Patent Did Not Claim Dosage Form As Required by PM(NOC) Regulations
Bayer Inc. v. Canada (Health) 2009 FCA 133 (Pelletier, J.A.)

April 28, 2009

Gunars A. Gaikis, Nancy Pei for the Appellant, Bayer Inc. (“Bayer”)
David Cowie for the Respondents, The Minister of Health (“the Minister”) and The Attorney General of Canada

Bayer had previously brought an application for judicial review of a decision of the Minister holding that Canadian Patent No. 2,167,970 (“‘970 Patent”) was ineligible for listing on the Patent Register. The application judge dismissed the application for judicial review and Bayer appealed.

The decision of the application judge was upheld upon appeal. Specifically, the Court of Appeal stated that the “essential question” before the application judge was whether the ‘970 Patent claimed a dosage form of the drug whose use had been approved by the issuance of a notice of compliance.

Under the relevant provisions of the PM(NOC) Regulations (“Regulations”), a patent on a patent list in relation to a supplement to a new drug submission is eligible to be added to the Patent Register if the supplement is for a change in dosage form, and the patent contains a claim for the changed dosage form that has been approved through the issuance of a notice of compliance in respect of the supplement. [emphasis in original decision of the Minister]

Claim 1 of the ‘970 Patent is as follows:

A transdermal drug delivery device comprising: a non-aqueous carrier comprising a dissolved drug that forms a solid hydrate when exposed to water vapour; a desiccant package permeable to water vapour and defining a desiccant compartment containing a desiccant; and a water vapour impermeable product package, wherein the carrier and the desiccant package are contained within the product package.

The application judge referred to the specification of the ‘970 Patent and concluded that the term “delivery device” recited in the claims was a unique way to overcome the stability problem associated with the exposure of the drug to ambient moisture. Accordingly, the application judge held, and the Court of Appeal concurred, that the ‘970 Patent did not claim a dosage form, as required by the Regulations.

By: Alaka Chatterjee, Gowling Lafleur Henderson LLP