J. Bradley White, Nathaniel Lipkus
Feb 22, 2017
The Federal Court of Canada recently issued the world’s first ruling on the validity of a VIMOVO® formulation patent in AstraZeneca Canada Inc v Mylan Pharmaceuticals ULC, 2017 FC 142. In a post for Legal Feeds, the blog of Canadian Lawyer and Law Times, Jennifer Brown explores the Federal Court’s decision, which makes a generic version of the anti-inflammatory combination drug available for the first time in Canada and the world at a reduced cost. Similar patents are currently being litigated in the United States.
According to the blog post, the naproxen-esomeprazole combined drug is used for arthritis patients who may have some risk of stomach-related side effects. The post points out that naproxen and esomeprazole are already generically available, but the VIMOVO patent “enabled AstraZeneca to charge a higher price for its combination product.” Mylan argued the formulation patent was obvious in view of the prior art, while AstraZeneca stated the formulation was inventive.
Two of Osler’s lawyers who represented Mylan talk to Legal Feeds about the case. Bradley White, a partner in Osler’s Intellectual Property Group who led the case for Mylan, explains, “[w]hat the patent in this particular case covered was a formulation that combined these two products [naproxen and esomeprazole] together into a single dosage and it was that formulation they asserted was inventive.”
“The fact these two components were already generically available, it really seemed like a formulation patent that had been put in place that would permit the brand company to charge brand prices for something that to some extent was already being done,” says Brad, who adds that the case turned specifically on the expert evidence filed in this case. Justice Alan Diner agreed with Mylan, finding the “combination formulation to be obvious given prior art and common general knowledge.”
The post states that it is common for patent holders to try to combine their drug with another drug and see if there is a means to extend their patent protection.
“In this case, we had a very decorated clinician who said these drugs are being combined in the clinic all the time and there isn’t really anything special about putting them together,” says Nathaniel Lipkus, an Osler IP partner and member of the team representing Mylan. “When you added it all up, there wasn’t an inventive contribution,” says Nathaniel, who tells Legal Feeds that the legal team’s formulators did a great job helping the judge step into the shoes of the scientist.
For more information on the Mylan decision, read Jennifer Brown’s full blog post “Mylan wins in patent battle over combo arthritis drug.”