[Ip-health] Fwd: [a2m-tb] TAG applauds Indian TB activists in opposing patents for critical TB prevention drugs

Suraj Madoori suraj.madoori at treatmentactiongroup.org
Thu Dec 5 09:04:52 PST 2019

Treatment Action Group Applauds Indian TB Activists in Opposing
Patents for Critical TB Prevention Drugs

Civil society takes legal action to contest patent applications filed
by Sanofi on fixed-dose combinations of two decades-old drugs used to
prevent tuberculosis

New York City, December 5, 2019—Treatment Action Group (TAG) applauds
the legal actions undertaken by our colleagues from the Delhi Network
of Positive People (DNP+) and tuberculosis (TB) survivor and activist
Ganesh Acharya of Mumbai, with support from the Third World Network
(TWN), contesting two patent applications on combinations of two
decades-old TB medicines filed in India by French pharmaceutical
company Sanofi.

DNP+ and Acharya lodged pre-grant patent oppositions with the Indian
Patent Office in Kolkata on November 5, 2019. The oppositions contest
the granting of two patents applied for by Sanofi: one on a
combination of rifapentine and isoniazid formulated for adults, the
second on a child-friendly, water dispersible formulation of these
drugs designed for young children. Isoniazid and rifapentine have
separately each been approved and on the market since 1952 and 1998,

Indian activists opposing the patents are arguing that Sanofi’s patent
claims are not a new invention but simply the combination of two
existing drugs. They say such patent claims by Sanofi are aimed at
blocking Indian generic manufacturers from entering the market and
keeping control over the supply of new TB preventive therapies to TB
and HIV programs. The oppositions seek to ensure that the Indian
Patent Office correctly applies patentability examination standards to
reject Sanofi’s patent applications.

When used together, isoniazid and rifapentine form the 3HP regimen, a
preventive treatment with the potential to avert millions of cases of
TB, especially among vulnerable populations such as people living with
HIV (PLHIV) and children. According to the World Health Organization,
a mere 17% of PLHIV newly diagnosed and enrolled into HIV care in
India received TB preventive therapy in 2018—most received an older
regimen consisting of isoniazid taken alone.[2] 3HP is a shorter
regimen with less liver toxicity than isoniazid alone.[3]
Co-formulating rifapentine and isoniazid will make 3HP even easier to
take, but granting patents on these combinations could limit the
regimen’s availability and affordability by blocking access to generic
competition until 2033/2034.

"PLHIV are 20 times more likely to get TB than the general population.
Treating TB infection is a critical cog in the wheel to end AIDS. The
Indian Patent Office should speedily reject Sanofi’s attempt to patent
3HP—a combination of two old TB drugs. We cannot afford to allow
frivolous patents to block generic competition that could further
lower prices for improved TB prevention for kids and adults,” said Jai
Prakash, president, DNP+.

Ganesh Acharya remarked, “We have seen that nearly 70% of patents
granted in India are bogus–they did not meet the criteria according to
the Indian law.[4] Therefore, as a TB/HIV activist, I have to
intervene before the patent office to ensure that public health is not
compromised in the interest of Big Pharma. People are dying of TB in
my city Mumbai.”

The patent oppositions are especially important given the development
history of rifapentine and isoniazid. Isoniazid was never patented,
and the primary patent on rifapentine expired decades ago. Moreover,
the safety and efficacy of the 3HP regimen was demonstrated in
clinical trials primarily funded by public research networks.[5]

“Rifapentine and isoniazid are public goods,” said Mike Frick, TAG TB
project co-director. “Sanofi is not the innovator behind rifapentine,
but instead the beneficiary of public funding. The idea that the
company is now seeking monopoly control over the combination of two
decades-old medicines in the public domain shows that the patent
system is broken; the idea of patents on combinations of medicines
should be opposed.”

In the coming weeks, TAG will release a 3HP Access Roadmap dedicated
to analyzing Sanofi’s patent filings on 3HP regimen combinations in
countries across the world. The Roadmap aims to encourage civil
society organizations in other countries to follow the example of
DNP+, Acharya, and TWN by opposing these patents in order to safeguard
the equitable availability and affordability of 3HP for all people at
risk of TB.

# # #

For more information on 3HP and patent oppositions, contact:

India: Ganesh Acharya, +91 9619954104

USA: Mike Frick +1 2122537922

France: Pauline Londeix +33 647984858

About TAG: Treatment Action Group (TAG) is an independent, activist
and community-based research and policy think tank fighting for better
treatment, prevention, a vaccine, and a cure for HIV, tuberculosis,
and hepatitis C virus. TAG works to ensure that all people with HIV,
TB, and HCV receive lifes aving treatment, care, and information. We
are science-based treatment activists working to expand and accelerate
vital research and effective community engagement with research and
policy institutions.

About 3HP: 3HP is a WHO-recommended regimen of rifapentine (900 mg)
and isoniazid (900 mg) for the treatment of TB infection taken once a
week for 12 weeks. Treatment of TB infection is referred to as TB
preventive therapy (TPT) and is one of the most powerful ways to
prevent TB. The advantages of 3HP over the older standard of care of
isoniazid alone (isoniazid preventive therapy) include shorter
duration, less liver toxicity, simpler adherence, and higher
completion rates. Rifapentine is currently available as a 150 mg
single tablet from a single supplier (Sanofi). In October 2019,
Unitaid and the Global Fund announced a deal with Sanofi to discount
the price of the rifapentine component of 3HP to US$15 per patient
course for 100 countries. In the absence of patent barriers, generic
competitors can develop and supply fixed-dose combinations and
child-friendly formulations of rifapentine and isoniazid. With generic
competition and high volumes, the price of 3HP could fall to as low as
US$10 per patient course, including outside the 100 countries in the
agreement signed with Unitaid and the Global Fund. For more
information on 3HP, please consult TAG’s An Activist’s Guide to
Rifapentine for the Treatment of TB Infection.

[1] The U.S. Food and Drug Administration approved isoniazid in 1952
and rifapentine in 1998 (though rifapentine was first synthesized much
earlier in the 1960s).

[2] World Health Organization. Global TB report 2019. Geneva: World
Health Organization; 2019.

[3] Frick M. An activist’s guide to rifapentine for the treatment of
TB infection. New York: Treatment Action Group; 2018.

[4] Ali F, Rajagopal S, Raman V, John R. Pharmaceutical patent grants
in India: how our safeguards against evergreening have failed, and why
the system must be reformed. New Delhi: accessibsa; 2018.

[5] Frick M. An activist’s guide to rifapentine for the treatment of
TB infection.

Contact Us: Treatment Action Group, 90 Broad Street, Suite 2503, New
York, New York 10004, 212-253-7922.
communications at treatmentactiongroup.org. TAG fights for life-saving
medications for people living with, and at risk for, HIV, TB, and HCV.
Please consider supporting this work by making a donation today.

Suraj Madoori
U.S. and Global Health Policy Director
Treatment Action Group
mobile: +1.917.530.5996

Treatment Action Group
90 Broad St, Suite 2503
New York, NY 10004 USA
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