Market it or lose it: A cautionary tale for innovators

6 minute read
30 August 2022

In AbbVie Corporation v Canada (Health), 2022 FC 1209, Justice Fothergill of the Federal Court upheld the Minister of Health's finding that innovator pharmaceutical companies must actively market their drugs in Canada in order to benefit from Canada's patent linkage regime.

The decision stems from the judicial review of two related and consequential decisions of the Minister of Health concerning JAMP's product SIMLANDI, a biosimilar of AbbVie's highly successful biologic drug HUMIRA (adalimumab). First, the Minister determined that JAMP was not a "second person" for the purposes of s. 5(1) of the Patented Medicines (Notice of Compliance) Regulations (Regulations) in respect of its new drug submission (NDS). Second, the Minister issued a Notice of Compliance (NOC) to JAMP, authorizing it to market its SIMLANDI products. These decisions allowed JAMP to circumvent AbbVie's patents and quickly land its biosimilar drug on the market.

AbbVie launched judicial reviews of the Minister's decisions. On August 17, 2022, the Court dismissed AbbVie's applications.

JAMP relied on three presentations of AbbVie's HUMIRA in its NDS, all of which were the same dosage forms, strengths, and administration routes as the drugs to be marketed as SIMLANDI. While AbbVie has marketing authorization in Canada for several presentations of HUMIRA, none of those relied on by JAMP was marketed in Canada at the time of its submission. In light of this, JAMP did not initially include any Form Vs for SIMLANDI when it filed its NDS, which did not go unnoticed by Health Canada. JAMP explained its position to Health Canada, provided the Form Vs, and served Notices of Allegations on AbbVie pursuant to s. 5(3) of the Regulations, but on a "without prejudice" basis.

Upon review, the Office of Patented Medicines and Liaison (OPML) noted that two of AbbVie's three HUMIRA presentations had never been marketed in Canada, and that the third presentation had not been marketed in Canada in recent years. The OPML concluded that JAMP was not a "second person" under s. 5(1) of the Regulations and that the "drug" referred to in s. 5(1) must be DIN-specific and restricted to the same presentations of the reference biologic drugs, which at the time of JAMP's NDS filing, were not marketed in Canada. Following this decision, the Minister issued NOCs to JAMP for its three SIMLANDI presentations, which were subsequently launched in Canada.

AbbVie's judicial review challenged the Minister's interpretation of the term "another drug" in s. 5(1) of the Regulations, noting that the term was neither defined nor limited to a DIN-specific drug in this provision. According to AbbVie, if s. 5(1) was intended to be DIN-specific, it would have been explicitly stated as in other provisions, and hence, the requirement for a generic to address a patent listed on the Patent Register is not DIN-specific. AbbVie argued for an interpretation of s. 5(1) that intentionally encompasses all comparisons to a drug that has received market authorization by way of NOC where the first person has submitted a patent list.

JAMP, on the other hand, argued that patent listing under s. 4(1) of the Regulations is DIN-specific and that ss. 4 and 5 of the Regulations are "reciprocal in nature." The Minister maintained its earlier position which ultimately determined that JAMP was not a second person under s. 5(1) for "the simple reason that AbbVie was not marketing in Canada the HUMIRA drugs that JAMP relied on for its NDS." The Court agreed with JAMP's arguments and held that both the Minister's determination and issuance of an NOC to JAMP was reasonable.

In agreeing with the Minister's position, Justice Fothergill found that, "[t]he marketing condition is included to ensure that the advantages of the PM(NOC) Regulations are not conferred on patent holders whose products are, for whatever reason, not generally available to consumers." AbbVie did argue that a narrow interpretation of s. 5(1) creates a "loophole" that allows the Regulations to be circumvented and frustrates the purpose of the Patent Act such that generic or biosimilar manufacturers could abuse the early-working exception under s. 55.2(1) and rely on innovator data after significant research, development, and expenses. These arguments, however, were dismissed by the Court.

This decision highlights the apparent nexus between "drug" and "DIN." The Court held that the patent enforcement under the Regulations is only available to innovators that market their innovative drugs on a DIN-by-DIN basis in Canada. Both the Federal Court and Health Canada have reiterated that there is an explicit marketing requirement under s. 5(1). Drugs that have not been made available for sale or have been withdrawn from the market such that the DIN is cancelled or dormant will, according to the Court's decision in AbbVie, not be considered to be marketed in Canada.

The Federal Court's decision undoubtedly presents a material concern for AbbVie and its HUMIRA portfolio, and all innovative drug manufacturers. An appeal of the Federal Court's decision is anticipated.

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