On July 5, 2012, the Federal Court dismissed two applications by Fournier Pharma ("Fournier") for Orders of prohibition relating to its LIPIDIL EZ (fenofibrate) and Patents Nos. 2,372,576 (’576) and 2,487,054 (’054). In both applications, Justice Zinn held that Fournier had not established that Sandoz's allegations of non-infringement were not justified.
Justice Zinn stated that there were two problems with fenofibrate. First, it is insoluble in water and therefore must be consumed in large doses to be effective, and second, it is absorbed better if the patient is in a fed state, and, in particular, when taken with fatty foods.
Both patents are directed to formulations of fenofibrate — the ’054 patent concerns bioequivalence in the fed and fasted state and the ’576 patent concerns dissolution and bioequivalence. Sandoz alleged non-infringement (as the size of the fenofibrate particles in its tablets do not fall within the particle size ranges set out in the patents) and invalidity in both proceedings.
Justice Zinn generally rejected the complaints raised by both sides regarding the other party's experts, noting that the experts had read and agreed to be bound by the Federal Court's Code of Conduct for Expert Witnesses. However, he accepted that one of Fournier's experts did not meet the definition of a person of ordinary skill in the art and accepted Sandoz's experts' evidence when in conflict with this particular witness of Fournier.
Regarding the infringement allegations, Justice Zinn considered whether Sandoz's allegation of non-infringement was justified. He stated that the parties were in agreement that it was the particle size of the fenofibrate in the Sandoz tablet that was relevant to infringement, but that there was "no direct specific evidence of the particle size of the fenofibrate in the Sandoz Tablet; no one actually measured the particles," although the evidence showed that the particle size could have been measured. Sandoz had provided tablets to Fournier, but neither party entered any testing results as evidence. Sandoz asked the Court to draw the adverse inference that Fournier had done testing but the results would not support its position due to Fournier's lack of evidence. Justice Zinn declined to do so, stating that Sandoz could also have performed testing on its tablet to establish particle size.
The experts therefore relied on details of Sandoz's manufacturing process, in particular, information about particle size in a dispersion, to assess particle size. Justice Zinn held that Fournier was unable to establish the particle size in the Sandoz tablets, and, therefore that the particle size was within the claims of the patents.
Although his findings on infringement were dispositive, Justice Zinn also considered Sandoz's invalidity allegations in the two applications. Sandoz alleged anticipation, obviousness and lack of utility/sound prediction for both patents and claims broader than the invention for the ’054 patent, and overbreadth, insufficiency of disclosure and ambiguity for the ’576 patent. Justice Zinn found that each of Sandoz's allegations of invalidity was not justified. Fournier has appealed.
Tracey L. Stott, Toronto
Fournier Pharma Inc v Canada (Health), July 5, 2012.
Federal Court decisions — 2012 FC 740 (Canadian Patent No. 2,487,054), 2012 FC 741 (Canadian Patent No. 2,372,576).