The US pharmaceutical giant’s 20-year primary patent on drug-resistant TB medicine bedaquiline expires in a majority of countries this month, including India.
Paris-founded MSF has also called for a commitment from J&J to not take any legal action against any generic drug manufacturer that exports versions of bedaquiline to or from TB high-burden countries where secondary patents on the drug exist.
“The corporation should make this announcement public by the UN TB Summit taking place in New York this September,” it said in a statement.
Stop TB Partnership/Global Drug Facility (GDF) had announced last week a deal with J&J to increase access to affordable generic versions of bedaquiline. However, MSF said the deal offers only a partial solution to the access problem, as it excludes many countries that have a high burden of people living with TB, primarily in Eastern Europe and Central Asia (EECA).
J&J holds secondary patents in at least 34 of the 49 countries with a high burden of TB, TB-HIV and/or DR-TB, for which bedaquiline is an essential part of treatment regimens, MSF said. “Several of these countries are in the EECA region,” the medical charity said.In India, J&J had attempted to extend its patent by four years by filing for a secondary patent. However, in March this year, the Indian Patent Office rejected its plea.”With the primary patent expiring in India today, multiple manufacturers will now be able to produce and sell generic versions of the drug freely in India and export them to any other country where patents do not stand in the way,” MSF said. “Enforcing the secondary patent in countries excluded from the deal would delay access to more affordable generic bedaquiline by at least four years, resulting in higher treatment costs that would not only limit access for people who urgently need it, but would also mean less funding to cover other crucial TB care costs.”
