In Gilead Sciences, Inc. v. Canada (Health), Justice Heneghan of the Federal Court granted Apotex’s motion and concluded that Canadian Patent No. 2,261,619 was ineligible for listing on the Patent Register in respect of the combination drug product TRUVADA (emtricitabine/tenofovir disoproxil fumarate) pursuant to paragraph 4(2)(a) of the Unamended (pre-2015 amendments) Patented Medicines (Notice of Compliance) Regulations. The 619 Patent claimed tenofovir disoproxil and its salts. It did not claim emtricitabine.
Section 4 of the Regulations determines whether a patent is eligible for listing on the Patent Register. Under paragraph 4(2)(a) of the Regulations in force when Apotex challenged the listing of the 619 Patent, a patent is eligible for listing on the Patent Register if the patent claims a medicinal ingredient and the medicinal ingredient has been approved through the issuance of a notice of compliance in respect of the submission.
The Amended Regulations came into force on June 19, 2015. Section 4(2)(a) was supplemented with s. 4(2.1)(a), which provides that a patent that contains a claim for the medicinal ingredient is eligible for listing on the Patent Register, even if the submission includes, in addition to the medicinal ingredient claimed in the patent, other medicinal ingredients.
The associated transitional provision (s. 5) of the Amended Regulations states that ongoing motions under paragraph 6(5)(a) of the Regulations initiated on or after May 2, 2015 are governed by the Amended Regulations.
Justice Heneghan considered the following two issues:
- Is this motion governed by the Amended Regulations?
- Is the 619 Patent eligible for inclusion on the Patent Register in respect of TRUVADA?
Issue 1 – Transitional Provision
Justice Heneghan considered the statutory interpretation of the transitional provision. She concluded that the “plain and ordinary meaning” of the words “any ongoing motion made under paragraph 6(5)(a) of the [Regulations] that are initiated during the period that begins on May 2, 2015 and ends on the day on which this section comes into force” is that the Unamended Regulations apply in respect of any motion that was filed before May 2, 2015.
Although this motion was pending on June 19, 2015, it was filed on March 6, 2015 and was not “initiated” after May 2, 2015, and was subject to the Regulations in force prior to the recent amendments.
Issue 2 – Reconciling Previous Jurisprudence
Justice Heneghan considered the relevant jurisprudence, namely, Gilead Sciences and ViiV Healthcare, (see our previous posts here and here) both of which were relied upon by Apotex, and Eli Lilly relied upon by Gilead (see our previous post here).
Justice Heneghan agreed with Apotex that these three decisions can be read consistently. She followed the Federal Court of Appeal decisions in Gilead Sciences and ViiV Healthcare:
 I have already determined that the interpretation of the transitional provision, that is section 5 of the 2015 Amendments, means that the motion to strike the ‘619 Patent from the Patent Register is subject to paragraph 4(2)(a) of the Unamended Regulations. The interpretation of that paragraph was addressed by the Court of Appeal in ViiV, supra at paragraphs 15-16:
In Gilead, this Court found that paragraph 4(2)(a) of the Regulations sets an exacting threshold of specificity between what is claimed in the patent and what has been approved in the NOC – a patent that does not explicitly claim all of the medicinal ingredients contained in the drug for which the NOC was issued cannot be listed against that drug.
In Gilead, the Court considered the policy arguments put forward by the appellants and the Minister in this matter with respect to the interpretation of paragraph 4(2)(a) and did not accept them …
While the Court of Appeal in Eli Lilly allowed a patent to be listed even though the claims did not perfectly match the medicinal ingredients, with Justice Dawson determining that Gilead was wrongly decided, Justice Heneghan distinguished the facts, as the Court of Appeal had done in Eli Lilly.
Justice Heneghan found no basis to depart from the Court of Appeal’s interpretation of paragraph 4(2)(a) of the Unamended Regulations in ViiV and Gilead. In order to be eligible for listing on the Patent Register, the patent must claim all medicinal ingredients contained in the NOC approved drug. Since no claim of the 619 Patent perfectly matched the medicinal medicinal ingredients in TRUVADA, it was not eligible to be listed on the Patent Register.
A copy Justice Heneghan’s Reasons may be found here.
Gilead has appealed Justice Heneghan’s Order.