SUMMARY:

On April 3, 2009, Health Canada released a revised version of the Guidance Document: Patented Medicines (Notice of Compliance) Regulations (“Revised Guidance Document”). The Guidance on the PM(NOC) Regulations was initially published in 2000, and last revised in December of 2007.

The Revised Guidance Document does not reference Health Canada’s recently proposed regime for subsequent entry biologics, as announced on March 27, 2009 and presently subject to a 60-day comment period. Health Canada’s proposed draft guidance document for subsequent entry biologics was discussed in a March 31, 2009 Pharma in brief.

Health Canada Revised Guidance on PM(NOC) Regulations – Key Provisions:

The Revised Guidance Document focuses primarily on the 2008 amendments to the PM(NOC) Regulations, SOR/2008-211 (“2008 Amendments”), which clarify the status of patent lists submitted prior to June 17, 2006 (“Grandfathered Patents”). The Revised Guidance Document states that:

  • The Minister of Health will not delete Grandfathered Patents submitted before June 17, 2006 from the Patent Register, unless one of the following four exceptions applies:
    • (a) the patent has expired;
    • (b) the patent has been declared invalid or void by a court under subsection 60(1) of the Patent Act;
    • (c) the DIN assigned has been cancelled under paragraph C.01.014(1)(a) of the Food and Drug Regulations; or
    • (d) the patent is determined to be ineligible for listing on the Patent Register under section 6(5)(a) of the PM(NOC) Regulations.
  • The Minister of Health will not refuse to add Grandfathered Patents submitted prior to June 17, 2006 to the Patent Register on the sole basis that the patent was not relevant to the submission against which it was listed.
  • The Minister of Health will no longer process complaints against Grandfathered Patents on the sole basis that the patent was not relevant to the submission against which it was listed.

Aside from addressing the 2008 Amendments, the Revised Guidance Document also provides some further explanation of the “patent-specific analysis” adopted by the Minister of Health to determine the application of the PM(NOC) Regulations in light of the Supreme Court of Canada’s decision in AstraZeneca Canada Inc. v. Canada (Minister of Health), [2006] 2 S.C.R. 560. The "patent-specific analysis" only applies to generic drug submissions filed prior to October 5, 2006, which was the date the 2006 amendments to the PM(NOC) Regulations came into force. The Revised Guidance Document states that:

  • Where an NOC is issued to a first person for a new use after a generic drug manufacturer has filed its ANDS, “a timing analysis remains appropriate” in most situations for determining whether or not the generic manufacturer is seeking approval for the new use such that it must address any relevant patents added to the Patent Register after the date of filing its ANDS.
  • In most cases, the fact that a generic drug submission was placed on patent hold before an NOC for a new use was issued, and has remained inactive, is demonstrative that the generic manufacturer could not have amended its ANDS to include the new use(s).
  • If the generic drug submission is placed on patent hold after an NOC for a new use is issued to the first person, the Minister of Health may seek clarification as to the use of a first person’s drug submission by issuing a Clarifax. The first person will have fifteen days to respond to the Clarifax request.
  • Similarly, the Minister of Health may also seek additional clarification if the generic drug submission is amended while on patent hold, and an NOC for a new use is issued to the first person.

The Revised Guidance Document is effective as of April 3, 2009.

LINK TO GUIDANCE DOCUMENT:

Health Canada Revised Guidance on the PM(NOC) Regulations