[Ip-health] Obama Administration, Congress Intensify Opposition To Global Generic Drug Industry
Riaz K Tayob
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Fri Jun 28 06:06:00 PDT 2013
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Obama Administration, Congress Intensify Opposition To Global Generic
Posted: 06/28/2013 7:32 am EDT | Updated: 06/28/2013 7:45 am EDT
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WASHINGTON -- The Obama administration and members of Congress are
pressing India to curb its generic medication industry. The move comes
at the behest of U.S. pharmaceutical companies, which have drowned out
warnings from public health experts that inexpensive drugs from India
are essential to providing life-saving treatments around the world.
Low-cost generics from India have dramatically lowered medical costs in
developing countries and proved critical to global AIDS relief programs;
about 98 percent of the drugs purchased by President George W. Bush's
landmark PEPFAR AIDS relief program are generics from India. Before
Indian companies rolled out generic versions priced at $1 a day, AIDS
medication cost about $10,000 per person per year.
But India's generic industry has also cut into profits for Pfizer and
other U.S. and European drug companies. In response, these companies
have sought to impose aggressive patenting and intellectual property
standards in India, measures that would grant the firms monopoly pricing
power over new drugs and lock out generics producers.
On Thursday, a House subcommittee held a hearing on international trade
disputes with India that included testimony from American manufacturing
and solar energy groups. Most of the event, however, was devoted to U.S.
drug company Pfizer's complaints about Indian policies that have
fostered the country's billion-dollar generics industry. The hearing
followed Secretary of State John Kerry's trip to India earlier this week
for the U.S.-India Strategic Dialogue, a major diplomatic mission.
Last week, a bipartisan group of 170 House lawmakers sent a letter to
Kerry and President Barack Obama raising objections to India's patent
system. But at Thursday's hearing, few seemed well-versed on
intellectual property or public health issues.
"I first learned of this issue just a few short weeks ago from Pfizer,
my largest employer in my district," said Rep. Fred Upton (R-Mich.),
before asking Pfizer Chief Intellectual Property Officer Roy Waldron if
his company had talked to the Obama administration about its concerns.
"We have been speaking with [the Office of the U.S. Trade
Representative] and the administration and we're very hopeful that this
issue has been raised during Secretary Kerry's visit to India," Waldron
A State Department spokesperson told HuffPost that during his trip,
Kerry "discussed a number of economic and trade issues with Indian
officials, including ongoing issues in the pharmaceutical sector."
Kerry's involvement represents an escalation in the Obama
administration's opposition to India's generic drug policies. Following
two recent landmark court decisions, the U.S. Patent and Trademark
Office and the Office of the U.S. Trade Representative have been
the Indian government on its patent standards
In January, India's Supreme Court rejected a patent on a Novartis
leukemia drug called Gleevec (or Glivec)
clearing the way for cheaper generic production. The active ingredient
in Gleevec has been available for years, but Novartis filed for a patent
on an updated version available in pill form. India's highest court
turned down <http://judis.nic.in/supremecourt/imgs1.aspx?filename=40212>
the application on the grounds that the delivery format did not
constitute a legitimate innovation.
Gleevec is protected by multiple U.S. patents, and costs upwards of
$75,000 a year
domestically. In India, where annual per capita income is about $1,400,
Novartis was charging about $31,000 a year for the medication. The
generic version legalized by the court's decision costs around $2,100
Last year, India also permitted a generic manufacturer to produce a
of another cancer drug patented by Bayer AG. Bayer was charging $5,000 a
month for the drug, while only servicing about 2 percent of the
population that needed it. The generic version was priced at $157 a month.
By securing secondary patents, as Novartis tried to do with Gleevec,
drug companies can effectively extend monopolies on their medicines
beyond the standard 20-year window required by World Trade Organization
treaties. The practice is known as "evergreening," and is frowned upon
by the World Health Organization.
At Thursday's hearing, Rep. Jerry McNerny (D-Calif.) appeared more
concerned than other lawmakers about the public health consequences of
altering India's existing patent system. He asked Rohit Malpani of the
international medical aid group Doctors Without Borders to elaborate on
problems that arise from evergreening.
Rep. Henry Waxman (D-Calif.) also extolled the importance of access to
inexpensive medications for PEPFAR, which has seen its budget cut in
Otherwise, lawmakers appeared receptive to Waldron's contention that
U.S.-style intellectual property policies in India will help develop a
more robust and innovative medical system there. Waldron also said such
practices would lead to the creation of more American jobs, pointing to
a study from the U.S. Department of Commerce that was also cited in last
week's letter from lawmakers.
That study has been widely ridiculed
for overstating the impact of intellectual property protections on jobs,
claiming that "IP-intensive" industries are responsible for nearly 20
percent of all American jobs. Yet the pharmaceutical industry, which is
largely comprised of firms dependent on government copyright and patent
protections, accounts for a little less than 300,000 jobs, according to
The U.S. has attacked the global generic drug industry before. President
Bill Clinton adopted policies during his presidency that were hostile
toward the introduction of generic AIDS medications in Africa, relenting
only when activists disrupted campaign events over the issue. Clinton
later came to regret his administration's position and has been very
active on international AIDS relief efforts through the Clinton Global
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