[Ip-health] Isoniazid/Rifapentine (3HP) Access Roadmap & Patent Landscape

Pauline Londeix pauline.londeix at gmail.com
Tue Mar 3 10:26:20 PST 2020

Dear colleagues

Treatment Action Group (TAG) is delighted to share this report titled
(3HP) Access Roadmap and Patent Landscape*
*."* The report provides a landscape of patent applications filed by Sanofi
on combinations of two essential medicines used to prevent tuberculosis
(TB): isoniazid and rifapentine.

In 2014, Sanofi applied to patent two combinations of isoniazid and
rifapentine in 69 countries/territories. One application seeks to patent a
fixed-dose combination tablet formulated for adults, and the second covers
a water-dispersible tablet dosed for young children. When used together,
isoniazid (H) and rifapentine (P) form the 3HP regimen, which is
recommended by the World Health Organization for preventing TB in people
living with HIV, children, and close contacts of persons with active TB

If granted, Sanofi would have a monopoly on these two particular 3HP
combinations until at least 2034. Such a monopoly could block or slow the
entry of generic manufacturers, limiting the availability of this
life-saving preventive treatment for the world’s deadliest infectious

In addition to showing where Sanofi applied for patents, the report
provides a detailed development history of isoniazid and rifapentine. Each
drug was discovered decades ago—isoniazid was never patented, and the
primary patents on rifapentine are long expired. Moreover, the safety and
efficacy of their combination for preventing TB was primarily demonstrated
by publicly funded research. This development history shows that isoniazid
and rifapentine are global public goods.

After reading this document, national patent examiners will understand why
Sanofi’s patent claims do not fulfill patentability criteria. Activists
from TB affected communities and civil society can use this information to
challenge Sanofi’s attempt to take these drugs out of the public domain by
patenting two obvious combinations. Such challenges
have already been lodged in India, where in November 2019 the Delhi Network
of Positive People (DNP+) and Ganesh Acharya contested these two patents
applications by submitting pre-grant oppositions at the Indian Patent
office. Similar pre-grant oppositions followed in Thailand in December 2019
and are planned for other countries.

In late 2019, Sanofi withdrew
its patent applications on these two combinations in *Indonesia* and *at
the European Patent Office*. But these applications remain under
examination in most countries where Sanofi filed, including many
high-TB-burden countries. Activists are now urging Sanofi to withdraw its
patent applications in all countries where they remain pending, and to
surrender their patents in places where they have already been granted.
This report provides evidence and arguments to support these demands.

We hope the information in this report helps you and your colleagues fight
for a world free of TB.

Best regards,

Pauline Londeix + Mike Frick

Treatment Action Group - TB team

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