Supreme Court of Canada strikes down "promise doctrine", upholds AstraZeneca’s NEXIUM patent as useful

As previously reported, on June 30, 2017, the Supreme Court of Canada granted AstraZeneca’s appeal in the NEXIUM (esomeprazole) patent infringement action against Apotex, rejecting the “promise doctrine” of utility as “not good law”, and thereby overturning the lower courts’ decisions that the patent was invalid: AstraZeneca Canada Inc v Apotex Inc (2017 SCC 36).

CETA Draft Regulations Published on Patent Linkage and Term Restoration

As previously reported, on July 15, 2017, the government published draft regulations regarding:

1. changes to the Patented Medicines (Notice of Compliance) Regulations [“PMNOC Regulations”], and
2. proposed Regulations to implement Certificates of Supplementary Protection (CSPs) [“CSP Regulations”] to compensate innovators for lost patent term due to regulatory delays.

The proposed changes to the PMNOC Regulations and the new CSP Regulations will herald a new environment for pharmaceutical companies, with long lasting impact. Representations may be made until July 30, 2017. Canada and the EU agreed to September 21, 2017 as the start date for the provisional application of CETA. The final amendments are therefore expected to be released before September 21, 2017.

Supreme Court of Canada dismisses Janssen’s application for leave to appeal FCA decision regarding administrative drug submissions

As reported previously, on October 12, 2016, the Federal Court of Appeal allowed four appeals relating to decisions by the Minister of Health to issue a notice of compliance (NOC) to Teva for exemestane tablets (a generic version of Pfizer’s AROMASIN) and an NOC to Hospira for INFLECTRA, an infliximab powder for solution (a biosimilar of Janssen’s REMICADE). The FCA found that the Minister was reasonable in finding that these cross-referenced drug submissions did not trigger section 5 of the PMNOC Regulations absent early working: Teva Canada Limited v Pfizer Canada Inc et al, 2016 FCA 248. Janssen’s application for leave to appeal the FCA decision was dismissed on June 22, 2017 (SCC Case No. 37342).

Health Canada News

Plain Language Labelling Regulations come into force for non-prescription drugs. On June 13, 2017, Health Canada issued a statement regarding the same-day coming into force of the Plain Language Labelling Regulations for non-prescription drug products. As reported previously, Health Canada has released a related guide: Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products. As reported previously, the Plain Language Labelling Regulations for prescription products and those administered or obtained through a health professional have been in force since June 2015.

Proposed amendments to Food and Drug Regulations to warn patients about opioids. On June 17, 2017, proposed amendments to the Food and Drug Regulations were published that would allow the Minister of Health to add or amend terms and conditions to an authorization for opioid sales. The Minister of Health could then require the opioid authorization holder to implement a risk management program to identify, mitigate and monitor risks associated with opioid use. The amendments will also require a warning sticker and patient information handout accompany the sale of all prescription opioids. Comments may be provided until August 31, 2017. In the news release announcing the amendments, Health Canada stated that “[w]hen finalized, this will be the first time that the Government of Canada will use the power granted by Vanessa’s Law to apply terms and conditions.”

Health Canada publishes regulations permitting importation of drugs for an urgent public health need. As previously reported, Health Canada proposed amendments to the Food and Drug Regulations that would provide for importation and use of drugs authorized for sale in the United States, European Union or Switzerland to meet an urgent public health need. As announced in a news release, the amended Regulations were released on June 20, 2017 and an initial list of drugs (covering certain drugs for the treatment of opioid dependence and tuberculosis) was also published. By this regulatory pathway (see description here), public health officials in a jurisdiction may seek access to a drug and its addition to the list by notifying Health Canada of an urgent public health need for the drug within their jurisdictions.

Consultation on possible changes to generic drug equivalence under the Food and Drug Regulations. Health Canada is soliciting comments (until October 13, 2017) regarding possible changes to the Food and Drug Regulations relating to establishing pharmaceutical equivalence between a proposed generic drug product and a Canadian Reference Product (CRP)(see Consultation document here).Under the proposed changes, a notice of compliance constituting a “declaration of therapeutic equivalence” to a CRP could be issued to a generic product when the generic product and CRP are “pharmaceutical equivalents” (same medicinal ingredient in same dosage form) or “pharmaceutical alternatives” (different salts, esters or complexes of the medicinal ingredient, and/or different but comparable dosage forms to the CRP), if the generic for which bioequivalence has been demonstrated has the same route of administration and the same safety and effectiveness as the CRP. The Regulations currently define “pharmaceutical equivalent” as “a new drug that, in comparison with another drug, contains identical amounts of the identical medicinal ingredients, in comparable dosage forms, but that does not necessarily contain the same non-medicinal ingredients”. Health Canada’s current interpretation of “identical medicinal ingredient” is set out in its 2003 policy and 2015 interim supplemental policy (as previously reported). The proposed changes would also define “medicinal ingredient” as the active substance that contains the therapeutic moiety in the drug product that is administered or consumed, rather than the starting active pharmaceutical ingredient/input material.

CADTH consultation regarding proposal to allow revisions to CDEC recommendations

CADTH is seeking feedback until August 11, 2017 on a proposal to permit revisions, during the therapeutic review process, to existing Canadian Drug Expert Committee (CDEC) recommendations made through the Common Drug Review (CDR) process, eliminating the need to update recommendations through the request for advice process. During the therapeutic review process, CDEC will consider whether any recommendations should be revised. Manufacturers will be notified at the stage of initial therapeutic review of any recommendation that is being revised, the rationale, as well as the revised reimbursement criteria and/or conditions. There will be no embargo period. A formal reconsideration process will not be available, but manufacturers may provide stakeholder feedback. Their input will be considered prior to finalizing the revised recommendations, which will occur at the meeting to finalize the therapeutic review recommendations.

PMNOC proceedings

Other Proceedings

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