Urszula Wojtyra September 28 2022 Federal Court finds minister of health reasonable in concluding JAMP not "second person" for Simlandi biosimilar Smart & Biggar | Healthcare & Life Sciences - Canada Urszula Wojtyra Healthcare & Life Sciences IntroductionFactsMinister of healthFederal CourtCommentIntroductionOn 17 August 2022,(1) the Federal Court, per Justice Fothergill, dismissed AbbVie's applications for judicial review of the minister of health's decisions that:JAMP was not a "second person" and therefore it was not required to address the patents listed on the Patent Register; andnotices of compliance (NOCs) could issue for JAMP's Simlandi, a biosimilar of AbbVie's Humira (adalimumab).The Federal Court found that the minister of health's interpretation of section 5(1) of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) as applying only to the drug identification number (DIN)-specific version of the innovator's drug that is marketed in Canada was reasonable.FactsAbbVie has NOCs for Humira in two different concentrations: a low concentration of 50 milligrams per millilitre and a high concentration of 100 milligrams per millilitre. AbbVie has NOCs for one strength of the low concentration Humira, 40 milligrams per 0.8 millilitres, which AbbVie markets. AbbVie also has NOCs for four strengths of high concentration Humira:10 milligrams per 0.1 millilitres;20 milligrams per 0.2 millilitres;40 milligrams per 0.4 millilitres; and80 milligrams per 0.8 millilitres.Of these, however, AbbVie only markets the 20 milligrams per 0.2 millilitres strength in Canada.JAMP filed a new drug submission (NDS) for its high concentration biosimilar Simlandi in three presentations:40 milligrams per 0.4 millilitres (pre-filled syringe and auto-injector pen); and80 milligrams per 0.8 millilitres (pre-filled syringe).During the screening process, Health Canada considered JAMP's NDS incomplete because it did not include Form V declarations, as required by section 5(1) of the PMNOC Regulations:5 (1) If a second person files a submission for a notice of compliance in respect of a drug and the submission directly or indirectly compares the drug with, or makes reference to, another drug marketed in Canada under a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the second person shall include in the submission the required statements or allegations set out in subsection (2.1).JAMP therefore submitted the Form Vs, listing the non-marketed 40 milligrams per 0.4 millilitres and 80 milligrams per 0.8 millilitres high concentration Humira as the reference drugs. However, JAMP maintained its position that it was not required to comply with section 5(1) of the PMNOC Regulations because the Humira reference products were not marketed. JAMP also served notices of allegations on AbbVie, "without prejudice" to JAMP's position that it was not required to comply with the PMNOC Regulations.Minister of healthFollowing submissions from both AbbVie and JAMP, the minister of health concluded that JAMP was not a second person under the PMNOC Regulations. The obligations under the PMNOC Regulations did not arise unless JAMP's NDS "directly or indirectly compares the drug with, or reference" to "another drug [marketed in Canada]". The minister interpreted "another drug" as the Canadian reference product (CRP) for small molecule drugs or the reference biologic drug (RBD) for biologics, and specifically the strength, dosage form and route of administration of the reference drug – that is, "another drug" is specific to the DIN. According to the minister, the marketing requirement for "another drug" is therefore likewise DIN-specific.As AbbVie was not marketing the 40 milligram per 0.4 millilitre and 80 milligram per 0.8 millilitre Humira presentations when JAMP filed its NDS, the minister issued NOCs to JAMP for its three presentations of Simlandi. JAMP launched Simlandi in April 2022.Federal CourtAbbVie applied for judicial review of the minister's decisions:that JAMP was not a "second person"; andissuing the Simlandi NOCs.The Federal Court found that the minister's decision that JAMP was not a "second person" was reasonable and dismissed the judicial review application.In finding the minister's decision reasonable, the Court addressed the minister's "lengthy and careful reasoning", including the following:sections 4 and 5 of the PMNOC Regulations are reciprocal, and product specificity is key – section 4 of the PMNOC Regulations establishes the requirements for listing patents on the Patent Register. The minister interpreted subsection 4(4) as requiring the patent list contain a description of the drug at a DIN-specific level, and product specificity is a key consideration. Sections 4 and 5 of the PMNOC Regulations are reciprocal: section 4 establishes the patent list a second person must circumnavigate under section 5;appropriate Humira RBDs for Simlandi – AbbVie argued that the three non-marketed Humira DINs identified by the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) could serve as the RBDs for JAMP's Simlandi submission, not that they had to, and the marketed 20 milligram per 0.2 millilitre high concentration Humira product could also serve as the RBD. The Court disagreed with AbbVie, holding that there was no basis upon which the minister could have expanded the RBDs to encompass presentations beyond those identified by the BRDD, particularly as the BRDD had confirmed that the dosage form(s), strength(s) and route(s) of administration of Simlandi should be the same as that of the Humira RBD;RBDs and CRPs are functionally equivalent – the approval of generic drugs via the ANDS pathway is legislated in the Food and Drug Regulations, which requires that the CRP for a generic drug "contain identical amounts of the identical medicinal ingredients, in a comparable dosage form". No such corresponding requirements exist for an RBD for a biosimilar. The Court held that the lack of a legislative definition for an RBD does not preclude the minister from recognising a functional equivalence between RBDs and CRPs. Further, the minister cannot be faulted for following the recommendation in the biosimilar guidance document that the dosage form, strength and routes of administration of a biosimilar "should be the same" as the RBD. The Court concluded that AbbVie had not demonstrated that the minister's decision to treat RBDs and CRPs as performing an "equivalent role" was unreasonable; andmarketing condition supports a narrow interpretation of subsection 5(1) – AbbVie conceded that the three Humira RBDs were not marketed when JAMP filed its NDS. The minister concluded that a drug that is not marketed is not eligible for the protections under the PMNOC Regulations, and the Court agreed, stating that:[t]he general policy behind the marketing condition 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.CommentThe Court concluded that the minister's interpretation of subsection 5(1) as "applying only to a DIN-specific version of a drug that is marketed in Canada" was reasonable, "particularly considering the statutory objective of providing a patent enforcement mechanism only in relation to products that are in fact available to Canadians".AbbVie can appeal as of right. In response to JAMP's notices of allegations in 2021, AbbVie commenced patent infringement actions pursuant to the PMNOC Regulations. Shortly thereafter, JAMP commenced actions to invalidate the same patents and following JAMP's launch of Simlandi, AbbVie counterclaimed for infringement. The trial of all the actions is scheduled to commence on 14 November 2022.For further information on this topic please contact Urszula Wojtyra at Smart & Biggar by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar website can be accessed at www.smartbiggar.ca.Endnotes(1) AbbVie v Canada (Health) and JAMP, 2022 FC 1209.