'Relief to poor': MNC patent on costly TB drug rejected, to 'help' generic production

By Our Representative
On March 23, 2023, the Indian Patent Office (IPO) rejected pharma company Janssen’s application for an extension of its patent on bedaquiline, a drug used in the treatment of tuberculosis patients. The verdict that came just a day ahead of World Tuberculosis Day was celebrated by health activists and tuberculosis survivors in India.
Janssen, owned by multinational Johnson and Johnson, applied for an extension of their original patent on bedaquiline on the basis of having discovered a new formulation. According to Indian law, in order to be granted a patent extension in such a situation, the manufacturer has to show that the new formulation leads to an enhanced therapeutic effect. Janssen repeatedly failed to prove that in the case of bedaquiline salt formulation.
If the patent on bedaquiline had been extended, public and family budgets would have remained burdened by unjustifiable high costs of the drug. Bedaquiline is an important drug for TB patients on many counts. The older TB drugs include injectables such as kanamycin, which have severe side effects including permanent hearing loss. On the other hand, bedaquiline is an oral drug with much higher safety and efficacy profile.

Bedaquiline was the first new tuberculosis drug in forty years when it was approved by the US Food and Drug Administration in 2012. According to the most recent Global Tuberculosis Report, in 2021, India recorded 119,000 cases of multidrug resistant tuberculosis and over half a million deaths caused by the disease.
Priyam Lizmary Cherian, an intellectual property lawyer who argued the case at the IPO, said that the decision should ease the generic production of bedaquiline, making safe and effective treatment more accessible. “India, being a generic production hub, can count on companies being able to pick up production after the original patent expires in July 2023,” she said.
Widely recognized as a disease of the poor, tuberculosis is generally not a prominent field in Big Pharma research and development, although it affects the lives of hundreds of thousands in the Global South. In 2021, the money invested in this field globally was not even half of what a UN High Level Meeting identified as a target.
---
Source: Peoples Dispatch / Globetrotter News Service

Comments

'Enough evidence' in Indian tradition to support legal basis for same-sex marriage

By Iyce Malhotra, Joseph Mathai, Sandeep Chachra* The ongoing hearing in the Supreme Court on same-sex marriage provides space for much-needed conversations on issues that have hitherto remained “invisible” or engaged with patriarchal locker room humour. We must recognize that people with diverse sexualities and complex gender identities have faced discrimination, stigma and decades of oppression. Their issues have mainly remained buried in dominant social discourse, and many view them with deep insecurities.

Buddhist shrines were 'massively destroyed' by Brahmanical rulers: Historian DN Jha

Nalanda mahavihara By Our Representative Prominent historian DN Jha, an expert in India's ancient and medieval past, in his new book , "Against the Grain: Notes on Identity, Intolerance and History", in a sharp critique of "Hindutva ideologues", who look at the ancient period of Indian history as "a golden age marked by social harmony, devoid of any religious violence", has said, "Demolition and desecration of rival religious establishments, and the appropriation of their idols, was not uncommon in India before the advent of Islam".

Victim of communal violence, Christians in Manipur want Church leadership to speak up

By Fr Cedric Prakash SJ* The first eleven days of May 2023 have, in many ways, been a defining period of Indian history! Plenty has happened in a rapid-fire stream of events. Ironically, each one of them are indicators of how crimes and the criminalisation of society has become the ‘new norm’; these include, the May Day rallies with a focus on the four labour codes which are patently against the rights of workers; the U S Commission on International Religious Freedom (USCIRF) released its Annual Report on 1 May stating that conditions for religious freedom in India “continued to worsen in 2022”; the continued protest by the Indian women wrestlers at Jantar Mantar for the expulsion of the chief of the Indian Wrestlers Federation on very serious allegations; the Elections in Karnataka on 10 May (with communalism and corruption as the mainstay); the release of the fake, derogative and insensitive film ‘The Kerala Story’; the release of World Free Press Index on 3 May which places India

Swami Vivekananda's views on caste and sexuality were 'painfully' regressive

By Bhaskar Sur* Swami Vivekananda now belongs more to the modern Hindu mythology than reality. It makes a daunting job to discover the real human being who knew unemployment, humiliation of losing a teaching job for 'incompetence', longed in vain for the bliss of a happy conjugal life only to suffer the consequent frustration.

Unlike other revolutionaries, Hindutva icon wrote 5 mercy petitions to British masters

By Shamsul Islam* The Hindutva icon VD Savarkar of the RSS-BJP rulers of India submitted not one, two,or three but five mercy petitions to the British masters! Savarkarites argue: “There are no evidences to prove that Savarkar collaborated with the British for his release from jail. In fact, his appeal for release was a ruse. He was well aware of the political developments outside and wanted to be part of it. So he kept requesting for his release. But the British authorities did not trust him a bit” (YD Phadke, ‘A complex Hero’, "The Indian Expres"s, August 31, 2004)

Delhi HC rules in favour of retired Air Force officer 'overcharged' for Covid treatment

By Rosamma Thomas* In a decision of May 22, 2023, the Delhi High Court ruled in favour of petitioner Group Captain Suresh Khanna who was under treatment at CK Birla Hospital, Gurugram, between April 28 and May 5, 2021, for a period of eight days, for Covid-19 pneumonia. The petitioner had to pay Rs 3,55,286 as treatment costs, but the Ex-Servicemen Contributory Health Scheme (ECHS) only reimbursed him for Rs 1,83,748, on the basis of government-approved rates.

Polygamy in India "down" in 45 yrs: Muslims' from 5.7 to 2.55%, Hindus' 5.8 to 1.77%, "common" in SCs, STs

By Rajiv Shah Amidst All India Muslim Personal Law Board (AIMPLB) justifying polygamy, saying it “meets social and moral needs and the provision for it stems from concern and sympathy for women”, facts suggest the the practice is down from 5.7 per cent of Muslim families in 1961 to 2.55 per cent in 2006.

Savarkar 'criminally betrayed' Netaji and his INA by siding with the British rulers

By Shamsul Islam* RSS-BJP rulers of India have been trying to show off as great fans of Netaji. But Indians must know what role ideological parents of today's RSS/BJP played against Netaji and Indian National Army (INA). The Hindu Mahasabha and RSS which always had prominent lawyers on their rolls made no attempt to defend the INA accused at Red Fort trials.

India joining US sponsored trade pillar to hurt Indian farmers, 'promote' GM seeds, food

Counterview Desk As many as 32 civil society organisations (CSOs), in a letter to Union Commerce Minister Piyush Goyal on the Indo-Pacific Economic Framework (IPEF) and India joining the trade pillar, have said that its provisions will allow the US to ensure a more favourable regulatory regime “for enhancing its exports of genetically modified (GM) seeds and GM food”, underlining, it will “significantly hurt the livelihoods of Indian farmers.”

Modi govt 'wholly untrustworthy' on Covid data, censored criticism on pandemic: Lancet

By Rajiv Shah* One of the world’s most prestigious health journals, brought out from England, has sharply criticised the Narendra Modi government for being “wholly untrustworthy on Covid-19 health data”, stating, the “official government figures place deaths at more than 530 000, while WHO excess death estimates for 2020 and 2021 are near 4·7 million.”

Search This Blog