Under our patent linkage system, a patent that is ultimately held to be invalid can keep competitors off the market until the conclusion of the NOC proceedings. Section 8 of the NOC Regs provides a remedy in the form of damages to the generic that has wrongly been kept off the market. However, there are limitations to this remedy. Both the FCA and the ONCA have held that if the generic is successful in the s 8 proceeding, s 8 entitles it only to its own damages, and not disgorgement of the patentee’s profits: Apotex v Eli Lilly Canada 2011 FCA 358 (here); Apotex v Abbott Laboratories 2013 ONCA 555 JJA (here). The FCA has also held that if the generic is unsuccessful in the NOC proceeding, it cannot claim s 8 damages, even if the patent is subsequently held invalid in an infringement action: see Eli Lilly Canada v Apotex 2013 FCA 282 (blogged here). Undeterred, in a series of actions Apotex has sought a way around these limitations by pleading a bewildering variety of causes of action. None has so far proceeded beyond the pleading / certification stage. I haven’t blogged all of them and this decision presents an opportunity to try to summarize the holdings, though so many causes of action have been raised that I can’t guarantee that I have caught them all.
This decision itself is also noteworthy in a few respects. Most importantly, Lederman J refused to strike the claim for unjust enrichment [36]. In so doing, he declined to follow the BCCA decision in Low v Pfizer 2015 BCCA 506. As discusssed here, Low held that the claim for unjust enrichment had no prospect of success because there was a juristic reason for the infringement. Lederman J noted that Low was not binding on him [30], and he consequently held that jurisprudence is inconclusive [33]. He also distinguished Apotex v Eli Lilly 2015 ONCA 305 (here) on the basis that in that case Apotex had been seeking disgorgement of all of the patentee’s profits, whereas in this case, Apotex “claims only that portion of Pfizer’s revenues that represent the revenues Apotex was deprived of because of the delay in obtaining its Notice of Compliance” [35]. That is, in this case Apotex is in effect seeking its own damages in the guise of an unjust enrichment claim.
Lederman J also allowed a claim for damages in nuisance [39]. I believe this is the first time Apotex has advanced a nuisance claim.
A third point of interest is that Lederman J also struck Apotex’s claim for damages under s 8 [18]. This is not too surprising, as he was simply following [14] the FCA holding in Eli Lilly Canada v Apotex 2013 FCA 282 n this point but given his view of the BCCA decision in Low, it was not a foregone conclusion that he would accept the FCA’s reasoning.
Apotex also pleaded treble damages under the English and Ontario Statutes of Monopolies [1]. Pfizer did not seek to have this struck, in light of the prior jurisprudence allowing such a claim to stand. Lederman J also allowed the claim under s 7(a) of the Trade-marks Act to stand, in light of prior decisions [28]. He rejected the claim based on Ashby v. White, on the view that “The principle borrowed from that case – ‘no right without a remedy’ – is simply a phrase, a principle or a maxim. By itself, it does not disclose a cause of action and should be struck” [40].
To summarize (at least partially) the cases to date:
No prospect of success
Disgorgement under s 8
Apotex v Eli Lilly Canada 2011 FCA 358 (blogged here); Apotex v Abbott
Laboratories 2013 ONCA 555 (here) aff’g 2013 ONSC 356
Damages under s 8 if patent held valid in NOC proceeding
Unlawful interference with economic relations
Low v Pfizer 2015 BCCA 506 (here)
Waiver of tort
Low v Pfizer 2015 BCCA 506 (here) The “principle” in Ashby v White
Allowed to stand
Damages under the Trade-marks Act s 7(a)
Apotex v Schering 2016 ONSC 3407
Treble damages under the English and Ontario Statutes of Monopolies:
Damages in nuisance
Conspiracy
Apotex v Pfizer Ireland 2016 ONSC 4966
Unjust enrichment
No cause of action in unjust enrichment
No disgorgement of patent’s entire profits
Apotex v Eli Lilly 2015 ONCA 305 (here)
Disgorgement of profits corresponding to generic’s damages
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