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Generic not required to address Patent Register when reference innovator drug is no longer marketed in Canada

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On August 17, 2022, the Federal Court dismissed applications for judicial review regarding the product-specificity requirements for addressing patents listed on the Patent Register under the Patented Medicines (Notice of Compliance) Regulations (the Regulations).

Background

This case concerns biosimilar presentations of an AbbVie Corporation and AbbVie Biotechnology Ltd. (collectively, AbbVie) product, HUMIRA (adalimumab), sought to be marketed by JAMP Pharma Corporation (JAMP).

AbbVie holds Notices of Compliance (NOCs) for HUMIRA in several concentrations. However, it only sells the original 50 mg/mL presentation (in 40 mg/0.8 mL strength auto-injector pen and pre-filled syringe presentations) and the newer 100 mg/mL presentation (in a 20 mg/0.2 mL strength pre-filled syringe). Several patents are listed in respect of the various presentations of HUMIRA on the Patent Register.

JAMP filed a new drug submission (NDS) for its biosimilar adalimumab product, SIMLANDI, in three presentations: (i) a 40 mg/0.4 mL pre-filled syringe; (ii) a 40 mg/0.4 mL auto-injector pen; and (iii) an 80 mg/0.8 mL pre-filled syringe.

JAMP took the view that it was not required to address any of the patents listed on the Patent Register for HUMIRA because its presentations corresponded to non-marketed presentations of HUMIRA. In response to a request from the Office of Patented Medicines and Liaison (OPML), and to avoid delay, JAMP submitted, on a “without prejudice” basis, Form Vs listing the non-marketed HUMIRA presentations as its reference biologic drugs (RBDs). JAMP also served notices of allegation on AbbVie, again on a “without prejudice” basis.

The Minister’s decisions

OPML contacted AbbVie for information regarding the marketing status of HUMIRA RBDs. OPML ultimately heard representations from both AbbVie and JAMP regarding its preliminary findings on whether JAMP was a second person, as well as the issuance of an NOC to JAMP. This led to two decisions:

  • The Minister found that JAMP is not a “second person” under subsection 5(1) of the Regulations on the basis that the RBDs were not marketed in Canada at the time JAMP filed its NDS. Therefore, JAMP was not required to address the patents listed on the Patent Register in respect of HUMIRA in pursuing its SIMLANDI NDS.
  • The Minister issued NOCs to JAMP for its three presentations of SIMLANDI.

AbbVie brought applications for judicial review challenging both decisions.

The Minister’s decisions are reasonable

The Court dismissed AbbVie’s applications, finding that the Minister’s interpretation of subsection 5(1) was reasonable. Even though there were patents listed against the RBDs, JAMP was not required to address those patents because the RBDs were not marketed. The Court rejected AbbVie’s argument that JAMP could be required to address these patents on the basis of the marketed presentations of HUMIRA.

  • Sections 4 and 5 work together.  JAMP submitted, and the Court agreed, that patent listing under section 4 of the Regulations is DIN-specific. This, in turn, determines which patents a second person must circumnavigate under section 5.
  • Subsection 5(1) is DIN-specific. The Court held that, under subsection 5(1), the enforcement mechanism of the Regulations is only available to an innovator that actually markets its innovative drug in Canada. The Court found this to be consistent with the policy 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 [Regulations].”
  • The SIMLANDI RBDs were appropriate.  AbbVie argued that its marketed presentations of HUMIRA could also serve as RBDs for SIMLANDI. The Court disagreed: there was no basis upon which the Minister could have expanded the RBDs to encompass presentations beyond the three non-marketed ones identified by the Biologic and Radiopharmaceutical Drugs Directorate (BRDD). The Court also rejected the argument that this creates a “loophole”.
  • Functional equivalency of RBDs and CRPs. The Court also rejected AbbVie’s argument that it was unreasonable to treat a BRD as “functionally equivalent” to a Canadian Reference Product (CRP) in the context of generics. AbbVie noted that, unlike a CRP, a BRD is not required by the Food and Drug Regulations to “contain identical amounts of the identical medicinal ingredients, in a comparable dosage form”. It was not unreasonable for the Minister to rely on its guidance document, which provides that the “dosage form(s), strength(s), and route(s) of administration of the biosimilar [drug] should be the same” as that of the RBD.

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