J. Bradley White, Nathaniel Lipkus
Feb 09, 2017
In a decision by the Federal Court of Canada, a generic version of a popular anti-inflammatory combination drug will be made available for the first time across the country.
The decision, AstraZeneca Canada Inc v Mylan Pharmaceuticals ULC, 2017 FC 142, was issued February 7th. It is the first ruling on the validity of a VIMOVO® formulation patent anywhere in the world. Similar patents are currently being litigated in the United States.
Although naproxen and esomeprazole are both generic drugs in Canada, the VIMOVO patent enabled AstraZeneca to charge a premium price for its combination product. In a decision that could offer a preview for VIMOVO patents around the world, the Court found the combination formulation to be obvious in view of prior art and common general knowledge that was available to a skilled formulator at the time of the patent. The Court was unpersuaded by AstraZeneca’s argument that the prior art had taught away from the patented formulation.
At a time when the soaring costs of treatments, especially pharmaceuticals, are receiving intense scrutiny by regulators, hospitals, activist investors, media and engaged consumers, the decision means Canadian patients will be the first in the world to access the naproxen-esomeprazole combination therapy at a greatly reduced cost.
The Osler team advising Mylan Pharmaceuticals led by J. Bradley White included Nathaniel Lipkus, Carina De Pellegrin and Rebecca Stiles.