Judicial review of listing decision; 2009 FC 102; testosterone; January 30, 2009

The Court upheld the decision of the Minister refusing to list a patent on the Patent Register. An SNDS was filed to update the product monograph to reflect the safety and efficacy of the use of the drug in longer term therapies. The Court held that the SNDS was not a change in use of the medicinal ingredient. A change in use is measured by the approved use in the product monograph. The indications in clinical use of the product monograph section were not changed.

Further, the patent does not claim a changed use as it does not address the issue of duration of testosterone therapy. The court found that the expert evidence was clear that the patent at issue contains no limitation as to duration of use.

The full text of the decision can be found at:

http://decisions.fct-cf.gc.ca/en/2009/2009fc102/2009fc102.html