[Ip-health] FT: Indian health activists move to prevent Gilead’s drug patent

Thiru Balasubramaniam thiru at keionline.org
Sun Nov 24 15:02:00 PST 2013


November 24, 2013 6:56 pm
Indian health activists move to prevent Gilead’s drug patent
By Andrew Jack in London

Indian health activists are seeking to prevent
Gilead<http://markets.ft.com/tearsheets/performance.asp?s=us:GILD>
from
patenting its new treatment for Hepatitis C in the country in a fresh
battle over affordable access to medicine.


The Initiative for Medicines, Access & Knowledge in India said it had filed
a “pre-grant” application in Calcutta to block a patent application on the
drug sofosbuvir, just as Gilead, the US pharmaceutical group that developed
the medicine, won European regulatory authorisation for its use.


The legal action, which follows previous spats in India over intellectual
property on medicines<http://www.ft.com/cms/s/0/0b00c0cc-0263-11e2-b41f-00144feabdc0.html>
including
those for HIV and cancer, could open the way for local generic drug
manufacturers to sell low-cost versions of the product domestically and
export it to other low-income countries without strong patent protection
laws.


The move would be a blow to Gilead, which is spearheading a race for new,
more effective oral treatments for Hepatitis C with fewer side-effects,
widely viewed as having the potential to cure Hepatitis C, a condition that
affects nearly 200m people around the world and causes damage to the liver
and sometimes cancer.



Following its European approval for drug, branded as
Sovaldi<http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002798/smops/Positive/human_smop_000612.jsp&mid=WC0b01ac058001d127>,
Gilead is braced for regulatory authorisation in the US next month. Other
drug companies including
AbbVie<http://markets.ft.com/tearsheets/performance.asp?s=us:ABBV>
, Johnson & Johnson <http://markets.ft.com/tearsheets/performance.asp?s=us:JNJ>
and Bristol-Myers Squibb
<http://markets.ft.com/tearsheets/performance.asp?s=us:BMY>are
competing with experimental products for the condition in a market that
analysts forecast could generate billions of dollars in annual sales.


“Old science, known compound,” said Tahir Amin, lawyer and director at the
I-MAK, the group that filed the opposition. “India’s patent law doesn’t
give monopolies for old science or for compounds that are already in the
public domain. We believe this patent on sofosbuvir does not deserve to be
granted in India.”


The legal action could stall for several years the granting of patents in
India, which one generic drug manufacturer said could permit the production
of low-cost equivalents over several years.


Médecins Sans Frontières, the humanitarian organisation, said it welcomed
the legal challenge, expressing concern that even at a significant discount
to the estimated $80,000 US price for the drug treatment, it would be
inaccessible to the vast majority of Hepatitis C patients who live in low
and middle income countries.


Dr Simon Janes, medical co-ordinator with MSF in India, said: “We know from
our experience providing HIV treatment over more than a decade in dozens of
developing countries that treatment needs to be simple and affordable –
preferably less than $500 to start with. An unaffordable price for this
drug will have a chilling effect on funders and governments who need to
start financing and providing treatment.”


Gilead has in the past sought to develop an access programme
<http://www.gilead.com/responsibility/developing-world-access/viral%20hepatitis>for
patients in low-income countries by licensing its HIV drugs to generic
manufacturers while controlling for quality.


“As Gilead [Hepatitis C] medicines advance through the research and
development pipeline, we will evaluate opportunities to incorporate them
into our access programmes,” the company said on its website.



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