Executive Summary: Key Legal and Evidentiary Issues

• Amgen Canada Inc. sought a provisional interlocutory injunction that would require the RAMQ to stop systematically refusing exceptional patient measure requests for Repatha and to review them individually.
   
• At the heart of the dispute is whether "therapeutic indication" in the List of Medications means the general category of cardiovascular event prevention or the full indication recognized for payment, including its clinical conditions.
   
• Urgency, the threshold criterion for a provisional injunction, was assessed strictly, and any doubt required refusal.
   
• Patients, the court found, still had access to Praluent as a recognized alternative and could buy Repatha at their own cost. Those refused could seek review and then challenge the review decision before the Tribunal administratif du Québec.
   
• Claims of permanent market loss rested largely on general statements, with no evidence of market share or sales trends and no estimate of lost revenue or profits.
   
• Delay arguments raised by the defendants were rejected because Amgen acted diligently after the RAMQ's first detailed response on July 16, 2026.
   

Facts of the case

Amgen Canada Inc. manufactures Repatha (evolocumab), a cholesterol-lowering drug. Until February 2026, Repatha appeared on Quebec's list of exception drugs for only two therapeutic indications. It was not listed for the prevention of cardiovascular events. Patients prescribed Repatha for that purpose could instead apply for coverage under the exceptional patient measure, a safety net that covers unlisted drugs or exception drugs prescribed for an indication not on the List of Medications.

INESSS made a recommendation in 2020, and Amgen concluded a listing agreement with the Minister of Health and Social Services. Following both, Repatha was added in February 2026 as an exception drug for cardiovascular event prevention. The listing applies to patients who have had an acute coronary syndrome in the last 24 months, have LDL-C levels of at least 1.8 mmol/L, and have inadequate cholesterol control after the specified statin and ezetimibe regimens, or cannot use those drugs.

Since February 2026, the RAMQ has refused exceptional patient measure requests for Repatha prescribed for cardiovascular event prevention. It reasons that this indication now appears on the List. Given the listing and the RAMQ's interpretation, the cost of Repatha would be covered through neither route for certain patients. These include patients who have never had an acute coronary syndrome, those whose syndrome occurred more than 24 months earlier, and those with another form of atherosclerotic cardiovascular disease.

A competing drug, Praluent (alirocumab), manufactured by Sanofi Canada Inc., is not listed as an exception drug. Amgen filed an originating application on July 23, 2026, seeking judicial review, a declaratory judgment and provisional, interlocutory and permanent injunctions. The judgment addresses only the provisional injunction application, which was heard on September 1, 2026.

Policy and legislative provisions at issue

Under section 2 of the Act respecting prescription drug insurance, the plan's purpose is to ensure reasonable and fair access to the drugs Quebecers need for their health. Under section 60 para. 5, the Minister sets the list of covered drugs by regulation, and exception drugs are covered in the cases, under the conditions or for the therapeutic indications the Minister determines. Appendix IV of the List of Medications is titled "List of exception drugs and indications recognized for their payment." The RAMQ treats the diamond-marked entry ("prevention of cardiovascular events") as the therapeutic indication. It treats the bulleted criteria as payment conditions.

Amgen asked for a declaration that "therapeutic indication" means the full indication recognized for payment, including all clinical conditions. In the alternative, it asked that the phrase "therapeutic indication not stated in the List" in section 6.1 of the List of Medications be declared ultra vires the enabling statute. The injunction framework comes from arts. 509 to 511 of the Code of Civil Procedure. Under art. 510 para. 2, the court may grant an interlocutory injunction provisionally in cases of urgency.

Reasoning and analysis

Justice Pérodeau set out four cumulative criteria for a provisional injunction: urgency, an appearance of right, serious or irreparable harm, and a favourable balance of inconvenience. He treated urgency as the essential threshold. Relying on Société minière Louvem inc. c. Aur resources inc., he held that a provisional injunction is reserved for extremely urgent cases in which even the time needed to obtain an interlocutory injunction would irreparably harm the applicant's rights. He also cited Justice Bisson's description of the required urgency as "911-style."

On patient harm, the court found no evidence of an evident, imminent and irreparable harm. Praluent is a recognized treatment for cardiovascular event prevention. Amgen's own physician affiant acknowledged that both drugs are used for atherosclerotic cardiovascular disease linked to high LDL cholesterol. Patients could still buy Repatha, although the court recognized its cost is significant and not everyone can afford it. Refused patients could seek review from the RAMQ and then challenge the review decision before the Tribunal administratif du Québec, which has exclusive jurisdiction. Authorizations issued before February 2026 continue to be renewed.

According to the RAMQ's exhibit, 38 initial requests were refused. The judgment gives this figure once for February 4 to August 14, 2026 and once for February to July 2026 [source-level inconsistency: the two passages state different periods for the same figure from the same exhibit]. Amgen, for its part, claimed knowledge of at least 45 refusals and 32 pending requests.

On market harm, the court accepted that some physicians may be switching patients to Praluent, that those patients will likely not return, and that Amgen may lose revenue. However, the evidence said nothing about Amgen's market share or Quebec sales since February 2026. It also provided no estimate of lost revenue and did not address lost profits.

Figures from the sworn statement of Alain Albert showed that 208 of 690 initial exceptional patient measure requests (about 30%) were accepted between July 2, 2025 and February 3, 2026. By comparison, 213 of 573 requests (37%) were accepted under the exception drug measure between February 4 and August 12, 2026, so the acceptance rate rose after the listing.

The court also weighed Amgen's size, noting its leading role in biotechnology for more than 40 years. It distinguished Novopharm Ltd. c. Rochon on three grounds: that case concerned an interlocutory rather than a provisional injunction, it involved the removal of all of a manufacturer's products from the List for three months, and the evidence there showed substantial losses. The court added that the orders sought would not significantly change Amgen's position, given their nature, the ten-day period they would be in effect, and the two-to-three-month processing time for authorization requests.

The defendants' argument that Amgen had delayed was rejected. Amgen appeared to have learned of the refusals only anecdotally between February and April 2026. The RAMQ was slow to respond to its concerns and, until July 16, 2026, largely referred Amgen to its role. From that point, Amgen acted diligently. Because urgency was not established, the court declined to examine the remaining criteria.

Ruling and overall outcome

The Superior Court dismissed Amgen's application for a provisional interlocutory injunction, with legal costs in favour of the defendants, the Régie de l'assurance maladie du Québec and the Attorney General of Quebec. The judgment does not quantify those costs, and no other monetary amount was awarded. The judgment deals only with the provisional injunction application. The interlocutory injunction application remains scheduled for hearing on January 13, 2027.