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To Market, To Market, or the Regulations Will Not Apply

The Federal Court dismissed two applications for judicial review by AbbVie Corporation, who challenged the Minister of Health’s decisions (1) finding JAMP is not a “second person” under the Patented Medicines (Notice of Compliance) Regulations in respect of its New Drug Submissions for three adalimumab products; and (2) issuing Notices of Compliance for these adalimumab products.

Upon request, JAMP had provided the Minister with Form Vs comparing its SIMLANDI products to versions of AbbVie’s HUMIRA products that are approved but not currently on the market in Canada. JAMP also served AbbVie with Notices of Allegation, all “without prejudice” to its position that it was not required to comply with section 5 of the Regulations. The Minister and the Court ultimately agreed.

This post highlights two notable aspects of Justice Fothergill’s decision: (1) declining to apply a correctness standard of review; and (2) upholding that the Regulations apply to marketed drugs at Drug Identification Number-specific level.

First, the Court rejected that the correctness standard should apply to the Minister’s decision. Earlier this summer, the Supreme Court in Society of Composers, Authors and Music Publishers of Canada v Entertainment Software Association, 2022 SCC 30 announced a new category of correctness review “where both the executive and judicial branches of government have concurrent first-instance jurisdiction over a question of legislative interpretation.” Justice Fothergill found, however, that the Court did not have concurrent jurisdiction with the Minister to determine whether an entity is a “second person” for the purposes of subsection 5(1).

Justice Fothergill noted the Federal Court of Appeal in Teva Canada Limited v Pfizer Canada Inc, 2016 FCA 248 had squarely rejected a similar argument, finding “the Minister has exclusive jurisdiction to decide whether a drug submission filed by a second person makes a comparison with a Canadian reference product so as to require the second person to address a patent listed on the Patent Register,” [internal quotes omitted].

Second, applying the reasonableness standard, the Court upheld the Minister’s interpretation of the phrase “another drug” in subsection 5(1) as a particular dosage form, strength, and route of administration, identified by a specific DIN. As JAMP had compared its SIMLANDI products to versions of AbbVie’s HUMIRA product that were not marketed in Canada, subsection 5(1) was not triggered.

The Court held, “The general policy behind the [condition that a reference product is marketed in Canada] is that a patent holder who obtains an NOC, but does not use it, should not be entitled to rely on that NOC to obtain collateral advantages because of the PM(NOC) Regulations. This tends to support a narrow interpretation of s 5(1),” [cites omitted].

The Court also rejected that this interpretation creates a loophole to circumvent the application of the Regulations. Instead, under the clear language of subsection 5(1), Justice Fothergill found “[t]he enforcement mechanism of the PMNOC Regulations is only available to an innovator that markets its innovative drug in Canada.”

A copy of the decision can be found here.