Differing Results for Same Drug in Notice of Compliance Proceedings

The Federal Court Trial Division recently prohibited the Minister of Health from issuing a Notice of Compliance (NOC) to Rhoxalpharma Inc in connection with its 25 mg and 50 mg capsules of the drug cyclosporine until the expiry of Canadian Patent No 1,308,656 (the "˜656 Patent). The owners of the "˜656 Patent, Novartis Pharmaceuticals Canada Inc and Novartis AG (Novartis) had commenced the application in response to having received a Notice of Allegation from Rhoxalpharma asserting that its capsules would not infringe the'656 Patent. The "˜656 Patent is directed to pharmaceutical preparations containing particles of the drug cyclosporine within a hydrosol. The principal issue raised in the proceeding was whether one of the independent claims of the patent – which is also directed to a "pharmaceutical preparation"- could be construed as covering a hydrosol, formed inside the human stomach following ingestion. Rhoxalpharma had argued that the term "pharmaceutical preparation" should be interpreted as limiting the claim to pre-ingestion preparations. (There was no dispute that Rhoxalpharma's capsule did not contain a hydrosol prior to ingestion). Justice Lemieux disagreed and held that the Rhoxalpharma's argument was artificial. Applying the principles of construction that had been laid down by the Supreme Court of Canada in previous decisions, The Court ruled that the inventors had not introduced a limitation to the claim to exclude from its scope hydrosols formed inside the body following ingestion. (See Novartis Pharmaceuticals Canada Inc and Novartis AG v Rhoxalpharma Inc and The Minister of Health, 2004 FTC 474). Interestingly, in a previous NOC proceeding involving the same parties and the same patent – but involving the 100 mg dosage form of the capsules – Rhoxalpharma had been successful. Thus, although the recent decision prevents Rhoxalpharma from marketing the 25 mg and 50mg dosage form of its cyclosporine capsules, as a result of the previous proceeding, it has the right to market a 100 mg dosage form. For a copy of the decision by the Federal Court, visit: http://decisions.fct-cf.gc.ca/fct/2004/2004fc474.shtml. Summary by: Lenni Carreiro