A patent infringement complaint was filed by Schering Corp a subsidiary of a Multi national pharma company Merck & Co against Sun Pharma Indian Pharma Company last week in the district court for New Jersey.
This complaint was filed in regard to the generic version of most widely used brain cancer drug Temodar. Sun Pharma filed an Abbreviated New Drug Application (ANDA) to launch a Generic version of Temodar in the US Market.
Temodar, which Merck acquired through the acquisition of Schering-Plough last year, has annual global sales of about $1 billion. It has sales of about $380 million only in the US market.
Interestingly Merck & Co has the patent protection for Temodar in US till 11th August 2013. The world's leading generic company, Israel's Teva Pharmaceutical-owned Barr Laboratories, had succeeded early this year in invalidating patent rights of the same drug so Sun Pharma assuming the significance of the above decision filed an ANDA.
The patent litigations were very common in generic drug business in the US. According to the US rules for generic drug launches, the generic company which files a patent-infringing ANDA has to be sued by the innovator within 45 days to prevent the FDA from approving the generic for the next 30 months. In most such cases, the companies settle the litigation out of court.
This complaint was filed in regard to the generic version of most widely used brain cancer drug Temodar. Sun Pharma filed an Abbreviated New Drug Application (ANDA) to launch a Generic version of Temodar in the US Market.
Temodar, which Merck acquired through the acquisition of Schering-Plough last year, has annual global sales of about $1 billion. It has sales of about $380 million only in the US market.
Interestingly Merck & Co has the patent protection for Temodar in US till 11th August 2013. The world's leading generic company, Israel's Teva Pharmaceutical-owned Barr Laboratories, had succeeded early this year in invalidating patent rights of the same drug so Sun Pharma assuming the significance of the above decision filed an ANDA.
The patent litigations were very common in generic drug business in the US. According to the US rules for generic drug launches, the generic company which files a patent-infringing ANDA has to be sued by the innovator within 45 days to prevent the FDA from approving the generic for the next 30 months. In most such cases, the companies settle the litigation out of court.
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