The Court granted an application for an Order of prohibition brought under the Patented Medicines (Notice of Compliance) Regulations regarding rosiglitazone. Justice Hughes found that the allegations of invalidity made by Pharmascience against GSK’s Canadian patent 1,328,452 were unjustified.

With respect to obviousness, Justice Hughes noted that Pharmascience’s allegations were not justified especially since the inventor’s work, over the period of several years, was applauded by the scientific community, and since Pharmascience’s expert’s opinion was based on the impermissible application of hindsight. Justice Hughes refused to consider additional obviousness arguments made by Pharmascience which were not raised in its NOA.

With respect to utility and sound prediction, the Court found that the case was not one where the patentee was relying on a sound prediction, but a demonstration of utility. In this regard, Justice Hughes pointed out that there is no requirement for a patent to demonstrate utility in the disclosure so long as the Court finds it to be proven when challenged in Court. In addition, Justice Hughes stated that utility is to be determined on the basis of what was done by the inventors prior to the filing date as compared to the utility as promised in the patent. Because the ‘452 patent promised that rosiglitazone was of potential use in the treatment of hypoglycaemia, all that GSK had to prove was that the animal data available at the time of filing established such a potential. GSK did not have to show that the data supported that rosiglitazone will work in the treatment of hypoglycaemia since that is not what the patent promised.

A copy of this decision may be found at the following link:

http://decisions.fct-cf.gc.ca/en/2011/2011fc239/2011fc239.html