Intubated patients sedative patent the focus of ACS Dobfar suit

Sun Pharmaceutical has been sued by ACS Dobfar subsidiary InfoRLife and WG Critical Care for allegedly infringing on a patent with its proposed midazolam-an anaesthesia medication.

The complaint filed on Friday with the US District Court for the District of Delaware, asks the court to issue injunctions preventing Sun Pharma from manufacturing or selling its drug, as well as a declaration of infringement.

The dispute arises from a Sun Pharma amendment to a New Drug Application (NDA) to the Food and Drug Administration (FDA) seeking approval for a midazolam solution in 0.9% sodium chloride at 100mg per 100ml dosage for intravenous use.

This particular sedative is used to treat intubated and mechanically ventilated patients in a critical care setting.

InfoRLife offers its own Midazolam in 0.9% sodium chloride at both 50mg/50ml and 100mg/100ml doses.

In Sun Pharma’s notification letter to InfoRLife, it provided an Offer of Confidential Access to Application to show certain information from the company’s NDA in order to determine whether infringement had taken place.

Upon review, InfoRLife concluded that Sun’s NDA product is a generic version of Midazolam and filed the complaint.

InfoRLife claims that the NDA infringes its US 10,966,990 patent entitled “Midazolam in Flexible Bags”, and describes a “ready-to-use” water injection solution.

InfoRLife has asked the court for a judgment that the patent has been infringed as well as a preliminary and permanent injunction enjoining Sun from manufacturing and selling its NDA until the expiration of the ‘990 patent.

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