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Canadian Court Finds Novartis Osteoporosis Drug Not Patentable

Friday, October 11, 2013
By Peter Menyasz

Oct. 9 --The Federal Court of Canada has rejected Novartis Pharmaceuticals Canada Inc.'s bid to block a generic version of the osteoporosis drug Aclasta, finding that the drug is a form of treatment that is not patentable in Canada (Novartis Pharmaceuticals Canada, Inc. v. Cobalt Pharmaceuticals Co., Fed. Ct., No. T-724-12, 9/25/13).

The invention claimed in Novartis's Canadian patent for zoledronic acid, also called zoledronate and marketed as Aclasta, is the recognition that the product can be administered infrequently, such as once a year in injections of 5 mg, to provide effective treatment for osteoporosis, Justice Roger T. Hughes said in the ruling, made Sept. 25 and made public Oct. 4.

“It is in reality, however contrived the wording of the claim may be, a method of medical treatment; hence, under Canadian law, unpatentable,” Hughes said.

The ruling, which also awarded Cobalt Pharmaceuticals its costs in the case, rejected Novartis's application for Health Canada to issue a Notice of Compliance under the Patented Medicines (Notice of Compliance) Regulations to block Cobalt from marketing a generic version of Aclasta.

Novartis did not respond Oct. 7 to a request for comment on the ruling; the company Sept. 27 filed a notice of appeal with the Federal Court of Appeal.

Cobalt Pharmaceuticals is pleased with the Federal Court's acceptance of the arguments that Novartis's patent claims were for non-patentable methods of medical treatment, the company said Oct. 7. Cobalt intends “to vigorously defend Novartis' appeal of the decision,” the company told Bloomberg BNA in an e-mail.

Cobalt was the first generic manufacturer to successfully challenge the validity of the Aclasta patent, and as a result a generic version may be available on the Canadian market more than seven years before the patent was due to expire, it said. 

Treatment Key to Finding

Novartis's counsel argued that the Aclasta patent, Canadian Patent No. 2,410,201, issued Oct. 26, 2010, and expiring June 18, 2021, claims a vendible product, namely a bottle containing 5 mg of zoledronic acid for use as a once-a-year injection to treat osteoporosis, the ruling said. It is the last portion of that argument that is critical in the case, the ruling said.

If the patent had claimed only zoledronic acid, or even 5 mg of zoledronic acid, for treating osteoporosis, it would have been patentable under Canadian law, provided that other necessary criteria, such as novelty and non-obviousness, were met, the court said. However, each claim of the patent, directly or by incorporation by reference, includes as well the concept of treatment by intermittent dosages, it said.

Some claims specify a dosage range, others specify dosages, some even claim more or less frequent intervals of dosing, it said. “The claims include that which lies within the skill of the medical practitioner and are thus invalid,” it said.

In Europe, legislation has been put in place to deal with methods of medical treatment, and the English Court of Appeal addressed that legislation in a 2008 ruling in Actavis UK Limited v. Merck & Co., Inc., including whether the drafting of a claim in the form of a “Swiss” claim (i.e., “the use of A in the manufacture of a medicament to treat condition B”) would save it from being a method of medical treatment even though it included a dosage regime, the ruling said.

After considerable agonizing, the English Court of Appeal refused to follow its earlier decision in a 2011 ruling in Bristol-Myers Squibb v. Baker Norton and instead followed the 2006 decision of the Legal Board of Appeal of the European Patent Office in a case involving Genentech and the method of administration of IFG-1 to accept Actavis's claim for a patent, it said.

But in the present case, the court is not bound by a European Patent Office decision, and further, both Novartis and Cobalt construed the Aclasta patent's claims, including the “Swiss” claims, as being “use” claims, it said.

The ruling rejected, however, Cobalt's arguments that the patent should also be invalidated on the basis of obviousness. The inventor dared to go beyond what a person of ordinary skill in the art would have done at the time, and unexpectedly achieved a good result, so the invention was not obvious, it said.

It also rejected Cobalt's assertion that the patent did not qualify for listing under the Patented Medicines (Notice of Compliance) Regulations at the time it was listed, which was based on the argument that Aclasta did not meet the regulations' definition of “claim for the use of a medicinal agreement.”

To contact the reporter on this story: Peter Menyasz in Ottawa at correspondents@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com


The ruling is available at http://bit.ly/15REUK9.

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