On October 29, 2020, the Federal Court ordered the Minister of Health to immediately issue a notice of compliance (NOC) for a biosimilar drug following a dispute about the effective date of a consent letter under the  Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court held the Minister acted unreasonably in refusing to issue the NOC given the nature of the consent provided.

Background

Fresenius Kabi Canada Ltd. (Fresenius Kabi) seeks to market its adalimumab product, IDACIO, in Canada. IDACIO is a biosimilar of AbbVie Biotechnology Ltd.'s (AbbVie) HUMIRA. AbbVie owns a number of patents listed on the patent register against HUMIRA; under the Regulations, Fresenius Kabi was required to address these patents before the Minister could issue an NOC for IDACIO.

In addition to patent litigation and other alternatives, a “second person” (i.e., generic or biosimilar sponsor) can address patents under the Regulations by providing the Minister with evidence of the patentee's consent to the second person doing four activities listed in subs. 7(2): making, constructing, using, or selling the drug.

Pursuant to a confidential licensing agreement (the Agreement), AbbVie agreed to let Fresenius Kabi perform certain acts under the patents and provided its consent to the Minister on the following terms:

  • Issuance of a NOC in accordance with the Agreement;
  • Making and constructing of IDACIO; and
  • Using and selling of IDACIO on or after February 15, 2021.

Fresenius Kabi took the position that this consent was sufficient for an immediate NOC. The Minister disagreed, leading to a series of exchanges with both AbbVie and Fresenius Kabi attempting to clarify the nature of the consent provided.

The Minister's Decision

Ultimately, the Minister refused to issue an NOC to Fresenius Kabi on the basis that the patentee's consent must (a) be unequivocal and (b) authorize all four activities listed in subs. 7(2). The Minister took the view that AbbVie's consent was not effective until February 15, 2021, when Fresenius Kabi would be permitted to use and sell IDACIO in addition to making and constructing it. The Minister also took issue with the fact that the parties made reference to the terms of the Agreement in correspondence with the Minister.

No barrier where there is unequivocal consent

Manson J. held that the Minister acted unreasonably in refusing to issue the NOC. The Court was satisfied that the requirements of the Regulations  were met because AbbVie (a) provided unequivocal consent to all four activities under subs. 7(2) of the Regulations and (b) did not object to the immediate issuance of an NOC. Manson J. held that this interpretation was consistent with the purpose of the “dual purpose” of the Regulations  to “balance effective patent enforcement over new and innovative drugs with the timely market entry of their lower-priced generic competitors”.

In reaching this conclusion, Manson J. agreed that the Minister should not be required to interpret agreements and that it was appropriate to require consent directly from the patentee. However, having received that consent, the Minister could not refuse to issue an NOC on the basis that consent to some of the four activities listed in subs. 7(2) was not effective until a later date.

By the time of the decision under review, Health Canada had completed its examination of the IDACIO submission. Since the only barrier to approval was the Regulations  and there was no discretion to refuse an NOC, Manson J. granted an order of mandamus compelling issuance of the NOC. Manson J. also commented that the timing of NOC issuance when launching a biosimilar product is “critical for biosimilars to remain competitive and establish their market position”.

Health Canada's NOC database indicates that the NOC was issued to Fresenius Kabi the day after the decision, on October 30, 2020.

Decision

Fresenius Kabi Canada Ltd. v Minister of Health,  2020 FC 1013

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