[linux-elitists] Patent Laws
Brooklyn Linux Solutions CEO
Thu Apr 19 19:41:44 PDT 2001
before my involvement with SOftware, I was a Pharmacist. Patent issues are
very parallel in the two fields.
A note that I recieved a Patent Office letter thanking me for nominating
April 20, 2001
News Analysis: Defensive Drug Industry
Fuels Fight Over Patents
By ANDREW POLLACK
he big pharmaceutical
companies march to the beat of
a steady chant - that patent
protection for drugs is essential for
innovation. At the urging of the drug
companies, the United States
government has pressed many
nations to honor patents on
But now, it seems, the industry may have overplayed its hand.
patents are under attack, blamed for high AIDS drug prices that
deny life- saving therapy to millions of people in developing
countries. And some analysts say the industry itself fueled the
backlash by staunchly defending its intellectual property in the
of a pandemic that could claim more lives than the Black Death of
the Middle Ages.
The latest clash over patents on AIDS drugs came to a boil in
Africa yesterday, when 39 drug companies dropped a suit trying to
block a law the companies asserted would make it too easy for the
government to abrogate their patents.
The debate has erupted in other countries as well. Brazil has
threatened to grant licenses to local manufacturers on patents
AIDS drugs held by Merck and Hoffman-La Roche. In Thailand,
AIDS patients and activists are planning a legal challenge to the
validity of a Bristol-Myers Squibb patent on an AIDS drug.
The uproar over AIDS drugs is threatening moves toward more
globalization, eight years after most nations approved the
Agreement on Trade-Related Aspects of Intellectual Property
Rights, or Trips, which commits them to enforce drug patents.
Activists are campaigning against the proposed Free Trade Area of
the Americas, saying the United States wants more patent
"The Trips agreement was probably the greatest political economic
achievement that the pharmaceutical industry ever had," said Jim
Keon, president of a trade group representing generic drug
companies in Canada. "Now it's coming home to roost, though. Can
the world afford it? Is it ethical?"
Even some supporters of patents are pulling back somewhat.
Washington says it will no longer pressure poor countries that
production of cheaper versions of patented drugs for major health
problems, provided they adhere to Trips guidelines. The European
Parliament has expressed "solidarity and support" for South
and Kenya in their efforts to gain access to lower- priced AIDS
Until recently, the industry worried that erosion of patent
prices in one country could lead to similar actions elsewhere,
particularly in the United States, where the industry gets much
"There was a feeling that if a country deliberately went against
there would be a castle-of-cards effect," said Jean-Pierre
chief executive of GlaxoSmithKline, a major supplier of AIDS
drugs. "Without patents, the industry ceases to exist."
But now, judging from their actions, drug companies have decided
sacrifice prices in some poor countries in order to argue that
manufacturers are not needed and to relieve the pressure on the
patent system. In Brazil, for example, Merck recently agreed to
price cuts for two AIDS drugs to prevent the government from
allowing a local generic manufacturer to make a copy of one of
Some AIDS activists, however, say it is better to rely on
from generic manufacturers than on voluntary actions by big drug
companies. They say drug companies' recent discounting was only
response to an offer of low-priced AIDS drugs by a generic
manufacturer in India. But under Trips, India and other countries
will have to enforce patents by 2005 or 2006.
"If we don't deal with the problem now, 5 to 10 years from now
have no possibility of bringing prices lower and we'll be
at the mercy of the big drug companies," said Ellen 't Hoen, an
attorney with Doctors Without Borders.
Drug company executives argue that patents are not a barrier to
treatment of AIDS. Even generic drugs are out of reach for
countries that spend less than $10 a year per person on public
and lack doctors and clinics to deliver the medications.
many countries of Africa besides South Africa, AIDS drugs are not
"At least for AIDS drugs, patents have been a barrier only as an
exception rather than the rule in Africa," said Amir Attaran,
director of international health research at Harvard University's
Center for International Development. Drug companies and some
experts argue further that if developing countries honor patents,
drug companies will have more incentive to develop treatments for
tropical diseases. But others say what deters companies from
developing those drugs is the small market size.
Patents award an inventor exclusive rights to make or sell a
for a set period. In countries that adhere to the Trips
patents run for 20 years from the filing of the application.
provide an incentive for innovation, and in return, the invention
publicly disclosed so others can learn from it.
Drug companies argue that they need patents because it can take
more than a decade and hundreds of millions of dollars to develop
and test a drug, which can be copied relatively easily once it is
market. Many countries have viewed drugs as meriting exceptions
patent law because of their importance to public health. But with
trade agreements like Trips, countries have tightened their
Trips does not go as far as drug companies would like, and it
some exceptions to patent protection. For example, countries can
force patent holders to license their patents to others, like
manufacturers. But so far, no country has.
Some activists say the countries have not used licensing because
pressure from drug companies and Washington. But the United
States has partly reversed its policy and is no longer raising
objections to compulsory licensing in the case of health crises
The country with the most experience with compulsory licensing,
albeit before Trips took effect, is Canada. For decades Canada
allowed any company to apply for a license to make a patented
In 1969, it allowed copies of patented drugs to be imported, and
generic industry began to thrive. The compulsory licensing system
was weakened in 1987 and then abandoned in 1993.
Since then, spending on research and development by drug
companies in Canada has zoomed, to about $900 million in 1999
from $166 million in 1988. The Canadian experience suggests that
protecting intellectual property may prompt greater investments
drug companies and even the development of a homegrown industry.
But it is not clear if African countries have the scientific
for a research-oriented drug industry. Moreover, some experts say
the drug companies promised in advance to increase spending in
Canada if the law was changed.
The precedent that most worries drug companies now is that
weakened patent protection in developing countries will lead to
pressure to weaken patents - and in the process, their latitude
prices - in the United States.
The Consumer Project on Technology, a Washington group founded
by Ralph Nader, has asked the government to let it make a
low-priced version of d4T, the Bristol-Myers AIDS drug. The
National Institutes of Health has in the past rejected such
Even without the AIDS crisis, there is pressure on patents as a
of high drug prices in the United States. While innovation should
rewarded, some drug industry critics say, the drug industry is
most profitable in the nation. Moreover, many drugs are initially
developed with government money.
Gail Wilensky, a senior fellow at the international health
organization Project Hope who ran Medicare under former
President George Bush, has proposed shortening the life of drug
patents to let competition lower drug prices, as an alternative
regulatory options that are sometimes discussed.
A report issued last year by the National Institute for Health
Management Foundation, an organization supported by health
insurers, said the effective patent life for some drugs has grown
8 years in the early 1980's to 14 or 15 years now.
"We have moved more toward increasing market power of
pharmaceutical companies than we wished to," Dr. Wilensky said.
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