Astellas accuses Cipla of infringing overactive bladder patent
Pharmaceutical company Astellas Pharma has filed a patent infringement claim against India-based Cipla over a drug for treating an overactive bladder.
The claim was filed at the US District Court for the District of Delaware on Tuesday, June 5.
The patent in question is “Quinuclidine derivatives and medicinal composition thereof” (US patent number 6,017,927), which is a formula that can be used as a preventive or remedy for urologic diseases.
Astellas markets the formula under VESIcare (solifenacin succinate), which contains the active ingredient solifenacin succinate. VESIcare is used for the treatment of an overactive bladder with symptoms of “urge” urinary incontinence, urgency, and urinary frequency. The medication is available in 5mg and 10mg strength tablets.
According to the claim, Cipla has filed an Abbreviated New Drug Application (ANDA) seeking approval from the US Food and Drug Administration ( FDA) to market generic pharmaceutical products containing solifenacin succinate.
Astellas alleged that the ANDA application for the generic drug is also for the treatment of overactive bladder. The ‘927 patent doesn’t expire until November 19, 2018, with paediatric exclusivity until May 19, 2019.
The patent infringement claim alleged that Cipla is “seeking FDA approval to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of generic solifenacin succinate 5mg and 10mg tablets as a pharmaceutical composition in an oral dosage form for the treatment of overactive bladder prior to the expiration of the ‘927 patent”.
According to the claim, Cipla is aware that Teva Pharmaceuticals holds first filer marketing exclusivity for solifenacin succinate.
In April 2018, Cipla sent a notice letter to Astellas informing the latter of its intentions to produce the generic drug. According to Astellas, Cipla wrote that the claims of the ‘927 patent are invalid, unenforceable and/or not infringed.
Astellas is seeking damages and an injunction preventing Cipla from producing the generic drug.
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