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Anticipation test takes the middle ground

Justice McVeigh’s recent decision has addressed an area of debate within the jurisprudence and academic commentary regarding the proper legal test for anticipation in AbbVie v JAMP Pharma, 2023 FC 1520.

Justice McVeigh’s decision was issued in the context of patent infringement and impeachment actions where AbbVie asserted that JAMP’s SIMLANDI product (a biosimilar of AbbVie’s HUMIRA product) would infringe Canadian Patent Nos. 2,504,868 (the “868 Patent”) 2,801,917 (the “917 Patent”) and 2,904,458 (the “458 Patent”). One of the validity issues was whether claims of the 917 Patent and 458 Patent were anticipated in view of certain prior art. The 917 Patent related to the use of adalimumab to treat hidradenitis suppurativa (an autoimmune disorder), while the 458 Patent related to protein formulation.

Sanofi is the leading case on anticipation where the Supreme Court held that a prior publication will anticipate a claim if it satisfies a two-part test requiring (i) disclosure; and (ii) enablement. No trial and error is permitted at the disclosure stage. The enablement component is satisfied if the skilled person is able to perform or make the invention of the second patent without undue burden (Sanofi at para 37).

AbbVie and JAMP agreed in broad terms on the legal principles of anticipation but disagreed on the parameters of the disclosure component. Specifically, the parties disagreed on whether prior art which disclosed a range of dosage options can anticipate a point within a range or embodiment.

JAMP relied on several cases where the Federal Court held that a range or broad disclosure anticipated a point within a range, including Eli Lilly v Mylan, 2020 FC 816 (see our blog post here). In contrast, AbbVie relied on a recent Court of Appeal decision in Apotex v Shire, 2021 FCA 52 to argue that the test for anticipation is not met where a disclosure broadly includes or encompasses the claimed invention without necessarily planting the flag at the precise destination. AbbVie also pointed to Professor Siebrasse’s academic commentary which has taken the view that the Federal Court has conflated the disclosure and enablement steps by finding that a range plants the flag, when the proper approach is to permit the trial-and-error exercise of selecting a point from within a range, only at the enablement stage.

Justice McVeigh concluded the proper approach is the middle ground, supported by Justice Rennie’s decision in Apotex Inc v Shire LLC: a range does not necessarily anticipate a point within the range, but it may. Justice McVeigh held that “if the range is sufficiently small, based on the factual situation (e.g. in a pharmaceutical context 0.10 – 0.12 mg/ml), it can be said that inventor planted their flag with sufficient specificity to anticipate a point in a claim.” The take-away message for parties asserting invalidity based on anticipation is that:

… where the evidence presented at trial shows that the range is narrow enough, such that a flag can be planted based on the context and examples given, then it is anticipated. If the evidence shows a very broad range that the Judge, with the experts’ assistance (if needed), does not see it as a precise enough to plant the flag before proceeding to the enablement stage, then it fails at the disclosure stage.

Justice McVeigh concluded that the 917 Patent claims were not anticipated by the prior art 868 Application because the skilled person reading that application would have a range of dose amounts, dosing intervals, and durations of treatment to choose from when creating a multiple variable dosing regimen to treat an inflammatory-related disorder. The Court was not satisfied that the skilled person would know to select adalimumab and to administer it using the specific dosing regimen claimed in the 917 Patent, and the unknown elements could not be supplemented by the common general knowledge.

Justice McVeigh also concluded that the 458 Patent claims were not anticipated by the prior art 181 Application. Among other reasons, the Court held that the range of protein concentrations in the prior art was a “very large range,” and that this range did not plant a flag at the specific concentration of 100 mg/mL, especially since the specific formulation examples set out in the prior art application did not include the protein relevant to the 458 Patent. With respect to enablement, the Court held that the 181 Application left open too many choices. 

Read the full decision here.