drug trial. As patients challenge patent, J&J commits to tackling drug-resistant TB

Johnson & Johnson has tripled its commitment on tuberculosis drug Bedaquiline by offering 90,000 doseages to its global donation programme that ends in March, Paul Stoffels, J&J’s Vice-Chair of the Executive Committee and Chief Scientific Officer, said, on a programme that has given medicines to India as well.

Stoffels’ statement reiterating J&J’s commitment to tackling TB in India comes less than a week after two TB patients filed a patent challenge on a salt form of Bedaquiline at the Mumbai Patent Office to prevent J&J from pursuing a secondary claim on the drug.

While the patent is being contested on grounds of not being novel or innovative, health advocacy representatives explain that a patent on the salt would extend J&J’s monopoly on the drug from 2023 (when the compound patent expires) to 2027. And this would further delay generic drugmakers from being able to make less expensive versions of the drug, they say.

J&J, however, refutes this. Generic producers will be able to make versions of the drug’s active pharmaceutical ingredient, post 2023, it clarifies.

Responding to this developing situation, Stoffels said that ensuring access to bedaquiline in India was a top priority for J&J, given the country’s high burden of mutli-drug resistant TB (at more than a quarter of the world’s cases). “We’ve worked to expand access to bedaquiline, and we are collaborating with partners to build health systems capacity and ensure appropriate use of our antibiotic to protect its efficacy for the future.”

Less toxic, more effective

Bedaquiline is critical as it is the first medicine for drug-resistant TB in nearly 50 years. These newer drugs are less toxic and more effective than the traditional ones.

Pointing out that India has received medicines from the global programme since 2016, Stoffels said, “a stockpile of medicine is readily available to treat patients.”

Once the programme ends on March 5, India will be able to procure bedaquiline through the Stop TB Partnership’s Global Drug Facility at “our special-effort price of $400, announced in July 2018,” Stofells’ statement says, adding that “Bedaquiline is cost-effective and the price is on a par with some decades-old generic drugs.”

A J&J spokesperson added that the company had committed itself to providing more than 10,000 courses of bedaquiline free to support India’s efforts to scale up access from six centres to the goal of 147

The global programme was started with a commitment to donate 30,000 courses of bedaquiline in eligible countries, including India, with the aim of enabling countries to build capacity to introduce a new TB antibiotic. In response to the high demand, it was tripled before the donation programme ended.

Patent challenge

Responding to concerns on blocking generic drugmakers from making a less expensive version of the drug, the J&J spokesperson told BusinessLine , “a formulation patent would not prevent generic manufacturers from developing the active pharmaceutical ingredient in their own formulations after July 2023.”

The patent application in question, for the formulation of bedaquiline, was filed in 2007, and became publicly available in 2008 as part of the standard procedure when developing new medicines. The application was first considered by the Indian Patent Office in 2012 and remains under review, the spokesperson added.

Countering the view that J&J was not justified in pursuing the patent as it benefited from public spending on the research, the spokesperson said, “All clinical trials that supported the registration of bedaquiline were principally funded by Johnson & Johnson. A small amount of public funding was used in support of a few specific studies (eg, drug-drug interaction), as is generally the case when new drugs become available. As a responsible medical innovator, Johnson & Johnson continues to fund studies and collaborate with external partners to advance the clinical development of bedaquiline.”