TB vaccine development: monitoring international patent filings to anticipate access challenges

Maria Florencia Florencia Pignataro¹Carolinne Thays Scopel²Maria Lorena Bacigalupo³Mike Frick⁴Sergiy Kondratyuk⁵Gabriela Costa Chaves^6*

• ¹Independent researcher, Buenos Aires, Argentina
• ²Independent Researcher, Rio de Janeiro, Brazil
• ³Independent researcher, Neuquén, Argentina
• ⁴Treatment Action Group, New York, United States
• ⁵Intellectual Property Scientific Research Institute of the National Academy of Legal Sciences of Ukraine, Kyiv, Ukraine
• ⁶Independent researcher, Ferney Voltaire, France

Every year, an estimated 10 million new cases of tuberculosis (TB) are diagnosed, and 1.6 million deaths occur worldwide due to this disease. The lack of new health technologies has affected the response to the global epidemic and control of this disease. The global TB vaccine pipeline has seventeen candidates in clinical trials. Stakeholders are actively beginning readiness activities to prepare, introduce and deliver new TB vaccines that prove safe and effective in a timely and equitable way. This study develops a patent landscape for late-stage TB vaccine candidates. Our findings constitute a tool to anticipate global access challenges. Two vaccine candidates were selected (MTBVAC and M72/AS01E) based on their development stage and platform features. The international patent landscape for the vaccines and for a key adjuvant component (QS-21) was performed. Importantly, our methodology encompassed identification of developers in the different steps, patent search of the applications through the Patent Cooperation Treaty (PCT), content analysis of the claims and estimates of patent term. National and regional patent filings were searched, focusing the analysis on the 30 high TB burden countries. Six PCT applications for MTBVAC, 22 for M72/AS01E and 21 for the formulation adjuvant QS-21 were analysed, potentially extending the protection period and constituting a barrier to the development/production if filed and granted at the national level. National patent applications were identified in high TB-burden countries (e.g., Brazil and India), as well as in countries where the natural source of the adjuvant is mainly grown and extracted (Chile). Our results show that there were patent filings in countries with existing manufacturing capacity, unveiling a corporate strategy to include those countries. The study anticipates the potential access challenges related to intellectual property barriers for expanding manufacturing capacity in middle-income countries to allow future TB vaccines to be available in a timely and equitably manner for those most in need.