Background:

• Pharmascience appealed a Federal Court decision affirming the validity of Janssen’s Canadian Patent No. 2655335, related to INVEGA SUSTENNA, a medication for schizophrenia, arguing the patent covered unpatentable methods of medical treatment.

Legal Issues:

1. Whether certain claims of the patent were improperly excluded from the method of medical treatment analysis.
2. Whether the patent was patentable based on the distinction between fixed and variable dosing regimens.

Court’s Analysis and Decision:

• The court examined the prohibition against patenting methods of medical treatment, focusing on whether the patent claims required professional skill and judgment to implement, which would render them unpatentable.
• Claims related to fixed dosages and schedules were scrutinized to determine if they entailed method of medical treatment.
• The Federal Court’s finding that the patent did not constitute a method of medical treatment because it did not necessitate professional skill and judgment in its application was upheld.
• The appeal argued that the patent’s regimen wasn’t “one size fits all” and required physician judgment, hence it was a method of medical treatment. The court, however, maintained that the regimen’s fixed nature and lack of need for professional judgment in its application kept it within patentable subject matter.

Outcome:

• The appeal was dismissed, affirming the Federal Court's decision that the patent disclosed patentable subject matter and not a method of medical treatment. Costs were awarded to Janssen in the agreed amount of $10,000, all-inclusive.