NOC Cases

Merck v Pharmascience

Drug: finasteride  

In this proceeding commenced pursuant to the Patented Medicines (Notice of Compliance) Regulations (the “Regulations”), the Court considered a claim to the use of the active ingredient for the preparation of a medicament useful for the treatment of male pattern baldness at a particular dosage, referred to as a Swiss-type claim.  

The Court reviewed decisions of the U.K. Courts, the Enlarged Board of Appeal of the European Patent Office as well as the Canadian Courts in respect of Swiss-type claims. Ultimately, the Court decided that for the purposes of this type of proceeding, namely one commenced pursuant to the Regulations, Pharmascience is bound by the allegations made in its Notice of Allegation (“NOA”). Thus, the claim should be considered, as alleged by Pharmascience, to be directed to the use of the active ingredient at a particular dosage in oral form to treat male baldness, and not directed to the manufacture of a tablet.  

The Court found that the claim did not claim a method of medical treatment because of the limitation to a fixed dosage as opposed to a dosage range requiring a physician to determine the dosage. The Court found that the patent at issue was invalid for double patenting on the basis that the claims in the patent at issue were identical or co-terminus to those of an earlier Merck patent, and also on the basis of obviousness double patenting. The Court noted that the analysis for obviousness double patenting involves the comparison of the claims of the two patents, and is different than a consideration of obviousness wherein the art known to a person skilled in the art is considered. The previous patent disclosed, but did not claim, a preferred dosage range, and the impugned patent claimed a fixed dosage that was outside the scope of the preferred range disclosed previously. The Court found that the invention was both disclosed and enabled and therefore lacked novelty. However, the Court found the claim to be inventive on the basis that prior art that existed at the relevant time would discourage a researcher from pursuing research in the area. The Court also found that Pharmascience had not raised the issues of sound prediction and overbreadth in its NOA with respect to the claim in issue, and therefore could not raise them at the hearing.