STAMFORD, Conn.--(BUSINESS WIRE)--Jan. 12, 2004--Purdue Pharma L.P. today filed a Notice of Appeal in the United States District Court for the Southern District of New York, stating that the company will ask the United States Court of Appeals for the Federal Circuit to overturn the District Court's Jan. 5, 2004 ruling that certain patents for OxyContin® (oxycodone HCl controlled-release) Tablets are unenforceable against Endo Pharmaceuticals Inc. "By filing our Notice of Appeal promptly, we want to make two things perfectly clear. First and foremost, we believe our patents for OxyContin should be held valid and enforceable. As a consequence, we will move expeditiously in the District Court and in the Court of Appeals to vindicate our position," said Howard R. Udell, Purdue's executive vice president and chief legal officer.
"In the next few days, we will take additional legal steps. In doing so, I must reiterate the fact that we have great respect for the judge who heard our case at trial. Nevertheless, we believe his ruling was in error and believe that it is in the interests of the parties to the litigation and of the general public that our claims be resolved as promptly as possible," Udell concluded.
On Jan. 5, 2004, Judge Sidney Stein found that, while Endo had infringed three of Purdue's patents, the patents were unenforceable due to "inequitable conduct" by Purdue. In cases where district courts have made findings of inequitable conduct, the Court of Appeals for the Federal District has either reversed or vacated those rulings in more than 70 percent of the cases within the last year.
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. This and other recent announcements are available on the Purdue Pharma website at http://www.purduepharma.com
Contact:
Purdue Pharma Tim Bannon, 203-588-8450
Source: Purdue Pharma L.P.
