Big Win Against Evergreening For Tuberculosis Sufferers In India, But Will Johnson & Johnson Allow Those In Other Countries To Benefit?
from the do-the-decent-thing dept
“Evergreening” refers to the practice by pharmaceutical companies of making small changes to a drug, often about to come off patent, in order to gain a new patent that extends its manufacturer’s monopoly control over it. The first Techdirt post about evergreening appeared almost exactly ten years ago. It concerned the rejection by the Indian Supreme Court of an attempt to “evergreen” the drug Glivec. Now the Indian Patent Office has rejected Johnson & Johnson’s attempt to extend its monopoly on a lifesaving drug for treating tuberculosis, in what is arguably one of the most important wins against evergreening.
Tuberculosis (TB) is a serious illness that kills nearly two million people each year. Drug resistant forms are a major problem, which makes two newer TB drugs – bedaquiline and delamanid – particularly important. However, these drugs are expensive: typically, a course of treatment costs thousands of dollars. Research in 2017 showed that large-scale manufacturing of generic versions would cost just 10-20% of that. Patents prevent these drugs being made more cheaply, which in turn limits the number of people who can be treated with them in poorer countries.
Fortunately, bedaquiline goes off patent this year, something that Johnson & Johnson naturally wants to prevent. Two TB survivors filed a petition with the Indian Patent Office to stop Johnson & Johnson’s attempt to evergreen its Indian monopoly on the drug. The petition was supported by Médecins Sans Frontières/Doctors Without Borders (MSF), which has issued the following update on the move:
the 2019 patent challenge by two tuberculosis (TB) survivors, Nandita Venkatesan and Phumeza Tisile, was successful: the Indian Patent Office rejected the US pharmaceutical corporation Johnson & Johnson’s (J&J) attempt to extend its monopoly in India on the TB drug bedaquiline beyond the primary patent’s expiry this July. Médecins Sans Frontières/Doctors Without Borders (MSF) welcomed this as a significant step toward increasing access to the lifesaving TB drug.
Indian patent law does not allow evergreening of patents and prevents pharmaceutical corporations from abusing the patent system through making minor changes that can further extend their 20-year drug monopolies. Such evergreening practises are explicitly prohibited in the Indian patent system through a health safeguard — Section 3(d).
The rejection by the Indian Patent Office is a huge win for those suffering from TB in India, but potentially the benefits could be even wider. India’s generic drug manufacturers supply many countries with vital medicines at low prices. The hope is that once they start producing bedaquiline more cheaply, it can be sold in countries that have been unable to afford the current version from Johnson & Johnson.
However, there is a problem, once again caused by the threat of evergreening. Although India does not allow evergreening, thanks to Section 3(d) of its 1970 Patents Act, that’s not the case in other countries. Johnson & Johnson could still bring lawsuits to prevent generic versions of bedaquiline being sold where evergreening is permitted. Because of this possibility, the MSF has issued the following call:
Moving forward, J&J must not block the supply of more affordable generic versions of bedaquiline to high TB burden countries and stand by its 2019 statement from the Managing Director in India of Janssen (J&J’s pharmaceutical division), that generic manufacturers will be able to make generic versions of bedaquiline starting in 2023. This means that the US corporation should also urgently withdraw its patents in other countries, including high TB burden countries, where the equivalent of the Indian patent application still remains.
It remains to be seen whether Johnson & Johnson will do the decent thing and allow TB sufferers around the world to receive treatment they have hitherto been denied, or whether the company is so addicted to evergreening – and the profits it brings – that it sticks to its bad old ways.
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Filed Under: big pharma, drugs, evergreening, generics, india, msf, multidrug-resistant tuberculosis, tuberculosis
Companies: johnson & johnson
Comments on “Big Win Against Evergreening For Tuberculosis Sufferers In India, But Will Johnson & Johnson Allow Those In Other Countries To Benefit?”
Would not the new patent only cover the version with the small change? If so, what prevents a company from manufacturing the unmodified (and now off-patent) version?
Re: Too similar to permit generics of the old version of the drug, yet similar enough to consider the new version innovative enough for a new patent
As a US resident, I’d like to know why too. Is it because of court precedents which accept evergreening as valid (which is my guess)? Or is it more because the cost of creating precedent against evergreening is too costly for anyone with standing to try creating?
As I pointed out in an admittedly clumsy comment on a previous Glyn Moody post about evergreening:
Re: Re: tks
A vendor claiming “military-grade encryption” is like claiming that a brand of water is better because it’s “mapquest directions”
Re:
‘Potentially ruinous legal fees from being sued and having to prove that they’re using the no longer covered ‘old’ recipe, fees that they would be on the hook for no matter the outcome of the case that would be filed against them’ would be my guess.
Excuse me while I roll around on the floor laughing at the idea that a modern day multinational company cares enough about human suffering to lower its profits by even a penny.
'... Oh wait, you're serious, let me laugh even harder.'
It remains to be seen whether Johnson & Johnson will do the decent thing and allow TB sufferers around the world to receive treatment they have hitherto been denied, or whether the company is so addicted to evergreening – and the profits it brings – that it sticks to its bad old ways.
Given they already tried to keep generics out of the market once via evergreening the question if they will willingly allows them to show up in other markets if they have any say in the matter has already been pretty solidly answered I’d say.
Such evergreening practises are explicitly prohibited in the Indian patent system through a health safeguard — Section 3(d).
If ever there was a clause that should be adopted by every government around the world that one should be near if not at the very top of the list.
reverse settlement payments,
I read about this some time ago, here is an article from 2015:
“Known as “reverse settlement payments,” or “pay-to-delay” deals, the financial arrangements are a unique but common practice in the pharmaceutical industry. Essentially, they allow drug manufacturers in some instances to pay competitors not to manufacture generic versions of their products, thereby ensuring that they maintain patent protection for as long as possible.”
https://www.nbcnews.com/business/business-news/drug-firms-stave-generics-costing-consumers-billions-critics-say-n447916
“Any headline that ends in a question mark can be answered by the word no.”
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