Purdue Pharma L.P. Announces Resolution of OxyContin(R) Patent Lawsuit with Mallinckrodt...

Purdue Pharma L.P. Announces Resolution of OxyContin(R) Patent Lawsuit with
Mallinckrodt Inc.
Mallinckrodt acknowledges validity of Purdue patents; Purdue licenses limited
sales of some generic oxycodone strengths

STAMFORD, Conn., Sept. 2 /PRNewswire/ -- Purdue Pharma L.P. of Stamford,
Connecticut and Mallinckrodt Inc. of Hazelwood, Missouri have agreed to end
the OxyContin(R) (oxycodone HCl controlled-release) Tablets patent
infringement lawsuit between them in the United States District Court for the
Southern District of New York.
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," said John H. Stewart, President of Purdue Pharma, in
announcing the end of the lawsuit. "We will continue to defend our inventions
against infringers."
Purdue Pharma is a privately-held pharmaceutical company 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 www.purduepharma.com.
The professional product labeling for OxyContin(R) 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 60 mg, 80 mg, and 160 mg Tablets, or a single dose greater than
40 mg, ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. A single dose greater
than 40 mg, or total daily doses greater than 80 mg, may cause fatal
respiratory depression when administered to patients who are not tolerant to
the 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 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/PI/Prescription/Oxycontin.pdf .
SOURCE Purdue Pharma L.P.

Tim Bannon of Purdue Pharma L.P., +1-203-588-8450