FOLLOW US

Astellas has successfully defended one of its U.K. patents against two generic drug manufacturers in a high-stakes courtroom battle over a treatment for overactive bladder syndrome. Despite this, Astellas could not convince the judge that its competitor's product would infringe on its intellectual property.

In a comprehensive 102-page ruling, Judge Rachel Mellor, at the High Court, dismissed the arguments put forward by the defendants, Sandoz AG and Teva Pharmaceuticals, who contended that the patent for mirabegron, a specific compound, was invalid due to being obvious and failing to offer enough information for replication.

Teva had previously admitted that an earlier version of its generic product infringed the patent but did not introduce arguments concerning a new version in time for the trial. However, Astellas' infringement claims against Sandoz, a Swiss company, fell short of convincing the judge.

Judge Mellor found a lack of evidence regarding whether Sandoz's medication reduced the impact of food on the drug's absorption rate, a crucial element of Astellas' patent, which had been a subject of intense debate.

"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.

Astellas had argued that the phrase didn't necessitate demonstrating that the medication reduced food's impact on absorption. However, the judge concluded that it did require at least "some" reduction. Hence, Astellas' invention was not considered obvious, making it unlikely that other scientists aiming to diminish food's impact on similar medications would have arrived at the same product.