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Federal Court orders Minister of Health to issue NOC to Fresenius Kabi for its biosimilar IDACIO following filing of consent letter

On October 29, 2020, Justice Manson of the Federal Court ordered the Minister of Health to issue a notice of compliance (NOC) to Fresenius Kabi for IDACIO (adalimumab), a biosimilar of AbbVie’s HUMIRA: Fresenius Kabi v Minister of Health, 2020 FC 1013.

The Minister of Health had completed its review of Fresenius Kabi’s new drug submission for IDACIO; the only outstanding issue was whether Fresenius Kabi had addressed the patents listed on the Patent Register in respect of HUMIRA.

Fresenius Kabi and AbbVie had entered into a licensing agreement including for the listed patents and AbbVie provided the Minister of Health with the following consent:

Pursuant to s. 7(2) of the Patented Medicines (Notice of Compliance Regulations), and solely for the purpose of these Regulations, AbbVie […] herby consents to the making, constructing, and, on and after February 15, 2021, to the using and selling in Canada by Fresenius Kabi Canada Ltd, of IDACIO…

Subsection 7(2) of the Regulations exempts a submission from the effects of the Regulations if “the Minister has been provided with evidence from the owner of the patent of their consent to the making, constructing, using or selling of the drug in Canada by the second person.”

The Minister of Health considered AbbVie’s consent to be effective only as of February 15, 2021, because in contrast to the activities permitted by an NOC, which allows “selling” and “advertising”, the consent to only “making” and “constructing” would not meet the requirements of subsection 7(2) of the Regulations. The Minister also read the word “or” in subsection 7(2) conjunctively, requiring unequivocal consent for all four activities.

Fresenius Kabi sought judicial review of the Minister’s refusal to issue an NOC until February 15, 2021. 

Justice Manson held that the Minister was unreasonable in refusing to grant the NOC, including on the basis that he viewed AbbVie’s consent as “unequivocal consent to all four activities in subsection 7(2) of the NOC Regulations. The temporal nature of the consent does not render it ineffective.” Justice Manson noted that AbbVie did not object to immediate issuance of an NOC and any patent infringement issues between Fresenius Kabi and AbbVie are resolved by way of the licensing agreement. Justice Manson also held that the Minister erred in her analysis of the text of subsection 7(2) of the Regulations and her interpretation of the disjunctive, but inclusive “or”.

Given that Health Canada had completed its examination of the IDACIO submission, and the sole outstanding issue was the requirement of consent under subsection 7(2) of the Regulations, Justice Manson held that there was no useful purpose in remitting the issue back to the Minister of Health. As such, he ordered the Minister of Health to issue the NOC.

The NOC issued for IDACIO on October 30. The Minister of Health may appeal as of right.

Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation group.

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