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Federal Court of Appeal upholds obviousness finding re: Janssen’s abiraterone acetate and prednisone combination therapy patent

As previously reported, the Federal Court found Janssen’s Canadian Patent No. 2,661,422 (the 422 patent) invalid on the basis of obviousness and dismissed its actions against Apotex, Dr. Reddy’s Laboratories, and Pharmascience.

In a decision released on November 1, 2022, the Federal Court of Appeal dismissed Janssen’s appeal on all issues, as discussed below: Janssen Inc v Apotex Inc, 2022 FCA 184.

Trial judge’s finding that abiraterone acetate was known to be a prostate cancer treatment

The 422 patent concerns the treatment of prostate cancer in humans by co-administration of abiraterone acetate (AA)  and prednisone (PN). The trial judge found, as part of the state of the art, that AA was known to treat prostate cancer. Janssen argued that this conclusion was based on two erroneous findings: (i) that an admission in the 422 patent to this effect was binding on Janssen, and (ii) that the results of a study of AA as a treatment for prostate cancer (the 001 Study) were reported in the prior art O’Donnell 2004 paper.

With respect to the first alleged error, Locke J.A. for the panel held that there was evidence on which the trial judge was entitled to rely that supported the factual conclusion. He declined to decide whether, to what extent, and under what circumstances an admission in a patent will be binding on the patentee. As to the erroneous statement that the 001 Study was reported in O’Donnell 2004, Locke J.A. agreed with the respondents that it was merely a “slip of the pen”, which “may at any time be corrected by the Court” pursuant to Rule 397(2) of the Federal Courts Rules.

Identifying and applying the gap between the state of the art and the inventive concept

The Federal Court of Appeal also dismissed Janssen’s arguments that the trial judge failed to (i) explain how AA contributed to the treatment of cancer independent of PN, and (ii) consider the treatment of refractory prostate cancer in his obviousness analysis.

Locke J.A. found that there was sufficient evidence to support the trial judge’s conclusion that the invention was obvious to try. Whether or not the skilled person trying the invention would know that AA had anti-cancer effects independent of the combination is not critical – it is enough that a skilled person would have “expected” that each of AA and PN would contribute. As to the second error, the phrase “excluding those being refractory patients” in the trial judge’s decision is simply a clerical error and was intended to read “including”.

Declaring that the 422 patent is invalid

With respect to Apotex’s counterclaim, Janssen argued that the validity of the non-asserted claims should not have been addressed in the trial decision, as they are not permissible under s. 6(3)(a) of the PM(NOC) Regulations (Regulations). The Federal Court of Appeal disagreed. Having regard to the objectives of the Regulations as set out in the Regulatory Impact Analysis Statement, the Court held that the intention of the Regulations is to leave to the Federal Court the discretion to permit a counterclaim that includes non-asserted claims and declined to interfere with the exercise of discretion. However, the Court left open the question of whether a defendant to a s. 6(1) action may bring such a counterclaim as of right.

Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation Group.

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