Health

Bedaquiline and India's patent law

Opposition to the new patent claims on the Johnson & Johnson drug is a test of how well the rules against evergreening are working

 
By Latha Jishnu
Last Updated: Monday 18 March 2019
Illustration: Tarique Aziz

A report mid-February in a South African health journal was an eye-opener. It had a detailed account of how desperate patients suffering from cancer and other life-threatening conditions were sourcing generic versions of medicines from India since the original drugs made by pharma multinationals were prohibitively priced and out of their reach. The report tracked relatives who were making trips to Indian cities to buy supplies in bulk from wholesalers, underlining the point that even with the tab for a flight (lasting over 10 hours) and stay in hotels, the generic medicines were a fraction of the cost charged by the originator companies.

I chanced upon the story at about the same time Phumeza Tisile, a South African survivor of drug-resistant tuberculosis (DR-TB), was making international headlines for coming all the way to Mumbai from Khayelitsha, to file a pre-grant opposition to a secondary patent claim made for bedaquiline, the best known treatment for this deadly form of TB. The patent claims have been filed by Janssen Pharmaceutica NV, a subsidiary of pharma giant Johnson & Johnson (J&J), and these would not only have extended its monopoly on the core DR-TB drug bedaquiline but also on routine improvements and formulations on the compound. The original patent runs till 2023, and should the additional claims on the fumarate salt of bedaquiline be granted it would extend J&J’s monopoly till the end of 2027. This strategy is known as patent evergreening, a ploy adopted by originator firms to keep the prices inordinately high since it would keep reasonably priced generic versions of the drug out of the market till the term of the patent.

It is specifically to prevent evergreening that India’s Patent Act was amended in 2005 to include Sections 3d and 3e with a detailed enumeration of what is not patentable in the pharma sector. But sadly the patent office has been less than diligent in scrutinising such patent claims. In a study last year of patents granted between 2009 and 2016, it was found that a shocking 72 per cent were secondary patents given for marginal improvements on previously known compounds on which patents existed.

Yet, Phumeza Tisile, who joins Nandita Venkatesan from Mumbai, another DR-TB survivor, in opposing the new claim of J&J, is hopeful the effort will be successful. The two are supported by humanitarian organisation Medecins Sans Frontieres (MSF) which points out that J&J has already profiteered hugely from what was a collective effort on bedaquiline. It says several of the phase I and II trials conducted prior to the drug’s registration were funded by public and philanthropic organisations. Besides, J&J did not invest directly in phase III trials whereas research institutes and treatment providers, including MSF, were providing the necessary support.

J&J charges $30,000 for a six-month course of bedaquiline in high-income countries — some states in the US have baulked at paying this price — and $400 in a very small number of countries procuring it through the Global Drug Facility. That still leaves thousands of patients without access to the drug. Here’s hoping Venkatesan and Tisile succeed for the greater good.

This blog was first published in Down To Earth's print edition (dated 1-15 March, 2019)

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