Johnson & Johnson has agreed to enable generic copies of their tuberculosis drug to be provided to low-income countries, but the agreement has been criticized for not going far enough to eliminate the company's stranglehold on worldwide Bedaquiline supplies.

The drug's global patent expires on Tuesday, July 18, but Johnson & Johnson is maintaining market dominance in countries through secondary patents that include some adjustments to a product to extend a patent. Due to J&J's decision, the Stop TB Partnership coalition is expected to be able to procure and distribute generic Bedaquiline through its Global Drug Facility (GDF) to 44 low- and middle-income countries.

The MSF Access Campaign applauded the decision, but argued that it was merely a "stopgap" measure and that the deal's terms needed to be made public. "We remain concerned that J&J retains the global authority to determine access to lifesaving generic versions of Bedaquiline in countries with a high burden of TB, even after the expiration of the main patent,” said Christophe Perrin, TB advocacy pharmacist for MSF Access Campaign.

J&J’s Bedaquiline, according to MSF Access, is the most expensive component of the multi-drug regimen for people with drug-resistant TB, but this could be reduced from $1.50 (£1.15) a day to $0.50.

The corporation should not enforce its existing secondary patents and should withdraw any ongoing applications for additional ones, according to Perrin, but if that's not the case, governments are expected to override patents and purchase the medication from generic manufacturers.

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“Only by taking these actions will J&J truly demonstrate a commitment to improving global access to Bedaquiline and prioritizing the health needs of people most affected by this deadly disease over profits accrued through secondary patents.”

In a statement, the Treatment Action Group (TAG) said the deal "falls short" of demands by TB patients and that it was using "patent evergreening... to extend monopoly rights over publically funded innovation," adding that J&J is avoiding accountability for the harm done on people with TB and the ones taken advantage of, along with those who have purchased Bedaquiline at unjustifiably high prices.

The CEO of GDF, Brenda Waning, stated that the agreement will allow them to offer generic Bedaquiline to low - and middle-income nations, even if secondary patents are in effect, adding that the company considers that countries could be supplied, regardless of patents. 

Patent money is used to fund the development of additional pharmaceuticals, according to a J&J representative, which generic producers do not typically do. 

The J&J spokesperson added, “More and faster innovation is needed, and IP [intellectual property] protections make it possible for companies to make the sustained financial commitments to discover and develop new and improved medicines needed to end diseases like TB that primarily affect people in low- and middle-income countries and protect the effectiveness of existing ones.”