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Indian Supreme Court Denies Novartis Cancer Drug Patent 288

Posted by Unknown Lamer
from the better-luck-next-time dept.
beltsbear writes "Following a reasonable view of drug patents, the Indian courts have decided that making small changes to an existing patented drug are not worthy of a new patent. This ruling makes way for low cost Indian cancer drugs that will save lives. From the Article: 'Novartis lost a six-year legal battle after the court ruled that small changes and improvements to the drug Glivec did not amount to innovation deserving of a patent. The ruling opens the way for generic companies in India to manufacture and sell cheap copies of the drug in the developing world and has implications for HIV and other modern drugs too.'"
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Indian Supreme Court Denies Novartis Cancer Drug Patent

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  • Re:Huh? (Score:3, Interesting)

    by rst123 (2440064) on Monday April 01, 2013 @11:17PM (#43334839)

    except the old patent is probably expired / expiring.

  • Re:Innovation (Score:5, Interesting)

    by Zemran (3101) on Monday April 01, 2013 @11:17PM (#43334843) Homepage Journal

    Only a complete fool, April or otherwise, would base anything on imaginary property. There is nothing intellectual about that.

  • by Anonymous Coward on Monday April 01, 2013 @11:24PM (#43334875)

    Oh and the numbers I gave are based on the U.S. Dollar, inside the United States.

    I've been in remission for over 3 years thanks to Gleevec, but it still sucks that they (Novartis) push for profiteering over saving lives.

  • Re:Huh? (Score:5, Interesting)

    by whoever57 (658626) on Monday April 01, 2013 @11:29PM (#43334887) Journal
    The original invention/discovery was made before the date after which drugs are eligible for patent protection in India. So the original invention was too early and the changes were not sufficient for a new patent that would have been after drigs became eligible for protection in India
  • by bfandreas (603438) on Monday April 01, 2013 @11:49PM (#43334945)
    Problem is this practice is a bit more widespread than just one drug. It's called "evergreening". You take a drug, you make a minute change to it, you tell everybody its fresh&new&patent plx!
    India said no to that. They said that Novartis had its run of the full duration of patent protection and that it wouldn't be fooled.
    Also Novartis does bill patients thousands of dollars per month for this particular drug. Which is extortionist. A little bit competition is more than just a little bit needed.

    The big news is India said no while Europe and the US said yes.
  • by bayankaran (446245) on Tuesday April 02, 2013 @12:01AM (#43334985) Homepage
    Now, NOVARTIS will start making generics.

    Generic drugs made by third parties are sorely needed by non G8 nations across the world. Indian companies are the leaders in making generics....like Chinese companies in making electronics / hardware. The argument of multinationals pharma companies like NOVARTIS claims the high cost of R & D for inventing new drugs for keeping up the high price. This has been debunked by the report on TIME [time.com] (and many other sources) which proved the same drug or treatments costs vary highly depending on who pays. And such costs are amortized from G8 nations itself. Also none of these companies are making any losses in their balance sheet whatsoever...what they demand is permanent 'rent seeking'. [wikipedia.org]

    Today's TIME has an OPED by their Delhi correspondent [time.com] with grave warnings on future of Indian pharma - the type of warnings issued by World Bank / IMF / West on Developing countries - basically on the lines on "do as I say, not as I do". I guess NOVARTIS marketing droids called TIME headquarters and asked them to run a sympathetic piece. We are talking about a company with $54 billion sales and $9 billion plus profit in 2012! Imagine their power. And now imagine the 'purported losses' on a few drugs going out of patent in developing countries - it will be negligible at best.

    There is no way any Indian - except for the 2-3% of the elite - can afford a $2600 ~ Rs 130000 / - cost for a month long treatment. This is a country with no health social safety net other than public medical colleges and affordable primary health care facilities and medicines. (Private Health Insurance is a new phenomenon, slowly catching on, the advantages and disadvantages we know...we have to look at USA.)

    The only argument which can be made against Indian generics - "if you can't afford the drug, why don't you suffer the consequences". I guess even the most hard nosed penny pinching corporate drone is not THAT heartless.

    Instead of fighting the generic manufacturers, NOVARTIS should create their own special generic versions and beat them on a price point. But the suits running the show looked at some powerpoint and decided, lets first fight, if we lose start making generics.
  • Re:Innovation (Score:4, Interesting)

    by sFurbo (1361249) on Tuesday April 02, 2013 @12:14AM (#43335025)
    Until we have a better system in place for coming up with the hundreds of millions of dollars it takes to prove the efficacy and safety of a new drug, drug patents are one of few cases where patents make sense.
  • This is very big... (Score:5, Interesting)

    by tanveer1979 (530624) on Tuesday April 02, 2013 @12:17AM (#43335027) Homepage Journal

    "Evergreening"
    This is a process where pharma companies make teeny weeny changes to compound and get a new patent, bypassing the 20 year limit on patents. Indian law(thankfully) does not allow "Evergreening". Patents cannot be issued on "new versions" or "slight changes".
    The courts are very sensitive to this, and will not allow pharma companies to get away.
    What this ruling has done is that many more common drugs can now be sold as generics. Cancer is a relatively rare disorder, but there are other more common diseases where patented drugs are very expensive.
    With this ruling generics will get a big boost. Not only that, there is a push by the govt to prevent doctors from recommending "brands" and recommend generic brand name drugs which are 1/10 the cost, or even cheaper.
    There has been lot of pressure by the WTO to allow corporate to plunder the masses, but the govt has held out on its own. There are many things wrong with India. Thankfully. patent system as it stands today is not one of the things wrong!

  • by Okian Warrior (537106) on Tuesday April 02, 2013 @01:59AM (#43335295) Homepage Journal

    You appear to know about biology and related public policy, so let me ask a few questions:

    1) Suppose I don't have insurance and get cancer. Why can't I simply opt out of the FAA regulation system? Why can't I get a less tested and less expensive medicine (with informed consent) the same way I would get a less expensive car? Is "death of the patient" really the best outcome?

    2) The Hippocratic oath has a statement, words to the effect "first do no harm" [wikipedia.org]. Sometimes this is interpreted as "do more good than harm" (example: medicines which cause side effects) and sometimes as "do no harm whatsoever" (patient dies because treatment is not yet vetted, safe treatment but off-label application, &c). Shouldn't these two points of view be reconciled?

    3) A car mechanic will give me a diagnosis of what's wrong with my car, and an accurate estimate of what it will take to fix it. He's then bound to that estimate by strong state laws which protect the consumer. If a doctor doesn't get the diagnosis right the first time, I have to pay for a 2nd diagnosis and cure and then possibly a third one until he gets it right. For surgery, you never know ahead of time how much it will cost, or even how many separate bills you will get. Should states have consumer protections laws for medicine, in the manner of automobile repair protections?

    4) If not, why?

    5) Doctors make educated guesses based on statistical inference. (Example: A Recent Maryland death from rabies [cbsnews.com]. The correct diagnosis was only determined after the patiend had died) An inexpensive broad-spectrum testing grid that identified [for example] 2,000 infectious agents would seem to be the answer, yet FDA testing requirements would make such a product prohibitively expensive. Why shouldn't we have a less-well-tested version which is cheap, and can be used for initial screening?

    6) Magnifying glasses are available at the convenience mart. Why can't they sell inexpensive (but with limited functionality) hearing aids? Why are medical devices which do not directly affect the health of the patient (such as hearing aids) so expensive, and why do they require expensive fitting by professionals? Why can't artists build and sell prosthetic hand attachments?

  • Re:Innovation (Score:3, Interesting)

    by jewens (993139) on Tuesday April 02, 2013 @02:12AM (#43335319)
    How about this: Allow anyone to take an existing product (even one that is still under patent protection), make is slightly stronger or last slightly longer and allow them to file for a patent on the new product. The original patent owner would still have their patent but the owner of the improved-product patent is not encumbered in anyway by the still existing patent for the inferior=original patent. If minor changes indeed create a new patentable idea then it shouldn't matter who makes them. This would at least prevent the original patent owner from sitting on improvements until 1-day before his existing patent expires. First-to-file might be good for something after all.
  • Re:Innovation (Score:3, Interesting)

    by Anonymous Coward on Tuesday April 02, 2013 @02:14AM (#43335327)

    To hell with safety.

    Allow life-saving drugs to be developed more quickly and cheaply, give them an "experimental" classification complete with a legal waiver. If I'm going to die of cancer in 2-3 years without medicine, do you think I give a shit about "safety"? There's no shortage of volunteers for these kinds of drug trials.

    Now that developing drugs just got cheaper, more pharma startups can enter the market, and the number of years drug patents last for can be reduced.

    Since doing this would benefit everybody except lobbyists, lawyers and politicians, there is of course no chance that it would ever happen.

  • by Phrogman (80473) on Tuesday April 02, 2013 @03:57AM (#43335523) Homepage

    Those millions often end up in the hands of the companies doing the research - or in the hands of the universities doing the research which is then given to those companies. Either way its just another way of providing more money to powerful corporations - our money.
    More power to India if it can break the medical patent system and provide much needed drugs or treatments to those in need, and not just those who are rich and in need. We have been fed the line that the exclusive patents are needed or no research would be done on any new drugs.
    Do you honestly think that is true? That researchers won't do any research suddenly? that all that money collected to help pay for research won't actually be collected any more?
    All that will happen is that Big Pharma will make less billions than it does now, and more people will live longer and happier than they do now.

  • by Anonymous Coward on Tuesday April 02, 2013 @06:13AM (#43335801)

    A lot of the so called innovation is turning something from subcutaneous shots into pills. I'm sorry, but that is nothing that takes BEEEELLLIONS to research. It's worthwhile. But it's not the tedious research bit where you painstakingly find out how an illness works and how to counter it.

    A lot of the "research" leading to these evergreen patents is even more trivial than that. See this article [nih.gov]. Adding caffeine to the pill is a good one. Changing the binding agent in the pill so it dissolves with a different time course. Many of these don't involve the extensive FDA testing required for new drugs, or can capitalize on existing off-label studies.

    Evergreening inhibits innovation. eg, if doc's discover that Drug A causes a lot of stomach pain and routinely add/promote calcium carbonate (Tums) along-side Drug A. As the patent on Drug A comes up, the drug company just adds some CaCO3 to the formulation and Bam! new patent. The only reason to introduce this "innovation" before the patent expires is the convenience of the consumer, but delaying the "innovation" until expiration allows the company to maintain a monopoly on a nominally superior product.

    Kudos to the Indian courts for standing up to this crap

  • by Rich0 (548339) on Tuesday April 02, 2013 @06:36AM (#43335867) Homepage

    Do you honestly think that is true? That researchers won't do any research suddenly? that all that money collected to help pay for research won't actually be collected any more?

    Certainly the researchers paid by Pharma companies (to the tune of tens of billions a year in the US) won't be doing research any longer. Those who work for the NIH would be completely unaffected by a change to the patent system.

    There is a lot of ignorance about how the costs break down for drug development. Here is how it works:

    1. Government and academic R&D spends a few million to come up with a cure for cancer in mice. Discovery makes front page of NYT.

    2. Pharma company pays government or academic lab $100k to license the molecule. Activists point out that this amounts to corporate welfare.

    3. Pharma company goes on to spend $10M to show that the molecule will never work in people. Drug dies with no publicity.

    That's basically the drug development model - the drugs that actually get marketed are an aberration. Most companies do heavy investment in testing dozens of drug candidates per year (the ones that make it fairly far), and they only release maybe a few per decade. Far more drugs get rejected early in testing before anybody even hears about them.

    However, once in a while you get to step 4:

    4. Pharma company spends about $100M on the molecule and it works out. Activists point out that the company is making billions per year on a drug that only cost $100M.

    You can only spend $100M to get a successful drug if you know in advance which drug will be successful. That only applies if you're copying the work done by some other company (though you don't need all that testing in the first place on a true copy). The reality is that it costs billions to come up with a new drug, because you have to test a lot of stuff that doesn't work.

    Drug discovery is a bit like ice hockey, but make the goals about half their current size. Lots of passing and skating, little scoring.

"Bureaucracy is the enemy of innovation." -- Mark Shepherd, former President and CEO of Texas Instruments

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