On October 30, 2014, Justice Noël of the Federal Court of Appeal, released the Reasons for Judgment in Apotex Inc. v. Pfizer Canada Inc. stemming from two separate NOC hearings in respect of Pfizer’s CELEBREX product and Canadian Patent No. 2,177,576.
In January and April 2014, Justice Harrington of the Federal Court allowed applications brought by Pfizer Canada Inc. and G.D. Searle & Co., and issued orders prohibiting the Minister of Health from issuing notices of compliance in respect of Mylan’s and Apotex celecoxib products, respectively.
The NOC applications addressed 5 discrete issues, however for the purposes of this post, I will examine the Court’s treatment of the following utility issues: (1) whether the 576 Patent lacked utility in treating inflammation in humans, (2) whether the 576 Patent lacked utility in reducing harmful side effects, and (3) whether the 576 Patent lacked utility in preventing colorectal cancer.
With respect to the first issue, Justice Harrington held that the promise of the patent was not to treat inflammation in humans as Apotex proposed, rather, since the patent only made reference to the treatment of inflammation in “subjects”, this could be defined more broadly, to include, for example, rats. In the Federal Court’s opinion, the promise to treat inflammation in subjects had been demonstrated.
With respect to the second issue Apotex and Mylan argued that the 576 Patent promised reduced side effects in humans, and since Celecoxib did not provide reduced side effects, the 576 Patent was invalid for lack of utility. In support of their position, Apotex and Mylan referred to the “description of the invention” section of the 576 Patent, which stated that the compounds were useful as anti-inflammatory agents…with the additional benefit of having significantly less harmful side effects. Pfizer maintained that the Patent contained no such promise with respect to side effects, relying on a separate passage of the 576 Patent stating that celecoxib “may” reduce side effects. Justice Harrington agreed with Pfizer, ruling that the 576 Patent did not promise reduced side effects. Justice Harrington pointed to the equivocal nature of the specification and relied upon a line of case law stating that uses which did not appear in the claim specification ought to be considered as mere statements of advantage, absent clear and unequivocal language promising such uses.
With respect to the third issue, Justice Harrington held that there was evidence to support the position that the claim for the treatment of colorectal cancer was invalid. However, he also held that this claim could be severed from the patent pursuant to section 58 of the Patent Act, and the remaining claims would remain valid.
Apotex and Mylan appealed their respective decisions on the basis that Justice Harrington erred in his analysis of the utility of the 576 Patent. The two underlying decisions shared common lines of reasoning, so they were heard together.
The Federal Court of Appeal Decision
Justice Noël dismissed the appeals by Apotex and Mylan, largely re-iterating the analysis conducted by Justice Harrington with respect to the 3 issues identified above.
With respect to the utility analysis, Justice Noël relied upon the promise doctrine as stated in Sanofi-Aventis v. Apotex Inc. and held that there was no reason to interfere with the findings of Justice Harrington. The Federal Court analyzed the promise of the patent by carefully canvassing the expert evidence, construing the promise of the patent on the basis of the patent language, and analyzing it from the perspective of the skilled person. Furthermore, Justice Harrington was correct in finding that the patent only extended to “subjects” (not humans), and that even if the patent contained an undelivered promise with respect to colorectal cancer prevention, this claim could be severed from the rest of the patent, as this was not a case where imposing utility requirements across each of the patent’s claims was warranted.
A copy of the Federal Court of Appeal’s Reasons for Judgment can be found here.