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[e-drug] ARV patent debate moves to USA

E-DRUG: ARV patent debate moves to USA
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[crossposted from Pharm-policy with thanks. NN]
 
This is the NYT story on the Abbott offer, but about half the story is
about the new corporation we are setting to apply for compulsory
licenses for medicines.  The first license request will involve the d4T
patent, for the US market.  The article notes that if the new (name not
decided yet) entity succeeds in obtaining a license under the federal
Bayh-Dole Act March in provisions, the price for d4T would drop by at
least 90 percent, to US consumers.  As noted in the story, the plan is
to also apply for licenses on other patents, for use in the USA and
outside the USA, including, for example, drugs for cancer, breast cancer
diagnostic (BRAC1 patent) procedures,  and other important medical
technologies.  This will initially focus on inventions discovered on a
US federal grant or contract, but we will also consider applying for
licenses here or in other countries, regardless of who funded the
invention, for example, to ensure that the latest asthma inventions are
available at affordable prices in a country where there are IP barries
to competition.    Jamie

http://www.nytimes.com/2001/03/28/business/28DRUG.html

March 28, 2001 

Abbott to Sell Low-Cost AIDS Drugs in Africa

By MELODY PETERSEN

In the latest drug industry response to the growing global debate on the
prices of AIDS drugs, Abbott Laboratories said yesterday that it would
sell two of its treatments for H.I.V. infection at "no profit" in
Africa.

The announcement by Abbott, based in Abbott Park, Ill., follows similar
offers earlier this month by Merck and Bristol-Myers Squibb. All of the
makers of AIDS drugs are under increasing pressure to reduce the prices
of their medicines in African nations and other developing countries.
Health officials estimate that in Africa alone, 25 million people may be
infected with H.I.V.

And yesterday, it also became clear that the debate on the high prices
of AIDS drugs is moving to the United States, where the typical cocktail
of medicines that can keep the virus at bay costs $10,000 to $15,000 a
year.

Members of the Consumer Project on Technology, a patient advocacy group
in Washington, said yesterday that they had formed a nonprofit company
that would soon ask the government to allow it to make and sell a
low-cost version of d4T, an AIDS medicine that is sold by Bristol-Myers
for $10 a day in the United States. The group said it believed it could
sell d4T, which is sold under the brand name Zerit, for 10 percent or
less of the Bristol-Myers price.

The group argues that under a 1980 law known as the Bayh-Dole Act, the
government must grant the nonprofit company a license to sell a low-cost
generic version of Zerit. A provision in the Bayh-Dole Act allows the
government to require a company selling a drug developed with
government-sponsored research to grant a license to another party if it
is shown that the drug company is not making the invention available to
the public on "reasonable terms." The advocates say they will show that
Bristol- Myers' price for Zerit is excessive and that it is creating
hardships for patients.

The consumer group says government grants covered most of the cost of
discovering and developing Zerit, and the government holds certain
patent rights on the drug. Yale University also holds a patent on Zerit,
and in the early 1990's it granted Bristol-Myers an exclusive license to
sell the drug, which was approved in 1994.

James Love, director of the Consumer Project, which was founded by Ralph
Nader in 1995, said that he had researched how much Bristol- Myers paid
for the clinical trials to have Zerit approved, and that he believed
that the company paid less than $15 million for those trials, but has
generated more than $2 billion in revenue from the drug.

A spokesman for Bristol-Myers said yesterday that Mr. Love's figures
were "inaccurate." But he said he could not immediately provide the
amount the company had invested to develop Zerit. Bristol-Myers earned
$618 million from Zerit last year.

The government has never approved a petition under the Bayh- Dole Act.
But a spokeswoman at the National Institute of Health said if the
government received the petition, "it will be taken seriously."

"There is a clearly set-out process whereby a group can do this," she
said.

Bristol-Myers said yesterday that it did not have an immediate comment.
"This is the first that we're hearing of this, so it's impossible for us
to say anything," said John Kouten, a company spokesman. 

A spokesman for Yale said yesterday that officials could not comment
without seeing the group's proposal.

Mr. Love said the group was in the process of appointing directors to
the new company's board, which does not yet have a name. He said the
group expected to file the petition with the Department of Health and
Human Services in mid-April.

If the petition is successful, Mr. Love said, the group may also ask the
government to let it sell cancer drugs and other medicines that the
government discovered.

In the other development yesterday, Abbott Laboratories said that it was
offering to sell its two antiretroviral medications, Norvir and Kaletra,
in Africa at prices that would cover the company's costs of
manufacturing, distribution and import duties. Rick Moser, a company
spokesman, said that the price of each drug for a patient was likely to
be less than $1,000 a year. The price would vary, he said, from country
to country.

To receive the lower-priced drugs, Mr. Moser said, a government or group
must apply to a consulting firm that Abbott has hired, Axios
International, to help distribute the medicines. Those who want to buy
the drugs must prove that they can properly and consistently treat
patients, he said.

Patients taking AIDS medications must be monitored by health
professionals to ensure that they are taking the drugs properly and are
not having significant side effects.

"AIDS has taken an unprecedented toll on the health, economic and social
structures of Africa," said Miles D. White, Abbott's chairman. "Abbott
has taken this action to give people most affected by this disease a
better opportunity to access care."

Some advocates for AIDS patients praised Abbott's move yesterday, but
questioned whether the prices Abbott is offering would really provide no
profit to the company.

Kate Krauss, a member of Act Up Philadelphia, said that it wanted Abbott
and the other drug companies to offer voluntary licenses to their
products so that generic manufacturers could make lower-priced versions
of the drugs.
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