SCC Update. On October 23, 2017, the Supreme Court of Canada dismissed Apotex’s motion to amend the Supreme Court of Canada’s judgment in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36 (reported here, relating to esomeprazole, AstraZeneca’s NEXIUM). Apotex had asked that the case be remanded to the Federal Court to determine if “overpromising” renders the 653 patent invalid on the basis of insufficient disclosure, overbreadth and willful misleading. Apotex had also asked that anticipation and obviousness, rejected by the Federal Court, be remanded to the Federal Court of Appeal.
Two recent Federal Court decisions also illustrate attempts to raise “overpromising” as a ground of invalidity outside of the “promised utility” doctrine rejected in AstraZeneca.
Pfizer Canada Inc v Apotex Inc, 2017 FC 774 (desvenlafaxine, PRISTIQ; see our main article here). The Applications Judge rejected Apotex’s post-hearing submissions that the 668 patent “overpromises” in violation of the requirements of subsection 27(3) of the Patent Act. Apotex had argued that the statements in the patent “to the effect that the compounds of the patent have the utilities (1)-(3) above were thus not ‘correct and full’ descriptions of the invention but rather were overpromises. As such, they ought to invalidate the 668 patent as a whole.”
The Judge found no rationale for interpreting the Supreme Court of Canada in AstraZeneca to have “removed the Promise Doctrine from the utility analysis yet simultaneously required it to be considered, in the manner Apotex proposes, in the specification analysis. If that was the case, a major underlying problem identified by the Supreme Court itself would remain, namely that ‘a patentee will be dissuaded from stating the invention can be used for things that are not sufficiently established at the time of filing if doing so would risk invalidating the entire patent’.” The Judge also found no basis to find that the Supreme Court in AstraZeneca intended to overrule itself on the disclosure requirement under subsection 27(3) as set out in Teva Canada Ltd v Pfizer Canada Inc, 2012 SCC 60. Apotex has appealed.
Apotex Inc v Shire LLC, 2017 FC 831. The Case Management Judge allowed Apotex to amend its pleadings to “recast” factual allegations that formed the basis of its plea of inutility of Shire’s Patent No 2,527,646 (lisdexamfetamine, VYVANSE). The Prothonotary found that the amendments reflect “a refusal to come to terms with and embrace the essence of the Supreme Court’s teachings” and were an attempt to shoehorn Apotex’s promise allegations into each and every ground of invalidity known to law. Nevertheless, this was not a reason to disallow the amendments or to strike the original pleadings related to the plea of inutility, as a party is not bound by the legal characterization it has used in its pleading and can argue at trial any legal consequence that the pleaded facts present.