The Federal Court of Appeal has affirmed one of the last judgments granting a prohibition order under subsection 6(1) of the pre-September 2017 Patented Medicines (Notice of Compliance) Regulations (the PM(NOC) Regulations). The Court of Appeal upheld the prohibition order despite a decision in a subsequent action under the amended PM(NOC) Regulations finding that the same patent was invalid.
ZYTIGA® (abiraterone acetate or AA) is a drug marketed in Canada by Janssen Inc., Janssen Oncology, Inc., and BTG International Ltd. (collectively, Janssen) for the treatment of prostate cancer. Canadian Patent No. 2,662,422 (the 422 Patent) was listed on the Patent Register in respect of ZYTIGA®.
As we previously reported, the Federal Court held that the 422 Patent was valid, infringed by Apotex Inc. (Apotex), and eligible to be listed on the Patent Register (2019 FC 1355, the First Proceeding).
Following the September 2017 amendments to the PM(NOC) Regulations, a second Federal Court proceeding was commenced by way of action against Apotex and other defendants (2021 FC 7, the Second Proceeding). The Federal Court in the Second Proceeding found the 422 Patent invalid for obviousness (contrary to the First Proceeding).
Following that declaration of invalidity, the Minister issued a Notice of Compliance for Apotex’s generic AA product, rendering the appeal of the First Proceeding moot. Despite the mootness and the findings in the Second Proceeding, the Court of Appeal exercised its discretion to decide the appeal of the First Proceeding, in part because of potential implications for liability under section 8 of the PM(NOC) Regulations. However, the Court of Appeal emphasized that the appeal of the First Proceeding must be decided on the evidentiary record of the First Proceeding.
The Court of Appeal dismissed Apotex’s appeal of the First Proceeding. The Court’s findings included the following:
- Patentable subject matter: Apotex argued that the combination of components covered by the 422 Patent was not patentable subject matter because it did not produce a greater benefit than the sum of each individual component (i.e., produce a synergistic effect). The Court of Appeal found that, in the context of cancer treatment, there was no way to properly assess synergy and in any event, the key consideration is whether the patented combination offers something that was not previously available to the public. A combination cannot be excluded from patentability simply because its benefit cannot be compared to the benefit produced by the sum of its component parts. The 422 Patent’s combination provided improved results over what was previously known and was patentable subject matter.
- Obviousness: Apotex’s main allegation was that the Federal Court treated the “more or less self-evident that it ought to work” aspect of the obvious to try test as the ultimate question rather than a factor to be considered. The Court of Appeal reiterated that, in conducting an obvious to try analysis, “more or less self-evident that it ought to work” should be treated as a factor and not as a requirement. The Court found no error in the Federal Court’s obviousness analysis.
- Inutility: Apotex argued that utility had not been demonstrated because: 1) none of the studies relied on by Janssen showed that the specific combination described in the claims of the 422 Patent was better than either drug alone; and 2) effectiveness was gauged using a surrogate measurement rather than a direct measurement. The Court of Appeal found no error in the Federal Court’s decision. It was not an error to consider the totality of test results, nor was it necessary that the tests conclusively proved the requisite utility. It was sufficient that the test results were strongly suggestive of utility, and that no other logical explanation for the test results was likely.
- Infringement: Apotex argued that its Product Monograph did not induce infringement because the second component of the combination was being used for a different purpose than the 422 Patent contemplated (i.e., a palliative effect rather than a treatment effect). The Court of Appeal rejected the distinction drawn by Apotex and found that following the Product Monograph will inevitably result in an act of infringement, and this inducement of infringement would clearly be within Apotex’s knowledge.