“Plausibility is a different standard to that required to prove infringement, and I have held that, to prove infringement, at least some reduction in food effect must be demonstrated … Astellas did not attempt to establish this, either directly or by inference via expert evidence,” Judge Mellor explained.
It’s known that food can influence the absorption of mirabegron, potentially diminishing its effectiveness. The judgment stated that Astellas aimed to create a product that allowed unrestricted food intake, a commercially sound strategy, as it’s undesirable for a drug to require specific food consumption instructions.
Astellas resolved this issue by slowing down the drug’s absorption rate, extending it beyond the conventional four hours to a maximum of seven hours, as detailed in the judgment.
The judge ultimately determined the validity of Astellas’ patent based on her interpretation of a disputed phrase in the patent claim. The phrase “pharmaceutical composition for modified release” was seen as making a “promise” to reduce food’s effects, even if it didn’t explicitly state so, according to the judge.
