Single Medicinal Ingredient Patents To Become Listable on "Canada's Orange Book" Against Combination Drug Products

Recent decisions of the Federal Court and Federal Court of Appeal (FCA) have reinterpreted the requirements of section 4 of the Patented Medicines (Notice of Compliance) Regulations (the PM(NOC) Regulations); specifically, the Federal Court has ruled that patents claiming a single medicinal ingredient are not eligible for listing on Canada’s patent register (Canada’s version of the U.S. Orange Book) against drugs which contain multiple medicinal ingredients.¹ To ensure that patents that were rendered ineligible for listing following these recent decisions are eligible for listing, Industry Canada has published proposed amendments to the PM(NOC) Regulations which clarify the listing requirements for patents with claims to the medicinal ingredient in combination drugs.²

What You Need To Know

• The proposed amendments to the PM(NOC) Regulations will allow Health Canada to return to its past practice of listing on Canada’s patent register patents which claim a single medicinal ingredient against drugs that contain multiple medicinal ingredients.
• The proposed amendments to the PM(NOC) Regulations are not law. Industry Canada will be accepting comments on the proposed amendments until June 1, 2015.
• The proposed amendments clarify that:
  • A patent that contains a claim for the medicinal ingredient will be eligible for listing on Canada’s patent register against a drug submission that includes, in addition to the medicinal ingredient claimed in the patent, other medicinal ingredients.
  • A patent that contains a claim for the formulation that includes non-medicinal ingredients will be eligible for listing against a drug submission that includes the non-medicinal ingredients specified in the claim, even if the drug submission contains additional non-medicinal ingredients.
  • A patent that contains a claim for the use of one medicinal ingredient will be eligible for listing against a drug even if
    • the submission includes additional medicinal ingredients,
    • the submission includes other additional uses of the medicinal ingredient, or
    • the use in the regulatory submission requires the use of the medicinal ingredient in combination with another drug.
• The proposed amendments are not intended to affect the requirement for a formulation claim to specify all of the medicinal ingredients contained in the drug in order to be eligible for listing.
• The proposed changes will allow a drug manufacturer who has had a patent denied for listing or deleted from the patent register since October 18, 2014 as a result of the ViiV Healthcare ULC v. Teva Canada Ltd. (2014 FC 893) (ViiV) decision to resubmit the patent list for that patent within 30 days after the day that the proposed amendments come into force. However, if a generic manufacturer has filed a regulatory submission in the intervening period while a patent was not listed on or was deleted from the register, then the generic will not be required to address that patent under the PM(NOC) Regulations.
• For ongoing proceedings under the PM(NOC) Regulations, a Court will be required to apply the proposed amendments, if the proceedings are still ongoing at the time that the amendments come into force.

Analysis

Since the creation of the PM(NOC) Regulations, Health Canada’s practice has been to list patents containing a claim for the medicinal ingredient on the patent register in respect of any approved drug that includes that medicinal ingredient in addition to other medicinal ingredients. However, the Federal Court’s decision in Viiv and the FCA ruling in Gilead Sciences Canada v. Canada (Health) (2012 FCA 254) (Gilead) have determined that a patent that claims one, but not all, of the medicinal ingredients contained in an approved combination drug product may not be listed on Canada’s patent register.

In Gilead, the patent at issue included a claim to a combination of two medical ingredients, plus a further claim to a third ingredient selected from a drug class. The third medicinal ingredient was not specifically identified in any of the claims. The FCA held that the patent was not eligible for listing because the patent did not specifically claim each of the three medicinal ingredients in the combination drug product.

In ViiV, the Federal Court, relying on the FCA’s Reasons for Judgment in Gilead, held that for a patent to be eligible for addition to the patent register under section 4(2)(a) of the PM(NOC) Regulations, it must specifically claim all of the medicinal ingredients in the approved drug containing more than one medicinal ingredient. This decision was affirmed at the Federal Court of Appeal³.

According to the Regulatory Impact Analysis Statement (RIAS) published by Industry Canada with the proposed amendments, delisting a large number of patents pursuant to the rationale set out by the Federal Court and the FCA in the Gilead and ViiV decisions would "compromise the ability of brand-name manufacturers to seek protection under the PM(NOC) Regulations for their innovative combination drugs, undermine the balanced interests of brand-name and generic drug producers, and harm consumers, who could be prevented from accessing combination drug products if companies opt to wait until single ingredient drug patents expire before introducing combination drugs to the Canadian market."

Also according to the RIAS, the proposed amendments, if enacted, would restore the original policy intent of the listing requirements and ensure that patents that were rendered ineligible for listing following the Gilead and ViiV decisions are eligible for listing moving forward.

Within 30 days after the amendments come into force, manufacturers may seek to list those patents that were denied listing or removed from the register as a result of ViiV. However, if a generic manufacturer files an abbreviated new drug submission (an ANDS, the Canadian equivalent of an ANDA) before such "corrective" listing occurs, the generic manufacturer will not be required to address those patents under Canada’s PM(NOC) Regulations.

The proposed regulations are not law and may be amended further before they become law. The next step in the regulatory amendment process is for Industry Canada to collect and review comments. The proposed changes are open for public comment for until June 1, 2015. Following that, Industry Canada may proceed with a further public consultation, or Industry Canada may publish the amendments (as previously published, or with minor revisions) in Part II of the Canada Gazette. Any amendments will only come into force after the final version is approved by the Treasury Board and has been published in Part II of the Canada Gazette. There is no indication from Industry Canada around a proposed timeline for this process.

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* With assistance from Kaitlin Soye, articling student.

¹ Torys bulletin, April 7, 2015: http://www.torys.com/insights/publications/2015/04/combination-drugs-industry-canada-to-amend-the-pmnoc-regulations

² http://www.gazette.gc.ca/rp-pr/p1/2015/2015-05-02/html/reg3-eng.php

³ http://www.canlii.org/en/ca/fca/doc/2015/2015fca93/2015fca93.html