STAMFORD, Conn., Aug. 28 /PRNewswire/ -- Purdue Pharma L.P. of Stamford, Connecticut and Endo Pharmaceuticals Inc. of Chadds Ford, Pennsylvania have agreed to end the patent infringement lawsuit between them now pending in the United States District Court for the Southern District of New York concerning certain Purdue Pharma patents on OxyContin® (oxycodone HCl controlled- release) Tablets (“OxyContin”). According to the agreement, Endo will stop selling infringing versions of OxyContin by the end of 2006. In exchange, Purdue Pharma will not pursue damages against Endo for Endo’s past infringement of its OxyContin patents.
On February 1, 2006, the United States Court of Appeals for the Federal Circuit ruled that Endo’s extended-release oxycodone products infringe the Purdue Pharma patents. In its ruling, the Court also vacated a trial court finding that the Purdue Pharma patents were unenforceable and sent the issue back to the trial court for reconsideration.
Under the terms of the settlement agreement, Endo will no longer dispute that the Purdue Pharma OxyContin patents are valid, enforceable and infringed by Endo’s extended-release oxycodone product. The parties also have agreed to propose to the Court a consent judgment holding that Endo is infringing the Purdue patents and prohibiting Endo from infringing sales after December 31, 2006.
“We are pleased that this matter has been resolved in a manner that respects our invention of an important medicine. Today’s agreement permits us to achieve the result we were seeking in the lawsuit -- to stop Endo from selling its infringing products -- by the end of the year, while also relieving us of the risks, distractions and costs of continued litigation,” said Michael Friedman, President and CEO of Purdue Pharma, in announcing the end of the lawsuit. “We will continue to defend our invention of that medicine against all infringers. Our dedication to serving both healthcare professionals and patients with innovative prescription and non-prescription products has never waned during the long course of this litigation and we look forward to maintaining that commitment long into the future.”
By agreement, Endo and Purdue Pharma will make no public announcements about the resolution of the litigation beyond their written statements.
Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on persistent pain. Headquartered in Stamford, CT, Purdue is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. Additional information about Purdue can be found at http://www.purduepharma.com.
The professional product labeling for OxyContin® Tablets contains the following boxed warning:
WARNING:
OxyContin is an opioid agonist and a Schedule II controlled substance with an 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 dispensing OxyContin in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time.
OxyContin Tablets are NOT intended for use as a prn analgesic.
OxyContin 80 mg and 160 mg Tablets ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. These tablet strengths may cause fatal respiratory depression when administered to patients not previously exposed to opioids.
OxyContin TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OxyContin TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.
Full prescribing information for OxyContin is available at http://www.purduepharma.com/PRESSROOM/PI/OXYCONTIN_PI.PDF.
Source: Purdue Pharma L.P.
