Windels Marx IP - Hatch-Waxman Team Wins Appeal for Dr. Reddy's Laboratories in esomeprazole/naproxen (Vimovo®)
On Wednesday, May 15, a Windels Marx IP – Hatch-Waxman Act team achieved a significant victory on behalf of firm client Dr. Reddy’s Laboratories (“DRL”) against Horizon Medicines and Nuvo Pharmaceuticals (collectively “Nuvo”), winning a reversal and findings of invalidity before the Federal Circuit.
The case arose when DRL filed an Abbreviated New Drug Application (“ANDA”) seeking regulatory approval to market a generic version of Nuvo’s esomeprazole/naproxen product, brand name Vimovo®. Nuvo sued DRL in the District of New Jersey alleging that DRL’s ANDA products infringed its patents directed to pharmaceutical compositions with an uncoated proton-pump inhibitor (“PPI”) and an enteric coated non-steroidal anti-inflammatory drug (“NSAID”). DRL alleged that the asserted patents were invalid as obvious and invalid for lack of enablement and written description. The district court had granted DRL summary judgment of non-infringement with respect to the first Nuvo patents. After a bench trial, the district court found the patents not invalid as obvious and not invalid for lack of enablement or written description.
DRL and co-defendants Mylan and Lupin appealed the district court’s written description findings, and Nuvo cross-appealed the district court’s grant of summary judgment of non-infringement to DRL. The Federal Circuit first found that the claims require a therapeutically effective amount of uncoated PPI, and that the evidence demonstrated that a person of ordinary skill in the art would not have expected an uncoated PPI to work. The Federal Circuit held that “[i]n light of the fact that the specification provides nothing more than the mere claim that uncoated PPI might work, even though persons of ordinary skill in the art would not have thought it would work, the specification is fatally flawed.” The Court rejected Nuvo’s argument that a description of how to make and use the claimed invention was sufficient for an adequate written description.
The Court thus reversed the district court’s holding and declared the asserted patents invalid for lack of an adequate written description. The Court dismissed Nuvo’s cross-appeal (seeking to reverse the district court’s summary judgment of non-infringement as to DRL’s ANDA) as moot.
Read the Federal Circuit's Opinion.