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Not So Evergreen
April 1, 2013 12:26 PM   Subscribe

"India's supreme court has ruled against Swiss drug giant Novartis in a landmark case that activists say will protect access to cheap generic drugs in developing nations."

"Glivec sells in developed nations for more than $3,000 for a month's worth of treatment, but a generic version is sold in India for less than $200."

"The Indian Patent Office in 2006 denied a patent to Novartis, a decision upheld by the Indian Intellectual Property Appellate Board. The board cited a provision of Indian law that aims to prevent “evergreening,” in which companies make an incremental change to a drug’s chemical makeup, without any real medical benefit, to extend its patent life and prevent the introduction of low-cost generic copies."

Novartis says it will stop investing in R&D in India.
posted by vidur (15 comments total) 6 users marked this as a favorite

 
As usual, in the pipeline has a good analysis.
posted by lalochezia at 12:30 PM on April 1, 2013 [4 favorites]


I was kind of surprised about this, not because of the ruling, but because of all the "Landmark Ruling!" headlines. I've somehow long been under the impression that getting a drug patent enforced in India was already fairly impossible.
posted by Thorzdad at 12:36 PM on April 1, 2013


Wiki link on evergreening; may be useful for background on this term as it applies to Novartis trying to patent a reformulation of an existing drug.
posted by Blazecock Pileon at 12:38 PM on April 1, 2013 [1 favorite]


I was trying to read a Science article on this and hit a paywall. Is this ironic?
posted by sciencegeek at 12:52 PM on April 1, 2013


Thorzdad, as linked above, In The Pipeline has a good overview. That article notes that part of the complexity in this case arises from the fact that India updated its patent laws in 2005, a condition placed upon India for it to join the WTO, and that this drug wasn't patented in India previously. Now that the Indian laws are in place, Novartis apparently didn't even try to actually bolster their case that the drug was improved. From the In The Pipeline article:
The Indian Supreme Court, in fact, noted in its decision that Novartis had never provided any data on the effect of bioavailability on therapeutic efficacy, with the implication being, I think, that if they had such data they surely would have presented it by now in order to strengthen their case.
I'm not sure why this is a landmark, either, except it might be noted that India used its laws to prevent a drug being copyrighted, instead of not issuing any composition patents, as used to be the case.
posted by filthy light thief at 12:59 PM on April 1, 2013


Hmm, Novartis had $14.8 billion dollars in sales in 2012 (.pdf warning). Countdown to their press release announcing that due to this decision their company will tank and that they can no longer fund research into drugs and other pharma blah blah.
posted by Purposeful Grimace at 1:13 PM on April 1, 2013


I was kind of surprised about this, not because of the ruling, but because of all the "Landmark Ruling!" headlines. I've somehow long been under the impression that getting a drug patent enforced in India was already fairly impossible

This is not about enforcing patents but about establishing/clarifying standards for issuing one.
posted by asra at 1:18 PM on April 1, 2013


Has anything changed, or does the pharma industry still only devote about 20% of their expenditures toward R&D?
posted by mullingitover at 2:01 PM on April 1, 2013


Indian Supreme Court Rejects Trivial 'Evergreening' Of Pharma Patents

"Here, for example, is the story of how Novartis came to gain its highly-lucrative monopoly on Gleevec/Glivec, as told by the key researcher who actually developed it: Brian Druker, chair of Leukemia Research and professor of medicine at the Oregon Health and Science University Cancer Institute..."
posted by homunculus at 7:12 PM on April 1, 2013


I've found some interesting things looking through their shareholder report from last year (6Mb PDF). Of gross profit of $38.8b, they spent 9.3b (24%) on R&D. This is high, but compare that with spending on marketing and sales: 14.4b (37%), or almost 65% more than they spent on R&D.

So yeah, when pharma companies say they spend a lot on R&D, I believe them. But that's not where most of their money goes, not even close. Like many people I find it a bit pathetic when the marketing budget exceeds production budget on a AAA video game or a movie, but it seems this is par for the course in pharma.
posted by vanar sena at 10:13 PM on April 1, 2013


Novartis used to be called "Sandoz".
posted by telstar at 11:22 PM on April 1, 2013


This approach to "evergreening" has always confused me. I feel like I'm missing a really obvious piece of the puzzle. As I understand it, the patent on drug A is about to expire, meaning that other companies are allowed to start making and selling it. They'll probably do so at a fraction of the original cost, since the copiers have dramatically less R&D outlay to recoup. To avoid losing income to these new competitors, the drug company introduces the near-identical drug B, patents it and markets it as the new hotness. So we now have A, which anyone can make cheaply, and B, which only the original company can make.

There are two basic scenarios that I can think of:

1) B is demonstrably better than A: in which case, we're not talking about "evergreening", we're talking about progress, the system working as intended. Besides which, the existence of new drug B doesn't make old drug A any worse: the generics companies can still churn out A at massively reduced cost, and patients would benefit just as much as if B had never been thought of.

2) B and A are pretty much the same: in which case, who gives a damn whether B is patented, or even exists? Everyone can ignore B, buy A cheaply from generics manufacturers, and benefit just as much as if B had never been thought of.

Am I just being grossly optimistic about healthcare providers' deference to the evidence base when prescribing drugs,* or am I missing something else obvious here? If India really was convinced that the new version of gleevec is no better than the previous version that's already being produced as a generic, why do they care about the new version being patented?

*I know that in some areas of the UK, GPs are much more likely to prescribe expensive brand-name statins than identical generics. With the restructuring of the NHS, we can expect this sort of thing to increase, as "giving power to doctors" inevitably means more complex purchasing and treatment decisions made by people without the resources to build or interpret a large and complex evidence base. But that's a different rant.
posted by metaBugs at 11:29 AM on April 2, 2013


Can We Patent Life?
posted by homunculus at 2:44 PM on April 2, 2013






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