Apotex v. H. Lundbeck.

Drug: escitalopram

Apotex sued for impeachment of Lundbeck’s patent. Lundbeck counterclaimed for infringement. The Court held that the patent was valid and infringed. The patent claimed, inter alia, the escitalopram enantiomer.

The Court held that the previous disclosure of citalopram was not anticipatory. In considering obviousness, the Court held that the issue is not which techniques would have been used, but rather, “whether those techniques would have been successful, given the wide range of chemicals and other variables which might be used in the reactions.” According to the Court, it boiled down to whether it was obvious to try certain techniques, or whether one would give up in frustration. (para 93). The Court recognized, in this analysis, that a different skill set is required to create a recipe, than to follow it. Regarding motivation, the Court recognized that “wishing does not make something come true” or make it easier. Motivation may make one try harder to make something work, but at some point, the experiments are no longer routine.

Regarding inutility, Apotex tried to rely on a statement about the toxicity of a particular salt made in another patent application as a binding admission. The Court held that what was said was not important, but rather, whether the salt was actually toxic. As Apotex filed no evidence on the issue, the Court accepted Lundbeck’s evidence and dismissed the allegation of inutility.

Apotex argued that a misstatement in the patent should lead to the patent being declared void for insufficiency. The Court held that the sentence in question was not essential, and thus, the patent should survive. The Court also held that testing done with the patent in hand for the purposes of determining which compound is escitalopram is different than testing done in order to find the invention. Thus, the patent does not fall for insufficiency.

Regarding sound prediction, the Court held that the patent did not promise that escitalopram would be more potent than racemic citalopram. Most of the inhibition was found in escitalopram as compared to racemic citalopram, but the comparison in the data could not be taken as a promise. In this case, the inventive concept was the two enantiomers and methods to obtain them. The patent was not invalid for a lack of sound prediction.

The Court then considered infringement and remedies. Infringement was admitted if validity was found. Apotex had stockpiled escitalopram in advance of both the NOC decision and the Appeal. It then sold some of that stockpile. The Court held that both of these activities were infringing, but did not warrant an award of punitive damages. However, Apotex did make a profit on those sales and the Court held they must account for it. “It would be completely unreasonable to hold that the only consequence of infringement over several years would be to declare the patent valid and to enjoin them from continuing to do what they should not have done in the first place.” (para 272). In considering the approach to accounting for profits, the Court distinguished other jurisprudence and held that because the only active ingredient in Apotex’ product was escitalopram, it must turn over all profits less legitimate expenses incurred. The Court also granted a permanent injunction.