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Sanofi Withdraws Two Patent Applications on Life-Saving Tuberculosis Prevention Drugs in Europe and in Indonesia

Activists Urge Sanofi To Do the Same in Other Countries

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Mike Frick (United States) +1 347 691 6372
Pauline Londeix (France) : +33 6 47 98 48 58

This is a joint statement from Treatment Action Group and Observatoire de la transparence dans les politiques du médicament (OTMeds)

New York, NY, Paris; January 22, 2020 — In December 2019, TAG issued a statement applauding Indian activists for taking legal action to oppose two patent applications filed by Sanofi in India.[1] The applications sought to patent two obvious combinations of two critical drugs used to prevent tuberculosis: rifapentine and isoniazid.

Jointly with our colleagues from L’Observatoire de la transparence dans les politiques du médicament (OTMeds), TAG has stressed that rifapentine and isoniazid are global public goods and should remain in the public domain. Rifapentine and isoniazid were each discovered decades ago.[2] The safety and efficacy of their combination for preventing TB was primarily demonstrated by publicly funded research. Moreover, isoniazid was never patented, and the primary patents on rifapentine are long expired. Sanofi’s efforts to patent a simple combination of rifapentine and isoniazid is a perfect illustration of how the patent system is broken.[3] No company should be allowed to take two drugs out of the public domain by privatizing their combined form.

The pre-grant patent oppositions in India lodged by the Delhi Network of Positive People (DNP+) and Ganesh Acharya contested two patents applied for by Sanofi: one on a combination of rifapentine and isoniazid formulated for adults, and the second on a child-friendly, water dispersible formulation of these drugs designed for young children. These formulations can be used to prevent TB as part of the World Health Organization-recommended 3HP regimen.

Activists in Thailand followed the legal actions in India by submitting additional pre-grant patent oppositions with the Thai Department of Intellectual Property.

Shortly following these oppositions, in December 2019 Sanofi withdrew its patent applications at the European Patent Office (EPO) and in Indonesia, but its applications in India and Thailand, as well as in Brazil, Nigeria, and other countries, are still pending.

We urge Sanofi to deliver on its promise to withdraw in all countries where the applications were filed and are still pending. We further call on Sanofi to surrender their patents in places where they have already been granted, including in the United States and China (where the patent on the pediatric combination was granted) and in Australia, Russia, and South Africa (where both patents were granted).

We are happy that Sanofi has walked back its attempt to patent fixed-dose combinations of rifapentine and isoniazid in Europe and Indonesia. We now expect Sanofi to surrender its patents in other countries where they were granted and withdraw its applications everywhere else.

Rifapentine and isoniazid are common goods and should remain in the public domain

[1] See Treatment Action Group’s press statement (December 2019) https://www.treatmentactiongroup.org/statement/treatment-action-group-applauds-indian-tb-activists-in-opposing-patents-for-critical-tb-prevention-drugs/

[2] See Treatment Action Group’s publication “An activists guide to rifapentine for the treatment of TB infection” (May 2019) https://www.treatmentactiongroup.org/publication/an-activists-guide-to-rifapentine-for-the-treatment-of-tb-infection/

[3] See the Op’Ed co-signed by OTMeds in Le Monde (January 2020) : “Novartis scandal : the product of a system encouraged by the lack of public policy https://blogs.mediapart.fr/edition/transparence-dans-les-politiques-du-medicament/article/160120/novartis-scandal-product-system-encouraged-lack-publi

 

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