In the decision summarized below, Apotex successfully obtained a dismissal of Gilead’s application for a prohibition order in respect of Canadian Patent 2,261,619 on the basis of improper listing on the Patent Register. The ‘619 Patent, along with two other patents, had been listed by Gilead against the innovative drug TRUVADA, which contains two medicinal ingredients: tenofovir disoproxil fumarate and emtricitabine). TRUVADA is used to treat persons infected with HIV and as pre-exposure prophylaxis.

Background

While Gilead’s underlying prohibition application relates to all three patents listed against TRUVADA, Apotex’s motion to dismiss was only in respect of the ‘619 Patent. The motion was filed on March 5, 2015 and heard before Madam Justice Heneghan on June 23, 2015, just after amendments to the Patented Medicines (Notice of Compliance) Regulations (“the Regulations”) came into force on June 19, 2015.

Under the version of the Regulations that was in force when the motion was filed, the Federal Court of Appeal had previously held that a patent would only be listed where there was an “exact match” between the claims and the composition as approved by the Minister of Health (see, e.g., Gilead Sciences v. Canada, 2012 FCA 254 (“Gilead Sciences”)). In other words, where a product contains two medicinal ingredients, the patent claim also has to list these two ingredients. However, prior to the hearing of the motion, the Regulations had been amended to allow a patent claiming only one medicinal ingredient to be listed against a product which contained both the claimed medicinal ingredient and other medicinal ingredient(s).

After Apotex’s motion for dismissal was heard, the FCA released its decision in Eli Lilly v. Canada, 2015 FCA 166 (“Eli Lilly”). The majority of the FCA in Eli Lilly held that the Gilead Sciences matching requirement required only that “the patent which the innovator seeks to list on the Register contains… a formulation of certain medicinal ingredients which the Minister has approved through the issuance of a NOC.” Thus, contrary to Gilead Sciences, the pre-amendment Regulations did not require an exact match.

In concurring reasons, Justice Dawson agreed with the majority of the FCA in result, but expressly held that Gilead Sciences was wrongly decided, stating that “it is not necessary to require a patent to specifically name every medicinal ingredient approved through the issuance of a notice of compliance.”

The Decision

Despite the amendments to the Regulations, Justice Heneghan applied the version of the Regulations in force when the motion was filed and that were before the FCA in Eli Lilly. In doing so, Justice Heneghan held that the amendments were retrospective only to the date of their introduction.

This interpretation is problematic as the Regulatory Impact Analysis Statement accompanying the amendments states that the law was simply being restored to what it had always been (before decisions such as Gilead Sciences). Thus, the Court’s interpretation in this case frustrates the intent of the amendments.

The Court went on to hold that the decision in Eli Lilly did not alter the law set out in Gilead Sciences in respect of the pre-amendment version of the Regulations. In doing so, the Court did not acknowledge both the majority and concurring reasons of the FCA in Eli Lilly, which clearly held that there was no requirement for a claim to specifically recite every medicinal ingredient to be listed against a product containing multiple medicinal ingredients.

Justice Heneghan concluded that “in order to be eligible, the patent must claim all medicinal ingredients contained in the NOC approved drug. Since the ‘619 Patent does not claim emtricitabine, which is a medicinal ingredient in TRUVADA, it is not eligible to be listed on the Patent Register.” In doing so, the Court appears to have conducted a ‘word search’, ignoring the guidance provided by the FCA in Eli Lilly.

While the Court’s decision in TRUVADA appears to be irreconcilable with the FCA’s decision in Eli Lilly, one possible distinction appears to be that the parties in the TRUVADA decision agreed that the ‘619 Patent did not claim both active ingredients. As a result, Justice Heneghan held that she did not need to construe the claims in coming to her decision. Conversely, in Eli Lilly, Lilly successfully argued that the person skilled in the art would understand that the claimed formulation could include other medicinal ingredients than those specifically listed.

Gilead has appealed this decision, which is available here.