Gilead Sciences, Inc. v. Canada (Health), 2016 FC 231

Apotex has successfully challenged the listing of a patent on the Patent Register pursuant to paragraph 4(2)(a) of the PM(NOC) Regulations.

The patent does not claim both active ingredients in the approved drug. It only claims one of the active ingredients.

In 2015 the PM(NOC) Regulations were amended to provide that "a patent that contains a claim for the medicinal ingredient is eligible even if the submission includes, in addition to the medicinal ingredient claimed in the patent, other medicinal ingredients."

However, Apotex filed this motion challenging the listing before this amendment came into force. Therefore, the Court had to determine which version of the PM(NOC) Regulations applied, the version in force when Apotex filed its motion, or the amended version in force at the time of the hearing and issuance of the reasons. This issue was important because Apotex did not make submissions on whether the patent was eligible for listing on the Patent Register under the amended regulations.

The Court held that the transitional provision only allowed for the amended regulations to apply if the motion was filed after May 2, 2015, but since Apotex's motion was filed before that date, on March 6, 2015, the old regulations applied.

Applying the facts to the old regulations, the Court held that the patent was ineligible to be included on the Patent Register.