Product Monographs Given Flexible Reading Informed by Patent Analysis

In Janssen Inc. v. Apotex Inc., 2019 FC 1355, the Federal Court granted Janssen’s application for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex for its proposed abiraterone acetate product until the expiry of Janssen’s patent listed for ZYTIGA.

Canadian Patent No 2,661,422 claims a combination of abiraterone acetate (AA) and prednisone (PN) for the treatment of prostate cancer. Among other allegations, Apotex alleged the claims were obvious and that it would not infringe with its proposed abiraterone product because its product monograph indicates that prednisone, when used with abiraterone, is used for managing side effects, not for treating cancer.

The Court found that the common general knowledge possessed by the skilled person did not include use of either abiraterone or prednisone as effective standalone anti-cancer agents even though the Court found that the prior art disclosed (1) that prednisone was used for side effect management in cancer patients; and (2) proposals that abiraterone may be useful for prostate cancer treatment.

In concluding that the 422 Patent was not obvious, the Court found that the skilled person  would not be able to bridge the gap between the prior art and the inventive concept:

The inventive concept in the 422 Patent requires not only the combination of AA and PN, but the combination for the purpose of treating prostate cancer, where each drug contributes to an anti-cancer effect. The experts agreed that neither drug in the combination was claimed in the Patent to treat the side effects caused by the other drug… To come to the inventive concept, the POS would have to determine that AA should be further tested for the treatment of prostate cancer and then decide to combine AA with PN to treat prostate cancer.

Citing AstraZeneca and Alcon Canada the Court concluded that “Although the use of PN with AA may have even been seen as ‘worth trying’ in order to prevent theorized side effects, that is insufficient unless the invention was more or less self-evident”.

The Court also rejected arguments of non-infringement and improper listing of the 422 patent based on proposed or indicated use of prednisone for side effect management and not cancer treatment:

Unless the word “treatment” in the product monograph is intended to include the management of side effects unlike the word “treatment” in the 422 Patent, the indication in the product monograph is almost exactly the same as the use claimed in the Asserted Claims. There is no evidence that “treatment” is used to connote management of side effects.

The Court further pointed out that “the effects of PN are not separable – if it has both the ability to treat side effects from AA and have an anti-cancer effect then it will do both of those things in the body” and that “The ZYTIGA Product Monograph emphasizes the role of PN in combination with AA primarily to alleviate side effects but there is acceptance of contribution to anti-cancer effects”.

The Court concluded that none of the allegations made in Apotex’s Notice of Allegation were justified and issued a prohibition order against issuance of a Notice of Compliance to Apotex for its proposed abiraterone product until expiry of the 422 patent.

The decision can be found here.

Post Script: Apotex appealed the decision on November 20, 2019.