Allergan Inc. v. Apotex Inc., 2016 FC 344 

Drug: gatifloxacin

Apotex sent a NOA in respect of a single patent, alleging obviousness and lack of utility. The Court held that allegation was justified.

In considering the evidence, the Court preferred the evidence of Apotex's expert witnesses. In particular, the Court held that greater weight is to be given to evidence on obviousness and patent construction from experts who have not seen the patent nor been apprised of the position of the litigants. The Court also held that Allergan's objections that Apotex's experts took the references cited in the NOA without doing their own search was without merit.

On the issue of obviousness, the Court agreed with Apotex's expert that a POSITA would have a fair and reasonable expectation that combining gatifloxacin with EDTA would produce an effective ophthalmic compound that would have the three advantages set out in the Patent. On the issue of utility, the Court agreed with Apotex's expert that those three advantages were promises. Despite several experiments being listed in the patent, utility was not held to be demonstrated as the claim at issue covered more compositions than those tested. Sound prediction was also held not to be established.