Apotex alleged in its NOA that Pfizer’s patent was invalid for double patenting, anticipation, obviousness, lack of utility and over-breadth. The Court rejected the allegations of invalidity as well as Apotex’ allegation of non-infringement of its product, APO-latanoprost.

The decision highlights the importance of determining correctly what is the inventive concept of a particular patent. This is necessary because it primarily determines the proper approach to take with many of the allegations such as anticipation, obviousness and utility. In this decision, the Court held that Apotex had based its allegations on a premise which the Court did not agree was sound. The Court therefore concluded that arguments made by Apotex founded on this premise could not have succeeded.

Of particular interest in this case was two creative arguments raised by Apotex in relation to the allegation of anticipation. However, both arguments failed to convince the Judge. The first was to suggest that Pfizer’s inclusion of a particular patent (which was cited by Apotex in the NOA as prior art) on the Form IV Patent List was an admission by Pfizer that the prior art disclosed a substance which anticipated the patent at issue. In dismissing the submission, the Court noted that there is no jurisprudence in support of what Apotex was seeking. The second argument was to try to persuade the Judge that the patent at issue was a selection patent over a particular piece of prior art. This ground, if accepted by the Judge, would have allowed Apotex additional arguments in support of its anticipation allegations. However, the Judge declined to make such a finding because, primarily, Apotex had not alleged such a ground in its NOA.

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