Listing a patent on the Patent Register maintained by the
Minister of Health is the gateway through which an innovator gains
access to the provisions of the Patented Medicines (Notice of
Compliance) Regulations (PMNOC Regulations). Any person seeking to
market a generic copy of a pharmaceutical product in Canada, in
respect of which a patent is listed, must address the infringement
and/or validity of that patent or await its expiry. There is an
opportunity for the innovator to seek an order from the Federal
Court prohibiting the Minister from issuing a Notice of Compliance
(NOC) to the generic on the basis that allegations of
non-infringement and/or invalidity are not justified. As this
exercise is conducted prior to generic entry, it can prevent
disruption of the marketplace. Conversely, in a patent infringement
action, given the absence in Canada of effective injunctive relief,
the generic entrant will often have access to the market over the
course of the action. If the Minister refuses to list a patent on
the Register at the time of submission for listing, the innovator
is deprived of any opportunity to seek the preliminary
determination under the PMNOC Regulations.
Recently, the Minister of Health has taken a more restrictive
view of which patents are "relevant" for the purposes of
the PMNOC Regulations. This change was precipitated by amendments
to the PMNOC Regulations in 2006 to clarify the types of
submissions which would engage an opportunity to list a patent.
There was a concern that a patent might be listed for virtually any
type of regulatory submission or change, leading to the listing of
patents with no relevance to the product approved by the
submission. To address this concern, the listing provisions were
amended to require what the government termed "product specifi
city." Generally, the amendments require that, where a
particular medicinal ingredient, formulation, use or dosage form is
approved, the patent listed in respect of the submission must
contain a claim to the approved medicinal ingredient, formulation,
use or dosage form.
In principle, the amendments are consistent with the purpose of
the PMNOC Regulations, which is the prevention of the abuse of the
"early working" exception to patent infringement. This
exception permits the marketer of a generic product to use the
patented invention to speed up its regulatory approval. However,
recent interpretations of the "product specificity"
requirement in positions taken by the Minister, and accepted to
some degree by the Federal Courts, have resulted in a more
restrictive application of the listing provisions.
The Minister has taken the view that it is not enough that a
patent claim encompass or cover the medicinal ingredient,
formulation, use or dosage form of the commercial product. The
claim must also expressly "match" the approved form. The
result is that even where a claim would be clearly infringed by a
generic copy, the claim would not be listable unless its language
precisely matches that of the submission. While such a stringent
requirement is not apparent from the language of the PMNOC
Regulations, and does not support the purpose of preventing abuse
of early working through infringement, the Court has recently given
support to this interpretation in certain contexts.
In the context of a patent where the claims listed one approved
medicinal ingredient in the formulation/dosage form and the
commercial product contained two medicinal ingredients, the Court
held that the Minister did not err in not listing the patent, given
that "precise and specific matching" is required.
(Purdue Pharma v. Canada 2011 FCA 132; 2010 FC 738; see
also Bayer Inc. v. Canada 2009 FC 1171). In a more recent
decision under appeal at the time of this writing, the Court
refused to list claims comprising three approved medicinal
ingredients, where two of the three ingredients were explicitly set
out in the claims, and the third was clearly encompassed within a
class of compounds listed in the claims. (Gilead Sciences
Canada Inc. v. Canada 2012 FC 2). Absent the explicit mention
of the third medicinal ingredient, the Court held the patent could
not be listed.
Given these developments, the best approach is to identify the
attributes of the potential commercial product and the contents of
the regulatory submission at an early stage and draft patent claims
accordingly. This can be difficult in view of the research and
development process and the effect of disclosure on patentability.
Nonetheless, absent a clarification in the legislation or the
jurisprudence, it is the most effective way to ensure entry through
the gateway to the PMNOC Regulations.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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