Purdue Pharma sought judicial review of a decision of the Office
of Patented Medicines and Liaison (OPML) in which the OPML
determined that one of Purdue's patents (the 738 Patent) was
not eligible for listing on the Patent Register maintained in
accordance with the Patented Medicines (Notice of
Compliance) Regulations (Regulations) in
respect of the drug TARGIN. TARGIN is a controlled-release drug in
tablet form that contains two medicinal ingredients: oxycodone
hydrochloride (a painkiller), and naloxone hydrochloride, which
counteracts certain side effects of oxycodone. The 738 Patent
contemplates a controlled-release technology for delivering
oxycodone, and contains 28 claims, none of which mention naloxone.
Claim 5 was particularly at issue, and claims, "A solid
controlled release oral dosage form, comprising oxycodone or a salt
thereof ... an effective amount of a controlled release matrix ...
and ... a suitable amount of a suitable pharmaceutical diluent
Purdue claimed that the OPML erred by misinterpreting paragraph
4(2)(c) of the Regulations, which provides that, "A patent on
a patent list in relation to a new drug submission is eligible to
be added to the register if the patent contains ... a claim for the
dosage form and the dosage form has been approved through the
issuance of a notice of compliance in respect of the
submission." The phrase "claim for the dosage form"
is defined at section 2 of the Regulations as meaning "a claim
for a delivery system for administering a medicinal ingredient in a
drug or a formulation of a drug that includes within its scope that
medicinal ingredient or formulation." Purdue asserted that the
word "comprising" in claim 5 of the 738 Patent
contemplated that medicinal and non-medicinal ingredients not
specifically mentioned could be included within the scope of that
claim. In particular, Purdue submitted that a product containing
all the ingredients in the dosage form as described in claim 5,
along with one or more other active ingredients, would still be
included within the scope of claim 5 for the purposes of section
4(2)(c) of the Regulations, so long as one of those active
ingredients was oxycodone or a salt thereof.
Justice Crampton disagreed with Purdue's position, however,
and found that the OPML correctly determined that the dosage form
contemplated by claim 5 of the 738 Patent related to a formulation
containing oxycodone as the sole medicinal ingredient, and that
naloxone was therefore not within the scope of the claim for the
purposes of the Regulations. A construction of claim 5 that would
include within its scope a potentially unlimited number of other
unnamed medicinal ingredients would be inconsistent with the
objective of product specificity that was enshrined in section 4 of
the Regulations by the 2006 amendments thereto. As a consequence,
where a patent relates to a delivery system for administering
medicinal ingredient(s) in a drug or formulation of a drug, in
order to be eligible for listing on the Patent Register against an
approved combination drug, the patent must contain a claim that
includes within its scope each of the medicinal ingredients
contained in the approved combination. Here, because naloxone did
not fall within the scope of claim 5, the 738 Patent was not
eligible to be listed on the patent register against the
combination drug product TARGIN.
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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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