Slashdot Mirror


Patents Choking Off Medical Research

pq writes "The New Republic has an insightful article talking about the "absence of truly innovative drugs in current drug company pipelines. And the explanation for that might well come from the supposed fount of American innovation: our patent system." Apparently they are trapped in a situation where "it's much easier to argue that `patents support innovation' than to try to explain that some patents are good for innovation while others are bad." A long read, but unlike the latest copy-protected mp3 player, this is definitely stuff that matters!"

37 of 229 comments (clear)

  1. Article contains no actual quantitative evidence by elefantstn · · Score: 3, Insightful

    The linked article claims that medical research is being harmed by the patent system, but then provides no concrete evidence to prove this is so. The closest it gets is an assertion that there are fewer new meds being produced -- with the laughable backup of "watch commercials on TV, you'll see!" -- without any exploration whatsoever of possible other factors.

    Was there a point to posting this on Slashdot, or are we just trying to jump on an easy-to-blame bogeyman?

    --
    If it ain't broke, you need more software.
  2. Drug Research is a farce. by SirGeek · · Score: 3, Insightful

    When is the last time that drug companies actually came up with a cure ?

    Answer: NEVER, cures are bad for business.

    The last cures that were found (Polio, etc.) were found by independant researchers not worrying about the bottom line and how the stockholders will react)

    I mean how many bloody treatments do we need ? Find a damn cure....

    1. Re:Drug Research is a farce. by elefantstn · · Score: 3, Insightful

      This is one of the stupidest things I've ever read on Slashdot. I mean, really, just think about it.

      AP (New York, Oct 2 2002): Stock prices for Merck Inc plunged 67% today when it was learned that it had discovered and planned on selling a cure for cancer. "How can a drug company with a cure for a widely-spread disease expect to make any profits?" said one industry analyst.

      --
      If it ain't broke, you need more software.
    2. Re:Drug Research is a farce. by aengblom · · Score: 5, Insightful

      No, it's right on. It's a well-known problem too.

      It's not that the drug companies are sitting on the cure.

      They're not LOOKING for it. The private money is funneled into drug possobilities that will pay off. Actually, I'm fine with this. Great, we get treatments. But government has to step up and pay the bill for research that benefits "the public good". Markets arn't the perfect solution for everything. In drug/health care, cooperatives that are put improving health above, investment returns are very important.

      Think about it. Any companies that put the amount of money towards vaccines etc that was relative to their health care value WOULD GO OUT OF BUSINESS. Why vaccines aren't profitable. They are one time use (or so). You only get so many years of monopoly anyway. People will (rightly so) riot if you charge $10,000 for a vaccine for polio, which might make it more profitable.

      --


      So close and yet so far from the world's perfect ID number
    3. Re:Drug Research is a farce. by gdyas · · Score: 3, Insightful

      I work in R&D at a major pharma company, and you are an asshole.

      We bust our hump trying to cure everything from osteoporosis to AIDS and you sit there smugly alleging that we're either holding back cures or not trying to make them? You're a fool. Everyone I work with spends every minute of the work day and most of our weekends trying to develop treatments AND CURES for ungrateful dickheads like you. And we don't do it for the money, which pays the bills but isn't that great, trust me.

      While you're busy making unsubstantiated allegations I'll be inventing drugs to make your life better, you pig.

      --

      The only tool you've got against psychosis is experience.

    4. Re:Drug Research is a farce. by Ralph+Wiggam · · Score: 4, Informative

      Actually, almost every drug company has gotten out of the vaccine business. The government is by far the largest buyer of vaccines and their budget would dictate how much they could pay. Companies couldn't make a profit selling for what the government was paying, so they just stopped doing it. Due to Wyeth-Ayerst dropping out of the tetanus vaccine market, there is almost none available in the country. Tetanus is a horrible disease that virtually nobody gets. Nobody gets it because up until now, the vaccine against it has been highly effective and rather inexpensive. That may be changing in the near future.

      I love free markets, but for certain things "the market" isn't the answer. People's health and safety need to take precedence.

      reference:
      http://archive.salon.com/tech/featur e/2001/03/08/t etanus/index.html - take the space out after you paste

      -B

    5. Re:Drug Research is a farce. by SirSlud · · Score: 3, Insightful

      I don't think he's talking about you (the reasearchers). I'd be very interested to hear the decision making process in terms of where your officers decide allocate the R&D dollars.

      What he's saying is somewhat true only in the sense that R&D companies wouldn't (or couldn't) sell cheap effective remedies if they couldn't sustain a huge business. It's not like a company would willingly make itself smaller, or take less profit, for the sake of humanity alone. Nobody is that naive.

      Your work is appreicated, but remember that the reason the suits get paid more is that they have to make the decisions which really have a huge bearing on the future. While you work your ass off, and nothing could get done without you, the decision of what to work on, and with how many resources is a touchy subject .. and those are the things he's blindly attacking.

      Not to say he's right, but I can tell you here at work that just because I work my ass off doesn't mean I can't appreicate that my company directs me to work my ass off for the sole benifit of the company instead of the benifit of our customers or humanity in some situations. My intent may be pure, but to assume that my company, as a system, isn't capable of actions with less-that-virtuous intents would be awfully reductionist.

      Anyhow, hats off to you. Its us in the trenches that make the world work, no arguments there; I just wish sometimes we could have a little more say in identifying what problems we truely think are the most important to solve.

      --
      "Old man yells at systemd"
    6. Re:Drug Research is a farce. by Telastyn · · Score: 3, Interesting

      So why isn't there a reward system for cure research? Have people, the government, or better yet governments put up a sum of money to the person, or group of people that create a verifiable cure. Stick it into something guaranteed and let the pot grow. Would drug companies work to cure aids if there was a few trillion dollars at stake?

    7. Re:Drug Research is a farce. by Fig,+formerly+A.C. · · Score: 3, Interesting
      What's it like to work at the Umbrella Corporation, anyway? ;-) (j/k)

      We bust our hump trying to cure everything from osteoporosis to AIDS and you sit there smugly alleging that we're either holding back cures or not trying to make them? You're a fool. Everyone I work with spends every minute of the work day and most of our weekends trying to develop treatments AND CURES for ungrateful dickheads like you. And we don't do it for the money, which pays the bills but isn't that great, trust me.

      So you are telling me that upper management would NEVER bury an R&D breakthrough that upper mangement thought would hurt their profits?

      I bet that breakthrough would get "lost" really quick.

      I'm not belittling you, or your coworkers, but when the people who only see numbers start making decisions the bottom line is everything.

      --
      Murphy was an optimist.
  3. Not just patents, profitability by Anonymous Coward · · Score: 5, Insightful

    OK, so part of this can be tossed off as a little bit of paranoia, but the patent issue is only a small part of the iceberg that is medical research. There is a dearth of substances out there that fight depression (St. Johns Wort), cancer, and other ailments that no-one is willing to put through the rigorous testing required by the AMA, and FDA because there's NO MONEY IN IT. They can't patent it, so as soon as it's approved, anyone can sell it. It's a sad but true fact that it happens all the time. If you're intersted in starting down the road of true paranoia, look at When Healing Becomes A Crime, The Harry Hoxsey Story if you can find it. try here if you're interested

  4. What's up with the fucking negativity? by Dark+Paladin · · Score: 4, Insightful

    Look, I'm sorry. I personally don't give a flying fuck about Michael or any others of the Slashdot crowd.

    This is not a professional news organization - for that, I'll watch 60 Minutes, Dan Rather, or people who make a good buck doing nothing but finding shit out that I think is important.

    Michael, Taco, Cowboy, and the rest are just guys saying "Hey, this is something I thought (or some poster) thought was interesting, and here's my $0.02 on it."

    Don't like - go get your own damn web site. I don't have time for arrogant pricks like yourself who feel you have to bash somebody because you a) don't agree with them, b) don't share there interests, or c) expect them to be more/less than they are.

    I'm getting off my soapbox now. I'm gonna go have some toast with peach and raspberry jam.

  5. Pharmasuticals have a hard sell by Brigadier · · Score: 4, Informative



    My sister used to work for Bristoll Myers. One of her main points was it takes an excess of 8 years to perfect a drug. Wherein a list of ten potentials you may get one that qualifies for clinicals. Now keep in mind your development team for lack of a better word concist of PhD chemist and Biologist commanding a 6 figure per anum paycheck. Now the catch is after all that R&D investment drugs that pass clinicals only have a patent lasting 5 years before generics can be made. Thus the consumers take it in the pocket with high drug prices.

    1. Re:Pharmasuticals have a hard sell by gowen · · Score: 3, Funny

      Pharmaceuticals have a hard sell.
      Pharmasuticals have a hard spell.

      --
      Athletic Scholarships to universities make as much sense as academic scholarships to sports teams.
    2. Re:Pharmasuticals have a hard sell by Zeinfeld · · Score: 4, Informative
      Now the catch is after all that R&D investment drugs that pass clinicals only have a patent lasting 5 years before generics can be made

      That is not the case. Drug patents are regulated under a special set of rules that tie the patent term to the date on which the FDA gives approval.

      There is also a set of riders that allow the drug companies to delay introduction of generics evan after the patent has expired. If a patent holder makes any claim against a generic, no matter how frivolous the generic is automatically denied approval until court proceedings on that claim. If the court throws out the claim the drug company can throw in another one. So generics makers are subject to a series of 18 month delays over the enforcability of suprious patents filled over the dosage rates or minor parts of the invention not disclosed in the original.

      The problem is that the congress and president were bought long ago by the drug companies.

      --
      Looking for an Information Security student project suggestion?
      Try http://dotcrimeManifesto.com/
  6. One reason is activists by avdi · · Score: 4, Informative

    As this article points out, one reason big drug companies are stepping away from AIDS drug innovation, at least, is because of AIDS activists and other anticorporate do-gooders. By forcing companies to practically give away their drugs to the third world, these misguided crusaders have removed all incentive from Big Medicine to research new AIDS drugs. Any new drug development requires an immense amount of R&D capital before a cent of profit can be made; and no intelligent CEO is going to throw billions at a product that'll wind up being either given away or copied illegally by third-world manufacturers.

    --

    --
    CPAN rules. - Guido van Rossum
    1. Re:One reason is activists by avdi · · Score: 3, Insightful
      Oh, great, and so thus we should kill off as many of the poor as possible so that drug companies can continue to make their money, huh?

      No, it's people like you who would kill off the poor in third-world countries to satisfy your own notions of social justice. No government in history has ever equalled the kind of productivity that our competitive market creates - and you would take that productivity away from the search for lifesaving drugs.

      --

      --
      CPAN rules. - Guido van Rossum
    2. Re:One reason is activists by SacredNaCl · · Score: 3, Informative

      That's a great PR story, unfortunately it has just one major problem ... It's major bull. I wonder which PR company handled that? Hill & Knowlton? Shandwick? It has their feel. I'm sure I'll read about it in a few months in PR-WATCH.

      Private companies never did. Every single AIDS drug on the market was studied, researched, developed, and subsidized with public sector money. Every single one. Even the "manufactuing process" research was generally done with public money. The NIH usually gives away it's drugs & research to companies to make a profit with ...but it's a rare event when they completely pay for the process to figure out how to mass produce them as well. They did this for just about all of the AIDS drugs in addition to developing them, and funding all of the research and testing. The private sector only spent money on "PR" to say what a nice bunch of guys they were. Nor did we put any restrictions on what they could charge for these drugs until very recently and we fought tooth and nail to keep other countries from manufacturing them at selling them at close to cost. The private sector didn't "lose any investment" ...They simply lost a very small portion of their guaranteed profit on drugs they were handed on a silver platter from the public treasury.

      How much subsidy can the truth take?

      "As this article [jpost.com] points out, one reason big drug companies are stepping away from AIDS drug innovation, at least, is because of AIDS activists and other anticorporate do-gooders. By forcing companies to practically give away their drugs to the third world, these misguided crusaders have removed all incentive from Big Medicine to research new AIDS drugs. Any new drug development requires an immense amount of R&D capital before a cent of profit can be made; and no intelligent CEO is going to throw billions at a product that'll wind up being either given away or copied illegally by third-world manufacturers."

      --
      Freedom is merely privilege extended unless enjoyed by one and all.
  7. Cap royalties by Tablizer · · Score: 3, Interesting

    I think one solution would be to put a cap on the royalties that one has to pay to X percent of the product revenue. If multiple patents are involved, then the *total* still would be no more than X percent. X is simply divided up among the patent holders.

    There is too much all-or-nothing problems and out-of-the-woodwork surprises right now. If you know that the total will be no more than X percent no matter what, then you are more likely to take the risk. There is too much "patent paralsys" right now.

  8. Most real innovation in drugs is public sector - by SacredNaCl · · Score: 4, Insightful

    Just about every major drug development in the past 15 years has come from the public sector, not the private sector. Cancer drugs? Almost 100% public sector. AIDS drugs? 100% public sector. Antibiotic research? ...Same thing.

    What is the private sector doing? "Weekly" Prozac, "Extended Release" Acyclovoir, "Controlled Release" Pain Killer/Paxil ...Or change one molecule, or change chilry slightly in the process ... Or launch patent on what the drug becomes once it enters the body to extent patent ...Lobby congress for patent extension ... etc

    I'm not saying that some of the controlled release drugs aren't quite useful -- but the mechanisms for making them controlled release are rarely innovative. Add Wax, or Cellulose to pill ..That's 90%.

    Add in captive market pricing (drug in US $212, same drug in Peru $7, same drug in Mexico $12, same drug in Australia $117). ...And you have some real scum at work.

    But drug companies have some some other shady things -- like using their influence at the FDA to keep new drugs from Europe off of the US market while they work on a one off version for release here. I'm sure some countries in Europe are doing the same thing. One of those areas that trade treaties don't really cover well.

    --
    Freedom is merely privilege extended unless enjoyed by one and all.
  9. We've gone as far as we can go by Theatetus · · Score: 3, Insightful

    The cliché of the moment is that pharmaceutical companies have picked the low-hanging fruit, developing drugs that interact with the limited number of enzymes and molecules that we already understand and have thoroughly modeled.

    And some luddite famously quit the Patent office in 1870-something because he determined everything that could possibly be invented had already been invented.

    Corporations aren't like people. If you leave a guy alone to do his job, he generally does it and even finds a better, more eficient way to do it than you taught him. If you leave a corporation alone to fulfill its mission statement, it tends to get lazier and lazier and do less and less

    Before the free-market theologians jump in and remind me that a corporation's sole purpose is to make money for its shareholders, let me quote some mission statements from phramaceutical companies:

    • Pfizer: "We will become the world's most valued company to patients, customers, colleagues, investors, business partners, and the communities where we work and live."
    • Genentech: "Our mission is to be the leading biotechnology company, using human genetic information to discover, develop, manufacture and commercialize biotherapeutics that address significant unmet medical needs."
    • Merck: "The mission of Merck is to provide society with superior products and services -- innovations and solutions that improve the quality of life and satisfy customer needs -- to provide employees with meaningful work and advancement opportunities and investors with a superior rate of return."

    Those were just the first three I happened to look at; the rest seem similar. So, there you have it straight from the horse's ass^H^H^H mouth: these companies' missions are not primarily to return profit (Genentech doesn't even mention that); all three have medical innovation and discovery as their primary mission. Just goes to show you can't trust a corporation to do what it sets out to do.

    --
    All's true that is mistrusted
  10. Re:Article contains no actual quantitative evidenc by SirSlud · · Score: 5, Insightful

    It's a difficult thing to prove quantitatively (although the market woes and the lack of any new groundbreaker like Viagra and Prozac in the pipeline is mentioned .. did you want that in a pie chart?) .. especially since the questions of what drugs are important, which arn't, whether some drugs are actually better than the problem they cure .. these are not neccessarily quantifiable things.

    The thing is, most of the people I know in the scienitific community right now agree with that main charge of this article. Yes, patents are important, but there is a crowing concensus that simply allowing anything and everything to be patented (which is increasingly the case) harms the very industry that patents were put in place to support.

    We've become so engrossed in the battle for the pie that we ruined the pie for everybody in the first place. There's plenty to share, so we shouldn't focus so hard on ensuring that yoou'll get your pie. Or in another analogy, if capitalism is people in competition to the finish line, we've gotten so good at tripping each other up and not actually runny that we might as well have all walked the distance.

    Yes, there is no quantitative proof, but the way the industry operates, you'd have to wait 5 or 10 years to see the effects that the current research climate has on the consumer end of the industry. So, we have to rely on people in-the-know to identify problems and solutions before we can tally them on a spread sheet.

    --
    "Old man yells at systemd"
  11. Re:Article contains no actual quantitative evidenc by Dannon · · Score: 5, Insightful

    I tend to agree. There isn't a new arguement here, and none of them hold water.

    A good bit of what I read was a poke at the prices of new drugs, and a drop in investment. Well, new drugs are expensive to produce and test thoroughly. There's the expensive research to find a new treatment. Then, there's the expensive and extensive government-mandated testing to make sure the drugs won't do more harm than healing. After that, before the drug can be marketed, it has to be patented... which means telling everyone else how to make it.

    And there's only a short time period for the research company to recoup its expenses before the 'generic' drug companies are allowed enter the market... to produce the same drug, without all the R&D costs. If it's an extremely useful drug, you'll hear of people lobbying the government to let the generics start early, cutting in on that short time period the patent-holder has to recoup losses and make enough money to satisfy the investors. And now, you've got more folks wanting the government to step in again and engage in more price-fixing for drugs used by retirees.

    Whenever the government limits the odds of receiving return on one's investment, investment will drop. And that applies to the investments of time and effort by drug researchers as well as the financial investments from Wall Street.

    --
    Good judgment comes from experience.
    Experience comes from bad judgment.
  12. Just Pisses me off by BrookHarty · · Score: 3, Interesting

    Quick overview.

    1. Pharmaceutical companies have big ties into our government, controlling legislation.
    2. Pharmaceutical companies can patent receptors which blocks other companies to interact with those receptors.
    3. The FDA has limited manpower, which means less drugs tested.
    4. Knowledge which researchers shared freely, is now corporate information, and locked away.
    5. Pharmaceutical companies are holding licenses. Screwing the public on new drug treatments from other corporations.

    And my favorite.

    6. breweries-and-distilleries index are up 25 percent; shares in the pharmaceuticals index, meanwhile, are down 25 percent.

    1. Re:Just Pisses me off by TheSync · · Score: 5, Informative

      1. Pharmaceutical companies have big ties into our government, controlling legislation.

      50% of every dollar spent on medicine in the US comes from the Federal Government. No big suprise it is politicized. With prescription drug coverage for Medicare coming, the percentage will rise.

      3. The FDA has limited manpower, which means less drugs tested.

      This is wrong. Every drug is tested by its maker, on its maker's dime. The FDA only requires testing and examines results. The average cost of testing is near $100 million, and the drug may then not work (most don't make it through testing). Backups due to the FDA do not lead to untested drugs being released, it leads to fewer drugs being released.

  13. Re:Article contains no actual quantitative evidenc by the+gnat · · Score: 5, Insightful

    Read the article again. They explicitly mention hepatitis research, and Harvard suing over osteoporosis research. Then there's the suggestion that HGS may be able to interfere with AIDS research. And aside from screwing other people, Big Pharma is now trying to squeeze every little bit of life out of existing products for which it has patents (or can get bogus new ones) rather than doing actual innovation.

    This isn't *quantitative* evidence, but it doesn't sound like the author just pulled all this out of his ass. And as a biomedical researcher, I assure you there is a huge body of evidence to support the article's assertion which did not appear there.

  14. Way to miss the point, buddy... by JohnDenver · · Score: 3, Insightful

    I'm sure Michael understands why DRM is pretty important and why the other issues matter, but what you don't understand is, his point wasn't to dismiss DRM and other technology issues, but rather highlight the apathy to these issues.

    What you don't SEEM to understand is, while MP3 patents and DRM issues are very big issues that will really affect us in 5-15 years time, people don't care or understand it yet. People understand when you tell them the patent system is gridlocking medical advancements (Cancer, HIV cures).

    What you also don't seem to understand is that we're a small voice of people who despirately need allies with organizations who have issues that people care about (Cancer research, HIV). First, you have to understand that a lot people won't care about DRM and MP3 patents. You're going to have to find another reason to get them to care. In this case, it's using HIV and Cancer issues to get people caring about an issue that affects us (Corrupt patent system). If we're smart, we'll would leverage the business interests of ISPs and consumer electronics on DRM issues.

    In other words, you need to give people a simple reason to care. Expecting otherwise is just stupid.

    --
    "Communism is like having one [local] phone company " - Lenny Bruce
  15. Re:Article contains no actual quantitative evidenc by SirSlud · · Score: 5, Insightful

    >Which drug companies are tripping the others up?

    s/tripping/patent-litgation

    So, effectively, you're saying this entire article is BS. Which I assume means that you believe that the actual granting, defence, and enforcement of patents can only be good, regardless of the situation, whats be patented, whos patenting it. It can only help humanity, right? All patents. More patents! More!

    No .. there comes a time when you're spending so many resources on trying to be competative other than the actual market fitness of your product that you sacrifice the over-all quality of the product being produced. One example: My father, being a principal R&D guy at a pharmaceutical technology company, was involved in patent litigation that delayed the development of a product they were working on. You simply cannot assume that the cost of not enforcing their patent ALWAYS outweigh the costs involved in filing it, defending it, nor preventing other companies from building off of it. You can't predict the future, either, which means that theres no way to actually prove that had you not filed/enforced a patent, you wouldn't be better off for it.

    Tripping each other up doesn't imply illigal action, it implies exactly what the article implies .. some patents are getting in the way of the very goal (to create better drugs) they are supposed to encourage. I have never met anybody in science who doesn't recognize that you can have too much of a good thing when it comes to patents. So then its just a matter of, like I said, figuring out the point where people are spending more time/money trying to defend what they have instead of using that time and money to do what they are chartered to do.

    --
    "Old man yells at systemd"
  16. Let's lay down a few facts here... by CommieLib · · Score: 3, Insightful

    1. Drug companies exist to make profit for the shareholders.

    2. Drug companies seek to maximize their profit by extending patents.

    3. Presumably, money cannot be spent on both legal matters and research.

    So it is the extensibility of patents, and not patents themselves that is "choking off" research. This is a very different thing to say than "the patents are choking off research". To fix this problem, if it is a problem, we need to tighten the laws regarding patent extensibility. Agreed?

    This whole golden goose B.S. bugs me. Can someone explain to me why someone would shell out 50 million dollars to develop a drug if, after the research is complete, my competitors can benefit equally from it?

    I think the general idea is to socialize drug research. That would be great, because then results wouldn't matter. Not only that, but we would have a value judgment forced on everyone as to the value of drug research (I don't care if you think that paying your credit card bill this month is more important, we're still taking your tax dollars for drug research).

    The real problem here is that people just cannot deal with the fact that there's only so much money and time and resources to go around. We wish that everything could be a priority. But it can't, so we have to use some system to ration those scarce resources. A free-market system says that resources will be rationed according to private agreement and negotiation, but there's always a few "never studied history much" folks who think that concentrating power and information is the way to Utopia. The road to hell, etc.

    --
    If your bitterest enemies are people who hack the heads off civilians, then I would say you're doing something right.
  17. This guy supposed to be telling us something new? by dh003i · · Score: 3, Interesting

    Is this guy supposed to be telling us something we don't already know?

    We all know damn well that no company in any industry is concerned about their consumers/users and the public good first. Companies are only concerned with the bottom line; those that aren't go out of business. A companies first goal is to make money, and the public good, consumers, users, the environment, anything, is only secondary and considered in regard to how it affects the bottom line.

    This isn't something companies should necessarily be chastized for. Their first obligation by the law is to maximize profit for their shareholders while obeying the law. But some companies use illegal, immoral, or unethical means.

    What this means is that you can't trust anything a company tells you. A company's position on social issues is never consistent and will always vary, depending on what will benefit that company the most. In "The Future of Ideas," Lessig noted that AT&T's position on whether or not cable lines should be open changed when from "open access" to "no way" when it became a large owner of them.

    That said, some industries have engaged in reprehensable behavior (biotech, software, etc), while others have no (referring here to non-technological industries, such as clothes industry).

    In particular, the biotech industry has:

    (1) Biopirated (stolen) treatments and cures for diseases from indigenous peoples around the world, patented those ideas, then turned around and charged indigenous peoples for the cures they themselves created.

    (2) (In conjunction with the software industry) extended patent rights and duration beyond all reasonable grounds. Companies can patent things for which they do not even know what they do. They can also receive patents on very basic and primitive things which are no-where near leading to a drug, but which will be needed to be used in the research necessary to product a drug (upstream patents). Upstream patents should be retroactively eliminated (retroactive elimination is OK in this case because the gov't had no right to create them in the first place). Only downstream patents on a specific drug should be allowed; minor modifications to the drug should not result in a new patent. The standard for obtaining a patent needs to be dramatically raised. Every minor and trivial adaptation of an existing drug does not deserve a patent. Furthermore, patents on downstream drug products should not apply to basic research. Universities, governments, and companies should be able to obtain the drug in question for research purposes at the cost of production, without licensing hindrances.

    (3) Denied people much-needed cures/treatments to further their bottom line. Companies have prevented patients from being treated so that they can get royalties on drugs. Lets save some scorn for the Universities too, which are recently becoming nothing more than corporations who also teach and train. My own University of Rochester was granted a patent to cox-2 inhibitors, which are used in Celebrex's anti-arthritis drug. The University received a patent recently (after Celebrex created the drug) and then filed lawsuite against Celebrex, potentially stopping those suffering from arthritis from getting the drug. While my respect is due to those at the UOR who researched cox-2, that research was done using public grants (which come out of the taxpayers pocket) and using the tuitions of students. It should be put in the public domain.

    (4) Denying people in third world countries cures. Rather than allowing companies in third-world countries to make generic drugs and sell them cheaply (saving millions of people's lives), drug companies have tried to prevent such. Blinded by their greed, they have failed to realize that you can't squeeze water from a rock. Perhaps drug companies would be happy if people in the third world started selling them their body parts in exchange for drugs.

    (5) Used propaganda to create the illusion that certain illnesses exist which in fact don't, boosting the sales of marginally useful drugs.

    (6) Spent far far more money on lawyers, public relations, lobbying, and paying greedy executives than on actually doing research to find cures (not that any company is researching cures anyways).

    I could go on and on.

    The point is this patent non-sense has to stop. Its a problem everywhere, but most importantly in the biotech industry where its a problem that get people killed by preventing people from being treated, or preventing cures from being researched. As harmful as copyrights are given the fact that their scope is overly broad and their duration overly long, patents are an even bigger problem for the same excesses.

    Initial innovation needs to be followed by subsequent innovation, sequential innovation; patents, in their current state, prevent this. I have a simple solution for this:

    (1) Reduce the duration of patents. 10 years instead of 20.

    (2) Force patent-owners to license patented drugs to those who wish to incorporate them into a product to be sold. A forced license of 50% of the profit from the venture going to the licenser is fine.

    (3) Force patent-owners to license patent drugs to anyone for research purposes under a minimally restrictive license. The drug should be provided (for research purposes) at the cost of production, and the only limitation to the license to use it is that the drug itself cannot be sold.

    (4) Prevent drug companies from strategic licensing. A company sitting on a patent while research is done based off of that patent and mentioning nothing, then when a product is made, suing for royalties, should be prohibited. (I'm referring here to the same thing happening in the drug industry [i.e., with cox-2] that happened with MP3's).

    (5) Retain a much stricter patent-granting scheme. Patents should not be granted for things which aren't really innovative. Currently, patents are granted on every minor modification of an existing drug.

    (6) Hold a strong stance on patent nullification of patents ill-gotten. Patents should not be granted for drugs obtained via the results of biopiracy. Those which are discovered to have been obtained from that should in invalidated. Similarly, patents should not be granted on things which were previously invented by others. Should such happen, the patent should be invalidated.

    (7) Punish companies for inappropriate patent behavior. If a compoany inappropriately attempts to use its patents to halt, or obtain patents by biopiracy, etc, it should lose all of its patent rights.

    (8) Prevent universities for filing for patents, or if they do, require them license the patents under a "patent-left" license. Universities obtain their money for research from the public -- from government grants, funded by the taxpayers, or from students tuitions (also basically the public). Thus, their discoveries and/or inventions should either be in the public domain or patent lefted; i.e., a license corresponding to that of the GPL -- any discoveries/inventions using this patent must either be put in the public domain or licensed under this license, which allows unabridged access.

    It is ever-important that we put these kind of restrictions on drug companies (and any technology companies). They will not govern themselves and act morally; indeed, it would be double standard to expect them to do so, since our laws require that they use any and all legal means to maximize profit for their shareholders. Thus, we need to make laws which prevent this kind of nonsense.

  18. PHRMA on Intellectual Property by TheSync · · Score: 4, Interesting
    (My wife is still alive because of a recent drug discovery, so I suppose that perhaps my view is pro-drug-manufacturer...)

    Celbrities, Pharmaceutical Researchers Urge House to Reject Patent Legislation that Would Harm Patients


    Tell legislators that changes to patent law would slow development of new drugs
    October 01, 2002

    Washington, D.C. - A group of celebrities and pharmaceutical researchers, including television talk-show host Montel Williams and actress Kate Jackson, urged the U.S. House of Representatives to reject pending patent legislation that would harm patients by slowing the development of new life-saving, cost-effective medicines.

    Along with Williams, who has multiple sclerosis, and Jackson, a breast-cancer survivor, the celebrities included television personality Leeza Gibbons, whose mother suffers from Alzheimer's disease; Peter Samuelson, a movie producer who has diabetes; and Nancy Davis, founder of Race to Erase MS, who also has MS. The group held a press conference on Capitol Hill before visiting Members' offices.

  19. Re:Article contains no actual quantitative evidenc by nachoworld · · Score: 4, Informative

    Drug companies have 20 years from the filing of patent to have exclusive rights to the drug. After going through NDA and FDA approvals the average drug gets 7 years on the market. Meanwhile, hundreds of millions of dollars are needed to be recovered in 7 years.

    If we combine the effects of foreign governments not allowing US based companies to charge for "R&D costs" (they allow a small amount of profit), US citizens usually get a bum deal in terms of name brand drugs. US residents are accustomed to paying high prices. That is why the main R&D center of the largest British pharmaceutical company is located near Philly.

    Luckily this summer, the Senate passed the Schumer-McCain bill that helps boost access to generics and boosts competition. The traditionally self-competing and bickering major generic manufacturers also have formed a pharmaceutical association in a similar vein as the major pharma companies.

    I am a med student who is concurrently getting an MBA in health administration. The current health care costs are 14% of our GDP (~$1.4 trillion) and drugs are the fastest increasing component of the cost.

    Please, if we are all to help force down drug prices, ask your pharmacist for generics

    --

    ---
    I'm just an ordinary man with nothing to lose.
  20. Then what's this long long list on my desk? by paiute · · Score: 5, Informative

    I work in an industry that supports the very early stages of drug discovery at all the large pharmaceutical companies, so I can give you a different perspective than the author, who is apparently not a chemist.

    First of all, the complaint that "Nexium... is essentially AstraZeneca's old heartburn drug Prilosec with a minor chemical twist that allowed the company to extend its patent." is shallow. Prilosec was a racemic mixture - a mixture of two mirror-image molecules with the same atomic connections. This is the old way that bioactive molecules with one or more chiral centers were patented and sold, because it was too expensive or impossible to separate the mixture into its chirally-pure components. Unfortunately, the mechanisms of the body are chiral, and often it is only one of the mirror-images which is the active ingredient. The other enantiomer is at best inactive and at worst toxic, mutagenic, teratogenic, etc. It is only with the chiral preparative and analytical methods and tools available in the last 15 or so years that it has become economically feasible to either prepare only the active enantiomer or to purify away the undesired enantiomer from the mixture. This is what AstraZeneca has done. From Prilosec to Nexium is not a minor chemical twist - it is a profound biochemical change. In the meantime, anyone else could have separated Prilosec into its components and patented only the active enantiomer, which is what a company called Sepracor has been doing. Sepracor is a company specializing in chiral separations. They have been taking patented compounds and isolating and patenting the active ingredient. Sometimes they license the compound back to the original manufacturer, but if the holder of the patent on the racemic mixture doesn't want to pay, Sepracor sells it themselves or in partnership with another firm.

    Second, my customers are under constant pressure to shorten the discovery pipeline so that successful drugs can be sold under patent protection for as many years as possible. That means more work for me, luckily. To argue that the patent process is wrong or flawed is to ignore the full shelves in the pharmacy. If it weren't for the patent process, those bottles would be full of roots and bark. (Not that there is anything wrong with roots and bark, just that they may also contain toxic compounds.)

    Which reminds me of: third, the author confuses small-molecule patents with biochemical patents. The old school (classical small-molecule therapies) patent system works pretty well. You get some years to make money to fund R&D on new drugs. It is the silly biochemistry and genomic patents which are insane, and the patent office has let them get away with it. From PCR to broad gene therapy claims based only on sequence - that process is as flawed as the software/business model patent crap that is every fifth story on slashdot. This is the area the author should have concentrated on.

    Last, the author gives the impression that there are no new areas for drug therapies out there. This is just a lack of effort on his part. Most drugs initiate change in the body by interacting with receptor proteins on the outside of cells. And each type of receptor - the calcium channel, for example - comes in subtypes which may be expressed in different amounts dependint on tissue type or even on different areas of the same organ. Many of the drugs currently in use do not differentiate very well between the receptor subtypes to which it binds or interacts. There is a huge opportunity for development of drugs which are more and more specific to a specific receptor and so demonstrates fewer and fewer side effects - which are manifestations of interactions with other receptors than the family targeted. The combination of high-throughput screening and combinatorial synthesis, both of which are still in their early stages, promise to supply us with many times more drug candidates than classical one-pot organic preparations and one-rat-at-a-time testing of those compounds.

    --
    If Slashdot were chemistry it would look like this:Cadaverine
  21. Not totally true. by nachoworld · · Score: 3, Insightful

    Just about every major drug development in the past 15 years has come from the public sector, not the private sector.

    Simply not true.

    Antibiotics are mostly private sector. You might be implying that drugs that are life preserving don't usually come from the private sectors. There are plenty of good examples of life preserving drugs (antibiotics). There are also plenty of good examples of life-enhancing drugs (omeprezol - Prilosec). Or the combination of the both (silfenildil - Viagra was originally indicated to reduce heart attacks, but it had an interesting side effect).

    IT IS NOT CAPTIVE MARKETING!!! Blame foreign governments for the high prices here. They don't allow drug companies to charge for R&D costs.

    But there are two sides of the argument here too. Here's an analogy The US may be seen as flying first class. They get from point A to point B but pay a much larger price than those in coach (foreign citizens buying drugs). But if airline companies started charging less for first class and distributing the cost to coach, then fewer people are inclined to pay for coach. There are much fewer people on the plane. The plane never leaves the ground.

    --

    ---
    I'm just an ordinary man with nothing to lose.
  22. Bounty System. by Grendel+Drago · · Score: 3, Insightful

    You know, that may be the best idea I've heard for this in a long, long time. There exists plenty of science which is good for people but bad for business---cheap launch technology, vaccines, that sort of thing. A bounty system would make it good for business.

    Of course, you'd run into nightmarish problems with fraud and deception---with that much money on the line, it not only becomes profitable to research, it becomes profitable to cheat. You'd need an honorable, impartial judge (or panel thereof) to test the supposed cures.

    All it takes is one crazy millionaire to get the ball rolling and set up this foundation. Any takers?

    --grendel drago

    --
    Laws do not persuade just because they threaten. --Seneca
  23. How About First To Market? by EXTomar · · Score: 3, Insightful

    Why is holding a legal monopoly over bodily functions fostering medical improvements? Medical costs are going way way way up. This is an honest question: has anyone shown that patenting bodily functions has improved medical care in the US?

    What happened with being first to market? If one company discovers WonderDrug A cures all that ills, going to market first assures some profit right? As market forces settle in, it then becomes who can make the better quanties at a lower price.

    The problem with current medical patents, as with many patents, is they are too far reaching. *Anything* that has to process BadGene B can be patented even if the resulting medical conditions are seperate. Are companies even sure what BadGene B is linked to when they patent or is it just "patent squatting"?

    I don't know...I seem to remember Salk saying he wanted to make the vacination for polio because he got tired of seeing people suffer. The fact he got money and glory for it after seemed like a nice bonus. Where did that kind of thinking go?

  24. Re:Article contains no actual quantitative evidenc by Zathrus · · Score: 3, Insightful

    Drug companies have 20 years from the filing of patent to have exclusive rights to the drug. After going through NDA and FDA approvals the average drug gets 7 years on the market

    A question for you, which you may not know - why so long? Yes, you have to do both animal and human testing during that period, but why is it taking (on average) 13 years to do all of this? As I understand it, the standard human testing period is 1 year. I don't know about animal testing, but I'd guess it's about a year as well. Even giving an additional year to do analysis on those tests, that's only 3 years. Does all the governmental approval really eat up another decade?

  25. Internal industry psychology by tomdarch · · Score: 3, Informative
    I have a friend in the pharma industry, and I've discussed the limitations of patents with my friend. I can say that from that sampling group of 1, people in the industry have a very strong perspective that patents are all good. My friend just couldn't get that patenting a DNA sequence that exists in everyone is a bad idea. (You know how you look at Microsoft and realize that they're blind to what they're doing ... it's like that.)

    I think that most people in the pharma industry 1)really want to make money (who doesn't?) and 2) are tied to a specific company at any given time. One looks at the situation and sees that for me to make money, my company must make money and my company can only make money by exercising patents (excluding generics) and my company can make more money by milking the patent system as much as possible (repackaging, etc.) Also, the industry is so 'rules' bound (by the FDA, which I think is a good thing) that they look at rules as a game to be milked as much as possible: first when selling the drugs to doctors regarding labeling and second when manipulating the patent system.

    It's not just the patent abuse. Don't forget that the pharma companies have zillions of high-pressure salespeople pounding on your doctor's door every day. Some are low cut top, batting eyelash, some are "Hey buddy, how's yer golf game, let's hit the strip club! Your escort will be at your room when we get back", some are "here's your check, er, honorarium, for your professional leadership speech at the luxury resort in Hawaii" and on and on. Sure, R&D is expensive, but the marketers/salespeople are paid insane amounts and have massive budgets. A big part of our health insurance premiums are being funneled to the pharma marketing/sales monster.