Nuvo Research and Apotex reach PENNSAID patent settlement
Canadian pharmaceutical firms Nuvo Research and Apotex have agreed a patent settlement allowing Apotex to launch a generic version of Nuvo’s arthritis treatment PENNSAID in the US in April 2014 or earlier under certain circumstances.
The settlement ends five months of litigation – in August 2012, Nuvo attempted to block the release of generic versions of PENNSAID by filing patent infringement claims against Apotex and generic drug manufacturer Lupin Pharmaceuticals at the US District Court of Delaware.
Nuvo’s composition of matter patent for PENNSAID expired in 2003, but the company was granted a patent for methods of administering the treatment in September 2012, which expires in 2029. Nuvo has also developed a follow-on product, PENNSAID 2%, which is pending approval from the US Food and Drug Administration (FDA).
Under the terms of the settlement, Apotex is free to launch a generic version of PENNSAID on the earlier date of either 45 days after the first commercial shipment in the US of PENNSAID 2% or April 1, 2014.
Nuvo has yet to reach a settlement with Lupin, but Tina Loucaides, vice president and general counsel at Nuvo, said proceedings will be initiated.
“Apotex was the first generic PENNSAID filer, so they had priority, but we’ll now be concentrating on settling with Lupin. We’re very pleased to have reached a settlement with Apotex, and our strategy now is to focus on PENNSAID 2%, which we believe is a better product,” she said.
Kathleen Carr, a partner at Edwards Wildman Palmer LLP in Boston, said the terms of the settlement are unusual.
"The follow-on 2% product, which has not yet been approved, potentially could end up triggering the 1.5% [original] product for launch 45 days later. So, the newly developed product would only be on the market for 45 days before a generic version of the original product would be allowed market entry,” she said.
