reporting requirements in the filing for the first reporting period in 2020, which come due no later than July 31, 2020.
Meanwhile, two court challenges have been launched against the government’s jurisdiction to make these amendments to the Patented Medicines Regulations: an action in the Quebec Superior Court, as well as an application for judicial review before the Federal Court. The Federal Court application—in which the Applicants are represented by counsel from Norton Rose Fulbright—is scheduled to be heard in April 2020, before the amendments come into force.
For more info:
- PIB: Budget 2019: Federal government announces intention to implement recommendations on national pharmacare (March 20, 2019); see also Final Report of the Advisory Council on the Implementation of National Pharmacare (June 2019)
- PIB: Government releases final amendments to the PMPRB’s Patented Medicines Regulations to lower the prices of patented medicines (August 13, 2019)
- PIB: PMPRB extends consultation on new Draft Guidelines implementing amendments to the Patented Medicines Regulations (December 10, 2019)
On December 10, 2019, Canada signed onto an amended version of the Canada–United States–Mexico Agreement (CUSMA), the trade agreement that replaces the NAFTA. Among other changes, the amendments deleted a provision of the original November 30, 2018 agreement that would have required Canada to provide ten years of data protection for biologics, up from the eight years’ protection available today.
With a new final agreement in place, attention will now turn to ratification and implementation by the parties. Prior to the December amendments, Canada had already taken steps toward implementing the November 2018 version of the CUSMA by introducing legislation (Bill C‑100). Bill C-100 was not passed before the October 2019 federal election and can no longer be debated in Parliament.
Following the demise of Bill C-100, a new bill will have to be introduced to implement the amended version of the CUSMA—without extended data protection for biologics. Canada has advised that its current intellectual property scheme is already compliant with the amended provisions of the CUSMA.
For more info:
- PIB: CUSMA Implementation Bill Introduced (June 4, 2019)
- PIB: Amended CUSMA no longer extends data protection for biologics (December 11, 2019)
(c) Changes to the Food and Drugs Act and the Food and Drug Regulations
In the first quarter of 2019, there were significant changes—both proposed and finalized—affecting the treatment of submissions and approval pathways for pharmaceuticals and medical devices under the Food and Drugs Act and the Food and Drug Regulations.
In February, the government amended the Food and Drug Regulations to allow for the public disclosure of clinical information in regulatory submissions for drugs and medical devices. Health Canada now maintains a growing public database of clinical information.
In March 2019, the government proposed various regulatory changes that would affect the eligibility of generics for the abbreviated new drug submission pathway. Health Canada concluded a consultation on the proposal later in the year but has yet to publish final amendments.
In April 2019, the government introduced several proposed amendments to the Food and Drugs Act in its 2019 budget bill, including the creation of a distinct approval pathway for a “new class” of advanced therapeutic products. The bill passed in June 2019, following which Health Canada held consultations on how best to implement these amendments. Health Canada has yet to publish on next steps following consultations.
For more info:
- PIB: Health Canada publishes new amendments to the Food and Drug Regulations and Medical Devices Regulations allowing for public release of clinical information in regulatory submissions (March 25, 2019)
- PIB: Regulatory changes for generics proposed to clarify ANDS pathway eligibility (April 1, 2019)
- PIB: Proposed amendments to Food and Drugs Act introduced in omnibus budget bill (April 23, 2019)
- PIB: Health Canada consulting on clinical trial requirements and “new class” of advanced therapeutic products (July 24, 2019)
(d) Other federal regulators
Outside the health portfolio, Advertising Standards Canada and the Competition Bureau were among the other regulators to amend policies that relate to pharmaceutical and life sciences businesses.
Here are some highlights:
- PIB: Advertising Standards Canada introduces new advertising dispute procedure for resolving disputes between competitors (February 4, 2019)
- PIB: Competition Bureau publishes Final IP Enforcement Guidelines (March 18, 2019)
- PIB: Competition Bureau issues statement regarding off-label use of vaccines (July 29, 2019)
2. New PM(NOC) Regulations: year two
As of September 2019, it has been two years since the new PM(NOC) Regulations came into force. As of yet, no action has proceeded to trial under the new PM(NOC) Regulations.
The first cases under the new regime were scheduled to go to trial in 2019, but were discontinued or adjourned to 2020. However, 2020 is off to a strong start: families of litigation about more than 15 drugs are ongoing, with several trials set down for January, February, and March. There is sure to be more activity under the new PM(NOC) Regulations in the coming months.
Meanwhile, the 2019 jurisprudence under the PM(NOC) Regulations focused on disputes about the procedure for conducting condensed actions under the new regime. Some of these decisions are currently under appeal and will be heard by the Federal Court of Appeal early in the new year.
For more info:
- PIB: Patent Act Infringement Actions Cannot be Joined to PM(NOC) Infringement Actions During NOC Prohibition Period (June 25, 2019)
- Related: Federal Court dismisses motion for determination of an issue of law under the new PM(NOC) Regulations (November 29, 2019)
- PIB: Federal Court rejects the concept of “first mover advantage” for generics in PM(NOC) infringement actions (November 7, 2019) — appeals in Court Files No. A-388-19 and A-389-19 were heard on January 13, 2020
- Related: Federal Court refuses to allow fifth generic to join common trial on validity (November 25, 2019)
3. Other litigation
Outside of litigation under the new PM(NOC) Regulations, there were other court decisions in 2019 that impacted the pharmaceutical and life sciences sector.
(a) Last of the old PM(NOC) applications
While there were no trial decisions under the new PM(NOC) Regulations in 2019, the Court issued what are likely among the last substantive decisions in section 6 prohibition applications under the old PM(NOC) Regulations.
- PIB: FCA Confirms Entirety of Inventors’ Conduct is Relevant in Obviousness Analysis and Upholds Inventiveness of Crystal Form Patent (February 14, 2019)
- PIB: Apotex held to induce infringement in one of the last applications under the old PM(NOC) Regulations (November 17, 2019) — under appeal in Court File No. A-437-19
(b) First application of the file wrapper to claims construction
At the end of 2018, the Patent Act was amended to make patent prosecution history (file wrapper) admissible as evidence to rebut any representation made by a patentee as to claims construction. The first and only case to apply this provision was decided in 2019. Although the patent in issue concerned methods for roasting oil seed, the Court’s approach to file-wrapper evidence could have implications for pharma and life sciences litigation. An appeal of the decision is underway.
- PIB: Federal Court relies on foreign prosecution history in first application of file wrapper estoppel (October 6, 2019) — under appeal in Court File No. A-408-19
(c) Other decisions
On December 19, just in time for the holidays, the Supreme Court of Canada released its long-awaited decision on the standard of review applicable to administrative decision-makers in judicial review proceedings. Canada (Minister of Citizenship and Immigration) v Vavilov (Vavilov) saw the Court unite around a presumption that the reasonableness standard of review should be applied. However, two justices issued dissenting reasons that were critical of the majority’s approach to both reasonableness review and the exceptions where correctness review continues to apply. The majority’s approach, they argued, results in reduced deference to administrative decision-makers.
The changes to the standard of review introduced by Vavilov will reverberate through ongoing and future judicial review proceedings in 2020, with potential implications for a variety of cases involving challenges to regulations and administrative action by government actors, such as the Minister of Health.
There were other decisions in 2019, in both the federal courts and the courts across the provinces, that were also relevant to the pharmaceutical and life sciences sector. Here are the Pharma in Brief Team’s takes on three of them:
- PIB: Quebec Court of Appeal confirms CPA does not apply to the sale of prescription drugs (May 15, 2019)
- PIB: Federal Court of Appeal agrees that the PMPRB incorrectly applied the patent-pertaining analysis (July 9, 2019)
- PIB: Stockpiling generic manufacturers may be liable for direct infringement of “composition for a use” claims (November 7, 2019)
The Pharma in Brief Team thanks you for readership in 2019. We will continue to monitor developments and share our findings with you in 2020 and beyond.