Industry Canada has sponsored proposed amendments to the
Patented Medicines (Notice of Compliance) Regulations (the
"PM(NOC) Regulations") that broadens the eligibility to
list patents on the Patent Register. These amendments are a direct
response to the "perfect match" doctrine recently
endorsed by Canadian courts. They reaffirm Health Canada's
long-standing practice regarding patent listing. In so doing,
Industry Canada is seeking to restore the balance between
innovators and their generic competitors as intended by the PM(NOC)
Notice of the proposed amendments were published in a Regulatory
Impact Analysis Statement (the "RIAS") published May 2,
2015 in the Canada Gazette Part I (Vol. 2, No. 18). As noted in the RIAS, Health
Canada has for many years interpreted the PM(NOC) Regulations as
permitting patents to be listed that contain a claim for a
medicinal ingredient on the Patent Register in respect of any
approved drug that includes that medicinal ingredient, including
combination drugs comprised of two or more medicinal
ingredients.1 This practice was recently struck down in
two decisions of the Federal Court2 and Federal Court of
Appeal.3 The courts construed the PM(NOC) Regulations to
require a "perfect match" between the claims and the
corresponding submission as a requirement for listing. For
combination claims, this required each medical ingredient in the
submission to be explicitly claimed.
Industry Canada has indicated that this is a purely
judge–made rule. The RIAS confirms that the interpretation in
both the Gilead and ViiV decisions was
"inconsistent with the policy intent of the PM(NOC)
Regulations", to allow the listing of patents that claim at
least one of the medicinal ingredients contained in an approved
combination drug, and noted that the "policy intent of the
PM(NOC) Regulations is reflective of the realities of the drug
development process", referring to the fact that innovators
often seek to create novel combination drugs without intending to
forgo the benefit of protection under the PM(NOC) Regulations.
The RIAS notes that listing patents on the Patent Register
"is perhaps the most important step to allow brand
manufacturers to protect their patented drugs". As the RIAS
further explains, refusing to list patents claiming only one/some
of the medicinal ingredients in a combination drug, "would
compromise the ability of brand 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".
Amongst other revisions, the proposed amendments include:
Medicinal Ingredients: Patents containing a
claim for "the medicinal ingredient" are eligible for
listing in respect of a submission that contains that medicinal
ingredient in combination with other medicinal ingredients (new ss.
Formulation: Patents containing formulation
claims can be listed even where the formulation does not claim all
of the non-medicinal ingredients specified in the submission (new
ss. 4(2.1)(b)); and
Use: Patents containing claims for the use of
a medicinal ingredient are eligible to be added to the register if
the submission includes the use claimed in the patent, regardless
of whether the submission in respect of which the patent is sought
to be listed includes additional medicinal ingredients, additional
uses, or the use requires the use of the medicinal ingredient in
combination with another drug (new ss. 4(2.1)(c)).
Transitional Provisions and Coming Into Force
The amendments will attempt to address past problems. The
amendments provide that previous listing denials to list, or patent
removals from the Patent Register, may be reconsidered within 30
days following the coming into force of the section.
The RIAS provides that interested persons may make
representations concerning the proposed Regulations within 30 days
after the date of publication of the notice, with the coming into
force scheduled for the day on which the amendments are registered
(yet to be determined),
1. See for example, Health Canada, Guidance Document:
Patented Medicines (Notice of Compliance) Regulations,
April 16, 2012 at 8-9.
2. ViiV Healthcare ULC v Teva Canada Ltd, 2014
FC 893 ["ViiV"].
A recent Saskatchewan Court of Queen's Bench decision allowed a court-appointed receiver to sell and transfer intellectual property rights free and clear of encumbrances, finding that a license to use improvements of an invention was a contractual interest and not a property interest.
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