The plaintiffs brought actions under the Patented Medicines (Notice of Compliance) Regulations to prevent the defendants from obtaining notices of compliance for generic versions of apixaban (ELIQUIS).
The defendants alleged the asserted claims of the 202 Patent (compound) and 171 Patent (formulation) were invalid on grounds including insufficiency, inutility, anticipation, obviousness, and double patenting.
The Federal Court found that the defendants failed to establish invalidity on any ground.
The 202 Patent was not anticipated or rendered obvious by a prior genus patent (the 330 Patent), and the 171 formulation patent possessed an inventive concept relating to particle size and dissolution rates.
The patents were held valid, and the plaintiffs' applications were granted.
