55.2 Decision on the Merits; 2009 FC 137; cefepime; February 10, 2009

The Court refused to grant prohibition on the basis that Apotex' allegation in respect of invalidity for obviousness was justified. The patent related to a polymorph of cefepime.

The Court considered the Supreme Court's tests for anticipation and obviousness pursuant to the new tests articulated by the Supreme Court in Sanofi. After considering the evidence of the parties on anticipation, the Court found that the evidence was contradictory and leads to an inconclusive result. As Apotex bears the burden, on a balance of probabilities, the Court concluded that the patent was not anticipated. However, the Court found that the essential elements of the patent were more or less self-evident having regard to the state of the art. Thus, the allegation of obviousness was justified.

Of note, a disclaimer was filed before the commencement of this application but after the NOA was received. The Court held that this disclaimer could not be considered in the context of the proceeding. The Court fixed the date of the NOA as the proper date to construe the claims of the patent at issue. Thus, neither party could rely on the disclaimer to its benefit in the proceeding.

The full text of the decision can be found at: http://decisions.fct-cf.gc.ca/en/2009/2009fc137/2009fc137.html