Purdue filed a New Drug Submission (“NDS”) as part of its application for a notice of compliance (“NOC”) to market and sell the drug TARGIN in Canada. Purdue received a NOC in December 2009. Along with its NDS, Purdue applied to list one of its patents (the ‘738 Patent) pursuant to section 4 of the PMNOC Regulations in relation to TARGIN.
In June 2009, the OPML advised Purdue that the ‘738 Patent was not eligible for listing on the Patent Register in relation to TARGIN. This was because to be eligible for listing on the Patent Register under s. 4(2)(c) of the Regulations, a patent must contain a claim to the formulation that contains all the medicinal ingredients that are included in the formulation that was approved through the issuance of the NOC.
The Federal Court dismissed the application for judicial review. The judge held that the approved dosage form of TARGIN is a delivery system for administering a formulation containing two medicinal ingredients, namely, oxycodone and naloxone. The judge also held that the dosage form claimed in the ‘738 patent is a delivery system for administering a formulation containing oxycodone as the sole medicinal ingredient and that naloxone, for the purposes of the Regulations, is not within the scope of the claim. Thus, the judge held that because the dosage form claimed in the ‘738 Patent and the dosage form that was approved by the NOC issued in respect of TARGIN are delivery systems for administering two different formulations, this fell outside of s. 4(2)(c) which plainly requires the claimed dosage form and the approved dosage form to be the same. To be eligible for listing under s. 4(2)(c) in relation to TARGIN, the dosage form claimed in the ‘738 Patent must include within its scope both of the medicinal ingredients included in the approved dosage form of TARGIN.
Purdue has appealed this decision.
The full text of the decision can be found at: