Teva Canada Limited v. Gilead Sciences Inc., 2016 FCA 176

Teva has lost both of its appeals seeking to amend its pleading to add in a claim that the patent at issue had been fraudulently obtained by misleading the Patent Office, contrary to subsection 53(1) of the Patent Act.

Teva said that on discovery, the inventors and the representative of Gilead admitted that they had not made and did not believe they could make any predictions of utility across the broad class of compounds claimed in the '619 Patent. In light of this, Teva took the view that Gilead has committed a material misrepresentation by filing the '619 Patent without a factual foundation to prove or to soundly predict utility. Thus, Teva sought to amend its statement of claim.

The Federal Court had found that the amendments improperly added allegations tantamount to fraud without sufficient evidence, and that the allegations had no reasonable prospect of success.

The Federal Court of Appeal agreed. Teva's proposed amendments were not found to have a reasonable prospect of success. The standard to be applied by the Court was described as being "more than just assessing whether there is just a mathematical chance of success. In deciding whether an amendment has a reasonable prospect of success, its chances of success must be examined in the context of the law and the litigation process, and a realistic view must be taken."