In a significant development, Johnson & Johnson (J&J) has announced the relinquishment of its secondary patents on a crucial TB medicine, marking a pivotal moment in the fight against tuberculosis.
This decision by J&J opens the door for additional drug manufacturers to produce more affordable generic versions of the medication, offering hope to countless individuals in low- and middle-income countries.
Tuberculosis, the world’s leading infectious disease killer with a staggering 10.6 million new cases and 1.6 million deaths reported in 2021, has long been a global health concern.
Access to treatment has been hindered, in part, due to pharmaceutical monopolies that have restricted affordability. One tactic employed by pharmaceutical companies to maintain their dominance in the market, particularly for drugs like bedaquiline, has been patent evergreening—a practice involving slight modifications to extend the patent life of an existing medication.
Christophe Perrin, TB advocacy pharmacist with MSF’s Access Campaign, expressed his enthusiasm regarding the announcement:
“We welcome J&J’s announcement, which will finally pave the way for unfettered access to affordable generic versions of bedaquiline for all people living with DR-TB who need the drug in low- and middle-income countries. This huge win is a testament to the persistent efforts of TB activists, civil society, and countries prioritizing public health over corporations’ interests.”
He went on to highlight recent developments in the TB landscape, including J&J’s price reduction and patent concessions, a 20 percent price reduction by Cepheid and Danaher for a critical TB test, and a declaration by governments at the United Nations to enhance access to essential TB tools.
Bedaquiline, a game-changing treatment recommended by the World Health Organization for drug-resistant TB (DR-TB), offers a shorter, better-tolerated, and more effective option. The current regimen, which includes bedaquiline, is an all-oral, six-month-long treatment that can cure up to 89 percent of DR-TB cases. This represents a substantial improvement compared to older treatments that spanned 18 months, required daily painful injections, and often caused severe side effects.
J&J’s decision to relinquish its secondary patents follows its unsuccessful attempt to extend its monopoly in India. Moreover, national TB treatment programs in Ukraine and Belarus, along with other heavily affected TB-stricken nations, appealed to J&J to drop its secondary patents. A recent investigation by the South African Competition Commission likely added pressure on J&J to take this historic step.
Perrin concluded by emphasizing the need for other pharmaceutical companies, such as Otsuka, to follow suit and publicly commit to refraining from enforcing secondary patents in low- and middle-income countries. This call comes at a crucial juncture, as Otsuka’s primary patent for another vital DR-TB drug, delamanid, is set to expire in various countries. The availability of affordable TB innovations is pivotal in the global effort to combat this curable disease, which continues to claim the lives of 1.6 million individuals annually. The urgency to act has never been greater.
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