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Slips of the pen do not restore Janssen’s Zytiga Monopoly

In Janssen Inc v Apotex et al., 2022 FCA 184, the Federal Court of Appeal affirmed the invalidity of Canadian Patent No. 2,661,422 (the “422 Patent”).

The underlying actions (commenced against Apotex, Pharmascience and Dr. Reddy’s) were heard concurrently by Justice Phelan (Janssen Inc et al v Apotex Inc., 2021 FC 7). Justice Phelan held that the 422 Patent, which claims the combination of abiraterone acetate and prednisone for the treatment of prostate cancer, was invalid on the basis of obviousness.

On this appeal, the Court of Appeal found that Justice Phelan made no error of law. The factual errors in the obviousness analysis raised by Janssen were not overriding but merely clerical in nature.

On appeal, Janssen argued that Justice Phelan erred in finding abiraterone acetate was known to be a prostate cancer treatment. Janssen argued:

  1. Justice Phelan erred in finding that the statement in the 422 Patent was a binding admission upon the patentee; and
  2. Justice Phelan erred by confusing the O’Donnell 2004 study for the 001 Study when he stated at paragraph 100:“[t]he results of the 001 Study were reported in O’Donnell 2004.”

The Court of Appeal noted that Justice Phelan had relied on the prior art as evidence that abiraterone acetate was a treatment for prostate cancer. Because of this, the Court of Appeal chose to not address the circumstances in which an admission in a patent is binding on a patentee. The Court of Appeal found that the second alleged error was a “slip of the pen” as Justice Phelan likely intended to say that “the results of O’Donnell 2004 were reported in the 001 Study”.

Janssen also failed to demonstrate that Justice Phelan erred in his obviousness analysis. Janssen argued:

  1. Justice Phelan needed to explain how abiraterone acetate contributed an anti-cancer effect independent of prednisone; and
  2. Justice Phelan failed to conduct an analysis on claims 14 and 15, directed to refractory prostate cancer, as he stated at paragraph 184: “it was reasonable to expect success in anti-cancer treatment to combine AA and PN to treat CRPC patients excluding those being refractory patients.”

The Court of Appeal found that Justice Phelan had before him ample evidence that would have led the skilled person to expect that each of abiraterone acetate and prednisone would contribute an anti-cancer effect. The expectation that each of abiraterone acetate and prednisone would contribute an anti-cancer effect was sufficient, and it did not need to be confirmed. The Court of Appeal found, after reading the decision as a whole, that the phrase “excluding those being refractory patients” was likely intended to state “including” and amounted to nothing more than “another slip of the pen”.

Lastly, the Court addressed the issue with respect to Apotex Inc.’s Counterclaim concerning the non-asserted claims. Janssen alleged that the non-asserted claims could not be addressed under subsection 6(3) of the PM(NOC) Regulations. The Court of Appeal disagreed, stating that subsection 6(3) was permissive following a review of the RIAS accompanying the amendments to the PM(NOC) Regulations. The Court of Appeal also corrected the Trial Judge’s order to state that the “counterclaim is granted”.

Dr. Reddy’s was represented by Bryan Norrie and Yaseen Manan.

A copy of the decision may be found here.

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