Novartis Pharmaceuticals Canada Inc. v. Canada (Attorney General)

Drug: TOBI® PODHALER (Tobramycin)

This is a case relating to the refusal by the Minister of Health (the “Minister”) to list a patent on the Patent Register. The Court dismissed the application.

The Court described the product in question: “Tobi Podhaler consists of a medicinal and a non medicinal component: the medicinal component consists of a capsule dosage form providing a dry powder formulation which contains the active ingredient tobramycin (an amino-glycoside antibiotic), intended for oral inhalation with the help of the Podhaler inhalation device (the non medicinal component).” The Court described the patent in question: “Of importance to the matter at bar, the ‘819 patent includes claims for the use of a bioactive agent in the manufacture of a medicament for pulmonary delivery, comprising a plurality of perforated microstructures and administered by an inhalation device (claims 1 to 11) and claims for a perforated microstructure powder comprising a bioactive agent (claims 41 to 50 and 59 to 68), as well as claims of an inhalation system for pulmonary administration of a bioactive agent to the patient (claims 51 to 58).”

The sole issue to be determined by the Court was whether the Minister erred in requiring the patent claims to explicitly mention the medicinal ingredient in order to be eligible for listing. The Court found the Minister’s construction of the relevant claims of the patent and the relevant provisions of the NOC Regulations to be correct in law.

The Court construed the claims to dosage forms in the patent to be generally directed to an improved delivery system. The approved dosage form was found to be the inhalation delivery system as a whole, and not the individual parts. Finally, the Court found that a “rather high threshold of specificity in the formulation claims is required for a patent to be eligible for listing”. The Court ultimately found that the Minister was correct in finding that none of the claims of the patent contain the approved medicinal ingredient tobramycin.