Source – Astellas
An important patent that Astellas has on the urinary incontinence medicine Myrbetriq has been declared invalid by the US district court, putting the company’s efforts to protect the popular treatment against generic competition at risk.
Myrbetriq (mirabegron), which is marketed in various markets under the brand names BETANIS and BETMIGA, is an extended-release selective 3-adrenoceptor agonist treatment that has been authorized in the US since 2012. It is used to treat overactive bladder with symptoms of urgency, incontinence, and frequency.
Since then, it has developed into one of Astellas’ best-selling medications, with global sales of 188 billion yen (~$1.4 billion) in Astellas’ most recent fiscal year, an increase of over 10%.
The action, which was tried in a Delaware district court, centered on US Patent No. 10,842,780, which protects extended-release versions of mirabegron and has an expiration date of 2030. Astellas brought the complaint in an effort to have the court rule that the launch of generics would violate this patent, and it has declared it would appeal the decision.
The patents on mirabegron’s crystal shapes and usage techniques, which were the focus of prior legal disputes, are still in effect, however they will expire in May of 2019.
The medicine has previously received approval for other knockoff versions, including those made by Zydus Cadila and Lupin Labs. Launching them would, however, be “at-risk,” perhaps exposing their developers to the possibility of damages if the appeals court rules in Astellas’ favor given their intention to take the matter to the Court of Appeals for the Federal Circuit (CAFC).
The patents related to the crystal forms and usage methods of mirabegron, which were previously involved in litigation, are still valid and will expire in May 2024. Astellas does not expect generic versions of mirabegron to be launched right away. This court decision will not affect the financial projections for the current fiscal year, which ends on March 31, 2024.
