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Federal Court of Appeal Rejects Apotex’s Appeal for Inclusion onto Patented Medicines List

In Apotex Inc. v. Janssen Inc., 2021 FCA 45, the Federal Court of Appeal recently dismissed an appeal of the Federal Court decision 2019 FC 1355 by Apotex. The Federal Court granted an application by Janssen to prohibit the Minister of Health from granting a Notice of Compliance to Apotex  for its proposed abiraterone acetate product until the expiry of Janssen’s Canadian Patent No  2,661,422.

The Federal Court of Appeal affirmed the original decision after evaluating the Federal Court’s reasoning on the issues of 1) patentable subject matter, 2) obviousness, 3) inutility, and 4) infringement.

It is interesting to note that a second Federal Court action (2021 FC 7) was commenced where the court found that Jansen’s patent in question was invalid for obviousness. However, the Federal Court of Appeal noted that the present appeal must be decided on the record in the original proceeding.

Read the full decision here.


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