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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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  • Well I imagine that if these small changes are not enough to get a new patent, then they are saying that this new variation of the old drug falls under the protection of the old drug.

    • Re: (Score:3, Interesting)

      by rst123 (2440064)

      except the old patent is probably expired / expiring.

    • 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
    • Well I imagine that if these small changes are not enough to get a new patent, then they are saying that this new variation of the old drug falls under the protection of the old drug.

      And you actually hit the nail on the head. You're entirely correct. Think about it this way, if the Original patten were still valid and another company came up with the same "Changes" could the first company sue under that patent and win? Of course they could. So how can that very same company claim that those changes are innovation? If they are innovation then the generic company should be able to make small changes and reproduce it.

      India is a screwed up country but this is one area they are getting right

  • It's a good thing... (Score:5, Informative)

    by Anonymous Coward on Monday April 01, 2013 @11:19PM (#43334855)

    A 30 day supply of 400mg tabs of Gleevec (imatinib sulfate) runs a lil over 6 thousand dollars. That's right, 6k a month to keep patients with CML, HES and certain stomach cancers alive. It's gone up over 2 thousand a month in the last 3 years alone.

    If you have insurance, good insurance, you might pay around 50 bucks of that a month. Without insurance, you get to use prednisone til it or the cancer kills you.

    Way to go pharmaceutical companies... and do you really think they are working on a cure when they can rake in thousands of dollars a month from each and every cancer patient??? Yeah right... think again... If they understand the cancer well enough to halt it in it's tracks for 90 to 95% of the patients that are treatable by this drug, and another 90 to 95 of those that take it are alive and in full remission 5+ years later, they certainly know enough to track down a cure if they were so inclined to do so.

    Greedy bastards...

    • 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.

      • by black6host (469985) on Tuesday April 02, 2013 @02:00AM (#43335297)

        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.

        I'm happy to hear you're in remission, even though I don't know you personally.

        You know, we have no problems taking peoples property under eminent domain for the "good of the people". There was a business owner where I used to live who was forced to sell his property to the local gov't because they needed to turn it into a parking lot to support the major retail center across the street. The reason put forth: the additional tax revenue would benefit the public. Of course the builder of this retail/hotel/restaurant center stood to profit the most and I am confident was the one who persuaded the city to take the property with the thought of increased revenue. Bastard.

        I'd like to see eminent domain apply to drugs that would help save, or greatly prolong the lives of many people. That makes sense to me. But it's not the big companies who get screwed.....

        • Problem with the scenario: the patents themselves are meant to benefit society through "advancement of the useful arts and sciences" (--quoted from memory so check), and they aren't property (though the legal priesthood likes to assert more and more that ideas can be rented) but limited monopolies on production authorized by the Constitution and subject to the dictates of Congress: I doubt therefore that they would count as property, they're tyrannies: I would say that Congress could probably just amend leg
    • by sFurbo (1361249) on Tuesday April 02, 2013 @12:21AM (#43335049)

      do you really think they are working on a cure when they can rake in thousands of dollars a month from each and every cancer patient??? Yeah right... think again...

      I would expect all of the other drug companies to also want a piece of that pie. That means they have to come up with something that works better.

      If they understand the cancer well enough to halt it in it's tracks for 90 to 95% of the patients that are treatable by this drug, and another 90 to 95 of those that take it are alive and in full remission 5+ years later, they certainly know enough to track down a cure if they were so inclined to do so.

      Greedy bastards...

      You are vastly, massively underestimating the complexity of cancer and of the human biology.

      • 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?

        • by sFurbo (1361249) on Tuesday April 02, 2013 @04:07AM (#43335543)
          I don't live in the US and am not a doctor, so my knowledge is limited, but I will try to answer the best I can.

          1. Because we have decided that the risk of people being swindled by quacks become too large if we allow that. What you can do is enlist in a test of a new drug, which should give you access to less tested drugs.
          2. There really aren't two different points of view. In all applications of medicine, the chance of benefit must be weighed against the risk of harm. For tested medicine, we have a good estimate of them both, and a judgment can be made. For untested medicine, the prior plausibility of the harm/benefit ratio is deemed too unfavorable.
          3-4. I don't know, as I don't know the American system. But remember that fixed prices moves the risk to the hospital or doctor, and they have to be compensated for taking that risk, so it will mean more expensive treatment.
          5. The depends on the rate of false negatives and false positives. Any screening causes someone to experience side effects from unnecessary side effects, and some people to not get the treatment they need.
          6. I imagine hearing aids are expensive because they are fiendishly advanced. Out ears are able to pick out sounds with abysmal S/N (next time you are in a crowded, noisy room, try to see how many different conversations you can listen to simply by choosing one over the other), and the hearing aids have to work with that system. Also, sweat and ear wax are not the least corrosive environment, and any leaching might be problematic. For prosthetics, I imagine it could be done, though the list of materials and the way the prosthetic sticks to the body might be a problem.
    • by Fjandr (66656)

      A single injection of Neulasta is $6,000, and you get two a month for many standard chemotherapy treatments.

    • There is no shortage of cancer patients. Pharmaceutical companies don't make their money on drugs that don't work. They make their money by making effective drugs that cure people. Do you seriously think there is some big conspiracy to keep cancer patients sick? Are you a fucking moron?

      Drug companies have no shortage of sick people. People take up smoking every day. They also have to pay millions in legal fees not to mention insurance and paying for the research they have to do. The more risky the drug

    • by hsmith (818216)
      Without those greedy bastards, you'd be dead already.
  • Huh? (Score:5, Insightful)

    by Locke2005 (849178) on Monday April 01, 2013 @11:32PM (#43334893)
    This doesn't make sense to me. If they make a small change, the small change should be patentable -- but that should in no way effect the extent of the patent on the original formulation. In other words, patenting the small change shouldn't stop anybody from copying the original drug. And if the "small change" actually makes a real difference in effectiveness, isn't that an argument that it _should_ be patentable?
    • Patents on new drugs make sense. When these patents expire, the companies try to find some way to re-patent the drug. Too often, the change is from "take 2 25mg tablets twice a day" to "take 1 50mg tablet twice a day". In other words, the changes often really have nothing whatsoever to do with the actual active ingredient being delivered. Instead of capsules, the drug become a tablet; instead of a syrup it's now a capsule.

      This case seems to be even more egregious, because Novartis did not even develop the o

    • by drinkypoo (153816)

      And if the "small change" actually makes a real difference in effectiveness, isn't that an argument that it _should_ be patentable?

      The problem with that idea is that drug studies can't show a small difference in effectiveness.

      Here's how the drug companies maintain their grip: They work on derivatives of the original drug which are slightly different but which do more or less the same thing, and have them ready before the patent on the existing drug expires. In the USA (and possibly other developed nations, but I haven't done the research) the approval of derivatives is fast-tracked. It is notably cheaper and the bar is much lower when

  • Can this combine with the "Doctrine of First Sale" case [slashdot.org] by the Supreme Court a few weeks ago about the textbooks bought in Thailand and sold in the USA? Then, instead of having USA-citizens buying cheap pharma-drugs from Canadian pharmacies, they could buy the cheap generic versions from Indian pharmacies.
    :>)
    Someone could start a business importing the generics from India and selling them here in the USA legally, rather than those generics being a "gray market" product: http://en.wikipedia.org/wiki/G [wikipedia.org]
    • by whoever57 (658626)

      (interestingly, the USA wikipedia uses the British spelling for grey, eh? How hoity-toity!)

      That's the correct spelling for grey to you, colonist.

      Actually, Wikipedia doesn't have a USA version, it has an English version.

    • by Zemran (3101)

      From the article that you linked to "A grey market or gray market, also known as parallel market,..." - It seems that the English version of the page that you cite is quite clear that there are 2 ways of spelling the word. I am British and when I write on that site I write in English and point out alternative spelling just as this writer has. There is nothing wrong with the page that you link to.

      • Greetings, across-the-ponder. I only said that it was "interesting", not that it was wrong. I assume that the Great Edit Wars of the '00s (the Twenty-O-O's) and the Great Revert Battles of Wikipedia of 2010 saw much churning both within the article and in the title itself. The skies must have been filled with the e's and the a's being catapulted back and forth as the Revolutionary Forces and the east-of-the-pond residuals of the once Mighty Empire hurled vowels and invective and inflections (and once, th
  • 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.
    • by TubeSteak (669689)

      Instead of fighting the generic manufacturers, NOVARTIS should create their own special generic versions and beat them on a price point.

      In the developing world, premium priced branded generics are turning into big money for pharmaceutical companies.
      The people are very aware of counterfeit drugs, so they'll pay a premium for Bayer Aspirin
      (festooned with holograms and safety seals on the boxes and bottle)
      even though aspirin has been generic for an exceedingly long time.

    • by stdarg (456557)

      India has the 7th largest defense budget in the world at about $50 billion (US). They have a space program. They develop and maintain nuclear weapons.

      All the talk about how poor India is and how they need free medicine is bullshit. They could pay for it but instead they choose the route of compulsory licenses and invalidating patents. Instead of working with drug companies to give them a fair profit while providing drugs, they want domestic companies to produce the generics and keep the profits (it's no cha

  • 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!

  • Big Pharma is a gigantic example of market failure. Easiest way to take care of this problem is to create a network of government/nonprofit drug design centres around the world, impose an R&D levy on all medication, and the contract out the manufacturing to the cheapest bidder.

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