… Critics have pointed out gaps in the deal. For one thing, 17 countries including Russia and other former Soviet republics with high burdens of MDR TB are excluded from generic access by a license that J&J signed in 2018 with the Russian pharmaceutical company Pharmastandard. The company has exclusive commercial rights to supply bedaquiline in those countries. There, it already charges significantly more for the drug than the current GDF pricing, which is $272 for a 6-month course, or $45 per month. (Researchers estimated in 2017 that the price of the generic medicine would range from $8 to $17 per month, based on the price of ingredients, regulatory requirements, and other variables.) These 17 countries can already procure the branded drug from J&J through GDF—and its price in some countries may drop as a result of the competitive bidding process this month, Waning notes. Other countries with high MDR TB burdens, such as South Africa and Indonesia, don’t procure drugs through GDF and are similarly excluded. … Waning says the Indian action didn’t influence the agreement with GDF, which had been under negotiation for more than 2 years. But others suspect the patent setback in India was an important turning point for the pharmaceutical giant, which declined comment for this article. The loss in India “has broken down J&J’s resistance in allowing generic supply,” argues Leena Menghaney, a lawyer who is global intellectual property adviser with MSF in New Delhi and who offered technical support on the Indian patent challenge. “I think it has played a tremendous role in changing J&J’s mind about licensing the drug.”
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