[Ip-health] Silverman: U. S. will respect Cipro patent

[love@cptech.org]

U. S. will respect Cipro patent 

Feds won't use power to copy key antibiotic 

10/18/01

BY ED SILVERMAN AND DAVID SCHWAB
STAR-LEDGER STAFF

The fight over Cipro supplies took an unexpected twist yesterday. 

In a surprise move, the federal government said it won't use emergency
powers that may have allowed copycat versions of Cipro, the preferred
antibiotic approved to treat anthrax. 

The decision goes to the heart of a long-standing debate about patent
rights and patient needs, a burning topic that prompted global scrutiny
earlier this year when the pharmaceutical industry fought a losing legal
battle with AIDS activists in South Africa. 

"It is illegal to break a patent," Secretary of Health and Human
Services Secretary Tommy Thompson said in a news briefing late
yesterday. 

Physicians in New Jersey and elsewhere report demand for Cipro has
skyrocketed in the past week because of anthrax fears. On Tuesday, U.S.
Sen. Charles Schumer asked the White House to invoke a seldom-used
federal law that would allow generic production. The law permits federal
officials to ignore a patent and issue a compulsory license to others. 

Several generic drug makers, including Barr Laboratories, which has
production plants in New Jersey, already have tentative regulatory
approval to make copycat versions of Cipro. 

Some say they can quickly make the medicine. But they're prevented from
doing so because Bayer's patent doesn't expire until December 2003. 

Under Schumer's proposal, the government would have contracted with
generic drug makers to purchase Cipro and compensate Bayer for any lost
royalties. By doing so, the government could more quickly boost its
Cipro stockpile. 

"Yes, there's a compensation issue, but this is about supply, nothing
else," said Alfred Engelberg, a patent lawyer whose memo to Schumer
outlined the argument. "There's no reason not to allow the generics on
the market. The generics are already approved." 

But Thompson -- who wants Congress to provide an extra $600 million in
order to stockpile enough Cipro for 12 million people -- said government
lawyers don't believe Washington has the legal authority to override
Bayer's patent. 

The U.S. currently has supplies to treat 2 million people for 60 days. 

Thompson argued that Bayer can meet demand, which has soared during the
past three weeks. The company said Tuesday it would triple production --
to 60 million tablets a month -- by running factories around the clock. 

"Bayer says they are very able to ramp up and produce enough for
America," Thompson said. And demand should be mitigated by the use of
other antibiotics after several days of treating anthrax. 

But several industry experts doubt Bayer can meet demand, given the
German drug giant's increased output will only yield 200 million tablets
over three months. At that rate, adding generic production is justified,
they said. 

"We're ready and willing to jump if everything is in place," said George
Barrett, chief executive of Teva Pharmaceuticals USA, one of a handful
of generic drug makers with regulatory approval to make Cipro. 

Barr Labs is ready to turn out Cipro, too, although the Federal Trade
Commission is investigating a 1993 agreement in which Bayer pays Barr
$30 million annually not to produce the antibiotic. 

Critics say this has kept the price artificially high. Cipro costs about
$350 month in the United States. Generic suppliers in India charge about
$10. 

Ed Silverman can be reached at esilverman@starledger.com or (973)
392-1542. David Schwab can be reached at (973) 392-5835 or at
dschwab@starledger.com.