The Federal Court of Appeal recently dismissed an appeal from Janssen v Apotex, 2019 FC 1355 (Phelan J.) in Apotex v Janssen, 2021 FCA 45. The decision under appeal granted Janssen's application for an order prohibiting the Minister of Health from granting Apotex a Notice of Compliance for APO-ABIRATERONE, its version of Janssen's ZYTIGA, as Apotex's allegations that Canadian Patent No. 2,611,422 was invalid, not infringed, and not eligible for listing on the Patent Register were held not to be justified. An earlier summary of the case under appeal can be found here.
On the issue of obviousness, at the first instance, Apotex had argued that based on Ciba Specialty Chemical Water Treatments v SNF, 2017 FCA 225 ("Ciba"), in the second step of the Sanofi framework which asks the Court to identify the inventive concept of the claim in question, the Court should "focus on construing the claim rather than attempting to determine the broader inventive concept of the claims." In other words, Apotex sought to argue that any characteristic or advantage not explicitly mentioned in the language of the claim should not be considered by the Court in determining the inventive concept of that claim. However, Justice Phelan clearly stated that the comments made by the Court in Ciba "cannot overturn or change the Sanofi test set out by the Supreme Court of Canada."
On appeal, Apotex alleged that the Federal Court had improperly looked beyond the scope of the claims in "setting the goalposts" for the obviousness analysis, namely, in defining the differences between the state of the art and the inventive concept of the claim in question.
The Federal Court of Appeal rejected Apotex's arguments, stating that "the setting of the 'goalposts' is not in dispute; the parties do not dispute the state of the art or the subject matter of the claims." The Federal Court of Appeal further held that it was not an error for the Federal Court to consider the advantageous properties of the claimed subject matter in assessing the differences between the state of the art and the claimed invention.
In dismissing the appeal, the Federal Court of Appeal has reaffirmed that when assessing obviousness, the Court may consider the characteristics or advantages of the invention which lie in the claimed subject matter, even if those characteristics or advantages are not explicitly mentioned in the claim language.