Despite the many health crises plaguing the country, South Africa is probably the best place to live if diagnosed with drug-resistant TB (DR-TB). The reason? Nowhere else can one receive the life-saving drug bedaquiline, which comes with a hefty price-tag, provided by the government for free.
Why then would South African activist and TB-survivor Phumeza Tisile be involved in the current challenge to a patent application for this drug all the way in India?
Known informally as the ‘pharmacy of the world’, India’s decision on whether or not to grant the discoverer of bedaquiline, pharmaceutical giant Johnson & Johnson (J&J), the additional patent will have ramifications beyond its own borders and will influence the entry of generic competitors to the market. The drug’s existing patent is valid for the next four years.
For Tisile, the success of bedaquiline in South Africa should be celebrated, but it is unacceptable that access to the drug remains almost non-existent beyond our borders.
‘Deaf or dead’
After surviving the most deadly form of the disease, and losing her ability to hear as a result, Tisile said she will continue fight for “patients over patents” – no-matter the geographic location.
No-one deserves to be given the option presented to her; become “deaf or die”, she told Health-e News after launching the patent opposition earlier this month.
“In 2010 – I wasn’t given a choice. It was either I die or go deaf,” she said.
A little-known but devastating side-effect of standard medicines to treat DR-TB is hearing loss. One in three patients suffer partial to complete deafness from this treatment and only half of those who manage to complete the two-year-long course of toxic drugs can expect to be cured.
After years of illness, Tisile was lucky to be declared DR-TB-free but from 2010 to 2015 she could not hear and struggled with the social pressures of being deaf in her early 20s.
“I lost out on five years of my life. I lost out on school and only seven years later I was able to start afresh at university,” said Tisile whose hearing has returned after sourcing funds for cochlear implant surgery.
Blockbuster drug: Bedaquiline
“There’s a drug that could prevent all of this but, for some reason, they’ve made accessing it impossible for those who need it most,” she said.
The drug in question, called bedaquiline, is the first anti-TB drug developed in almost half a century but costs up to $30 000 (about R410 000) for a six-month course of treatment in some countries.
The importance of this drug cannot be over-stated. It not only replaces the deafness-causing injectable drugs in the DR-TB regimen but it also saves lives; cure-rates for patients taking bedaquiline have been reported at over 80 percent.
Last week Tisile and another TB-survivor from Mumbai, Nandita Venkatesan, filed a patent challenge in India to prevent J&J from extending its exclusive monopoly on the life-saving medicine.`
J&J’s current patent expires in 2023 but if this application is successful their monopoly on bedaquiline, which prevents generic competitors from entering the market, will be extended until 2027.
India and SA health activism
“The Patents Act, 1970 in India allows ‘any person’ to challenge an application for patent. Hence, a TB-activist like Phumeza who is not a national of India could file an opposition,” said Priyam Lizmary from the Indian organisation, Lawyers Collective, which is spearheading the challenge.
“Indian and South African civil society have linkages more than two decades old when they fought together for access to HIV medicines at the height of the AIDS epidemic. This collaboration bolsters that continued mutual support,” she told Health-e News.
Last year South Africa became the first country in the world to offer bedaquilline to all DR-TB patients as a matter of policy, and has been praised for this move which even preceded the World Health Organisation recommendation to the same effect.
A small number of countries, including South Africa, have negotiated a greatly reduced price of $400 (R5 500) from J&J but activists have said this remains out of reach for most low and middle-income countries. To date, only 25 000 people around the world have received bedaquiline and two thirds of these patients have been in South Africa.
Doctors Without Borders (MSF) has condemned J&J’s request to extend its patent in India and noted the application, for the salt form of bedaquiline, does not deserve further intellectual property protection because it does not meet the standards for novelty and inventiveness.
According to MSF this “strategy of ‘patent evergreening’ through filing of additional, often unmerited patents, is commonly used by corporations to extend monopolies on their drugs beyond the standard of 20 years”.
“Preventing this patent barrier [in India] is expected to encourage TB drug manufacturers from India to enter the market with generics and supply bedaquiline at lower prices to national TB programmes and TB care providers globally,” it said in a statement released in support of the two women activists.
J&J has defended its patent application and prices for bedaquiline arguing that they are necessary to recoup the investment they made in developing the drug and bringing it to market.
“Ongoing suggestions that we generate a profit from the sale of bedaquiline are incorrect and have the potential to only further damage an already fragile environment for TB research and development,” said J&J in a statement in reaction to an MSF-lead protest against the price of the drug late last year.
Activists have told Health-e News that this is tantamount to a threat and is particularly concerning because investment in TB research and development is pitiful. This is despite the fact that the disease kills more people around the world every year than any other infectious agent.
“Most of the large pharmaceutical companies have stopped researching new TB medicines. Of total global investment in TB research and development in 2017, only 11 percent was from the private sector,” said Marcus Low, editor of the health publication Spotlight.
The true cost of bedaquiline?
While J&J has repeatedly refused to provide information about the detailed costs of developing bedaquiline, research from the University of Liverpool estimated the drug could be produced and sold at a profit at a dramatically reduced cost of between $50 and $100 (R700 and R1 400) per course.
The issue is made even more complex as the development of bedaquiline is not J&J’s success alone and multiple other organisations and governments made substantial financial investments especially in relation to clinical trials.
While the outcome of this patent challenge in India won’t directly affect South Africa, indirectly the impact for many countries is significant.
“Since generic competition in India will likely lead to dramatically lower prices and, even if we can’t access those prices, it could create some downward pressure by illustrating how cheap the drug really should be,” explained Low.
After nine years of development, the Department of Trade and Industry’s Intellectual Property Policy – which makes provisions for public health needs – was approved by Cabinet last year.
Yet, there has been very little action since then regarding the necessary legislative amendments needed to implement the policy.
IP reform: Slow progress in SA
The very patent Tisile is opposing in India has already been granted in South Africa.
Currently, patents are granted “far too easily” in South Africa as applications aren’t rigorously assessed. The country also lacks a mechanism like the one currently being used by Tisile in India to oppose a patent before it has been granted.
“Instead challenging a patent in South Africa typically requires expensive court proceedings – thus making it much harder for the public or other third parties to challenge poor quality patents,” said Low.
He urged the government to prioritise intellectual property reform, not only for access to TB treatment but for many other diseases including cancer and diabetes that require treatment with costly, yet life-saving, medicines.
Said Low: “Too many people are still dying, suffering, or going bankrupt unnecessarily because the medicines they need are excessively priced – and needlessly so.” – Health-e News
* After the publication of this story on 13 February Johnson & Johnson sent Health-e News the following statement in response to the bedaquiline patent challenge in India.
Bedaquiline: The J&J perspective
Johnson & Johnson is committed to ensuring that bedaquiline reaches as many patients as possible, and we are a committed partner in India’s efforts to combat TB.
The patent application in question – for the formulation of bedaquiline – was filed in 2007, and became publicly available in 2008, as part of standard procedures when developing new medicines.
The application was first considered by the Indian Patent Office in 2012 and remains under review. If granted, a formulation patent would not prevent generic manufacturers from developing the active pharmaceutical ingredient in their own formulations after July 2023, when the API patent expires in India.
However, we stress – and will continue to stress – the importance of appropriate stewardship to protect the effectiveness of bedaquiline. That is why we have carefully selected our manufacturing partners in India and Russia – to which we have transferred the manufacturing know-how for bedaquiline – and maintain a strong focus on providing quality-assured product and implementing strong stewardship programs to prevent resistance to the medicine from developing.
Since the introduction of bedaquiline in India, Johnson & Johnson has donated more than 10,000 courses of the medicine to support the government’s efforts to scale up access. Beyond providing access to bedaquiline, we have also supported efforts to improve diagnostic capacity, train health workers on the clinical management of TB, and raise awareness about TB at the community level.