Tuberculosis (TB) remains a significant public health challenge in India, representing one of the highest burdens of the disease globally. Despite extensive efforts to control it, TB continues to affect millions, particularly among vulnerable populations. In recent years, the emergence of drug-resistant strains has further complicated treatment strategies. In the midst of this crisis, the issue of access to effective medications has come to the forefront, with the patent challenge against Bedaquiline—a crucial drug in the fight against multidrug-resistant TB—highlighting the tension between pharmaceutical patents and public health priorities. This challenge underscores the need for innovative approaches to ensure equitable access to life-saving treatments for all individuals affected by TB in India and beyond.
TB Status in India and Bedaquiline Patent Challenge
About Tuberculosis
Tuberculosis (TB) is a bacterial infection transmitted by inhaling minute droplets released into the air through the coughs or sneezes of an individual carrying the infection. While its primary impact is on the lungs, TB has the potential to affect various parts of the body, such as the abdomen, glands, bones, and nervous system.
TB is a condition that, though potentially serious, is curable through appropriate antibiotic treatment. Prompt and accurate medical intervention plays a crucial role in successfully addressing this bacterial infection, leading to effective recovery.
Status of TB:Â
The total number of incident TB patients (new and relapse) notified during 2021 in India were 19.33 lakh as opposed to that of 16.28 lakh in 2020. In 2022, 24.22 lakh case s of TB were registered in the country. India continues to have the largest share of the global TB burden.
The World Health Organization (WHO) releases the Global Tuberculosis (TB) Report every year highlighting the intensity all around the world. As per 2023 report, India accounted for the highest number of TB cases in the world in 2022, with 2.8 million TB cases, representing 27% of the global burden.
Key Findings:
- TB Case Fatality Ratio in India: India reported a case fatality ratio of 12%, indicating that 12% of TB cases in the country resulted in death.
The report estimates that 3,42,000 TB-related deaths occurred in India in 2022, with 3,31,000 among HIV-negative individuals and 11,000 among those with HIV.
- Multidrug-Resistant TB (MDR-TB): India recorded 1.1 lakh cases of multidrug-resistant TB (MDR-TB) in 2022, highlighting the continued challenge of MDR-TB as a public health crisis.
Areas where India made Tremendous Progress:
- India has made tremendous progress in improving case detection and reversed the impact of COVID-19 on the TB programme.
- The case detection strategies have resulted in the highest ever notification of cases in 2022 – over 24.22 lakh TB cases were notified, surpassing the pre-COVID levels.
- The treatment coverage has improved to 80% of the estimated TB cases, an increase of 19% over the previous year.
- India’s efforts have resulted in reduction of TB incidence by 16% in 2022 (from 2015) almost double the pace at which global TB incidence is declining (which is 8.7%).
- The mortality of TB has also reduced by 18% during the same period in India and globally.
Key Initiatives:
- PM TB Mukt Bharat AbhiyanÂ
- Ni-kshay Poshan YojanaÂ
- National TB Elimination ProgrammeÂ
- National Strategic Plan for 2017- 25 for TB elimination in IndiaÂ
- Differentiated TB Care ModelÂ
- TB Mukt Gram Panchayat Abhiyaan, RajasthanÂ
- Integration of TB Services at Ayushman-Bharat Health and Wellness CentresÂ
- Har Ghar Dastak: A state-level initiative for Active Case FindingÂ
- National Framework for a Gender-Responsive approach to TB in IndiaÂ
Bedaquiline Patent Challenge
In recent news, the Indian Patent Office has dealt a significant blow to Johnson & Johnson’s attempt to extend its monopoly on the manufacturing of Bedaquiline in India. Bedaquiline, an oral medication crucial in treating active tuberculosis (TB), especially multi-drug-resistant tuberculosis (MDR-TB), is central to the World Health Organization’s recommended TB treatment regimens.
About Bedaquiline:
Oral medication for active tuberculosis, particularly multi-drug-resistant tuberculosis (MDR-TB). Unique mechanism targeting the adenosine triphosphate (ATP) synthase enzyme of TB mycobacteria.
J&J Patent and Evergreening:
- Bedaquiline is central to WHO-recommended TB treatment regimens, with Johnson & Johnson holding the patent.
- J&J filed for evergreening of its patent on the fumarate salt formulation, a move challenged by TB survivors.
- Evergreening aims to extend patent life by making multiple claims, often prior to expiration.
Indian Patent Office Decision:
- Rejected J&J’s attempt to extend monopoly.
- Cited the claimed invention as obvious, lacking inventive steps under Section 3(d) of the Patents Act.
Understanding the Indian Patent Regime:
The Indian Patent Act of 1970, governing patents in India, has undergone amendments in 1999, 2002, 2005, and 2006. Notably, the 2005 amendment extended product patents to various fields of technology, including drugs. The Controller General of Patents, Designs, and Trade Marks (CGPDTM) oversees the administration of the Act.
Challenges within the Indian patent system include a complex application process, long waiting times, unclear guidelines, and data safety concerns. Article 3(d) of the Indian Patent Act, excluding the mere discovery of new forms of known substances without enhanced efficacy from patentability, aims to prevent evergreening. However, disputes around this provision have been a point of contention, particularly in international trade relations.
Judicial delays, jurisdictional challenges, and the recent scrapping of the Intellectual Property Appellate Board (IPAB) contribute to the inefficiencies in the resolution of intellectual property cases.
Challenges in the Indian Patent System:
Complex Procedures:
- The Indian patent system grapples with prolonged waiting times for patent approvals.
- Unclear instructions regarding patentable subjects contribute to the complexity.
- Reporting requirements and concerns about data safety further add to the intricacies.
Compatibility Issues:
- A significant point of disagreement between India and the U.S. revolves around Article 3(d) of the Indian Patent Act.
- Section 3 delineates what does not qualify as an invention, with 3(d) specifically excluding the mere discovery of a new form of a known substance without enhancing its efficacy.
- Section 3(d) aims to prevent the practice known as “evergreening” in patent extensions.
Judicial Delays:
- Despite the 2015 Commercial Courts Act offering potential solutions, delays persist in patent-related proceedings.Â
- Limited courts have benefited from the Act, reducing its overall impact.Â
- Jurisdictional challenges further diminish the effectiveness of the courts, compounded by inadequate resources and training.Â
Intellectual Property Appellate Board (IPAB):
- The abolition of the Intellectual Property Appellate Board (IPAB) has left a void in handling intricate Intellectual Property Rights (IPR) issues.
- The efficient resolution of cases involving complex IPR matters is now at risk, potentially leading to a shift of cases to Commercial or High Courts, thereby increasing the backlog of pending cases.
FAQs
Q: What is the current status of tuberculosis (TB) in India?
India bears a significant burden of tuberculosis, being one of the countries with the highest incidence of the disease globally. Despite efforts to control TB, challenges such as drug resistance and lack of access to healthcare persist, making it a major public health concern.
Q: What efforts are being made to combat TB in India?
The Indian government, along with various international organizations and non-profits, has implemented several initiatives to tackle TB. These include increased funding for TB programs, improved diagnostic methods, and the promotion of directly observed treatment, short-course (DOTS) strategy.
Q: What is Bedaquiline, and why is there a patent challenge surrounding it?
Bedaquiline is a novel drug used in the treatment of multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB). There is a patent challenge surrounding it because of concerns about accessibility and affordability. Generic drug manufacturers argue that the patent restricts access to this life-saving medication for many who need it.
Q: Who is challenging the patent on Bedaquiline in India?
Various organizations and advocacy groups, including Médecins Sans Frontières (MSF), have been at the forefront of challenging the patent on Bedaquiline in India. They argue that affordable generic versions of the drug should be available to ensure wider access to treatment for TB patients.
Q: What are the potential implications of a successful patent challenge for Bedaquiline in India?
If the patent challenge is successful, it could lead to increased competition from generic manufacturers, resulting in lower prices for Bedaquiline. This, in turn, could improve accessibility to the drug for patients in India and other countries where TB is prevalent, potentially saving lives and reducing the spread of drug-resistant strains of the disease.
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