Tuesday, June 7, 2011

The CGPA Does Not Have Standing to Challenge a Listing on the Register of Innovative Drugs

Canadian Generic Pharmaceutical Association v Canada (Health) 2011 FC 465 de Montigny J aff’g 2010 FC 1211 (Lafrenière, Prothonotary)

The Canadian Generic Pharmaceutical Association (CGPA), sought to challenge the listing of a particular drug on the Register of Innovative Drugs by writing to the Minister requesting that the drug be removed from the Register. The Minister refused on substantive grounds. The CGPA sought judicial review. Lafrenière P struck the application for judicial review on the basis that the CGPA does not have standing, and de Montigny J affirmed.

de Montigny J held that the CGPA does not have standing under s 18.1 of the Federal Courts Act as a person “directly affected,” because it has never filed a new drug submission and does not intend to do so [42]; by way of analogy, under the PM(NOC) Regulations, a manufacturer does not have standing to challenge a listing on the Patent Register unless it has filed an ANDS [44].

On the question of public interest standing, de Montigny J agreed that there was a serious issue, but held that the CGPA failed on both the second and third prongs. On the second prong he held that public interest standing is intended to be used to challenge constitutional validity or general exercise of administrative authority, and not a discrete decision [60]-[61]. This distinguishes 2007 FCA 375 aff’g 2007 FC 154, which refused to strike the CGPA’s challenge to the vires of the data protection Regulations on the basis of standing. de Montigny J is an expert in this area, and his decision was thorough and well reasoned.

de Montigny J held that the CGPA also failed the third prong, which requires there is no other reasonable and effective way to bring the issue before the courts. In so holding de Montigny J usefully clarified that an individual manufacturer can challenge a listing, perhaps “merely through persuasive evidence of a genuine intention to file a drug submission” [68], or by filing an ANDS. On the latter point in particular, “it is clear from the procedure outlined above in the Guidance Document on Data Protection that it is not a criminal offence for a generic drug manufacturer to file an abbreviated new drug submission during the pendency of the data protection period” [71].

Thus the decision that the CGPA lacks standing to challenge an individual listing appears sound in law. With that said, the policy arguments advanced by the CGPA are interesting. The CGPA argued in effect that there is a collective action problem in challenging a listing. It is expensive to challenge a listing, but if the challenge is successful, all generics, not just the one that incurred the cost, will benefit. It is possible that no individual generic would find it worthwhile to challenge the listing; see generally [14]. There is a collective action problem in principle, though a similar collective action problem also arises under the PM(NOC) Regulations or indeed in a validity challenge in an infringement action. This does not prevent such challenges; presumably the generic bringing the challenge relies on a lead-time advantage to recoup its costs. (But see Pfizer Canada Inc. v Novopharm Ltd. / pregabalin (NOC), 2010 FCA 258 (Evans JA) aff’g 2010 FC 668 (Crampton J) aff’g 2010 FC 409, Milczynski Pr in which Novopharm sought to prevent free-riding off its NOA – in effect the generic was seeking data protection for the information contained in its NOA.) Nonetheless, even though the collective action problem may not preclude listing challenges, this decision, sound though it seems on current law, goes against the nascent trend of allowing collective challenges to monopoly rights, such as the Peer-to-Patent program.

On the other hand, the standing problem has another side to it. The requirement that a party must be directly affected serves to ensure that the party bringing the challenge has the motivation to present the case fully. The party who must respond should not have to endure multiple challenges from various parties with tangential interest and partial arguments. Of course the CGPA is not simply an officious inter-meddler, but on the other hand the innovator companies already face multiple attacks on their rights in a drug, first in NOC proceedings and then in infringement proceedings. The CGPA argued that denying it standing to challenge a listing would result in redundant litigation, since each manufacturer would be required to bring its own application for judicial review [66]. This would be far from the only redundant litigation in the pharmaceutical area. No doubt the process could be streamlined, but ideally this should be part of a holistic assessment.

This is not to say that there should not be a mechanism to allow some form of collective challenge to the listing, but it is just one part of a large problem of the multiplicity of actions and arises particularly in the pharmaceutical context.

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