On September 25, 2013, the Federal Court dismissed Novartis’ application for an Order prohibiting the Minister of Health from issuing a Notice of Compliance to Cobalt in respect of zoledronic acid (Novartis’ ACLASTA) on the ground of unpatentable subject matter (Novartis Pharmaceuticals Canada Inc v Cobalt Pharmaceuticals Company, 2013 FC 985).

Canadian Patent No. 2,410,201 (“’201 patent”), owned by Novartis, relates to the use of zoledronic acid or zoledronate in once-yearly doses for the treatment of osteoporosis. The ’201 patent contains “Swiss” claims (i.e. “the use of A in the manufacture of a medicament to treat condition B”) and other types of use claims. Representative claim 16, when expanded for claim dependency, provides:

Use of zoledronic acid, a pharmaceutically acceptable salt thereof, or a hydrate thereof for the treatment of postmenopausal osteoporosis wherein the zoledronic acid, salt or hydrate is in a unit dosage form of about 5 mg which is administered intermittently, with a period of about one year between the first and each subsequent administration, wherein each administration is intravenous.

Method of Medical Treatment. Justice Hughes began his analysis with a comprehensive review of the jurisprudence dealing with methods of medical treatment, including the Supreme Court of Canada decisions in Tennessee Eastman, Shell Oil, and AZT, Justice Mosley’s decision in Merck & Co Inc v Apotex Inc (alendronate; 2005 FC 755), Justice Harrington’s decision in Axcan Pharma Inc v Pharmascience (ursodeoxycholic acid; 2006 FC 527), the Patent Appeal Board’s decision in Re Allergan, Inc. Patent Application No 2,300,723, his own decision in Merck & Co Inc v Pharmascience (finasteride; 2010 FC 510) and Justice Barnes' decision in Janssen Inc v Mylan Pharmaceuticals ULC (galantamine; 2010 FC 1123). He summarized the jurisprudence as follows:

[91] What the jurisprudence establishes is that a claim to a vendible product, including a substance intended for the treatment of a medical condition, can be good subject matter for a patent claim. Thus, claims such as the following are proper subject matter:

  • the substance X for the treatment of Y
  • the substance X in the form of a 5 mg tablet for the treatment of Y

[92] What is improper subject matter is a claim that encompasses the skill of medical professional, such as:

  • the closure of a surgical incision by the use of adhesive X
  • the use of substance X in a dosage range between A and B for the treatment of X

Justice Hughes then turned to the claims of the ’201 patent. He found that every claim of the ’201 patent includes directions that zoledronate is to be used to treat a bone condition. While some claims do not specify any dosage, every claim provides (i) zoledronate will be used for intermittent administration; and (ii) the period between the first and subsequent administration is about one year. Justice Hughes also considered the patent disclosure providing that the mode of administration and dosage may be selected by the attending physician taking into account the particulars of the patient and describing intermittent administration regimens. Justice Hughes therefore held that all claims of the ’201 patent were directed to non-patentable subject matter:

[99]… However, 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 other 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 and are thus invalid.

Justice Hughes continued by considering the “Swiss” claims and held that the Court “should disregard the artificial nature of a ‘Swiss’ claim and look at what is the real subject matter of the claim”. He found that in the present case, the real invention lies in the infrequent administration (e.g. once yearly) of zoledronate to provide effective treatment of osteoporosis (i.e. a dosing regimen). He therefore concluded that the “Swiss” claims at issue are directed to a method of medical treatment and hence unpatentable.

Obviousness. Justice Hughes found that Cobalt’s allegation of obviousness was unjustified on the evidence before him, relying on the evidence of one of the inventors who “dared to go beyond what a person of ordinary skill in the art would have done at the time.”

Novartis has appealed.