Legal Issues

by Mike Masnick




Patents Or Your Life: Dealing With Patents When Lives Are On The Line

from the questions-questions-questions dept

This isn't a new issue and there isn't an easy answer, but questions concerning patents and life-saving drugs aren't going to go away any time soon. It's being highlighted now that there's a fear over Avian flu. First India said it would ignore Roche's patents to make a generic form of Tamiflu and now Taiwan is saying the same thing. In both cases, they make the claim that saving the lives of their citizens is a lot more important than protecting the intellectual property of a foreign company. The same argument has been made in the past in places like Brazil. In fact, it's been said for years that, especially in developing nations, it's often important to ignore intellectual property issues from developed nations in order to protect citizens. Of course, the counter argument is that none of these drugs would have been developed in the first place if there weren't these patent laws around. While that may be debatable, it is true that the cost of developing these drugs often requires a high expected payout at the end. So what are ways to align these two issues? How can companies expect to get paid for saving lives -- and still make the products affordable enough that they actually can save lives? One option bandied about from time to time is (more or less) what's happening: just make the drugs cheaper in less developed countries. Of course, that just opens up an arbitrage opportunity for someone to buy cheap drugs in those countries and resell them elsewhere (see: pharmacies, Canadian). It seems like perhaps it's time to start wholly rethinking the entire process.

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  • identicon
    dorpus, 24 Oct 2005 @ 3:34am

    If they can control the quality, sure.

    Earlier batches of Tamiflu had a nasty tendency to make patients hallucinate. One 8-year-old girl in Japan who received a dose of Tamiflu started chirping like a bird and jumped out of the hospital window.

    Can countries like Brazil or India make such fine adjusments to their drugs? Or will gullible Westerners think they can buy "bargain" drugs over the internet from those countries?

    reply to this | link to this | view in chronology ]

    • identicon
      Anonymous Coward, 24 Oct 2005 @ 8:03am

      Re: If they can control the quality, sure.

      Does anyone know where the drug companies are manufacturing now? With outsourcing and global supply Brazil and India might just be where the drugs are manufactured anyway!

      reply to this | link to this | view in chronology ]

      • identicon
        dorpus, 24 Oct 2005 @ 9:26am

        Re: If they can control the quality, sure.

        Manufacturing good drugs require high-quality ingredients, good logistic coordination, and skilled workers who know what they're doing. It's usually cheaper to do this in a rich country, than in some developing country where the available chemicals are full of impurities, scheduled deliveries are always late, and illiterate workers couldn't tell chemical A from chemical B -- they just dump whatever bottle they see into the vat.

        As for the microbes acquiring resistance -- people do die or lose fingers from infections. Antibiotics are a must. If microbes acquire resistance to existing antibiotics, then we have to discover new classes of antibiotics that attack the microbes differently. Of course, that costs money -- billions of it.

        reply to this | link to this | view in chronology ]

    • identicon
      sigmund fraud, 24 Oct 2005 @ 10:28am

      Re: If they can control the quality, sure.

      One benificial side effect of this Tamiflu hallucination is that the patient lays an egg before jumping. The protein in this egg is the only known cure for the disease. This is the only way we can stop the disease, since, as we all know, drugs cannot cure diseases.

      reply to this | link to this | view in chronology ]

  • identicon
    howard, 24 Oct 2005 @ 5:02am

    How much to copy?

    How much does it cost to copy a drug? Instead of violating the patent, what if the countries in question gave that money to the patent holder for the ability to manufacture the drug legally?

    Killing the goose (drug manufactures) that lay the golden egg (quality medicine) seems like a very short sighted thing.

    reply to this | link to this | view in chronology ]

    • icon
      MadJo (profile), 24 Oct 2005 @ 5:22am

      Re: How much to copy?

      Begs the question why these types of live-saving drugs are patented and protected so strongly. Shouldn't it be more open and more free? So that everyone and his dog/bird can have access to it legally and without too much costs.

      reply to this | link to this | view in chronology ]

      • identicon
        Oliver Wendell Jones, 24 Oct 2005 @ 6:12am

        Re: How much to copy?

        Did you read Mike's comments? Do you have any idea how much is involved in bringing a new drug to market?

        Even if God himself spoke to you in a vision and revealed to you the formula to a new drug, it would still take years and years of clinical trials and FDA (and other countries' regulatory bodies) to actually release that drug for sale.

        Believe it or not, that costs money - lots and lots of money, so even if you didn't spend a dime on research (holy vision, remember?) you still have to spend a truckload of money on all the necessary testing, marketing, packaging, etc.

        Even with all the testing that is done, there are always people out there who, for whatever reason, respond poorly to a drug and sometimes they end up permanently damaged or dead - and guess what, the family then sues the drug manufacturer. And how do the drug manufacturers protect themselves? Insurance - and guess what? Insurance costs a lot of money. The legal team that goes to court to fight the charges costs a lot of money, and so on.

        And where do the drug manufacturers get their money? From high-priced medications. Why are the prices high? So they can make back the billions of dollars spent bringing a drug to market before the patent runs out.

        If you want cheaper pills, then you need to convince the FDA to stop requiring all that time-wasting and money-intensive clinical testing and convince the American Bar Association to stop suing drug manufacturers every time someone has an adverse reaction to one of their pills. Then you'll have cheap pills - of course it might make your skin turn orange and your hair fall out and you won't be able to sue anyone - but it'll be cheap.

        reply to this | link to this | view in chronology ]

        • identicon
          Tim, 24 Oct 2005 @ 6:47am

          Re: How much to copy?

          How come nurofen costs upwards of GBP2 or 3 for a packet, while tesco can package ibuprofen for something like 20p?

          Was there originally a patent on some of this? Has it expired or been devalued? If you can expire a patent, you can replace it with a pure marketplace approach instead: the cost/time pattern caused bt recovering the costs of research and then mass-producing cheaply but with a tiny % markup will be much the same.

          reply to this | link to this | view in chronology ]

        • identicon
          Mike S., 24 Oct 2005 @ 7:57am

          Re: How much to copy?

          You (Oliver) speak of how much it costs to actually make a drug.

          That sort of begs another question, doesn't it? Like WHY does it cost so damn much to create a new drug?

          You mention lawyers and the FDA and insurance. Perhaps the issues we should address are reducing the barriers to new drugs and reducing idiotic compensation lawsuits.

          I understand that there should be both safeguards against bad drugs and a way for those injured to seek damages (but ONLY when it can be shown that the company being accused did or should have known about the danger). But we whine and moan about why companies charge so much, then we sue the shit out them for every time someone gets sick, despite the fact that government holds up drugs for YEARS doing testing. We can't have it both ways.

          Either we accept the government beauracracy and continue to sue the shit out of them AND accept that that stuff costs lots of money, OR we push for tort reform, simplify the approval process and accept the risks associated with cheaper drugs.

          reply to this | link to this | view in chronology ]

          • identicon
            DrZZ, 25 Oct 2005 @ 2:48am

            Re: How much to copy?

            By far the largest cost associated with finding a new drug is all the clinical trials that fail before you get the one that works. Most estimates I've seen indicate a 90-95% failure rate. By far most of these failures are not controversial, ie it is not that the FDA refuses to approve a drug that the company thinks should be approved, it is the company and anyone else looking at the results can plainly see that the drug didn't work. If it takes 10-15 clinical trials to find a drug that works, the price of that drug needs to cover all tose failures or the company will lose money. If other companies can wait around until the trials are run and then pick up the winner, they never have to pay for the failures and they always will always have a huge competative advantage. The long term solution is to advance the science enough that the failure rates aren't so large, but that just isn't the state of the art today. You just can't find new drugs with out a lot of failure and if the companies can't pay for the failures with their few successes, it won't make business sense to risk failure and hence you will have no new drugs.

            reply to this | link to this | view in chronology ]

            • identicon
              Yme Bosma, 30 Oct 2005 @ 4:23am

              No more intellectual property

              I don't believe in the concept of intellectual property and I think existing patent and copyright systems should be removed. They no longer make economic sense and are blocking, instead of stimulating, innovation. Both in the cultural and industrial parts of society. The only form of intellectual property that probably (still) makes sense is trademarks.

              I do think that as a society (on a global level) we have alternative means to stimulate innovation in the pharmaceutical industry. Why should a new form of public-private cooperation involving an organization like the United Nations, on behalf of all of us, not be able to map all problem areas (lack of innovation due to high economic risks) and provide necessary funding for research and development? Innovations should be published and allowed to be used, patent free, by anyone who thinks there is a market for them. Competition, always a good driver for innovation, should definitely have a place in such a (financing) model. Let examples like X-Prize, Darpa's Grand Challenge, the 'paid-pitch-model', scientific research, 'beauty-contests', etcetera, inspire us.

              And, at the same time, why not integrate the lessons and methods from the succesful open source communities in such a system in order to make sure innovations are being made accessible so that they can be further build upon?

              Granting monopolies for a certain period of time in order to protect profits, with the risk of slowing down innovation, can not seriously be the best possible answer in today's world. It's even costing lives.

              reply to this | link to this | view in chronology ]

        • identicon
          Erick Pal, 24 Oct 2005 @ 8:11am

          Re: How much to copy?

          I once thought your idea about the FDA requiring time-wasint clinical testing was a good one. But you should check out this documentary called The Corporation. It refers to BGH(Bovine Growth Horomone) that now plague the milk you drink, that's been known to cause serious after effects in humans, all because they tried to push it quickly through FDA. No doubt about it, once you ease up on any governmental control, corporations that fund the elections will find some way to abuse it just to sell stuff, even to your harm.

          reply to this | link to this | view in chronology ]

        • identicon
          Anonymous Coward, 24 Oct 2005 @ 8:15am

          Re: How much to copy?

          You said
          " you still have to spend a truckload of money on all the necessary testing, marketing, packaging, etc."

          I'm pretty sure in this case the marketing cost will be close to zero. 8-} And exactly how much do those little medicine bottles with the adult proof caps cost anyway?

          You said
          "Even with all the testing that is done, there are always people out there who, for whatever reason, respond poorly to a drug"

          Like Vioxx? It seems the legal cost go up considerably when they lie about or ignore bad reports.

          You said
          "If you want cheaper pills, then you need to convince the FDA to stop requiring all that time-wasting and money-intensive clinical testing"

          Are you seriously suggesting we go back to the age of patent medcines?

          Every process can be improved and FDA approval is no exception but would you really buy drugs that weren't tested? Would you buy a house that wasn't inspected. I guess if you were retarded you might.

          reply to this | link to this | view in chronology ]

        • identicon
          Pussy, 24 Oct 2005 @ 10:10am

          Re: How much to copy?


          “From high-priced medications. Why are the prices high? So they can make back the billions of dollars spent bringing a drug to market before the patent runs out.”

          Ahem... Bullshit. But nice try, pharmaceutical troll.

          This argument looses a LOT, probably ALL, of it’s credibility when faced with the fact that drug companies spend more on advertising (A product that most Americans cannot buy) then they do on research.

          This argument REALLY falls apart when one learns that there are patented medications to cure illnesses that the drug manufactures refuse to manufacture, not because it costs to much to make the pills – but because the illnesses are to rare to make any money from them. Of course if you happen to have the illness, and can’t buy the medication you need to treat it because the treatment doesn’t make someone else rich...

          When you further figure that a LOT of medical research is paid for with government, or non-profit money (Anyone here “race for the cure” or pin a ribbon on there lapel, or donate money to “research” recently?) the idea that the pharmaceutical ass-clowns should be making money while people suffer is difficult, at best, to justify.

          Yah, it costs a lot to produce a new medication. It costs a lot to produce a Hollywood style movie too. But the costs to produce do not justify the cost to the consumer. I don’t know why the argument “It costs so much to make a drug, so we need protection” (when it costs more to advertise than to make the drug) flies, but the argument “It costs so much to make a movie / hit record / insert other media here, so we need protection" doesn’t fly.

          reply to this | link to this | view in chronology ]

    • identicon
      Denis, 24 Oct 2005 @ 6:58am

      Re: How much to copy?

      Drugs are expensive, sure. However, the thing that bothers me is that the exact same drug from the exact same manufacturer in the exact same packaging costs much less in Canada than in US. It is produced in the same factory most likely so why are drugs more expensive in US than in Canada? Is it the case of pricing according to market? Seems only sometimes since the drugs are not availed to poor countries...

      reply to this | link to this | view in chronology ]

    • identicon
      Anonymous Coward, 24 Oct 2005 @ 8:07am

      Re: How much to copy?

      RTFA, Roche refused to license the drug. It sounded like the countries were willing but Roche wasn't.

      reply to this | link to this | view in chronology ]

  • identicon
    W Giles, 24 Oct 2005 @ 7:02am

    No Subject Given

    I hardly think it's debatable that patent laws make drug development a profitable endeavor. Without assurance that their property rights will be recognized and protected, pharamaceutical companies would disappear.

    This is another battle in the fight against socialized health care and it's advocates. Regardless of anyone's supposed motives, stealing is wrong. Harming a company by pilfering and looting it's intellectual products cannot be rationally justified. No one has "health care rights" that superceded the natural rights of others. The very idea invalidates the concept of rights altogether.

    reply to this | link to this | view in chronology ]

    • identicon
      The Other Mike, 24 Oct 2005 @ 7:21am

      Re: No Subject Given

      While I agree to a point that nobody has a "healthcare right." Governments do have the ability and duty to do what they can to protect its people from preventable things such as a pandemic of bird flu that could wipe out half it's population. A governments first duty is to its people, its allies financial income come in very far behind that issue.

      That being said, stealing is still stealing. There should be serious and long lasting repurcussions for doing something like ignoring patent rights on a drug. They should be done by our own government if the company is incapable of seeking reparitions on its own. Economic sanctions sound about right as a response to this kind of behavior.

      That's just my humble opinion though.

      reply to this | link to this | view in chronology ]

    • identicon
      Pete Austin, 24 Oct 2005 @ 7:37am

      Re: Health Care Rights

      (a) Copying is not stealing, nor pilfering, nor looting. It's copying..
      (b) I don't recall that monopoly profits was one of the inalienable rights.
      (c) If you would let people die, purely to make more money, then that is your god and graven image.
      (d) Medicine existed before the current IP nonsense and will outlast it - just with more ethics and fewer lawyers.

      reply to this | link to this | view in chronology ]

    • identicon
      John Hull, 24 Oct 2005 @ 8:32am

      Re: No Subject Given

      I think it is HIGHLY debatable whether or not patents are really needed on medicine. There's a HUGE market for drugs...and you're telling me that in the absence of patents that no drugs would get developed? That is ridiculous. Someone would figure out how to do it, and do it efficiently. I really don't see how that claim is any different than the broadcasting companies claiming that no more content would be broadcast or developed unless the broadcast flag is in palce.

      reply to this | link to this | view in chronology ]

    • identicon
      Anonymous Coward, 24 Oct 2005 @ 10:19am

      Re: No Subject Given

      Saying that something cannot abuse some invalidates the concept of rights altogether? I thought it was the PEOPLE who had the rights, not the corporations? Perhaps you need to reconsider what a “right” is.

      So... you would SERIOUSLY argue that the guy who steals a loaf of bread in order to feed his starving family should have his hands cut off?

      You are a fine example of American corporate greed.

      The very idea that a corporation should be allowed to watch people suffer and DIE just because they can’t pay the exorbitantly inflated prices the corporation wants to dispense there medication invalidates the idea of humans all together, and creates a race of people who a little more than indentured servants to corporations.

      reply to this | link to this | view in chronology ]

      • identicon
        The Other Mike, 24 Oct 2005 @ 11:06am

        Re: No Subject Given

        >So... you would SERIOUSLY argue that the guy who steals a loaf of bread in order to feed his starving family should have his hands cut off?< br>
        Not sure who this post was aimed at but...

        I am saying that a man who steals a loaf of bread in order to feed his already starving family should be made to do an equal amount of labor for his crime. The man who steals a loaf of bread because he knows that his family will one day starve should have his hands cut off.

        >I thought it was the PEOPLE who had the rights, not the corporations?

        Corporations have rights, just different ones than people. Does your bakery not have the right to demand money for your product instead of giving it away, no matter how good business was today?

        >The very idea that a corporation should be allowed to watch people suffer and DIE just because...

        You mean like when people do that? Wonder why people have the right to do that...

        reply to this | link to this | view in chronology ]

      • identicon
        Anonymous Coward, 24 Oct 2005 @ 11:16am

        Re: No Subject Given

        May I propose a simple solution? Why don't we split off into two separate worlds. The people who would like to stay in the world where the pharmaceuticals are developed the way they are now can stay. Those on this board that are so quick to villify companies that develop these medications can set up whatever the magic framework for developing medicine they have invented and treat themselves with the medications produced without, what was it that you called it, "a fine example of American corproate greed".

        In your world, you can forbid companies from spending any money on marketing the drugs, or whatever you believe it is that they're spending all your money on unjustifably. And that will solve all problems, right, because drugs will be instantaneously free and everyone will be healthy.

        Wait a minute. If you're sitting on such a gold mine of an idea, why don't you just set up a company that is not so greedy yourself. Surely, if this will make drugs cheaper and more effective, you will outsell everyone 10 to 1. If this is the answer to everything, why isn't anyone trying this? Could it possibly be because that statistic about marketing is completely and entirely made up?

        reply to this | link to this | view in chronology ]

        • identicon
          Anonymous Coward, 24 Oct 2005 @ 1:23pm

          Re: two worlds

          We already live in two Americas, don't you listen to the Republicrates? Please read carefully before flaming, with only two political parties it's just different sides of the same corrupt and corroded coin.

          We actually do live in both worlds. The second world is called generic drugs, which are manufactured once a drug comes off patent.

          Intellectual Property (an oxymoron if ever there was one) is a hot topic these days. Even companies like Microsoft (not exactly a bastion of socialism) is beginning to realize that current laws are not going to work in the future.

          Let's try a little quiz, who said

          "Monopoly is the enemy of good management"

          Marx, Keynes, Castro, Kennedy?

          Believe it or not Adam Smith in "A Wealth of Nations" Not exactly the place you would be expecting such a left wing quote.

          Now let's look at individuals, and yes corps are in a narrow legal view an individual, rights to monopolize IP.

          The U.S. Constitution Article I Section 8 Clause 8

          "To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries;"

          Great goal lousy approach, that is if you think capitalism, or at least the guy who created capitalism, knew a little something about human nature.

          You can see the influence of the corporate mindset in the Mickey Mouse IP laws. It's called that because it was done to extend Disney's monopoly on ?

          You guessed it Mickey Mouse.

          It was done long after the creators were dead and unable to be motivated to create additional cartoon characters. The Supremes chickened out and said that Congress (Pro is to Con as Progress is to Congress) had wide lattitude in writing the laws.

          Monopoly for IP is a bad idea for a number of reasons. It requires the inventor to become a manufacturer. Those two skills are very different. Even if you do possess both of those skills it requires that you drop your inventing and focus on manufacturing. A waste of a good inventors time. It gives the inventor a monopoly which, as we all now know, is the enemy of good management. It encourages the Not Invented Here syndrome. Since it's a civil matter it requires the plaintive to enforce the law, which encourages theft.

          There are a couple of great examples of the misuse of the patent laws. The guy who invented the intermittent windshield wiper, Robert Kearns, spent the rest of his life suing people trying to get his due. I think he probably could have come up with more nifty inventions if he spent his time inventing instead.

          Jerome Lemelson is famous, some say infamous, for his use and misuse of the patent system. Keeping submarine patents around for decades until someone tried to actually produce a product. Saying he invented something has been compared to Jules Vern inventing spaceflight.

          Once again, CEOs have a fiduciary responsibility to make a profit. They will do almost anything, if you don't believe me read the records of the tobacco companies, Ford Motors and the Pinto, or ...

          Of course a competitive market is not a gold mine, it requires hard work for modest returns, anyone with ambition will want to maximize their returns, and monoplies are the best way to do that. Once a company goes public there is little that can be done. Wall Street demands a return on their investments.

          reply to this | link to this | view in chronology ]

  • identicon
    Anonymous Coward, 24 Oct 2005 @ 8:37am

    Begging the question

    This whole discussion assumes that no matter what the health question is, new drugs are the answer. Nothing could be further from the truth. Drugs don't kill microbes they merely mutate them. Thinking you have to constantly develop new drugs show a complete lack of understanding of evolutionary biology.

    Drugs suppress the susceptible microbes giving the resistant ones the opportunity to dominate. All you end up doing is breeding resistant microbes. If you take an anti microbial drug and stop using it once it becomes ineffective the susceptible microbes will no longer be suppressed and in a few years time they will be able to compete making the drug effective again.

    Of course if you continue to sell it to farmers as part of a weight gain regime then it will never really be out of circulation.

    The same is true for many other modern maladies. If you're overweight take a pill. Forget diet and exercise, it's too hard. If you're stressed out forget finding a lower stress lifestyle, take a pill. Well you get the idea.

    What makes you think for profit drug companies will give us the best medicine? The heads of these companies have a fiduciary responsibility to make the most money they can, not to save the most lives they can. To think otherwise is simply naive.

    reply to this | link to this | view in chronology ]

    • identicon
      Have to be kidding me, 24 Oct 2005 @ 10:05am

      Re: Begging the question

      Are we actually going to find a way to say money is more important that lives? If drug companies would spend 1/100th of what they do in trying to "market" drugs and procedures to doctors, they they would be able to charge less for these things.

      The number one profitable drug last year was viagra, then came crazy pill. They make money on the ones that don't save lives, but try to make them better. The ones that save lives should be as low as they can possibly be and then let the people worried about not getting it up because their hair line is back, their bad chloresterol up and they can't sleep at night.

      I am glad these countries are saying what is necessary and putting the good of human life above profits. Now if we could do that to lawyers and health care here in this country then things might actually improve.

      reply to this | link to this | view in chronology ]

  • identicon
    Steve, 24 Oct 2005 @ 1:59pm

    Patents Or Your Life: Dealing With Patents When Li

    The process is fine. As pretty much always, what need be rethought is who should be allowed to have and raise human beings such that issues regarding integrity, trust, etc., are moot. Until then, you can rethink the pound of cure aka the likes of locks and passwords and policing and laws and business and etc. all you like.

    reply to this | link to this | view in chronology ]


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