Wednesday, June 11, 2014

Must a Challenge to Listing Eligibility Be Brought on a 6(5) Motion?

Bayer Inc v Apotex Inc / drospirenone (NOC) 2014 FC 436 Hughes J
            2,382,426 / drospirenone & ethinylestradiol / YAZ

In Apotex / YAZ, Apotex argued that the 426 patent is ineligible for listing on the Patent Register. The main legal question of interest is whether Apotex could even raise the issue at the hearing, or whether it must bring a prior motion under s 6(5)(a) of the NOC Regulations. Hughes J noted at [72] that in 2005 FC 1421 Mosley J had held that Apotex was not required to make a motion under subsection 6(5), and at [74] Hughes J noted that he had commented in obiter to the same effect in 2013 FC 985 [109]. He also relied at [73] on the FCA decision in 2007 FCA 187, as being to the same effect, but it must be said that that case was about the interpretation of “claim for the medicine itself” under s 2, and not about subsection 6(5). And on the other hand, in 2008 FC 308, [65]-[66], Gauthier J after a review of the case law, held that she did not have jurisdiction to consider eligibility issues in a s 6(1) motion, as they had to be decided as a part of a s 6(5) motion. After all this, Hughes J said “It is time to put the matter to rest” [76], and held, contrary to Gauthier J, that eligibility can be raised in a s 6(1) motion, nothwithstanding that no motion was brought under 6(5). Given that Gauthier J is now in the FCA, I am not sure that Hughes J’s holding will put the matter to rest, but at least his decision does frame the issue and the split case law for the FCA to resolve.

Turning then to 426 patent, Apotex argued that it could not be listed against YAZ because the ethinylestradiol in YAZ is contained as a clathrate (a solid mixture in which small molecules of one compound are physically trapped in the holes of the crystal lattice of another substance [88]), and ethinylestradiol as claimed in the 426 patent does not encompass a clathrate. An initial question is whether a patent claiming a clathrate is eligible for listing, recalling that a patent is only eligible if it contains “a claim for the medicinal ingredient,” which excludes “different chemical forms of the medicinal ingredient.” However, a Health Canada policy statement (albeit one issued before subsequent changes to the NOC Regulations), did define the active moiety of the medicinal ingredient to include a clathrate [87]-[88], and this interpretation appears to have been accepted by Hughes J. The next question was whether ethinylestradiol in the claim included a clathrate. Hughes J held it did, based both on a straightforward grammatical analysis [91]-[92], and on Apotex’s own use of the term in its ANDS as including a clathrate [95]-[96].

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