Listing decision; 2008 FC 1409; Etanercept; December 23, 2008

The Court upheld the Minister's refusal to list the patent on the Patent Register on the basis that it did not contain a claim for the dosage form. The Court held that the claim of the patent claimed a metered dose inhaler for dispensing an inhalation drug formulation comprising the medicines but then construed this claim as an improvement to a device. The Court accepted the Minister's interpretation of the dosage form as an inhalation aerosol despite the definitions in the Regulations defining a dosage form as a delivery system for administering a medicinal ingredient.

Thus, under these interpretations, the patent did not include a claim for the dosage form as defined, and the Court upheld the decision of the Minister. The Court also refused to consider any expert evidence in its decision.

Full text of the decision can be found at:  

http://decisions.fct-cf.gc.ca/en/2008/2008fc1415/2008fc1415.html