Narrow Window to Resubmit Patent Lists: Changes to "Canada’s Orange Book" Regulations Now in Force

Previously proposed amendments to the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) are now in force.¹ These amendments are intended to restore Health Canada’s past practices with respect to listing patents for combination drugs on the Patent Register, Canada’s version of the "Orange Book." The amendments provide the opportunity for drug manufacturers to resubmit previously rejected or deleted patent lists before the July 19, 2015 deadline.²

What You Need To Know

• Manufacturers whose patents were rejected for listing or were deleted from the Patent Register as a result of the Federal Court decision in ViiV Healthcare ULC v Teva Canada Ltd. (2014 FC 893) (ViiV) may resubmit those patent lists before July 19, 2015.
  • A patent that contains a claim to a single medicinal ingredient is now eligible for listing on the Patent Register in respect of a drug submission that contains a combination of medicinal ingredients, including the claimed medicinal ingredient.
  • A patent that contains a claim to a formulation is now eligible for listing on the Patent Register in respect of a drug submission, even if it does not identify any non-medicinal ingredients.
  • A patent that contains a claim to a formulation is now eligible for listing on the Patent Register in respect of a drug submission, if the submission includes non-medicinal ingredients not included in the claimed formulation.
  • A patent that contains a claim to a use of the medicinal ingredient is now eligible for listing on the Patent Register in respect of a drug submission, even if
    • the drug submission includes additional medicinal ingredients,
    • the drug submission requires the use of the medicinal ingredient in combination with another drug, or
    • the drug submission includes other uses not claimed in the patent.
• The amendments apply retroactively to any court proceedings under the PM(NOC) Regulations initiated after May 2, 2015.

Analysis

In 2006, amendments to the PM(NOC) Regulations introduced more stringent product-specificity requirements for listing patents on Canada’s Orange Book. Patents would be eligible for listing in respect of a particular drug submission only if they included at least one claim directed to the medicinal ingredient, formulation, dosage form, or use of the medicinal ingredient, as approved in the drug submission. In a series of court rulings culminating in Gilead Sciences Canada v. Canada (Health) (2012 FCA 254) (Gilead) and ViiV, the product-specificity requirements were further tightened.³ With respect to patent listing in respect of drug products with multiple medicinal ingredients, the Gilead and ViiV decisions required a patent to include at least one claim specifying all of the medicinal ingredients in the drug product in order for the patent to be eligible for listing on the Patent Register. This ran counter to the established practice of Health Canada’s Office of Patented Medicines and Liaison (OPML), which had interpreted the 2006 amendments as allowing the listing of a patent with a claim to a single medicinal ingredient against a drug product with multiple medicinal ingredients.

The amended PM(NOC) Regulations directly address Gilead and ViiV, making it clear that patents including a claim to a single medicinal ingredient are now eligible for listing in respect of a drug submission that includes that medicinal ingredient in combination with other medicinal ingredients. Further, the amended PM(NOC) Regulations address the lower court decision in Gilead in specifying that a claim to a formulation may be eligible for listing even if it does not specify any non-medicinal ingredients, or if the drug submission includes additional non-medicinal ingredients. The amended regulations also clarify the listability of use patents in relation to submissions for multiple uses, submissions for combination drugs, and submissions for a single medicinal ingredient used in combination with other another drug.

What’s Next

The amended PM(NOC) Regulations include a provision allowing for the re-listing of any patents deleted from the Patent Register as a result of ViiV, and also allow for the resubmission of patent lists that were rejected in view of ViiV. However, there is a limited window during which previously rejected or deleted patent lists may be resubmitted to OPML, with resubmission only available until July 19, 2015. Affected manufacturers should act quickly to resubmit patent lists in order to preserve their rights.

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¹ See Torys bulletin of May 5, 2015, available here. The Regulations were amended as proposed in the Canada Gazette Part I on May 2, 2015, available at http://www.gazette.gc.ca/rp-pr/p1/2015/2015-05-02/html/index-eng.php. The previously announced amendments to the PM(NOC) Regulations came into force on June 19, 2015, although they will not be published in the Canada Gazette until July 1, 2015.

² July 19 of this year falls on a Sunday; manufacturers intending to resubmit patent lists may wish to take this into account when coordinating the preparation of resubmissions.

³ For an analysis of the ViiV decision, see Torys’ bulletin of October 15, 2014, available here.

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