Historic Ruling Against First Modern Drug Patent In India

from the just-the-start? dept

Tue, Dec 11th 2012 12:09am — Glyn Moody

As Techdirt has reported over the last year, the Indian government is becoming increasingly keen on using cheaper, generic versions of important drugs to treat diseases, rather than paying Western-level prices its people can ill afford. Intellectual Property Watch reports on another instance of the Indian authorities easing the way for low-cost versions by striking down a patent granted to Roche for the treatment of Hepatitis C. As the article explains, it's notable for at least two reasons:

the patent granted to Roche in 2006 was the first product patent on a medicine in India after the country switched to a product patent regime for medicines as mandated by the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). It is also India's first successful post-grant opposition case.

Getting rid of the first modern drug patent in this way neatly symbolizes the country's aggressive new attitude to Western-held monopolies on medicines. It's interesting that in this case the opposition came not from the Indian government, but from Sankalp Rehabilitation Trust, a non-governmental organization, which hopes to source the drug from a manufacturer of generics cheaply enough to be able to give it away for free. This may well inspire post-grant opposition from other organizations seeking to provide cheaper drugs to the sick in India through the use of generic versions.

Follow me @glynmoody on Twitter or identi.ca, and on Google+

Thank you for reading this Techdirt post. With so many things competing for everyone’s attention these days, we really appreciate you giving us your time. We work hard every day to put quality content out there for our community.

Techdirt is one of the few remaining truly independent media outlets. We do not have a giant corporation behind us, and we rely heavily on our community to support us, in an age when advertisers are increasingly uninterested in sponsoring small, independent sites — especially a site like ours that is unwilling to pull punches in its reporting and analysis.

While other websites have resorted to paywalls, registration requirements, and increasingly annoying/intrusive advertising, we have always kept Techdirt open and available to anyone. But in order to continue doing so, we need your support. We offer a variety of ways for our readers to support us, from direct donations to special subscriptions and cool merchandise — and every little bit helps. Thank you.

–The Techdirt Team

Filed Under: generics, hepatitis c, india, patents
Companies: roche

39 Comments

If you liked this post, you may also be interested in...

Reader Comments

Subscribe: RSS

View by: Time | Thread

Yogi, 11 Dec 2012 @ 12:39am

Hate it
I would hate working for a drug company that makes a living off the death and misery of millions of people in the third world. How do these people even sleep at night?
Silly me - they take sleeping pills. Probably they get them for free...so I guess there are some perks for working in a drug company after all...
[ link to this | view in chronology ]
- Anonymous Coward, 11 Dec 2012 @ 1:30am
  
  Re: Hate it
  I've been hearing for years about how drug producers wont make any drugs if they don't get billions in returns, so I have to wonder why they got the job in the first place? Healing people or making money? The same complaint seems to come from money-hungry Hollywood leeches, no surprise there considering their own reputation is build on that. Honestly, if making money is the main reason you do anything, then Wall Street is always open, you could just switch jobs to the 'profit makers' instead.
  [ link to this | view in chronology ]
  - Badger (profile), 11 Dec 2012 @ 3:05am
    
    Re: Re: Hate it
    They're in business... what do you expect them to do? Are you about to hand over a few billion in R&D to your local doctor?
    [ link to this | view in chronology ]
    - G Thompson (profile), 11 Dec 2012 @ 4:17am
      
      Re: Re: Re: Hate it
      Nearly all the R&D for these medicines comes not from there pockets but from the hard work and PUBLIC usage of funds from universities!.. That or the drugs were discovered by accident (not unlike penicillin).
      
      The R&D costs are over inflated puffery and accounting witchcraft
      [ link to this | view in chronology ]
      - Anonymous Coward, 11 Dec 2012 @ 4:24am
        
        Re: Re: Re: Re: Hate it
        Biggest misconception of all. The gap between university discovery (which is cheap) and the pill on the shelf is several hundreds million of dollars. And most of that will go to doctors, and patients in clinical trials.
        [ link to this | view in chronology ]
        
        G Thompson (profile), 11 Dec 2012 @ 4:34am
        
        Re: Re: Re: Re: Re: Hate it
        Clinical trials are NOT R&D. Clinical trials are mandated by government for scientific. legal and ethical reasons.
        
        And even then they too are subsidised by tax refunds and other handouts. Also "hundreds of Millions" is a bogus figure, though even if not it is nowhere near the quoted "billions" that I replied too
        [ link to this | view in chronology ]
        
        The Real Michael, 11 Dec 2012 @ 4:56am
        
        Re: Re: Re: Re: Re: Re: Hate it
        Yeah, I was just going to say. How could it possibly cost hundreds of MILLIONS of dollars just to develop medicine? Somebody's wallet is definitely getting fatter.
        [ link to this | view in chronology ]
        
        Anonymous Coward, 11 Dec 2012 @ 5:08am
        
        Re: Re: Re: Re: Re: Re: Re: Hate it
        Yup: most of that cost is back-loaded into the clinical trials (such as the use of the hollow HIV protein sheath to deliver a gene-modifying virus in some cases of leukemia that's currently being tested.)
        
        Yes, it costs some money, but I would be hesitant to expect that it costs BILLIONS to run such trials.
        [ link to this | view in chronology ]
        
        The Real Michael, 11 Dec 2012 @ 5:19am
        
        Re: Re: Re: Re: Re: Re: Re: Re: Hate it
        Insightful. People deserve to know the full truth about how these pharma corps are pulling the wool over their eyes.
        [ link to this | view in chronology ]
        
        Badger (profile), 11 Dec 2012 @ 5:30am
        
        Re: Re: Re: Re: Re: Re: Re: Hate it
        Forbes reviewed costs earlier this year, came up with costs of between $1.3billion and $4.5billion per drug that reaches the market.
        
        http://www.forbes.com/sites/matthewherper/2012/02/10/the-truly-staggering-cost-of-inventi ng-new-drugs/
        [ link to this | view in chronology ]
        
        The Real Michael, 11 Dec 2012 @ 5:37am
        
        Re: Re: Re: Re: Re: Re: Re: Re: Hate it
        At LEAST 1.3 billion dollars? These guys make Hollywood seem like amateurs!
        
        I'm lost for words.
        [ link to this | view in chronology ]
        
        Rigo (profile), 11 Dec 2012 @ 10:00am
        
        Re: Re: Re: Re: Re: Re: Re: Re: Hate it
        I read through the piece, and tbh it reads like a puff piece written for the industry. The authors basically state that they took the numbers in an industry blog post made during the superbowl and used MATH to make them EVEN HIGHER and that something-something justifies the outrageous prices they charge for many drugs. The article mentions a contrary analysis only for the purposes of responding, to whit "lol come on these guys must be wrong".
        
        Pretty absurd. The authors should be ashamed of themselves unless they got an envelope full of cash for this.
        [ link to this | view in chronology ]
        
        Anonymous Coward, 11 Dec 2012 @ 10:54am
        
        Re: Re: Re: Re: Re: Re: Re: Re: Hate it
        From your own linked article:
        
        The high cost of developing drugs shouldn�t be a badge of honor for drug firms; there�s no reason it has to be this expensive. And using the cost of research to justify the prices of prescription drugs was always a dumb move on the pharmaceutical industry�s part. Just because something was expensive doesn�t make it good. And another: many medicines are over-priced, but high-cost drugs are only a small part of our general health cost problem. Medicines are just among the easiest products to scapegoat because their prices are easier to track.
        
        So it would seem that these numbers are still seen as ridiculous. Care to keep pushing them?
        [ link to this | view in chronology ]
  - John Fenderson (profile), 11 Dec 2012 @ 9:20am
    
    Re: Re: Hate it
    I have to wonder why they got the job in the first place? Healing people or making money?
    
    Making money. That is all.
    
    Drug companies don't give a damn about helping people as such. They also make or have made chemical weapons, biological weapons, and various and sundry other other poisons.
    [ link to this | view in chronology ]
- That One Guy (profile), 11 Dec 2012 @ 1:34am
  
  Re: Hate it
  I imagine it's a fairly simple, if horrifying process, where they don't even consider their customers as humans anymore, just numbers. Selling X number of doses isn't helping X number of people, it's just bringing in X amount of money.
  
  When the people making the decisions are only seeing numbers on a screen/page, and never bother or care to connect those numbers to actual people, it allows for, and leads to, atrocities like putting profit above lives to occur.
  [ link to this | view in chronology ]
  - The Real Michael, 11 Dec 2012 @ 5:03am
    
    Re: Re: Hate it
    When the Catholic Church created the first hospitals, they were not-for-profit organizations focused squarely on helping the sick and dying. Now, because opportunistic corporates saw a pot of gold at the end of the rainbow, it's become one of the most expensive things around. Heck, something as simple as a brief visit to the hospital for sterilizing and suturing a small open wound can easily set you and/or your insurance provider back a couple grand.
    
    It's all about the benjamins.
    [ link to this | view in chronology ]
- E G Nyquist (profile), 11 Dec 2012 @ 2:00am
  
  Re: Hate it
  It has been for some years that people in poorer countries, especially the developing world, have been essentially held hostage by western corporations and their influence on governments, WTO, and the world bank. From medication that actually costs more in Asia or Africa than it would in the US or UK, to forcing farmers to use seeds that are crippled so that they cannot be replanted...forcing them to buy them from Monsanto every harvest.
  
  India has been one of the worst victims of this post-colonial imperialism; and It is good to see the yoke breaking more and more.
  
  When one gets rich at the cost of human lives, when one benefits from human misery and suffering... You do wonder how they sleep at night. I would say these sorts of poeple, though they are wealthy and powerful, are the enemies of mankind, and are perhaps among the only human beings that truly deserve death; and sadly they'll be the last ones to suffer for the consequences of their actions.
  
  Unless, of course, the Hindu belief in reincarnation has merit.
  [ link to this | view in chronology ]
  - haiku, 11 Dec 2012 @ 3:19am
    
    Re: Re: Hate it
    South Africa's largest purchaser of drugs is the Government, purchasing (as it does) for the entire country's State hospitals / clinics / etc.
    
    Yet the price paid by the government - on annual tender - is higher than that paid by an individual in the USA.
    [ link to this | view in chronology ]
- Anonymous Coward, 11 Dec 2012 @ 4:13am
  
  Re: Hate it
  So, should we work for free, or stop new drug discovery altogether (so people can keep on dying in peace knowing that there is nothing can be done)?
  
  Your pick?
  [ link to this | view in chronology ]
  - G Thompson (profile), 11 Dec 2012 @ 4:42am
    
    Re: Re: Hate it
    No what you should do is stop bullshiting about "new" drugs, and start actually looking at vaccines and cures. Like what us Aussies did with the Cervical Cancer vaccine.. oops.. that was purely govt funded and not part of a big Pharma thing at all.. OMG! awww did capitalism not work there?
    
    Start actually doing something instead of re-discovering the same freakin bullshit compounds 'but different" that do the same things, and maybe the rest of the world might take notice of your 'new drugs" since they might actually achieve something that is pertinent to the science of medicine. And then maybe then you might get paid what you deserve, until then well dont let the door hit you on the arse on your way out of it.. You might need to "discover" a pill for it
    [ link to this | view in chronology ]
    - The Real Michael, 11 Dec 2012 @ 5:14am
      
      Re: Re: Re: Hate it
      The idea is to force people to keep generating revenue via dependency on their drugs, drugs which don't actually cure anything and just give users a temporary remedy (often with unwanted side-effects). If the industry produced actual cures, their profits would dry up. A healthy public would be their worst nightmare.
      [ link to this | view in chronology ]
  - John Fenderson (profile), 11 Dec 2012 @ 9:31am
    
    Re: Re: Hate it
    That's a completely false dichotomy. To say that the drug companies are ripping everyone off is not to say that nobody should be able to make money developing new drugs.
    
    It's a mistake to leave this critical activity solely in the hands of private for-profit industry, though. First, because it encourages the price-gouging that we currently see, but more importantly because it's harmful to public health.
    
    There is a desperate need for new drugs that can really save millions of lives. Drug companies put nearly all their R&D into drugs with the highest profit potential and neglect those that would make less return on investment (but would actually benefit huge numbers of people).
    
    So we see the plethora of drugs for trivial or noncritical issues: erection pills, heartburn pills, hair-growing formulas, etc., or we see important types of drugs that are made to be as expensive as possible (and therefore useless to most of the people on Earth) and end up being less effective with more side-effects than cheap drugs which are no longer under patent.
    
    The drug companies appear to do more harm than good when it comes to R&D.
    [ link to this | view in chronology ]
  - Anonymous Coward, 11 Dec 2012 @ 11:16am
    
    Re: Re: Hate it
    How about you drop the hyperbole and be a man once in your life?
    [ link to this | view in chronology ]
  - Anonymous Coward, 11 Dec 2012 @ 11:29am
    
    Re: Re: Hate it
    The problem with granting monopolies to others is that eventually those others stop working.
    
    Quote:
    The low number of novel therapeutics approved by the US FDA in recent years continues to cause great concern about productivity and declining innovation.
    
    http://www.nature.com/nrd/journal/v5/n9/full/nrd2131.html
    
    Then others start entering the market with new concepts to not fall into that trap.
    
    http://www.osdd.net/
    
    They do it at a fraction of the alleged costs isn't that something?
    [ link to this | view in chronology ]
- Mr. Oizo, 11 Dec 2012 @ 10:06am
  
  Re: Hate it
  No, they don't get sleeping pills, they get ego boosts. A lot more dangerous.
  [ link to this | view in chronology ]
Anonymous Coward, 11 Dec 2012 @ 2:18am

but didn't i read here recently that the USA via some body or other has just been threatening India and other nations that if they dont do away with this generic drug culture, ensuring that the major US drug companies carried on selling their own brands at 100s times the price, leading to 1,000s of deaths through lack of the people being able to afford to buy, there will be consequences taken against them?
[ link to this | view in chronology ]
- G Thompson (profile), 11 Dec 2012 @ 4:19am
  
  Re:
  What like economic sanctions??
  
  Threatened economic sanctions by the USA against anyone nowadays is laughed hard at, and basically thanked since then the country can scrap any and all contracts with the USA that they have been trying to get rid of for years and go to other countries where the trading is more equitable.
  [ link to this | view in chronology ]
Josef Anvil (profile), 11 Dec 2012 @ 2:25am

Life saving?
It would appear that pharma companies are in the business of creating maintenance drugs, rather than trying to cure anything. It seems the focus is more on how to manage chronic illness.

To be fair, creating addicts is an insanely profitable business model.

As for any drug that is potentially life saving, it seems the thought is to price those drugs as high as tolerable by first world nations. Extortion for human life is another insanely profitable business model.
[ link to this | view in chronology ]
Anonymous Coward, 11 Dec 2012 @ 4:20am

Good luck with that
A good part of the world is flooded with cheapo Indian and Chinese pharmaceuticals. Those, BTW, kill more people than the diseases they are suppose to treat. Some of them are even making their rounds back in the US.
So part of the high price you pay for the branded (or high quality generics) is the insane QC process built in drug manufacturing...
That said, the process is still not perfect (referring to the steroid shot meningitis outbreak), but could be much much worse.
[ link to this | view in chronology ]
- G Thompson (profile), 11 Dec 2012 @ 4:31am
  
  Re: Good luck with that
  You got any reports to back that up?
  
  Maybe from places like the International Red Cross, WHO, Medicins Sans Frontiers, some other world wide non-biased NGO?
  
  Not just the hearsay or bullshit reports that are given from USA HMO's and the Big Pharma consortiums.
  [ link to this | view in chronology ]
- Anonymous Coward, 11 Dec 2012 @ 5:15am
  
  Re: Good luck with that
  And Cow & Gate can get away with poisoning babies in Africa because it's Africa.
  
  And then there's the whole thalidomide thing in the 60s. And the tobacco thing from before then. And Coca-cola using cocaine powder in their original tonic recipe.
  
  And there's drugs all the time that don't do anything but affect the health of their cash c- err, sorry, "patients". And there's a factor-of-hundred markups on drugs that are, at best, minor improvements. Which are then patented and locked up for 14 years.
  
  And the knockoffs are the problem? Call me when the pharmaceuticals stop making drugs altogether.
  [ link to this | view in chronology ]
  - PRMan, 11 Dec 2012 @ 9:51am
    
    Re: Re: Good luck with that
    "Coca-cola using cocaine powder in their original tonic recipe"
    
    No, they've always used coca leaves. Now they just use de-cocained coca leaves. In their defense, it was served as a medicinal drink and this was prior to the formation of the FDA and was sold for only 5 cents a glass.
    [ link to this | view in chronology ]
- Karim, 11 Dec 2012 @ 5:30am
  
  Re: Good luck with that
  Those, BTW, kill more people than the diseases they are suppose to treat.
  
  Utter bullshit, and you know it.
  [ link to this | view in chronology ]
  - Anonymous Coward, 11 Dec 2012 @ 9:09am
    
    Re: Re: Good luck with that
    Sources, please, from either side.
    [ link to this | view in chronology ]
- Anonymous Coward, 11 Dec 2012 @ 6:51am
  
  Re: Good luck with that
  Did you know? Half of the generic medicines you are taking is made in india. Stop taking generics - go only with Brands :D
  [ link to this | view in chronology ]
  - Anonymous Coward, 11 Dec 2012 @ 7:04am
    
    Re: Re: Good luck with that
    And you thought all the brands are made in USA by pharma companies? Good luck with that.
    [ link to this | view in chronology ]
    - Anonymous Coward, 11 Dec 2012 @ 7:50am
      
      Re: Re: Re: Good luck with that
      Well most of my brand name drugs come from China. Except meth - that's All-American.
      [ link to this | view in chronology ]
- John Fenderson (profile), 11 Dec 2012 @ 9:34am
  
  Re: Good luck with that
  So part of the high price you pay for the branded (or high quality generics) is the insane QC process built in drug manufacturing
  
  But it's a tiny part. I can tell because once a drug patent expires, we see the retail price of the formerly expensive drugs fall dramatically, often to the level of "very cheap". The QC requirements don't change one bit, and it's still profitable to make the drugs at the lower prices.
  [ link to this | view in chronology ]
Anonymous Coward, 11 Dec 2012 @ 11:28am

Nobody deserves to suffer or die just because they're poor. The owners of these patents should be fucking ashamed of themselves.

They should be executed for genocide because not letting others make a cheaper drug is resulting in millions of deaths per year.
FFS they have destroyed more lives than any dictator could have dreamed of.
[ link to this | view in chronology ]