Our publication, Isoniazid/Rifapentine (3HP) Access Roadmap and Patent Landscape, provides a landscape of patent applications filed by the French pharmaceutical company Sanofi on combinations of two essential medicines used to prevent tuberculosis (TB): isoniazid and rifapentine. Together, isoniazid and rifapentine form the 3HP regimen, which is quickly becoming the global standard of care for preventing TB.
Starting in 2014, Sanofi filed for patents on adult and pediatric fixed-dose combinations (FDC) of 3HP in 68 countries. If granted, these patents could give Sanofi a monopoly on these 3HP FDC formulations until 2034. By limiting generic competition, this monopoly would undermine efforts to ensure that everyone at risk of TB can access the highest available standard of preventive therapy.
The Roadmap provides a detailed development history of each drug to show why isoniazid and rifapentine are global public goods that should remain in the public domain rather than fall under monopoly control. From a legal standpoint, the Roadmap illustrates why Sanofi’s patent claims do not fulfill basic patentability criteria. This analysis is intended to inform national patent examiners evaluating the merits of Sanofi’s patent applications, and to support civil society organizations interested in challenging Sanofi’s attempted monopoly through either pre- or post-grant patent oppositions.