Amendments to NOC Regulations Come into Force

On June 25, 2008, the Government of Canada published the Regulations Amending the Patented Medicines (Notice of Compliance) Regulations in Canada Gazette Part II. The amendments (Amending Regulations) were registered and came into force on June 12, 2008. As previously reported in E-TIPS® ("Proposed Amendments to NOC Regulations Change Patent Listing Requirements Established by Federal Court of Appeal", Vol 6, No 22, May 7, 2008), the Government proposed the Amending Regulations to remove the requirement that a patent submitted for listing on Canada's patent register before June 17, 2006, must be "relevant" to the submission for a notice of compliance (NOC) to which the patent relates. In effect, the Amending Regulations undo the results of the decision of the Federal Court and the Federal Court of Appeal in Wyeth Canada and Wyeth v Ratiopharm Inc and The Minister of Health, 2007 FC 340, rev'd 2007 FCA 264 (Wyeth decision). The Amending Regulations can be summarized as follows:

1. As a result of the addition of section 3.1, the Minister of Health (Minister) may delete a patent submitted for listing before June 17, 2006 from the patent register only if: (a) the patent has expired, (b) the Court has declared that the patent is invalid or void, (c) the identification number for a drug has been cancelled under paragraph C.01.014.6(1)(a) of the Food and Drug Regulations, (d) the patent has been found under section 6(5)(a) of the Regulations to be ineligible. In addition, the Minister may not refuse to add a patent on a patent list that was submitted before June 17, 2006, to the patent register solely on the basis that the patent is not relevant to the submission for a NOC to which the patent relates.
2. As a result of the addition of section 6(5.1), the Court may not dismiss an application in whole, or in part, solely on the basis that a patent submitted on a patent list that was submitted before June 17, 2006 is not eligible for listing on the patent register.

The Amending Regulations also contain transitional provisions which undo actions taken by the Minister as a result of the Wyeth decision in relation to patents submitted on a patent list before June 17, 2006. The transitional provisions provide that:

1. If, after March 29, 2007 (the date of the Wyeth decision), a patent submitted on a patent list before June 17, 2006 was deleted from the patent register by the Minister, or the Minister refused to add such a patent to the patent register, solely on the basis that it was not relevant to the submission for a NOC to which the patent relates, a "first person" may, within 30 days from the date that the Amending Regulations came into force, make a written request to the Minister asking that the patent be added to the patent register.
2. In the case of a patent deleted from the patent register, the Minister will be required to add the patent to the patent register within 30 days after receiving the "first person's" request. In the case of a patent that has been refused for listing, the Minister will be required to add the patent to the patent register within 30 days after receiving the request, or the day on which the relevant NOC is issued, whichever is later.
3. A "second person" who has already filed a submission for a NOC is not required to address patents added to the register (as a result of a first person's request under the transitional provisions) on or after the date the second person filed the submission.
4. The amendment to section 6(5.1) discussed above, does not apply to summary dismissal motions brought by second persons before the date the Amending Regulations were first announced in Canada Gazette Part I (April 26, 2008).

For the full text of the Amending Regulations, see: http://gazetteducanada.gc.ca/partII/2008/20080625/html/sor211-e.html Summary by: Nick Wong