Mylan Pharmaceuticals ULC has invalidated the Canadian formulation patent relating to the drug VIMOVO®. In its decision in AstraZeneca Canada Inc. v. Mylan Pharmaceuticals ULC, 2017 FC 142
, the Federal Court of Canada found the claims of Canadian Patent No. 2,449,098 (the “098 Patent”) invalid for obviousness. This decision paves the way for a generic version of the drug in Canada.
VIMOVO® is a drug currently sold in Canada by AstraZeneca, under a licence to the 098 Patent from Pozen (collectively, “Astra”). The drug contains naproxen (a popular non-steroidal anti-inflammatory drug, or NSAID) and esomeprazole (a proton pump inhibitor, or PPI, which protects the stomach). In VIMOVO®, the esomeprazole is formulated to release in the body before the naproxen. The 098 Patent is directed to this sequential-release formulation architecture.
Mylan alleged that the 098 Patent was obvious, for it merely applied a well-known formulation architecture to a well-known NSAID-PPI combination, using routine means, to achieve the well-known advantage of reducing gastrointestinal side effects in patients receiving NSAID co-therapy. Astra argued that the prior art taught away from formulating a PPI in this manner, without an enteric coat, rendering the invention non-obvious.
The court’s decision, issued by Justice Alan Diner, evaluated whether the 098 Patent was obvious. The Court agreed with Mylan that the supposed “teaching away” art had been superseded by subsequent art, including that from AstraZeneca, that taught how to make and use a non-enteric-coated PPI. In evaluating whether a skilled person would be motivated to try a sequential-release formulation, the Court provided a thoughtful discussion and concluded that the distinction between “specific” and “general” motivation may be a false dichotomy; that the truth behind this requisite motivation may lie somewhere in the gray — between the black of general motivation, and the white of specific motivation.
The court noted a similar formulation had been used for an earlier product, ARTHROTEC, which served a similar purpose in protecting against NSAID side effects. Whether or not it had the same mechanism of action, the court found it would have been self-evident to successfully apply an ARTHROTEC-type architecture to an NSAID-PPI formulation that sought to achieve the same effect.
J. Bradley White
, Nathaniel Lipkus
, Carina de Pellegrin and Rebecca Stiles of Osler, Hoskin & Harcourt LLP
acted for Mylan Pharmaceuticals.
, Andrew Mandlsohn and Paul Jorgensen of Smart & Biggar/Fetherstonhaugh
represented AstraZeneca Canada.