Case: Novartis Pharmaceuticals Canada Inc.
v. Cobalt Pharmaceuticals Company and the Minister of
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
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.
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.
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 effective treatment of osteoporosis. The inventive concept of the '201 Patent was the infrequent dosing of zoledronate to treat osteoporosis. The Court found the patent to be non-obvious.
Method of medical treatment not patentable subject matter
Following the line of case law that distinguishes between claims for a vendible product and those that employ the skill and judgment of a physician, the Court held that patents claiming a dosage range or providing dosage advice constitute a method of medical treatment which is not patentable subject matter.
The Court found that each claim of the '201 Patent includes, either directly or by reference, the treatment of osteoporosis by intermittent dosages, a dosage range, specific dosages, and frequency of dosing, all of which require the skill and judgment of a physician. Furthermore, the '201 Patent contains statements requiring a physician to take into account the particular circumstances of the patient and use skill and judgment in administering the dosing regimen. In the result, the Court concluded that the '201 Patent claims a method of medical treatment and is not patentable subject matter.
'201 Patent is eligible for listing on the Patent Register
Cobalt asserted that the '201 Patent does not contain "a claim for the use of the medicinal ingredient" as defined in the Regulations and as such, should not have been listed on the Patent Register. The Court held that claims for the use of the medicinal ingredient were clearly found in claims 10-18 of the '201 Patent and dismissed Cobalt's argument to the contrary. The Court also recognized that although a challenge to the eligibility of listing on the Patent Register is usually brought by way of a motion prior to the hearing, pursuant to s. 6(5)(a) of the Regulations, it is also possible for a second person (i.e. generic drug manufacturer) to challenge the patent listing at the hearing.
Link to decision:
1 Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61.
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