Patent listing under 4(2)(b) – perfect match not required

In Eli Lilly Canada Inc v Attorney General of Canada, 2015 FCA 166, Justice Nadon allowed an appeal from Justice Bédard affirming the Ministers refusal to list Canadian Patent No. 2,379,329  on the Patent Register.

In 2011, an NOC was issued for a precise formulation of medicinal ingredients, spinosad and milbemycin oxime.

The 329 Patent’s claims mention a single dose oral formulation of spinosad in combination with other compounds, but does not specifically mention milbemycin oxime explicitly in the claim.

One of the ways a patent will be eligible to be added to the register is under subsection 4(2)(b) of the PM(NOC) Regulations, which states that the patent contains “a claim for the formulation that contains the medicinal ingredient and the formulation has been approved through the issuance of a notice of compliance in respect of the submission.”

The disclosure of the 329 Patent does mention that the “other compounds” that can be taken in conjunction with the spinosad component include “milbemycins”. This led Justice Bédard to conclude that 329 Patent claimed a formulation of both spinosad and milbemycin oxime. However, following the Court of Appeal’s decision in Gilead, (see our previous post here) she still concluded that the 329 Patent was not eligible for listing under subsection 4(2)(b) of the Regulations.

Justice Nadon concluded that Justice Bédard misunderstood the holding of the Court of Appeal in Gilead, stating:

In my view, this examination of the facts and holdings in Gilead FC and Gilead FCA distinguishes these decisions from the present appeal. It is clear from Gilead FCA that Trudel J.A. accepted Mosley J.’s construction of the ‘475 Patent to the effect that it did not claim rilpivirine. In other words, contrary to the matter before us in this appeal, the patent at issue in Gilead FC and Gilead FCA did not claim the three medicinal ingredients found in the NOC-approved drug product Complera. In the present appeal, the Judge specifically found that the formulation claimed by the ‘329 Patent was the formulation found in Trifexis, i.e. a formulation which contained both spinosad and milbemycin oxime.

Justice Nadon allowed the appeal and returned the matter to the Minister for reconsideration.  Three days later, the 329 Patent was added to the Patent Register.

Justice Dawson concurred in the result but in her opinion the Gilead FCA decision was decided incorrectly.

A copy of the decision can be found here.