Bags right to sell another drug that was not even part of the litigation.
Drug major Lupin’s patent litigation settlement with Warner Chilcott has paved way for a new business model in the patent litigation battles in the US.
In a first of its kind deal, Lupin reached an out-of-court settlement with Warner Chilcott in the patent infringement suits on oral contraceptive products – Loestrin 24 Fe and Femcon Fe. The settlement also helped Lupin get marketing rights for another drug of the same company, which Lupin did not even challenge.
Lupin has been granted the rights to purchase and sell an authorised generic version of ulcerative colitis drug Asacol 400 mg in the United States, which would be supplied by Warner Chilcott. Lupin had not challenged the patent on this drug, which currently has a market size of $700 million. Normally, out-of-court settlements in generic drug battles are confined only to drug patents in litigation.
As the authorized generic, Lupin can launch the product if a generic version of Asacol 400 mg is launched by a third party in the United States. The drug has patent protection till July 2013. Roxane Pharma is believed to be the first to challenge the patent of this drug. If Roxane gets approval and launches the drug before the patent expiry, at-risk of possible damages in the event of losing the litigation, Lupin can also launch the drug at the same time without any risk.
“We see an exciting opportunity from the deal with Warner Chilcott and we cannot assess the gain at this point of time,” said Nilesh Gupta, executive director.
According to the terms of the settlement agreement, Lupin has agreed not to market Loestrin 24 Fe in the US prior to the patent expiry of July 22, 2014. If Lupin decided to launch the drug at-risk, Warner Chilcott had reserved its right to bring an infringement suit against Lupin and pursue all legally available remedies, said Lupin. In addition, Lupin has been granted a non-exclusive licence by Warner Chilcott covering Femcon Fe. This will permit Lupin to commence marketing either an authorized generic product which would be supplied by Warner Chilcott, or generic equivalent of Femcon Fe in the United States for 180 days after Teva Pharmaceutical Industries Ltd enters the market with a generic equivalent to Femcon Fe on January 1, 2013.