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Judge Says Maker of Oxycontin Misled Officials to Win
Pubdate: Tue, 06 Jan 2004
Source: New York Times (NY)
Copyright: 2004 The New York Times Company
Contact: http://www.nytimes.com/
Details: http://www.mapinc.org/media/298
Author: Gardiner Harris
Bookmark: http://www.mapinc.org/oxycontin.htm (Oxycontin/Oxycodone)
JUDGE SAYS MAKER OF OXYCONTIN MISLED OFFICIALS TO WIN PATENTS
Purdue Pharma, the maker of the highly profitable painkiller OxyContin,
deliberately misled federal officials to win patents protecting its drug, a
federal judge ruled yesterday. The ruling helps clear the way for a cheaper
generic version and could lead to more lawsuits.
The decision by Judge Sidney H. Stein of Federal District Court in
Manhattan came in response to a suit brought by Purdue against Endo
Pharmaceuticals Holdings, which had filed an application to sell a generic
version of OxyContin. Robin Hogen, a Purdue Pharma spokesman, said the
company was "surprised and disappointed" by the ruling and planned to appeal.
The ruling spells trouble for Purdue, which derives more than 70 percent of
its $1.8 billion in annual revenue from OxyContin. Generic pills often grab
80 percent of a branded drug's sales within just a few months. When Endo
introduces its pill, much of Purdue's business could disappear. And two
more generic companies are waiting to introduce their versions of the pill.
But that is not the end of problems for Purdue, which is a closely held
company based in Stamford, Conn. Judge Stein's finding that Purdue
deliberately misled the United States Patent Office could lead to lawsuits
from state attorneys general and consumer groups contending that Purdue's
actions cost American consumers billions of dollars. Mr. Hogen of Purdue
denied that the company had misled the Patent Office.
Steve Berman, a lawyer for the Prescription Access Litigation Project, said
that Judge Stein's summary of the OxyContin patent case described "a
classic situation that I'm sure will result in litigation in the imminent
future."
"P.A.L.'s whole mission is to spot these kinds of cases and institute
litigation on behalf of consumers," Mr. Berman added.
In a similar case, the Bristol-Myers Squibb Company agreed a year ago to
pay $670 million to settle claims that it improperly stymied generic
versions of two medicines. Purdue's introduction of OxyContin is based on
the simple idea that patients suffering from chronic pain like to get a
full night's sleep. Oxycodone, a popular and powerful narcotic, is
effective for only four to five hours. OxyContin delivers a steady stream
of oxycodone over 12 hours. The Food and Drug Administration approved the
drug in December 1995.
Sales took off in part because Purdue marketed the medicine aggressively.
It was soon immensely popular with addicts, who found that snorting crushed
pills delivered the full 12-hour dose instantly.
By the late 1990's, OxyContin abuse was rampant in Appalachia and other
areas where prescription drug abuse is common. It became known as
"hillbilly heroin." Some critics have attributed scores of deaths to abuse
of the pill, although Purdue disputes those contentions.
Just as the controversy surrounding OxyContin peaked, Endo filed an
application to sell a generic version of the medicine in July 2000. Purdue
sued Endo, and the case has been percolating since.
Endo said that Purdue's many patents on OxyContin were invalid. To win its
patents, Purdue told the patent office that OxyContin was unique because 90
percent of patients taking the medicine got pain relief by taking very
little medicine - from 10 milligrams to 40 milligrams.
But during the course of the trial, Dr. Robert F. Kaiko, OxyContin's
inventor, acknowledged that he had done no clinical studies and had no
evidence to support this claim. Purdue admitted that Dr. Kaiko's
"discovery" was made solely in his head but that it was valid even though
the company was unable to prove it to be true.
Internal company documents from 1993 show that Purdue executives concluded
that the claims that the company were making for OxyContin "weren't
anywhere close" to being proved and were "clearly Bob Kaiko's vision."
In his ruling, Judge Stein wrote that "Purdue made a deliberate decision to
misrepresent to the P.T.O. a 'theoretical argument' and an 'expectation' as
a precisely quantified 'result' or 'discovery.' "
The F.D.A. grants five years of exclusive selling rights to any drug that
wins its approval. After that, companies generally rely on patents to
maintain the monopolies that allow them to charge high prices. Purdue's
initial five years of exclusive selling rights ended in 2000. Since then,
it has been able to continue charging high prices for OxyContin because of
its patents - patents that were won fraudulently, Judge Stein ruled.
Caroline Manogue, a spokeswoman for Endo, said that her company might wait
for an appeals court ruling before introducing its version of the drug, a
process that could take more than a year. After Endo sells its version for
six months, other companies can enter the market. Teva Pharmaceuticals and
Impax Laboratories both have tentative approval from federal regulators to
introduce versions of the pill then.
Separately, Endo accused Purdue of antitrust violations, contending its
patents were illegal. Judge Stein's opinion "opens the way for the
antitrust claims to move forward," she said.
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MAP posted-by: Terry Liittschwager