STAMFORD, Conn., Sept. 2 Purdue Pharma L.P. of Stamford,Connecticut and Mallinckrodt Inc. of Hazelwood, Missouri have agreed to endthe OxyContin(R) (oxycodone HCl controlled-release) Tablets patentinfringement lawsuit between them in the United States District Court for theSouthern District of New York.
According to the agreement, Mallinckrodt acknowledges the validity andenforceability of Purdue's patents and admits that marketing generic versionsof OxyContin under its Abbreviated New Drug Application (ANDA) without alicense from Purdue would infringe these patents. In exchange, Purdue hasagreed to grant Mallinckrodt a royalty-bearing license, ending in 2009, tosell limited quantities of generic versions of 10 mg, 20 mg, 40 mg, and 80 mgextended-release oxycodone tablets.
In the most recent decision in the litigation which Purdue andMallinckrodt have now settled, the United States District Court for theSouthern District of New York rejected claims that the Purdue patents wereunenforceable because of Purdue's alleged inequitable conduct in obtainingthem. In an Opinion and Order dated January 7, 2008, the Court stated, "Thereis no evidence of deceptive intent with respect to Purdue's failure todisclose prior controlled-release formulations or its failure to disclose [aPurdue scientist's] affiliations, both of which were made in good faith."
"We are pleased to resolve the dispute with Mallinckrodt in a manner thatrespects our inventions," said John H. Stewart, President of Purdue Pharma, inannouncing the end of the lawsuit. "We will continue to defend our inventionsagainst infringers."
Purdue Pharma is a privately-held pharmaceutical company known forpioneering research on persistent pain. Headquartered in Stamford, CT, Purdueis engaged in the research, development, production, and distribution of bothprescription and over-the-counter medicines and hospital products. Additionalinformation about Purdue can be found at www.purduepharma.com.
The professional product labeling for OxyContin(R) Tablets contains thefollowing boxed warning:
OxyContin is an opioid agonist and a Schedule II controlled substance withan abuse liability similar to morphine.
Oxycodone can be abused in a manner similar to other opioid agonists,legal or illicit. This should be considered when prescribing or dispensingOxyContin in situations where the physician or pharmacist is concerned aboutan increased risk of misuse, abuse, or diversion.
OxyContin Tablets are a controlled-release oral formulation of oxycodonehydrochloride indicated for the management of moderate to severe pain when acontinuous, around-the-clock analgesic is needed for an extended period oftime.
OxyContin Tablets are NOT intended for use as a prn analgesic.
OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a single dose greater than40 mg, ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. A single dose greaterthan 40 mg, or total daily doses greater than 80 mg, may cause fatalrespiratory depression when administered to patients who are not tolerant tothe respiratory depressant effects of opioids.
OxyContin TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN,CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OxyContin TABLETS LEADSTO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.
Full prescribing information for OxyContin is available athttp://www.purduepharma.com/PI/Prescription/Oxycontin.pdf .
SOURCE Purdue Pharma L.P.