Vimovo had sales of around $67.6 million in 2018.
The US Court of Appeals for the Federal Circuit ruled in favour of Dr Reddy's and its co-defendants Mylan and Lupin in litigation related to patents of arthritis pain reliever drug Vimovo.
The court's order will help Dr Reddy's and Mylan to launch the drug immediately, while Lupin will have to wait until approval of USFDA.
Dr Reddy’s had received a final USFDA approval to manufacture Esomeprazole Magnesium + Naproxen delayed-release tablets, a therapeutic equivalent to Horizon Medicines' Vimovo in September 2018. Vimovo had sales of around $67.6 million in 2018.
The case came up when Dr Reddy's filed an Abbreviated New Drug Application (ANDA) before USFDA seeking approval to market a generic version of Vimovo in the US.
Horizon Medicines sued Dr Reddy's in the District Court of New Jersey alleging patent infringement related to the pharmaceutical compositions with an uncoated proton-pump inhibitor (Esomeprazole) and an enteric coated non-steroidal anti-inflammatory drug (Naproxen).
Dr Reddy's argued that the asserted patents were invalid as obvious and invalid for lack of enablement and written description. The district court ruled in favour of Horizon Medicines and upholding the validity of the patents.
Dr Reddy's appealed against the district court's judgement in the Federal Circuit.
The decisions of the Federal Circuit, particularly in regard to patent cases, are unique in that they are binding precedent throughout the US within the bounds of the court's subject-matter jurisdiction.
Federal Circuit rejected Horizon Medicines' argument that a description of how to make and use the claimed invention was sufficient for an adequate written description.
The Court reversed the district court’s holding and declared the asserted patents invalid for lack of an adequate written description.The Court also dismissed Nuvo’s cross-appeal.