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US-based drug-maker Fresenius Kabi has dragged leading pharmaceuticals company Dr Reddy's Laboratories to court for allegedly infringing on the former's patented injected anaesthetic Diprivan on four counts.
Diprivan (propofol) is an injectable general anaesthetic for the induction and maintenance of anaesthesia and can also be used for inducing sedating in ventilated patients and those undergoing diagnostic or surgical procedures.
In a petition filed against DRL in US District Court of Delaware, Fresenius said it held an approved New Drug Application (NDA) No. 19627 under section 505(b) of the Federal Food, Drug and Cosmetic Act.
Dr Reddy's officials declined to comment on the issue.
The inventors had assigned four patents to Zeneca in 1998 and subsequently they assigned them to APP Pharmaceuticals, LLC, which later changed its name to Fresenius Kabi USA, LLC. Accordingly, Fresenius is the owner of all rights, title and interest in the patents, Fresenius said.
In 1999 Zeneca and the Sweden-based pharmaceutical company Astra AB merged to form AstraZeneca plc.
The petition said DRL filed an Abbreviated New Drug Application (ANDA) with the US regulator seeking approval to manufacture, use, offer for sale, sell in and import into the US a Propofol injectable even before the expiration of the patent.
"By letter dated April 11, 2013, DRL notified Fresenius that it had filed an ANDA seeking approval to market DRL's generic Diprivan product prior to the expiration of the '520','355','356' and '869' patents," it said.
Fresenius said in his petition that the action of filing a patent infringement case was commenced before the expiration of 45-day period from the date of receipt of the DRL Notice Letter.
The US drug-maker requested the court to pass an order refraining DRL and all persons acting in concert with defendants from commercially manufacturing, using, offering for sale, selling, marketing, distributing, or importing DRL's generic Diprivan product, or any other product or compound the use of which infringes the patents, or inducing or contributing to the infringement of the patents until after the expiration of the four patents.
Fresenius said all the four patents which have allegedly been infringed by the city-based drug maker would expire on September 22, 2015.
