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Thread: Pharmaceutical companies

  1. #1

    Pharmaceutical companies

    Your knight in shining armor, folks.

    From today:
    Money, drugs and the Supreme Court: The multi-billion dollar case you haven’t heard of

    The Supreme Court has been front and center this week with its oral arguments on same-sex marriage. That is not, however, the only big issue before the justices this week. On Monday, the court took up a really important health policy case, one with billions of dollars riding on the verdict. The lawsuit centers on a practice known as “pay for delay,” where pharmaceutical companies essentially pay a settlement to a competitor to hold off on bringing a generic version of their drug onto the market. It’s a form of settlement in patent litigation that can actually be pretty advantageous for both parties—and one that both generic and brand-name drug makers don’t want the Supreme Court to abolish.

    The big pharmaceutical with a blockbuster drug gets to have the only product on the market for a little longer. It also doesn’t have to deal with price competition. The FDA estimates generics usually cost 80 to 85 percent less than brand-name drugs—not great news for the maker of the brand-name medication.
    As for the generic drug maker,it has to hold off on coming into a given market—but it also gets a settlement from a pharmaceutical, often in the millions. Not a shabby deal either.

    The Federal Trade Commission, which brought the suit, has a completely different take. It argues that this is horrible for consumers, who end up with higher drug prices as generics stay off the market longer than they otherwise would. With more than a dozen pay-for-delay deals struck annually, the FTC estimates that these settlements will cost consumers $35 billion over a decade.

    The case before the Supreme Court was one involving a prescription testosterone product called AndroGel, manufactured by a company called Solvay. Nina Tottenberg has helpful background:
    Generic competitors challenged Solvay’s patent, contending that the patent on the synthesized testosterone used in AndroGel had expired decades ago and that whatever innovative changes were made in the formula were not enough to justify a new patent that would bar generics from making similar products.

    The litigation pressed on for two years with both sides gathering evidence. But as the lawsuit progressed into its third year, one generic won FDA approval for its competitive product, and was preparing to market it at prices that were six times cheaper than the brand named AndroGel. That would have put AndroGel’s $400 million annual sales into the tank.

    So, they settled: Solvay paid the generic challengers as much as $42 million annually, on the condition they would not market their product for another nine years.
    The FTC has argued in court that this pay for delay agreement, and others like it, violate anti-trust laws and increase consumers’ medical costs.

    The payments “subvert the competitive process by giving generic manufacturers an incentive to accept a share of their rival’s monopoly profits as a substitute for actual competition,” deputy solicitor general Malcolm Stewart argued on behalf of the FTC on Monday.

    Drugmakers, meanwhile, think this is how the system should work. These challenges typically come up at some point in the 20-year lifespan of an FDA patent, just as the AndroGel challenge did. If the two parties want to meet in the middle on how much longer the patent lasts, what right do courts have to step in the way?

    “The patent gave the patentholder the legal right to exclude,” Jeffrey Weinberger argued for defendants. “So unless there’s a reason, there’s some reason to believe that it couldn’t reasonably assert that patent, it’s entitled to monopoly profits for the whole duration of the patent.”

    That is, in a nutshell, the case at stake. If the government wins, it will be a lot harder for courts to sign off on these pay-for-delay settlements. If it loses, business will continue as usual. Between the two options, there’s $35 billion at stake.
    SOURCE
    Last edited by crabbyshark; 03-29-2013 at 04:44 PM.

  2. #2
    Why don't we worry about the generic versions of our drug being pushed out of the market once someone has discovered ANY type of drug that regenerates the spinal cord?
    If your larger point is that big pharma is an impediment to even discovering such a drug... Well, I think we'll all have to be realpolitik about that fact and accept it for what it is. Curing SCI is tough enough of a scientific problem. May The Lord help us if we have to also break up global capitalism or reorganize the pharmaceutical industry in the process. We should look to large pharmaceutical companies to help us instead of simply viewing them as an impediment.

  3. #3
    Quote Originally Posted by ay2012 View Post
    Why don't we worry about the generic versions of our drug being pushed out of the market once someone has discovered ANY type of drug that regenerates the spinal cord?
    If your larger point is that big pharma is an impediment to even discovering such a drug... Well, I think we'll all have to be realpolitik about that fact and accept it for what it is. Curing SCI is tough enough of a scientific problem. May The Lord help us if we have to also break up global capitalism or reorganize the pharmaceutical industry in the process. We should look to large pharmaceutical companies to help us instead of simply viewing them as an impediment.
    I do not believe them to be opposing any of the research. Geron for example simply called the study off to pursue more lucrative cancer therapies. I do not know that any are getting a whole lot from our population just because compared to other groups we are very small in numbers. We need the right carrot or a bigger stick.

  4. #4
    Totally agree. My point was simply that, in my opinion, we will have to play the game as is rather than fundamentally change the rules of the game. Big pharma will have a huge role whether anyone likes it or not or gets soft about it or not.

  5. #5
    Quote Originally Posted by ay2012 View Post
    Totally agree. My point was simply that, in my opinion, we will have to play the game as is rather than fundamentally change the rules of the game. Big pharma will have a huge role whether anyone likes it or not or gets soft about it or not.
    Yes I agree.

  6. #6
    Quote Originally Posted by ay2012 View Post
    Totally agree. My point was simply that, in my opinion, we will have to play the game as is rather than fundamentally change the rules of the game. Big pharma will have a huge role whether anyone likes it or not or gets soft about it or not.
    Yes and No. There is definitely some room for changing parts of the game whereby some of the translational science can be liberated. Organisations like Alliance For Regenerative Medicine, FasterCures, PatientsLikeMe and U2FP are working hard to do this.

    Attachment 49194

  7. #7
    Quote Originally Posted by ay2012 View Post
    Big pharma will have a huge role whether anyone likes it or not or gets soft about it or not.
    Not if something already available alleviates spinal cord injury. Not talking specifically about ibuprofen either. This is why Wise Young creating a clinical trial network is a gamechanger.

  8. #8
    From yesterday:
    Drug maker Novartis loses India patent battle

    NEW DELHI (AP) — India's Supreme Court on Monday rejected drug maker Novartis AG's attempt to patent an updated version of a cancer drug in a landmark decision that health activists say ensures poor patients around the world will get continued access to cheap versions of lifesaving medicines.

    Novartis had argued that it needed a patent to protect its investment in the cancer drug Glivec, while activists said the drug did not merit intellectual property protection in India because it was not a new medicine. In response to the ruling, Novartis said it would not invest in drug research in India.


    The court's decision has global significance since India's $26 billion generic drug industry, which supplies much of the cheap medicine used in the developing world, could be stunted if Indian law allowed global drug companies to extend the lifespan of patents by making minor changes to medicines.


    Once a drug's patent expires, generic manufacturers can legally produce it. They are able to make drugs at a fraction of the original manufacturer's cost because they don't carry out the expensive research and development.


    Pratibha Singh, a lawyer for the Indian generic drug manufacturer Cipla, which makes a version of Glivec for less than a tenth of the original drug's selling price, said the court ruled that a patent could only be given to a new drug, and not to those which are only slightly different from the original.


    "Patents will be given only for genuine inventions, and repetitive patents will not be given for minor tweaks to an existing drug," Singh told reporters outside the court.


    Novartis called the ruling a "setback for patients," and said patent protection is crucial to fostering investment in research to develop new and better drugs.


    Ranjit Shahani, the vice chairman and managing director of Novartis India, said the ruling "will hinder medical progress for diseases without effective treatment options."


    He said the court's decision made India an even less attractive country for major investments by international pharmaceutical companies.


    "Novartis will not invest in drug research in India. Not only Novartis, I don't think any global company is planning to research in India," he said.


    The Swiss pharmaceutical giant has fought a legal battle in India since 2006 to patent a new version of Glivec, which is mainly used to treat leukemia and is known as Gleevec outside India and Europe. The earlier version of Glivec did not have an Indian patent because its development far predated the country's 2005 patent law. Novartis said Glivec is patented in nearly 40 other countries.


    India's patent office rejected the company's patent application, arguing the drug was not a new medicine but an amended version of its earlier product. The patent authority cited a provision in the 2005 patent law aimed at preventing companies from getting fresh patents for making only minor changes to existing medicines — a practice known as "evergreening."


    Novartis appealed, arguing the drug was a more easily absorbed version of Glivec and that it qualified for a patent because it was "a revolutionary treatment," not an incremental improvement.


    Anand Grover, a lawyer for the Cancer Patients Aid Association, which led the legal fight against Novartis, said the ruling Monday prevented the watering down of India's patent laws.


    "This is a very good day for cancer patients. It's the news we have been waiting for for seven long years," he said.


    Aid groups, including Medicins Sans Frontieres, have opposed Novartis' case, fearing that a victory for the Swiss drugmaker would limit access to important medicines for millions of poor people around the world.


    Glivec, used in treating chronic myeloid leukemia and some other cancers, costs about $2,600 a month. Its generic version was available in India for around $175 per month.


    "The difference in price was huge. The generic version makes it affordable to so many more poor people, not just in India, but across the world," said Y.K. Sapru, of the Mumbai-based cancer patients association.


    "For cancer sufferers, this ruling will mean the difference between life and death. Because the price at which it was available, and considering it's the only lifesaving drug for chronic myeloid cancer patients, this decision will make a huge difference," Sapru said.


    Leena Menghaney of Medicins Sans Frontieres said India would continue to grant patents on new medicines.


    "This doesn't mean that no patents will be granted. Patents will continue to be granted by India, but definitely the abusive practice of getting many patents on one drug will be stopped," Menghaney said.


    The judgment would ensure that the prices of lifesaving drugs would come down as many more companies would produce generic versions.


    "We've seen this happening with HIV medicines, where the cost of HIV treatment has come down from $10,000 to $150 per year. Cancer treatment costs have come down by 97 percent in the case of many cancer drugs," she said.


    "This decision is incredibly important. The Supreme Court decision will save a lot of lives in the coming decades," Menghaney said.
    SOURCE

  9. #9
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    Quote Originally Posted by ay2012 View Post
    Totally agree. My point was simply that, in my opinion, we will have to play the game as is rather than fundamentally change the rules of the game. Big pharma will have a huge role whether anyone likes it or not or gets soft about it or not.
    The rules are, big pharma makes far too much money from keeping people in wheelchairs to invest in anything that substantially improves funtion for sci people.

  10. #10
    Quote Originally Posted by ian View Post
    The rules are, big pharma makes far too much money from keeping people in wheelchairs to invest in anything that substantially improves funtion for sci people.
    Ok, you can take that viewpoint. But what is the value to them for a cure? Close to or more than the money from keeping people in wheelchairs? And lets say this is the situation, I.e. big pharmaceutical companies agree to not create a cure lest they lose all to money from catheters and wheelchairs, etc. why are some of them investing in both basic science and clinical trials? To trick everyone? To discover the cure and then hide it so no one else gets it?
    And lets say they still all agree to collude and hide a cure or simply refuse to invest in finding one... Isn't that gigantic market for a cure still there? Won't some entrepreneur fill it? Big pharma does not have a monopoly on medical research.
    Don't get me wrong, I'm not saying all the economic incentives are aligned perfectly for the best amount of investment in a cure. But your statement seems to imply that a) all big pharmaceutical companies collude, b) big pharma does not invest substantial amounts of money in a cure (perhaps this is true relative to other illnesses/diseases/injuries but ask yourself why), c) even if they found a cure they wouldn't want anyone to push it to market.
    I don't think I agree but hey just my opinion. I think it's not that they're afraid to lose their money from people being in wheelchairs so much as it is that they're not all that certain how to move towards making the money that comes in getting them out of wheelchairs. These are not the same things. Add the complexity of SCI and how little is still understood...

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