Drug: spinosad; milbemycin oxime
In this case, the FCA overturned the Federal Court Decision dismissing Eli Lilly’s application for judicial review of a decision of the Minister of Health refusing to list a patent on the Patent Register (Decision here; summary here). The FCA returned the decision to the Minister for reconsideration.
The drug product contains two medicinal ingredients. The patent at issue claimed oral formulations specifically relating to one of the medicinal ingredients. The disclosure indicated that the formulation may include compounds with antiparasite activity such as milbemycins. The FCA held that the Federal Court misunderstood the requirements of paragraph 4(2)(b) of the NOC Regulations.
The FCA held that the Federal Court had not made an error when it overturned the Minister’s construction of the patent, finding it to claim a formulation which included both spinosad and milbemycin oxime. However, the Court had erred in not then overturning the decision not to list the patent on the Patent Register. Once the finding was made that the patent claimed a formulation containing the approved medicinal ingredients, it was eligible for listing on the Patent Register