Listing decision; 2009 FC 474; olanzapine; May 8, 2009

Eli Lilly had submitted patent lists seeking to add the newly issued patent at issue to the Patent Register with respect to several supplemental new drug submissions. Those requests were initially refused by the Minister. However, upon the provision of additional information, the patent was added to the Patent Register.

Lilly then asked for the patent to be considered listed as of its submission date, instead of as of the date the Minister eventually determined the patent to be eligible for listing. The Minister refused and that decision was the subject of this judicial review.

The Court upheld the decision of the Minister. The Court found that when considered as a whole, the NOC Regulations indicate that a second person does not have to address any patent that has not yet been added to the Register. Further, a clear distinction is drawn between submitting a patent list to the Minister and the determination of its eligibility for listing. Thus, the Court held that the intent of the NOC Regulations must be that the listing of the patent on the Patent Register is done contemporaneously with the Minister’s determination of the patent’s eligibility for listing rather than at the time of the filing of a patent list. The fact that a generic manufacturer can obtain a procedural advantage from the delay between the filing of the patent list and the Minister’s eligibility determination does not deprive the innovator of its substantive patent rights.

The full text of the decision can be found at: http://decisions.fct-cf.gc.ca/en/2008/2009fc474/2009fc474.html