Drug: Complera® tenofovir disoproxil fumarate, emtricitabine and rilpivirine
The Federal Court dismissed a judicial review of a decision of the Minister of Health refusing to list a patent on the Patent Register. The drug at issue was a combination product containing three medicinal ingredients. The patent was refused for listing as the Minister decided it did not contain a claim for the medicinal ingredients, as it referred to the class of non-nucleoside reverse transcriptase inhibitors rather than specifically referring to the medicinal ingredient rilpivirine.
After construing the claims, the Court held that rilpivirine is not expressly referenced in any of the claims and can only be included by deductive reasoning since it falls within a named class. The Court held that on a plain reading of the Patented Medicines (Notice of Compliance) Regulations, all of the ingredients in the NDS must be found in the formulation in the claim. If not, the product specificity requirement is not met. Thus, the Court held the Minister correctly concluded that the patent was not eligible for listing on the Patent Register.