STAMFORD, CT - Purdue Pharma L.P. of Stamford, Connecticut and Mallinckrodt Inc. of Hazelwood, Missouri have agreed to end the OxyContin (oxycodone HCl controlled-release) Tablets patent infringement lawsuit between them in the United States District Court for the Southern District of New York, a press release by Purdue stated.
According to the agreement, Mallinckrodt acknowledges the validity and enforceability of Purdue's patents and admits that marketing generic versions of OxyContin under its Abbreviated New Drug Application (ANDA) without a license from Purdue would infringe these patents.
In exchange, Purdue has agreed to grant Mallinckrodt a royalty-bearing license, ending in 2009, to sell limited quantities of generic versions of 10 mg, 20 mg, 40 mg, and 80 mg extended-release oxycodone tablets.
In the most recent decision in the litigation which Purdue and Mallinckrodt have now settled, the United States District Court for the Southern District of New York rejected claims that the Purdue patents were unenforceable because of Purdue's alleged inequitable conduct in obtaining them.
In an Opinion and Order dated January 7, 2008, the Court stated, "There is no evidence of deceptive intent with respect to Purdue’s failure to disclose prior controlled-release formulations or its failure to disclose [a Purdue scientist's] affiliations, both of which were made in good faith."
"We are pleased to resolve the dispute with Mallinckrodt in a manner that respects our inventions," President of Purdue Pharma John Stewart said.
"We will continue to defend our inventions against infringers," he added.
Purdue Pharma is a privately-held pharmaceutical company known for pioneering research on persistent pain.
