Pharma In Brief - Canada: Federal Court Holds That ‘Methods Of Medical Treatment’ Are Not Patentable

Case: Novartis Pharmaceuticals Canada Inc. v. Cobalt Pharmaceuticals Company and the Minister of Health Drug: zoledronate (ACLASTA®) Nature of case: Patented Medicines (Notice of Compliance) Regulations, s. 6(1) Successful party: Cobalt Pharmaceuticals Company Date of decision: September 25, 2013

Summary

Novartis Pharmaceuticals Canada Inc. ("Novartis") brought an application pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations (the "Regulations") for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Cobalt Pharmaceuticals Company ("Cobalt") for its drug containing zoledronic acid until the expiry of Canadian Patent No. 2,410,201 (the "'201 Patent").

Cobalt alleged that the '201 Patent was invalid on the basis of obviousness and subject-matter ineligibility for patenting a method of medical treatment. Cobalt also alleged during the hearing that the '201 Patent did not qualify for listing on the Patent Register because it did not contain a claim for the use of the medicinal ingredient.

The Court held that Cobalt's allegations of obviousness were not justified and dismissed Cobalt's argument that the '201 Patent is ineligible for patent listing. However, the Court found that the claims at issue are not patentable subject-matter since they are directed to a method of medical treatment. As such, the Court dismissed the application.

Background

Zoledronic acid (also called zoledronate) is a bisphosphonate drug marketed by Novartis under the brand name ACLASTA® as a once-a-year administration in the treatment of osteoporosis. The '201 Patent for zoledronate relates to the pharmaceutical use of bisphosphonates in the treatment of osteoporosis. The patent contains 41 claims, including "Swiss claims" (i.e. the use of zoledronate in the manufacture of a medicament for treating osteoporosis), use claims, compound claims and claims to a pharmaceutical composition containing zoledronate.

Obviousness

The four-step test for obviousness, as elucidated by the Supreme Court of Canada in Apotex v. Sanofi1, was applied. The knowledge regarding the treatment of osteoporosis in the mid-2000's included a number of bisphosphonates; however, no clinical data in respect of zoledronate in the treatment of osteoporosis had been published. The Court accepted the evidence of Novartis' expert, that it would not have been evident to a person skilled in the art that once-a-year dosing of zoledronate would be an...