Faced with global calls to not pursue secondary patents on its breakthrough tuberculosis (TB) drug, healthcare major Johnson & Johnson said it would not enforce patents that it owns and controls for Sirturo (bedaquiline), used in the treatment of multidrug-resistant tuberculosis (MDR-TB) in 134 low- and middle-income countries.
“The decision is intended to assure current and future generic manufacturers that they may manufacture and sell high quality generic versions of Sirturo without a concern that the company will enforce its bedaquiline patents, provided the generic versions of Sirturo produced or supplied by generic manufacturers are of good quality, medically acceptable, and are used only in the 134 low- and middle-income countries,” J&J said.
The multinational company’s response comes on the heels of an open-letter from Unitaid’s Executive Director, Dr Philippe Duneton, to J&J Chief Executive Officer, on Friday, urging them to drop secondary patents on bedaquiline and make negotiated rates available to all countries, regardless of how they purchase drugs.
The significance of bedaquiline is that it’s the first drug for TB to be globally approved in over 40 years, and is less toxic and more effective than traditional TB treatments.
Citing a recent J&J - Global Drug Facility (GDF) agreement that saw a historic 55 percent price reduction of the drug, Unitaid said, the agreed price of $130 for a six-month supply of bedaquiline is only available to countries purchasing through GDF, effectively excluding several countries where the rates of MDR-TB are highest.
“Additionally, following the Indian Patent Office’s rejection of J&J’s secondary patent application for bedaquiline in the country in April, several generic manufacturers are expected to enter the Indian market, home to the highest number of people with MDR-TB in the world. This is likely to further reduce the cost of generic bedaquiline but secondary patents in place in low- and middle-income countries will restrict availability to these vital medicines in a subset of countries with the highest burden of disease,” it said.
At least three Indian companies, Lupin, Natco, and Macleods, have in the past, told businessline thatthey were readying to bring out generic versions of bedaquiline.
Unitaid said the letter followed numerous advocates’ unanswered calls for equitable access to bedaquiline in recent months, including action from nations not able to benefit from access prices such as South Africa, Belarus, and Ukraine, among others.
Humanitarian organisation Médecins Sans Frontières/Doctors Without Borders (MSF) has been another vocal campaigner for access to bedaquiline. Christophe Perrin, TB Advocacy Pharmacist, MSF Access Campaign, welcomed J&J’s announcement, saying, it would pave the way “for unfettered access to affordable generic versions of bedaquiline for all people living with drug-resistant tuberculosis (DR-TB) who need the drug in low- and middle-income countries.” The development is a testament to the persistent efforts of TB activists, civil society and countries prioritising public health over corporations’ interests, Perrin said.
J&J, however, maintained that underdiagnosis was the most significant barrier to treatment. Nearly two-thirds of the 4,50,000 people who develop MDR-TB each year are not diagnosed and enrolled in treatment, said Howard Reid, J&J Global Head, Global Public Health & Social Impact, in a statement.
“This addresses any misperception that access to our medicine is limited or restricted and builds on our decade of investments in collaborative efforts to help countries sustainably scale up access and bring people living with MDR-TB into treatment,” he added.