Wednesday, March 13, 2013

Janssen Files Patent Infringement Lawsuit over Hetero Drugs

Plaintiffs: Janssen Products and Janssen R&D Ireland (formerly known as Tibotec Pharmaceuticals)

Defendants: Hetero Drugs and Invagen Pharmaceuticals

A patent infringement case 2:13-cv-01444 was filed on Mar 08, 2013 in the District Court of New Jersey. The patents involved in this suit are US7126015 (Method for the preparation of hexahydro-furo [2,3 b]furan 3 ol) and US7595408 (Methods for the preparation of (3R,3aS,6aR) hexahydro-furo [2,3 b]furan 3 ol). These patents are currently assigned[i] to Tibotec Pharmaceuticals (source: MaxVal’s Assignment Database). The '015 and '408 patents cover processes that are useful for the preparation of hexahydro-furo [2,3 b]furan 3 ol (bis THF) as present in Prezista®. 

The complaint alleges that the defendants with Abbreviated New Drug Application (ANDA) no. 202-083 seek FDA approval for a generic version of Prezista® (darunavir) (400 mg and 600 mg) that infringes the above patents. Janssen Products with New Drug Application (NDA) no. 21-976 is the current holder of FDA approved Prezista® (source: Patent Marker). 

Prezista is a drug used to treat HIV infection. Developed by pharmaceutical company Tibotec, darunavir is named after Arun K. Ghosh, the chemist who discovered the molecule at the University of Illinois at Chicago. It was approved by the Food and Drug Administration (FDA) on June 23, 2006.

Other cases filed by plaintiffs 

2:12-cv-05358 and 2:12-cv-02840 for Lupin Limited
2:12-cv-03570 for Hetero Drugs, Ltd., Unit III
2:12-cv-03569 for Teva Pharmaceuticals USA

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[i] MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded.

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