Challenging Patent monopolies of the big pharmaceuticals on life-saving drugs; needs political attention// Long read

Title: Challenging Patent monopolies of the big pharmaceuticals on life-saving drugs;  needs political attention  

ATHIRA ELSSA JOHNSON 

PGDIMJ22024

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CONTENTS 

Acknowledgment and Declaration 

Introduction: The question of patenting life-saving anti-tuberculosis drugs  Abstract, Hypothesis and Personal Analysis 

Literature Review: The TB community has always been here  

Chapter 1: Background and Relevance of life patent oppositions of life-saving drugs Chapter 2: DR-TB Medication regimens, community response, and media coverage  Chapter 3: Affected community and legal battles 

Chapter 4: Logistics and challenges of Drug-Resistant illnesses 

Chapter 5: India’s Pharmaceutical patent overview 

Conclusion 

Bibliography and References 

Remarks 

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Acknowledgement 

My sincere thanks to The Asian College of Journalism, Chennai for the opportunity to do this project, I thank  my mentor, Anjana Krishnan for guiding me. My sincere gratitude to DR-TB community and collectives like: TB Proof, TBpeople, The International Union against Tuberculosis and lung disease and Survivors against  Tuberculosis. I thank Dr. Jaya Shreedhar, for the health reporting classes at ACJ. 

Thanks to Nandita Venkatesan, Phumesa Tisile, Rhea Lobo, Debashree Lokhande, Deepti Chavan, Paran  Saramita and many other TB survivors who are at the forefront of this cause ,who also made me want to take  this topic for study. 

Declaration 

I, Athira Elssa Johnson hereby declare that this project titled “Challenging Patent monopolies of the big  pharmaceuticals on life-saving drugs; needs political attention” is my original work; referring different  sources like Indian Patent laws and Government Health Records, as cited and I am solely accountable if found  otherwise.  

Submitted to: The Asian College of Journalism  

On 13th March 2023

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Introduction 

The question of patenting life-saving anti-tuberculosis drugs  

Tuberculosis (TB) is an illness caused by bacteria and spread human to human through the air. It can affect  all parts of the body such as the brain, the kidneys, the spine, and in most cases the lungs, it is caused by a  bacterium called Mycobacterium tuberculosis and not everyone infected falls ill. Two TB-related conditions  exist: latent TB infection (LTBI) the dormant existence of bacteria that attacks the body in immunity 

compromised situations that is mostly asymptomatic, and TB disease, which showcases a wide range of visible  symptoms.  

Though TB is treatable and curable, if not treated properly it can be fatal. A deadly form of TB exists which  is drug-resistant TB which occurs when bacteria become resistant to the drugs used to treat TB. This means  that the TB drug that is supposed to kill bacteria would no longer work, the drug that is meant to kill TB  bacteria (anti-tuberculosis drugs) no longer works in that situation. DR-TB is also spread through the air and 

If untreated it is far more dangerous than other forms of TB.  

A person living with Drug-resistant tuberculosis will be put through medication regimen as per the World  Health Organisation protocols and constant monitoring to check whether the medicines are responsive or not  and also drug susceptibility tests to see if the body is resistant to any more drugs.  

In medical terms <Resistance to one first-line anti-TB drug is mono resistance, resistance to more than one  first-line anti-TB drug other than both isoniazid and rifampicin is called polyresistance, resistance to at least  both isoniazid and rifampicin is called Multidrug resistance (MDR). Resistance to any fluoroquinolone, and  at least one of three second-line injectable drugs (capreomycin, kanamycin, and amikacin), in addition to  multidrug resistance, is called Extensive drug resistance (XDR). Then Rifampicin resistance (RR) is resistance  to rifampicin, mono-resistance, poly-resistance, MDR, or XDR.>  

The medication regimen to treat DR-TB used to include daily injections that come with adverse side effects  ranging from skin rashes to disabilities like hearing loss. 

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The injectables like Kanamycin and Capreomycin that might not even pass the safety trials today were part of  the DR-TB medication regimen. 

In simple terms, medication given to a DR-TB patient is mostly a set of pills- depending on what The World  Health Organisation WHO suggested, the medication regimen is prescribed by the doctor in the location  (district TB centre in case of India) , they will be monitored at the centre and medicine will be provided at the centre. Intake of the medicine is monitored under the DOT scheme which is direct observational therapy.  

The combination of pills differs from regimen to regimen, body weight of the person, medication response and the overall health. A regular (monthly routine check-ups) follow-up check-ups will be considered of  administering the drug to patients as the medicines are of high dosage. 

According to the Medicine Sans Frontiers (MSF) website; A person being treated for multidrug-resistant  tuberculosis typically swallows up to 14,600 pills & endures 240 painful injections. After all that, the chance  of being cured is only 50%. And this too will depend on the recovery patterns, in case of a resistance to more  drugs means more medicines and longer regimen.  

There is the availability of lifesaving drugs like bedaquiline and delamanid that can be taken orally for shorter  regimens that shows better result. According to the updated WHO guidelines, Bedaquiline-based treatments  are now recommended for DR-TB treatment. Implementation of WHO’s recommendations by countries can  increase the number of people who should receive this drug. 

Older TB treatment regimens have resulted in severe side effects in many survivors of the illness.  

It caused long term side-effects that caused disabilities, mostly - loss of hearing and vision impairment. The  drugs are also known to have compromised the quality of life of the patient during treatment and after.  

New TB regimen with bedaquiline and delamanid have proven to be much safer and are easier to administer.  The problem, however, is accessibility; the monopoly of pharmaceutical companies that do not allow for  increased production of the drug due to patents on the formula/molecules.  

This keeps the prices exorbitantly high, at times reaching thousands of dollars.

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The grounds for opposing patent application for bedaquiline formulation in India has to be widely learned understand how vital the rejection of the patent monopoly is. The civil society organisations around the world  have worked tirelessly to remove patent barriers on drugs for the treatment of cancer, HIV and hepatitis C.  

India being the largest manufacturer of affordable drugs for the developing world still struggle to scale up  access to medicines for drug-resistant tuberculosis (DR-TB). 

The patent challenge filed by TB survivors in order to prevent pharmaceutical corporation Johnson & Johnson  (J&J) from extending its monopoly on the core DR-TB drug bedaquiline is one decisive and important stage  to accessibility.  

The latest Global tuberculosis report 2022 shows a big fall in the number of tuberculosis (TB)cases reported  which means there is a hike in undiagnosed, untreated TB. This also means a high chance of drug-resistant  tuberculosis cases.  

A third of the world’s population has no means of obtaining essential medicines 

Individuals pay the largest portion of their income on healthcare. On top of this, patenting of medicines takes  place. As there is a dire need to treat illnesses, big pharmaceuticals drive up the cost of the medicines and  worse; prevents other countries from marketing cheaper generic versions of the drug (that can make it  affordable). 

What the patent supporters say of this is: 

- They are needed to protect drug company profits that pay for the research and development of new  drugs. 

Whilst the development of bedaquiline by big pharma is benefitted from public investment, and the  efficacy and potential cure rates with fewer side effects were the results of collective efforts of the global  TB community. This is where the patent challenge by DR-TB survivors becomes revolutionary.  

It is a life-threatening situation when big pharmaceuticals like Johnson&Johnson(J&J) (Jansen) overprice  drugs like bedaquiline. 

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By granting J&J’s monopoly on bedaquiline, the patent control would be extended from 2023 to 2027,  delaying the entry of generics by four more years. The generic version can and has done in India and how  corporate monopoly restricts the making of generic versions. Patent evergreening has been one of the strategies  that big pharmaceuticals play through the filing of additional mostly unmerited patents to extend monopolies  on their drugs beyond the standard 20 years. Overcoming this patent barrier will encourage TB drug  manufacturers from India to enter the market with generics, and supply bedaquiline at lower prices to national  TB programs. It is important to block corporations like J&J from attempting to extend a monopoly that will  delay the availability of quality-assured generic versions of bedaquiline in India and other countries 

Media Coverage: The media Coverage to the patents have been mixed and, in most cases, not helped in mass  educating about the need for challenging patents on life saving drugs. As tuberculosis is associated with a lot  of stigma, drug-resistant tuberculosis has not become a part of many reportages. Some news reports also enable misinformation regarding the medication regimens of the illness. There has been coverage from some media  about the patent challenge and profiles on the petitioners and the TB community who are forefront of the  battle. For an illness like drug-resistant tuberculosis as it involves daily medicines, the accessibility of the  medicines and a consistent check and monitoring of the side-effects from the medicines are important. 

While throughout the Covid-19 pandemic the narratives spread through the media about TB community, people with chronic illnesses, disabilities and others in similar conditions were ableist, mostly about hailing  the sacrifices they make. It is so appalling as it belittles the fight for accessibility and inclusion. 

The Covid-19 pandemic did bring a negative impact on TB community as TB care services were interrupted  .When the community had been voicing about enabling the essential services as it’s called now, including  online job and education services, communication, medicines delivery and lot of things that could have made  people’s lives easier which are provided now and the non-disabled get the advantages , there is always a  question of where were these services all this time and whether they going to stick around after the tackling  of the Covid crisis. While it took a global pandemic to make the services available the way many demanded and yet the direct services to TB patients or others in similar state are disrupted.

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Abstract 

In the wake of the Covid-19 outbreak where panic consideration and prioritization of the high -risked  communities are health emergencies of the time, the brushing off the drug monopolies would be yet another  healthcare menace. In India on an annual basis, there are over 1,00,000 new Drug Resistant tuberculosis  cases. DR-TB is caused by TB bacteria that are resistant to at least one first-line anti-TB drug. Multidrug resistant TB (MDR TB) is resistant to more than two anti-TB drugs mainly Isoniazid (INH) and Rifampin  (RIF). 

People with DR-TB are put through toxic drugs with long regimens and painful injectables causing severe  side effects, including disabilities like hearing loss. The availability of safer drugs like bedaquiline and delamanid, a regimen that is administered orally, would pave way for the patients to undergo the treatment  efficiently. 

The painful toxic injectables could be replaced with safer drugs. But the drug companies extend their patents  over these drugs that will otherwise be accessible to all who need them A DR-TB patient in India will be  registered with the Revised National Tuberculosis Control Program (RNTCP) and receive medication under the  scheme at DOTS centres.  

Hypothesis 

To understand the need for the rejection of patents on life-saving anti-tuberculosis drugs, particularly  bedaquiline that can replace toxic daily injectables that results in severe side-effects in survivors.  

Personal Analysis 

As a survivor of drug-resistant tuberculosis and tuberculosis, who was put on medication regimens including  Kanamycin, Capreomycin (daily injections), it is also my personal need to work on accessible life-saving  drugs for my TB community; and thereby, this study is a learning experience.

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Literature Review 

TB community has always been here  

When there is a mention of tuberculosis, not many want to associate with it, American writer Susan Sontag describes as to how the word Tuberculosis itself brought a fear of contagion in people in history. Today the  variants of Tuberculosis have grown to drug-resistant tuberculosis which is deadlier and is not talked about at  all.  

But even when the stigma of shame is there and even when tb community is not given attention, all spheres  of the world are all associated with tuberculosis, like all are associated with breathing.  

People living with Tuberculosis are in our proximity- someone in the family doesn't want to talk about it  because they do not feel safe to talk about it. The TB community were always neglected and stigmatised, so  forcing one to engage in talks about Tuberculosis is cruel. 

There is yet a celebration of the labour and art of the TB community in history, without addressing the  community. 

For instance, existential angst and melancholy did not kill Franz Kafka. He was suffering from tuberculosis,  he wrote letters to Milena Jesenská, in pain, in suffering. As his disease progressed, his throat became affected  by the TB and he could not eat regularly as it was painful. 

He died from starvation in a sanatorium in Kierling, near Vienna, after admitting himself for treatment there  and he died at the age of 40. He kept writing letters to Milena, he said “I have spent all my life resisting the  desire to end it.”, always mentions how he longs for love but a part of him knows that he wouldn't make it. He  says in a letter to Milena "I miss you deeply, unfathomably, senselessly, terribly.”

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He wrote, “I’m tired, can’t think of anything, and want only to lay my face in your lap, feel your hand  on my head and remain like that through all eternity." Even today Kafka's pain is romanticised into mere aesthetics. One does not want to count Kafka a part of TB community.  

Tuberculosis killed the entire Bronte family, all died from various forms of tuberculosis. 

When doctors asked to keep work aside and rest; Anton Chekhov sat down to write, completing two of his  most famous plays, The Three Sisters and The Cherry Orchard. When he was at the peak of pain suffering  from TB he still wanted to write, the illness might have crushed his plans for what he wanted to do.  

He was a physician also and must have known his symptoms already, he hid his illness from family and  friends, even as his health worsened in the years that followed. And doctors ordered him to reduce his medical  work and lifestyle. His health deteriorated bad and towards the end; surrounded with his people, he sat up  straight and said "I am dying" and died. 

When one celebrates people, be it a favourite poet, or someone in the family, a very close person or someone  in distant they adore, it is important to also hold the anger against what killed them or is killing them, 

This is why romanticizing and stigmatizing TB is dangerous. In literature and media, there is a usual stereotype of the portrayal of someone living with Tuberculosis: a character who goes in exile, someone who coughs and  throws up blood, spitting blood and dying scenes and so on.  

Albert Camus suffered from Tuberculosis and at the age of 17 he was heartbroken at having to give up his  position as goalkeeper on the University of Algiers football team. He suffered relapses of TB throughout his  life. 

George Orwell wrote '1984' when he was struggling with tuberculosis. Science Daily quotes, “Fever, weight  loss and night sweats sent him to the hospital where he underwent ‘collapse therapy,’ a treatment designed to  close the dangerous cavities that form in the chests of tuberculosis patients.” Orwell wrote in the book. “The 

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barrel of the ribs was as narrow as that of a skeleton: the legs had shrunk so that the knees were thicker than  the thighs, the curvature of the spine was astonishing.” 

Orwell struggled with health throughout his life, in the cold and damp of Scotland, under the stress of writing,  he got worse and worse with Tuberculosis. 

Writer Edgar Allan Poe lost members of his family to tuberculosis. 

Writer Charles Bukowski was about 70 years old, he got seriously ill. He visited all the expensive doctors but  none could help him. One day he took one of his cats to a vet who looked at Bukowski and immediately said  that he has tuberculosis. He got formally diagnosed later.  

Maxim Gorky suffered frequent bouts of tuberculosis. 

Kathleen Mansfield Murry aka Katherine Mansfield: chronic tuberculosis drained her, deteriorated her health,  limited her opportunities and made her cut off from a big part of life. It’s said that she had symptoms which  were fatal to the hope of recovery. The shock of the loss of her only brother was extremely severe and may  have contributed to neglect of her health  

While one part of her fought and rebelled against external restraint or domination, another part embraced "the  flight into illness". In a letter she wrote,"I have discovered the only treatment for consumption. It is not to cut  the malade off from life: neither in a sanatorium nor in a land with mild rivers, butter mountains and cream  valleys, one is just as bad as the other". 

Claudia Jones; feminist, political activist, leader, and journalist. Her education was cut short when she was  diagnosed with tuberculosis during her teens, it did bother her throughout her life.  

Tuberculosis made poet John Keats suffer a lot too, he lost his mother to Tuberculosis. Keats suffered from  the same. When first time coughing up blood, he said, "I know the colour of that blood! It is arterial blood. I  cannot be deceived in that colour. That drop of blood is my death warrant. I must die."

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In his last letter Keats mentioned, “Tis the most difficult thing in the world to me to write a letter. My  stomach continues so bad, that I feel it worse on opening any book – yet I am much better than I was in  quarantine." In his last days he was coughing up blood and covered in sweat. He said, "Severn—I—lift me  up—I am dying—I shall die easy; don't be frightened—be firm, and thank God it has come " and died. 

Writer Edith Sondergran wrote, ' I have a door to all four winds. I have a golden door to the east – for love  that never comes, I have a door for the day and another for sadness, I have a door for death – that one is always  open.” 

She died at the young age of 31 after suffering from Tuberculosis. When Södergran was a teenager, she was  diagnosed with Tuberculosis. The only treatments available were fresh air, moderate exercise, and nutritious  food. 

Södergran had already lost her father to the disease two years earlier and she was sent to the same sanatorium  where he had died. 

Edith was an avid letter writer, she wrote an essay advocating for universal suffrage from the TB sanatorium. Södergran’s poetry later became influenced by Nietzche, alongside other Russian poets. On one side her  poetry was reduced to the wild dreams of a woman with Tuberculosis, she was a poet that reflected on and  wrote about the political and societal context of those times. 

Modernist poet, Manuel Bandeira, spent most of his life suffering from tuberculosis. It has been said, "his  poetry spits blood". And he is a poet of wit and humour. He rested at the sanatorium. Tuberculosis forced him  to abandon his dream of becoming an architect. 

Eugene Delacroix, one of the greatest painters, also wrote a series of diaries, on his fears about the progress  of tuberculosis, later, he succumbed to the illness. 

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Amedeo Modigliani, Italian painter; contracted tuberculosis when he was eleven. Modigliani was spitting  blood and burning with fever. The doctors diagnosed him with nephritis. Ten days later, and at age of 28,  Modigliani died of tuberculosis. He died in Paris totally penniless 

Emily Shore suffered from tuberculosis too. Shore’s journals cover many topics, including natural history,  literature, travel, friendship, physiognomy, and illness, especially her tuberculosis. She loved excursions, and  she was frequently cautioned to rest or return to her bed. 

Shore wrote “I did not go out, but as usual Mary pinned me down to the sofa for a long time, which I cannot  bear, for it is making me much more of an invalid than I am, or like to be thought.” Shores's cough got worse.  She visited the English burial grounds, and says “I felt too, as I looked at the crowded tombs, that my own  might, not long hence, be amongst them. ‘And here shall I be laid at last,’ I thought. It is the first time such an  idea has crossed my mind in any burial ground.”; she succumbed to her illness soon then. she had written in  during her journal when she was ill with TB, “I have written much that I would show only to a very few, and  much that I would on no account submit to any human eye. Still, even now, I cannot entirely divest myself of  an uncomfortable notion that the whole may some future day, when I am in my grave, be read by some  individual.” 

Tuberculosis made artist Edvard Munch's life miserable. When he was only five years old, his mother died  from tuberculosis. A few years later, when he was thirteen, his older sister died of TB too. 

Writer, poet, editor, translator, thinker and revolutionary LuXun, died of tuberculosis. 

The numbers we see on the TB death graph are people, favourite figures, research topics, mere aesthetics,  politics, ideas, muse, study materials- it stayed this long and nothing's changed so much as far as suffering is  concerned. 

It is important to be angry that people are still dying of tuberculosis, drug resistant tuberculosis. To be aware  that survivors are only getting back to their normalcy after the medication and yet comes forefront to talk 

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about TB more than any governments. Patients research on their illness and fight medical gaslighting and the  system doesn't care unless one produce to capitalism. 

Susan Sontag has detailed in her book, " Illness as metaphor" on different social attitudes with various  illnesses, the interpretations, about euphemisms like consumption, long illness, weakness of the lungs about  tuberculosis. On how people feared contagion even just talking about it. Maybe even if one tries to demystify  a stigma today it’s going to be replaced with another, but someone will then call them out too and that’s where  we see that little hope. 

When one reads Kafka , learn intersectionality lessons from Claudia Jones, Gorky 's writing and politics, and  the way Orwell explained socio-political context that is relevant even today , Katherine Mansfield's powerful  ,and others whose stories of suffering, survival that we have no account of,  

Camus's friends helped him get through isolation, sending him love, solidarity and goodies. Melania  tried to understand Kafka, Chekov's wife and friends were there for him, went on trips with him,  

We have better medication now and recovery is possible. TB is curable. There was a time when only treatment  by diet therapy, climate therapy and symptomatic therapy without antituberculotic drugs were given, it was  basically just - staying at some sanatorium if one could afford, then just getting some sunlight, eating good  food. 

Stories of Survivors, support groups of patients, undergoing different regimen, TB activism, organisations that  work to end stigma etc are all over the internet, an online search away. In a dangerous,  ableist environment where eugenics is very alive, one would be in a difficult position to talk about  Tuberculosis. In a time where TB talks becomes difficult, it makes it even harder with barriers to medication,  a capitalist monopoly over lifesaving drugs, which shakes the foundation of the TB discourse.

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Chapter 1: Background and Relevance of patent oppositions of life saving drugs:  

TB treatment has become more complex, particularly with the emergence of mutated strains of  Mycobacterium tuberculosis. It requires extended treatment with more medicines that have side effects and  adverse effects than the regular TB regimens.  

Given the emergence of drug resistance and the need to shorten treatment duration, new drugs are required.  Medicines- rifampicin - was introduced in 1963. Since then, research for new TB treatments had come to a  halt. However, in recent years potential new TB treatments has started to look more promising than it has for  the past 50 years. 

Johnson & Johnson’s (J&J)/Janssen’s recently approved diarylquinoline compound bedaquiline (marketed  under the brand name Sirturo) - bedaquiline is a new treatment, approved for drug-resistant tuberculosis.  

Sequella Inc’s investigational compound SQ109 - SQ109, AstraZeneca’s investigational compound  AZD5847 - AZD5847, Pfizer’s investigational compound sutezolid , Otsuka Pharmaceutical’s delamanid, TB  Alliance’s investigational compound PA-824 - PA-824 have been found to treat drug-resistant tuberculosis  (Source: TB alliance report) 

Despite high rates of under-reporting and under-diagnosis there are still many cases of DR-TB cases detected. 

Treatment outcomes of multidrug-resistant (MDR)-TB have remained poor in the past. Regimens containing  bedaquiline have shown impressive efficacy in clinical trials and real-life use. 

However even with the use of these newer drugs, successful outcomes and treatment options are limited in  patients with fluoroquinolone-resistant and extensively drug-resistant TB (XDR)-TB). 

In appropriate patients with high-level resistance and/or poor prognosis, there is an increasing need to use a  bedaquiline–delamanid combination.  

Despite the concern of heart issues and more widespread use, few studies have reported on the concurrent use  of delamanid and bedaquiline and have mostly described early safety and efficacy of the combination.

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A person diagnosed with drug resistant tuberculosis goes through a detailed body examination and tests of  medical history  

Patent Barriers of the critical DR TB drugs; In much need of Political attention. 

The dependency on donations, high-priced drugs, and the patent battle with pharma corporations hinder the  access of drugs to all, farfetched and unfulfilled. The World Health Organization has prioritized these new drugs, saying it has the lowest risk of side-effects.  

Nandita Venkatesan from Mumbai and Phumeza Tisile from South Africa who have survived DR TB and  lost their hearing to the drug toxicity challenged Johnson & Johnson, the pharma giant and  global manufacturer of Bedaquilin , against its move in extending their patent of the drug. The patent expires in 2023 and the company has moved for an extension till 2027. 

Nandita and Phumeza have moved their cause with Indian patent office, Mumbai, referring the Indian Patent  Law based on their own testimonies to seek and ensure the availability of bdq to every eligible DR -TB  patients. 

If the patent is denied to J&J the basic compound patent will expire in India and alternative suppliers would  be able to make the drug available.  

This salt form of bedaquiline, does not merit patenting, it is what is termed as patent evergreening, that further  means If J&J attains to extend their patent rights, cheaper generic versions of the drug cannot be made in India  for Indian or global use for a twenty-year-old patent term.  

When considerable public resources had been used in the drug's research and being beneficiary of major  support in its development, it is a question of the time why life-saving drugs cannot be made available to those  in need. 

Mumbai based activist Ganesh Acharya who has battled HIV and TB and Delhi Network of Positive People  (DNP+) have challenged the two patent applications on combinations of TB medicines Isoniazid and 

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Rifapentine filed by the French pharmaceutical company Sanofi. Isoniazid and Rifapentine together form the  3HP regimen availing a preventive treatment that can protect millions of people from contracting the disease.  

Starting in 2014, Sanofi filed for patents on adult and paediatric fixed-dose combinations (FDC) of 3HP in 68  countries. If granted, these patents could give Sanofi a monopoly on these 3HP FDC formulations until 2034. 

By limiting generic version competition, this monopoly would undermine efforts to ensure that everyone at  risk of TB can access the highest available standard of preventive therapy. 

The pharma corporations extend their monopolies over wonder drugs like bdq and this delays the  introduction of the alternative sources of the drugs that could save lives of many. 

This should be a wakeup call to look into the healthcare emergency and the very need to back the legal  fights against them. The fact that anyone out there who is breathing is prone to any infectious deadly  illnesses like tuberculosis is a frightening fact.  

The capitalist and corporate takeover of healthcare has constrained the ways of availing the drugs to the  ones in dire need. When medicines are supposed to be our saving grace, when there are means to prevent  to survive, it become difficult for many to get a proper access to it due to the sad state of healthcare monopoly and looting. 

In order to annihilate health hazards like tuberculosis, the survivors of the same, testimony the trauma they  went through to provide first hand references and material for anybody out there struggling to cope with the  same. The inhalation of dangerous bacteria takes a financial, mental, and physical toll on anyone’s life and  it’s the need of the hour to end this through safer medication. In a time where the dangerous tentacles of  healthcare emergencies are aggressively visible, where covid-19 experience is shaking the world, sidestepping  the patent battles against the drug monopoly of the pharma giants could be a massive catastrophe. 

The perilous state that a patient under medication for illnesses like DR TB, pushes the person into a state of  numbness and chaos, so rallying up with them is a need of the time. The legal fight against pharmaceutical

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corporations for access to drugs is a healthcare revolution led by survivors. In the forefront are the testimonies  of patients all over the world. Such initiation of this healthcare revolution seeks world solidarity.

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Chapter 2: DR-TB Medication regimens, community response, and media coverage  

In case of a TB or DR-TB diagnostics; Usually there is a smear test - a skin test or blood test result indicating  TB infection, may have an abnormal chest x-ray, or positive sputum smear or culture, may feel sick and have  symptoms such as coughing, fever, and weight loss, the possibility of contracting others.  

Tuberculosis (TB) strains with drug resistance are more difficult to treat than drug-susceptible ones, and  present a major challenge for patients, healthcare workers, and healthcare services.  

There is a critical need for the continual development of evidence-based policy recommendations on the  treatment and care of patients with drug-resistant TB, based on the most recent evidence available.  

In the past decade, WHO has developed and issued evidence-based policy recommendations for the treatment  and care of patients with drug-resistant with consolidated guidelines.  

The consolidation of WHO recommendations on TB and drug-resistant TB has now been expanded to better  outline the path that a patient will take following exposure to resistant strains of Mycobacterium tuberculosis,  once infection has progressed to TB disease, and the patient has been identified by the health system and  referred for drug-resistant TB treatment.  

Community Response: Blessina Kumar, CEO The Global Coalition of TB Activists (GCTA) , confirms that – the injectables are no longer part of the regimen. Patients part of the peer support groups and  survivors also confirm that the use of injectables has come down to none.  

Ganesh Acharya (TB-survivor-HIV -activist) said that the need of the hour is a demand for a shorter regimen,  since the longer regimens still affect many lives. “We demand six-month MDR-TB treatment-means all  1,19,000 people with MDR-TB should be on a six-month regimen (short regimen)”, he said. 

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 Chapter 3: Affected community and legal battles: 

The rejection of patent extension and resistance from the community  

Tuberculosis survivors Nandita Venkatesan from India and Phumeza Tisile from South Africa filed a patent  challenge in India in 2019 to try to block J&J from extending its monopoly on bedaquiline, under Section  25(1) of the Indian patent law. The J&J patent application challenged is for the salt form of bedaquiline which  is only a formulation of an old drug that does not merit patenting under India’s patent law. 

Petitioners who are also survivors of DR-TB fought bouts of TB undergoing various medication regimens that  had injectables. Nanditha Venkatesan suffered a relapse after her first treatment. She underwent at least five  surgeries and multiple medicines including painful injections during the course of her treatment. She lost her  hearing as a result of injectable TB drugs (Kanamycin). 

Phumeza Tisile is an extreme drug-resistant TB (XDR-TB) survivor. First diagnosed with TB, then multi drug-resistant TB (MDRTB), and thereafter with XDR-TB. She lost her hearing to XDR-TB treatment.

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Figure 1The patent file page 1 

The World Health Organization (WHO) announced an update in August 2018, to the treatment guidelines for  multidrug- and rifampicin-resistant TB (MDR/RR-TB) - that include the use of bedaquiline as a core drug in  standard treatment regimens for MDR-TB, the WHO website says “the immediate steps to be taken to ensure  that MDR/RR-TB patients receive treatment in accordance with the latest evidence on effectiveness and  safety.”  

The updated treatment with the use of bedaquiline means the lowest risk of serious side effects. The guidelines  now include bedaquiline as the highest-ranked option (Group A) and to not follow the regimens with  injectables anymore - aminoglycosides (included in Group C, the least preferred option).

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South Africa’s DR-TB directorate in July 2018, acknowledged the improved cure rates and significant  reduction in mortality among patients treated with bedaquiline and recommended that access to the drug be  provided to all patients diagnosed with any form of drug-resistant TB (RR-TB, MDR-TB, pre-extensively  drug-resistant TB [pre-XDR-TB], or XDR-TB).  

According to the updated WHO guidance, bedaquiline-based treatments are recommended into the national  TB programmes to immediately increase access to bedaquiline-containing regimens. 

The all-oral, shorter-course regimens could result in even greater potential patient benefit and wider use of  bedaquiline in TB programmes globally. 

A majority of pharmaceutical patents in India are filed for secondary claims, i.e.for marginal improvements  on patented drugs that already exist and does not qualify to be granted protection again. These ‘evergreening’  tactics allow pharmaceutical corporations to maintain overpriced drug prices by extending their monopoly on  the market and delaying the introduction of alternative sources of drugs. 

It is concerning as it blocks Indian generics manufacturers from producing lower-priced generic versions of  drugs – including child-friendly formulations – despite their technical capacity to do so. 

Janssen Pharmaceutica, a subsidiary of the pharmaceutical corporation J&J, has filed for multiple patents on  bedaquiline in India, not limiting itself to the basic compound patent but also filing secondary patents to stake  claims on routine improvements and formulations. 

Janssen exerts control over the market until 2023, when its compound patent is set to expire. If granted; a  secondary patent on the fumarate salt of bedaquiline will further delay the entry of alternative suppliers to the  market until the end of 2027. 

While the barrier to competition created by the bedaquiline base compound patent can be effectively addressed  through a compulsory license and the TB community in India has written to the government on the matter, it  is crucial that the Indian Patent Office rejects the secondary patent claim, currently pending, as per the  provisions of the Indian Patents Act.  

The pre-grant opposition is then taken up for hearing and a detailed order is passed by the Controller of Patents.

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Patent oppositions to Janssen’s bedaquiline formulation are vital to preventing additional unmerited patents  from being granted.  

The rationale for granting monopoly rights on new medicines is allegedly to protect the patent holder’s  investment and encourage them to invest further in research and development of new medicines. 

However, patents permit pharmaceutical corporations to charge high prices in the absence of competition.  Moreover, pharmaceutical corporations charge high prices despite benefitting substantially from public  funding for drug research.  

The history of bedaquiline’s development reflects a genuinely collective effort. As such, Janssen should not  be allowed to extend its monopoly on bedaquiline through evergreening strategies in India or in other  countries.  

Several of the phase I and II trials conducted prior to the drug’s registration were sponsored by public and  philanthropic organisations like: US National Institutes of Health/National Institute of Allergy and Infectious  Diseases and the TB Alliance. 

J&J did not invest directly in phase III trials as part of their initial bedaquiline development programme.  Several research institutes and treatment providers, including national TB programmes and MSF, have  invested in additional trials, operational research, and pharmacovigilance to document the safety, efficacy and  optimal use of bedaquiline for the treatment of MDR-TB.  

The phase III trial was sponsored by the International Union against Tuberculosis and Lung Disease and  funded by USAID. 

With funding from Unitaid, MSF in collaboration with Partners in Health are also conducting a phase III  clinical trial that includes bedaquiline. 

J&J has also already received noteworthy financial compensation for the development of bedaquiline. The  pharmaceutical corporation received a 50 per cent tax credit on qualifying clinical research and development  expenditure.

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It also received a tropical disease priority review voucher, which the company used to accelerate review and  marketing authorisation of another drug in their portfolio – guselkumab, an important psoriasis drug.  

This drug sells for nearly US$60,000 per patient per year in the US and is estimated to yield US$3.49 billion  in sales by 2024. 

These public contributions warrant a common right that should ensure the bedaquiline access to all TB  patients who need it and to TB care services worldwide, especially in TB high-burden countries.  

J&J’s secondary patent application disregards public contributions to the development of the drug, and thus  the secondary patent claim should be rejected.  

When the Network of Maharashtra People Living with HIV (NMP+) filed a pre-grant opposition in 2013 and  the Indian Patent Office raised objections, Janssen modified its claims to cover a composition of bedaquiline  fumarate and a wetting agent. 

The opposition filed by Nandita Venkatesan, from Mumbai, India and Phumeza Tisile, from Khayelitsha,  South Africa, both of whom survived DR-TB but lost their hearing because of the toxicity of the treatment is  based on grounds of lack of novelty, lack of inventive step, lack of enhanced therapeutic efficacy, and for the  formulation being a mere admixture.  

Patents should not be granted on claims of ‘invention’ that have been disclosed in a published document before  the date of filing of the patent application of the claimed invention.  

The patent granted to Janssen, namely IN236811, already discloses the bedaquiline free-base compound and  its additional salts, including fumarate salts and surfactant (wetting agent).  

Patents should not be granted on compounds that would have been obvious to make or arrive at based on  existing knowledge or well-known techniques.  

Janssen’s patent on the bedaquiline free base compound, Janssen’s earlier patent on rilpivirine, and others have demonstrated that making a salt form of a known compound – in this case, bedaquiline – is obvious and  cannot be termed as inventive. Janssen’s claims are a verbatim copy of its earlier patent application on  rilpivirine, which was rightly rejected by the Indian Patent Office.

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India’s Patents Act stipulates that in order to be granted a patent, new forms of known substances have to  demonstrate that they have enhanced the therapeutic efficacy of the known product.  Janssen has not provided any evidence in its application to demonstrate enhanced therapeutic efficacy of the  allegedly new formulation of bedaquiline over its previous form. Such disclosure is required and has been  stipulated by the Supreme Court of India in its decision in Novartis AG vs. Union of India, 2013.15  In case a patent is claimed over a combination of substances, Section 3(e) of India’s Patents Act requires the  patent applicant to show that the combination being claimed as an invention with additional results. Janssen’s application does not disclose any data on a synergistic effect resulting from the combination of  known compounds, i.e., bedaquiline and the wetting agent. This is a classic case of evergreening so as to  extend the monopoly of the drug in the market, therefore the patent application should be rejected as it does  not meet the patent eligibility standards under the Indian Patents Act, 1970.

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Chapter 4: Logistics and challenges of Drug-Resistant illnesses 

An Interview with Dr.Babi at The Tamil Nadu AIDS control society (TANSACS) about the logistics of the  drugs in the HIV-TB regimen: She talked about the logistics of the drugs and how in case of a drug shortage  they have the means to procure them locally from listed suppliers. She mentioned that a full adherence to the  HIV treatment regimens is advised by the UNAIDS (Joint united nations program on AIDS/HIV) as treatment  interruptions can cause resistance to drugs- which means fewer options for treatment.  

TANSACS, therefore, keep a track of all opportunistic infections that can indicate any symptoms of drug  resistance (an example of how every state functionary works in India). CD4 testing (to check the health of  your immune system) and culture testing are the diagnostics followed to track this.  

“We keep track of immunological failures, as we have departments assigned to track drug response, this is  done on a routine basis,” said Dr. Babi, TANSACS work as per the guidelines from the national AIDS control  organization (NACO) to ensure the functioning of diagnostics and deliverance of ART. 

Antiretroviral therapy for people living with HIV is delivered through a single-window system followed by  district prevention and control units (DAPCO) and ART centres in all districts and zones. 

A fully functioning 55 ART centres are available in the state. Dr. Babi explains, “we take instructions from  the apex body- NACO, we have a chain of systems from UNAIDS to the ICTC (Integrated counselling and  testing centre- “Nambikkai Maiyam” in Tamil) which ensures services to diagnostics and lifelong treatment” 

TANSACS works as a medicine-delivering agency also that functions according to the NACO’s treatment  protocols, so in case of a drug shortage, NACO is in charge of the procurement. The national functionaries  work as per the UNAIDS guidelines, and NACO’s team of experts decides the regimen, and district  functionaries follow that.

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Chapter 5: India’s Pharmaceutical patent overview  

India did not have to grant patents on pharmaceutical products before 2005 as per the international trade rules.  India became a key producer of more affordable life-saving medicines, including for HIV, which are now used  across developing countries with an absence of patent barriers  

More than 80 percent of donor-funded HIV treatments in developing countries is sourced from Indian generic  manufacturers. 

However, India started reviewing and granting pharmaceutical patents in 2005, aligning with the World Trade  Organization (WTO).  

In the then newly designed patent law India included a number of key public health safeguards, which fully  conform to international trade rules outlined in the WTO’s Agreement on Trade-Related Aspects of  Intellectual Property Rights (TRIPS) Agreement. 

The law is clear and strict about what does and does not deserves patents. Reserving patents for new drugs, discouraging secondary patenting on modifications – extending patents of known drugs unless they show a  therapeutic advantage over treatments that already exist. 

It is thereby evident that some patents awarded in countries such as the United States do not merit patents in  India. Additional public health safeguards allow any interested party to oppose a patent if they deem a given  drug ineligible for a patent under India’s law.  

Oppositions to patents can be filed before (‘pre-grant’) or after (‘post-grant’) . 

Under the WTO TRIPS Agreement India has the right to allow a third party to produce a generic version of  the drug in question by granting a compulsory license. This mostly happens when a drug is unaffordable or  unavailable by the government. 

In March 2012, India issued its first such compulsory license which is a mechanism under TRIPS that increase  access to generic drugs. A government or court issues a license to a manufacturer to produce generic version 

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of a patented product – India made way for production to proceed of a more affordable version of a cancer  drug that the Indian government deemed unaffordable. 

This legal decision by the Indian government provoked a global outcry from multinational pharmaceutical  companies and representatives of the U.S. government, who continue to put forward a false narrative that  compulsory licenses can only be issued in public health emergencies cases and only for certain diseases.  

While there is no such restriction in the TRIPS Agreement. Indian courts have argued that the public interest  includes the potential risk of denying patients access to life-saving medicines.  

The Indian Supreme Court in April 2013, ruled against pharmaceutical company Novartis, ending a seven year legal battle the company had been waging against India’s patent law, following the rejection of the  company’s patent application for a leukemia drug in 2006.  

The Indian Supreme Court upheld the rejection of the patent application on a salt form of imatinib.  

The court denied its patentability as imatinib had already been disclosed in a 1992 patent and the salt form did  not fulfil the Indian law’s patentability requirements. 

This landmark court ruling has provoked a massive multinational pharmaceutical industry outcry and  intensified pressure to push the U.S. government to act against India’s legal decisions.  

These activities and interventions are aimed at pressuring the Indian government and judiciary to change its  patentability standards and practices and to limit the use of public health legal safeguards

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Conclusion 

There is a new generic version of bedaquiline produced by drug-manufacturer ‘Macleods’ that has the  potential to expand access to shorter, safer, and more effective regimens and make DR-TB treatment less  traumatic for patients. 

In addition to Macleods, other manufacturers are developing generic bedaquiline and may have already filed  their products with the ERP, meaning multiple bedaquiline generics could be available soon. University of  Liverpool based study estimate that with adequate volumes, generic competition could bring the price of  bedaquiline down to US$0.50 per day. 

But no one can experience the benefits of a more affordable version of bedaquiline immediately in the near  future in many places without government intervention. 

Johnson & Johnson’s and phramacueticals power to retain intellectual property protections on lifesaving drugs until in low- and middle-income countries means generic versions of the drug cannot be sold or distributed  until the patent protections expire. 

That is unless the Government of India, and other country governments where Johnson & Johnson and other  monopolies have filed or been granted patent protections on lifesaving drugs, issue compulsory licenses. And  then ensure their intervention to affordable healthcare. The curative model of healthcare is not the only  important element in health services, the rehabilitative element of social model of healthcare is utmost  important. 

Figure 2MSF Campaign

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Bibliography and References: 

Books 

• Mehra, C., Swaminathan, S. (2018). Tuberculosis: India’s ticking time bomb: the TB survivors’  manifesto. New Delhi: Speaking Tiger Publishing Pvt. Ltd. 

• Panos Institute South Asia and WHO (2001) TB Do or Die, Panos Institute South Asia, Nepal • Panos Report No 46. (2002), Patents, pills and public health, Panos Institute 

• Sontag, S. (2002). Illness as metaphor. London Penguin Books. 

• Vidya Krishnan (2022), Phantom Plague: How Tuberculosis Shaped History, Penguin Random  House India Private Limited 

• Vandana Shiva (2001) Patents myths and reality, New Delhi Penguin Books India(P)Ltd,  Community Centre, Panchsheet Park  

• Wright, B. (2009). Sudip Chaudhuri. The WTO and India’s Pharmaceuticals Industry: Patent  Protection, TRIPS, and Developing Countries. New Delhi: Oxford University Press 

E-Journals 

• Anoo Buyan, The Wire( 2019). TB Survivors Challenge J&J Patent Application on Life-Saving  Drug,Available form: https://thewire.in/health/tb-survivors-challenge-jj-patent-application-on-life saving-drug ,09,February, 2019 

• Garg, K. and Saini, V. (2018). Daily regimens: Seeing beyond conventional DOTS, Indian Journal of  Tuberculosis,  

• Médecins Sans Frontières, MSF (2019) , TB Activists Challenge Johnson and Johnson Patent  Application on Bedaquiline in India ,MSF in South Asia, Available from :  

https://www.msfindia.in/tuberculosis-tb-activists-challenge-johnson-johnson-patent-application bedaquiline-india/

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• News18. (2019). ‘Patent Makes No Sense When People are Dying’: TB Survivors Challenge Pharma  Giant’s Monopoly. Available at: https://www.news18.com/news/india/patent-makes-no-sense-when people-are-dying-tb-survivors-challenge-pharma-giants-monopoly-2031155.html 

• prezly.msf.org.uk. (n.d.). DR-TB survivors challenge TB drug patent to prevent J&J from extending  monopoly. Available form : https://prezly.msf.org.uk/tb-activists-challenge-tb-drug-patent-in-india to-prevent-jj-from-extending-monopoly 

• Suthentira-govender (n.d.). ‘Go deaf or die’: No one should face such a choice, says TB survivor,  Sunday Times Daily. Available form : https://select.timeslive.co.za/news/2019-02-12-go-deaf-or-die no-one-should-face-such-a-choice-says-tb-survivor/ 

• The Times of India (2019) The deaf girl fighting to be heard on a life-saving TB drug. 17 Feb 2023.  Available form : https://timesofindia.indiatimes.com/home/sunday-times/the-deaf-girl-fighting-to be-heard-on-a-life-saving-tb-drug/articleshow/68028318.cms 

• TB Online - Final hearing in TB drug patent case ends, verdict likely in a month. (n.d.). Retrieved  from www.tbonline.info Available form :https://www.tbonline.info/posts/2023/1/29/final-hearing-tb drug-patent-case-ends-verdict-lik/ 

• www.patentoppositions.org. (n.d.). Patent Opposition Database, Available form :  https://www.patentoppositions.org/en/drugs/bedaquiline/patent_oppositions/5c5c0b4bd2708f0005c9 8d08

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News Articles 

• Namita Kohli (2019)The Week. (n.d.). New TB drug caught in patent battle. Also available at:  https://www.theweek.in/news/health/2019/02/08/new-tb-drug-caught-in-patent-battle.html. The  week, 08, Dec,2019 

• Shelar, J. (2019). TB survivors challenge patents for better access to medicines. The Hindu. Also  available at: https://www.thehindu.com/news/cities/mumbai/tb-survivors-challenge-patents-for better-access-to-medicines/article30240796.ece The Hindu ,8 Dec 2019. 

• The Times of India (2019) ,Patent challenge mounted against J&J’s attempt to extend monopoly on  high-priced anti-TB drug, also available at :https://timesofindia.indiatimes.com/business/india business/patent-challenge-mounted-against-jjs-attempt-to-extend-monopoly-on-high-priced-anti-tb drug/articleshow/67908863.cms 

Video 

• AFP News Agency (2023). Activists challenge patent extension to TB drug in India. Available form:  https://www.news.com.au/world/activists-challenge-patent-extension-to-tb-drug-in india/video/6dcbbc9bdf283a1d01e6768f962808e8 (accessed :13-03-2023) 

• International Union against tuberculosis and lung diseases (2020) COVID-19 and TB: Personal  perspectives by Faculty / Presenters, coursesonline.theunion.org. Available form:  https://coursesonline.theunion.org/theunion/2020/covid-19-outbreak/304100 (accessed :13-03-2023) 

• WebsEdgeMedicine (2018). Stigma of Tuberculosis - personal stories. YouTube. Available form:  https://www.youtube.com/watch?v=v5eh3STEmGQ (accessed :13-03-2023)

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Websites 

• WHO (2022). Global Tuberculosis Report 2022. www.who.int. Available form:  https://www.who.int/teams/global-tuberculosis-programme/tb-reports/global-tuberculosis-report 2022#:~:text=The%20WHO%20Global%20Tuberculosis%20Report,global%2C%20regional%20an d%20country%20levels. 

• Zarocostas, J. (2019). Nandita Venkatesan: a voice of hope for tuberculosis survivors. The Lancet,  Available form: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)30582- 3/fulltext

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Remarks

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