Pen Drive
Laud the failure of J&J’s shot at patent evergreening
Bedaquiline is a TB drug that must reach large numbers as prices are pushed down by generic rivalry after its base compound goes off patent this July, as authorities have ruled
It was a cold winter afternoon in November 2013. At about 2pm, one of us (Nandita) took a short nap, drifting asleep over warm memories of a birthday party two days earlier on turning 24, and awoke 15 minutes later, unable to hear anything. The world around had turned silent, without a warning. Such an instant loss of hearing was supposed to be material for horror fiction, but this was real. The ‘culprit’ here was the side-effect of an injection named Kanamycin, a toxic old drug administered as part of Nandita’s treatment for tuberculosis (TB).
Last week, when the Indian Patent Office rejected an application by the US pharma major Johnson & Johnson (J&J) to extend its patent on its TB drug Bedaquiline beyond its primary patent’s expiry this July, the decision was unanimously cheered by public health experts and policy observers in India and elsewhere. As a TB survivor, one of us (Nandita), along with a fellow TB survivor from South Africa, Phumeza Tisile, had filed a challenge to the company’s patent application in 2019, a move supported by Médecins Sans Frontières (MSF). The patent office’s recent ‘landmark’ decision will prevent J&J from stretching its monopoly on this vital TB drug beyond this summer and allow the entry of generic versions to our market.
So, what prompted us to file this patent challenge? TB is an ancient airborne disease. Before covid arrived in our lives three years ago, TB was one of the deadliest infectious killers. 10.6 million fell ill worldwide with the disease in 2021 and an estimated 1.6 million people died from this ‘preventable’ disease, according to the World Health Organisation. India bears the world’s largest burden of TB as well as its multi-drug resistant version (MDR-TB). As the bacterium evolved to resist existing medications, strains emerged that could evade the effects of various drugs. This meant fewer treatment options, lower survival rates and a much longer duration of treatment (up to three years), often with drugs that have harrowing side effects ranging from kidney and liver disorders to permanent deafness. It was amid this dire landscape that Bedqualine made its debut. This drug, used against advanced TB, not only improved cure rates, it’s also observed to be a safer alternative to injectables such as Kanamycin and Amikacin, prompting the WHO to advise countries to scale up its use, with certain caveats, and phase out injectables.
Bedaquiline’s approval by the US Food and Drug Administration in 2012 was seen as a big moment, since it was the first new drug for TB in over 40 years. In 2015, it was granted conditional approval by the Indian regulator for use in our national TB programme. This approval did not mean anyone could sell the formulation. Patent rights ensure that only the patentee or its licensees can make, use, import or sell it.
In India, Janssen Pharmaceutica, a subsidiary of J&J, holds a patent on the base compound of Bedaquiline and has enjoyed a 20-year monopoly on its sales, as assured by its patent term dues to expire this year. After a patent expires, generic versions can be made and sold by other companies. To extend their exclusive rights, pharma companies often engage in the practice of ‘evergreening’ by making minor changes to their invention. This way, they can retain their chokehold beyond what the Patent Act had envisioned.
In India, however, special provisions to prevent evergreening were introduced through an amendment to the Indian Patents Act in 2005. This move, among others, ensured that a patent is not granted to a new form or use of a known substance, unless the modification shows enhanced efficacy. These provisions have acted as important public-health safeguards by allowing the timely entry of generics and helping bring down the cost of life-saving drugs, thus making them more accessible.
When we filed our pre-grant opposition, using a mechanism that lets anyone make a representation to India’s patent office on why an application should not be eligible for a patent grant, our intention was to ensure that TB patients in the future have timely access to the best available drugs, so that others would not fall prey to life-altering side effects like those we’ve had to brave. The Patent Office began hearing our case last year, recording representations made by us and the Maharashtra Network of Positive People, which had filed a representation separately. In its decision announced on 23 March, the office noted that J&J’s application did not meet the standards laid down under the Patents Act.
The order will have far-reaching implications. The failure of J&J’s evergreening attempt will let other drug-makers manufacture and sell this life-saving drug after July 2023. Competition will likely see its price drop. The national TB programme, which currently relies on J&J supplies for its Bedaquiline requirement, will be able to procure the drug from other players expected to enter the market once its patent protection is over. Moreover, as India exports generic drugs to several low-income countries where TB prevalence is high, patients elsewhere will also be able to access this drug at reasonable cost. To put an end to TB, affordable treatment is a must.
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First Published:30 Mar 2023, 10:34 PM IST
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