[Ip-health] New York Times: AIDS Groups in India Sue to Halt Patent for U.S. Drug

[Thiru Balasubramaniam]

May 12, 2006


  AIDS Groups in India Sue to Halt Patent for U.S. Drug

By AMELIA GENTLEMAN and HARI KUMAR

NEW DELHI, May 11 =97 AIDS
<http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopic=
s/aids/index.html?inline=3Dnyt-classifier>
groups this week brought an important test of India's
<http://topics.nytimes.com/top/news/international/countriesandterritories/i=
ndia/index.html?inline=3Dnyt-geo>
new patent law, which restricts the ability of Indian companies to
produce low-cost generic drugs.

Two patients-rights groups asked Indian authorities to stop Gilead
Sciences, a California biopharmaceutical company, from patenting the
antiretroviral drug Viread =97 its brand-name version of tenofovir, which
is available here as a generic drug. If it is patented, the groups
contend, making the cheaper versions will become illegal, and the drug
will become too costly for patients here and in other developing countries.

"These generic drugs are not only consumed in India," said Leena
Menghaney of Doctors Without Borders in New Delhi, which is working with
the Indian groups on the issue. "People in Africa and the Caribbean are
relying on India to produce these drugs," she said, later adding, "The
quality matches that of U.S.-manufactured drugs, but the prices are
affordable."

The lawyers for the two groups =97 the Delhi Network of Positive People
and the Indian Network for People Living with H.I.V./AIDS =97 presented
arguments on Tuesday, contending that tenofovir is not a new drug, but a
modified version of an earlier drug, and therefore not eligible for a
new patent under India's new law.

Those backing the legal challenge are hoping to gain a legal precedent
for use in other patent applications. They say the recent rejection of a
patent application by Novartis for a cancer
<http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopic=
s/cancer/index.html?inline=3Dnyt-classifier>
drug, Gleevac, on the grounds of similar legal arguments, gave some
cause for optimism.

The World Health Organization recently recommended tenofovir for
patients who are just starting treatment for AIDS and for those who have
been receiving antiretroviral treatment therapy but who have become
resistant to other treatments.

In developed countries, Gilead's tenofovir costs $5,718 per patient per
year. Cipla, one of the largest generic companies in India, is marketing
a version called Tenvir, at a cost of $700 per person per year in India.
Yusuf Hamied, chairman of Cipla, said the drug would eventually be made
available in Africa for about half that price.

But Tenvir would have to be withdrawn if Gilead were given a patent,
which would be in effect for 12 years.

Gilead Sciences said Thursday in an e-mail message, referring to its
brand name for the drug: "We disagree with statements that Viread should
not be patented; we believe that Viread represents innovation and is
patentable under Indian law. We will use this patent responsibly, and
will not block access to our medication in India or in other
resource-limited countries where the H.I.V. epidemic
<http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopic=
s/epidemics/index.html?inline=3Dnyt-classifier>
has hit the hardest."

The company, the message said, is "pursuing a broad policy of
nonexclusive voluntary licensing under this patent to generic
manufacturers in India for the local Indian market as well as provision
for manufacturers to export product to the 97 developing-world countries
included in Gilead's access program."