Federal Court Of Canada Dismisses Novartis Application Relating To The Drug ACLASTA® (zoledronic acid)

In Novartis Pharmaceuticals Canada Inc v Cobalt Pharmaceuticals Company, 2013 FC 985 [Cobalt ZA], Justice Roger Hughes of the Federal Court dismissed the Novartis application seeking an order prohibiting the issuance of a Notice of Compliance to Cobalt Pharmaceuticals Company (Cobalt) for a generic version of the osteoporosis drug ACLASTA® (zoledronic acid, or ZA) until after the expiry of Canadian Patent No 2,410,201 (’201 patent). Justice Hughes held that Cobalt’s allegation that the ‘201 patent claimed un-patentable subject matter - a method of medical treatment – was justified. (Deeth Williams Wall LLP represented Cobalt in the proceedings). Methods of medical treatment have been considered un-patentable in Canada since the Supreme Court of Canada decision in Tennessee Eastman Co v Canada (Commissioner of Patents) [1974] SCR 111, though the specific legal and policy underpinnings of the prohibition have eluded precise definition. In accordance with the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), it is clear that Canada has the right to exclude methods of medical treatment from patentability, either by way of legislation, or via judicial doctrine. The ‘201 claims at issue took several forms, but all were directed towards the use of ZA for the treatment of certain bone conditions where the ZA was administered intermittently. Justice Hughes noted that the patent specification described the dose frequency as being, among other things, at least once every six months and up to every two years or longer, depending on the attending physician’s professional judgment. He held that “because each claim of the ‘201 patent, directly or by incorporation by reference, includes as well treatment by intermittent dosages with some claims specifying a dosage range and others specifying specific dosages; and some claims claiming more frequent intervals of dosing, and others less; that the claims include that which lies within the skill of the medical practitioner” (see para 99). Thus, he concluded that the claims were directed to a method of medical treatment and, hence, un-patentable. Novartis has filed a Notice of Appeal and ETIPS® will report on any new developments. Summary by: John Lucas