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ARTICLE · 08 SEPTEMBER 2022

NOC Regulations Do Not Apply To Biosimilars When Reference Products Are Not Marketed

Borden Ladner Gervais LLP
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The Federal Court recently denied AbbVie's application for judicial review of two decisions of the Minister of Health (the Minister) relating to JAMP Pharma's SIMLANDI product...

CanadaIntellectual Property
Beverley Moore
Beverley Moore
Chantal Saunders
Chantal Saunders
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The Federal Court recently denied AbbVie's application for judicial review of two decisions of the Minister of Health (the Minister) relating to JAMP Pharma's SIMLANDI product, which is a biosimilar version of AbbVie's HUMIRA adalimumab product. The Court held that the Minister's decision interpreting the Patented Medicines (Notice of Compliance) Regulations (the NOC Regulations) as applying only to a single version of a drug with a drug identification number (DIN) that is marketed in Canada was reasonable (para 5).

Is JAMP a second person?

The first question to be considered by the Court was whether the Minister's decision determining that JAMP is not a "second person" for the purposes of the NOC Regulations could be upheld. The Minister had decided that JAMP was not a second person, meaning that it was not required to send AbbVie a Notice of Allegation (NOA) pursuant to the NOC Regulations. As a result, it did not have to clear non-infringement or

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