Sunday, February 27, 2011

Patent Mother Nature

TAG of the Week:     "Patent Mother Nature"

Advancement in science and medicine is often driven by the excitement of new knowledge, the ability to search for a cure, and the possibility of improving population health ... in some cases, the opportunity for fame, fortune, and "commercial interest" ... Patenting medical devices, intellectual property, and genes have been vehicles to promote innovation, competition, and better goods for all.  On the other hand, could one really patent something Mother Nature has programmed in everyone of us?   

Our discussion ties back to a previous post asking about who owns genetic property. In this case, does a company have a rights to a gene?  Make a case for how you would support the case for Myriad to keep their gene patents? Would allowing Myriad to keep the gene patents encourage research or stifle competition? Or is the central issue about who gets a bigger cut of the money and profits?

Current Event:  http://www.nytimes.com/2010/11/02/health/02gene.html

21 comments:

  1. From the prospective of virtue ethics, which I strongly believe in, no a company should not have the rights to a gene, but from the standpoint of piracy litigators, companies should be entitled to holding gene patents. Thus the real debate is over which principle should override the other?

    Supporters who uphold Myriad’s right would say that since they conducted the research on this gene and “discovered” it, then this entitles the company to ownership rights. This stance parallels to musicians in the music industry who copyright their music to prevent it from being reproduced. In both instances since an individual made/ discovered the “creation” whether is was a song or the discovery of a gene, since it was crafted by that individual, it is essentially theirs because they made it/ discovered it and anyone else who reproduces it there after is subjected to committing a felony. Others argue that endorsing the use of patents stimulates genetic research; because of the reward of ownership researchers receive from discovering the gene is an incentive to stimulate research for finding new genes.

    I however feel that this is a completely illegitimate stance spurred by research company’s attempts to monopolize on the production of all medical supplies and tests related to that gene, by eliminating competition in the markets for a particular gene. I believe that lifting gene patents would stimulate the competition in the market for that gene, because companies would be more inclined to creating new and innovative ways of supplying medical screening tests and or medication related to these genes associated with certain diseases and disorders.

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  2. In the economic market patents protect discoveries, but can still persuade other companies to invent their own type of the discovery. For instance, when the iPhone was created, it was one of the first touch screens phones, so I’m sure they had a patent on the phone, but not on the idea. That’s why now we see other cell phone companies who have created similar touch screen phones, but only one real iPhone product exists. However, a gene patent tries to control information that is already a fact of nature. So there really is no invention or modifications to be made. Similarly, if someone had a patent on human hands you couldn’t make gloves, hand sanitizer, or lotion. These products rely on hands, so any modification of your hands by these products would infringe the original hand patent. So how could anyone own part of the human body? In this same way, we see how patenting genes could be bizarre. Genes involve multiple biological processes, so owning a gene could include the entire or the partial ownership of these processes. If one or more of these processes were influential in humans, the patent could impair the possible application of these processes on other discoveries and additional research. So if gene patenting must exist, the amount of ownership, as well as the period of ownership, should be significantly decreased. Otherwise, in capitalistic endeavors, companies could introduce silent mutations and variations into genes so as to not infringe upon existing gene patents.

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  3. I do not think that anyone has the right to patent genes which are found in nature. Also the comment Mr. Noonan made that being able to patent genes was comparable to patenting ingredients in nature, such as antibiotics is ridiculous. Antibiotics, as with other natural ingredients, have to be determined to be beneficial in humans, or animals, and have to be combine with other ingredients, such as beta inhibitors and potassium for the drug to be properly processed by the body. I do not think that finding which gene can cause a certain disease is anywhere near comparable to creating a drug using ingredients that can be found in nature. Also, for products such as antibiotics it must be determined what dosage is beneficial for each individual and each type of infection, it is not one standard dose for all cases.
    I agree with T.Burks that in order for the Myriad company to claim that they own the gene they must claim that ownership and discovery are one in the same. I think the company would have a stronger case to patent the process they use to locate the deleted gene (assuming they have a different method than the norm for DNA sequencing). This way others could still access the gene and Myriad would still have some control over the use of the gene.
    I believe that allowing Myriad to keep the patient would stifle competition and research involving the gene. It limits the access others have to the gene. Also, by allowing others to determine if individuals have the deletion would cause an increase in economic competition.
    I do think the central issue is who gets the most money from the gene. I believe that people in such a field should be less concerned about how much money they can make and more concerned with helping individuals within their society.

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  4. Genes are a biological certainty and are not "invented". In this perspective, I agree with Contreras that there are no modifications or inventions in regards to genes that give a basis for researchers/scientists to have patents on a gene. However, I believe that if there is a research project that proves a mutation on a specific gene, then they may patent their findings for that gene and the linkage that mutation has on a disease.

    If Myriad were to keep their gene patents, I think that research competition would be heightened. There are roughly 25,000 genes and knowing that there has been previously a discovery on one of the genes, I would assume that other companies would focus around that area of the DNA. Combing the realization that discovering any mutation on a gene is completely time consuming and expensive, the result when a discovery is made is high compensation. There is an incredible and, on some levels, unnecessary excess of money for this type of research that will add to competition for other companies if Myriad keeps their patents as well. The amount of ownership and the period that the ownership lasts for needs to be decreased.

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  5. I think a company has rights to patent a gene. The ability to patent drives competition and an added incentive to locate specific genes. As the man representing Myriad in the video said, "it was a race." Competition promotes innovation and thus is an important driving force behind furthering our understanding genetics. Without this incentive, it is unknown how long it would have taken to discover genes such as the BRCA1/2 genes. It is also important to recognize that our culture is based largely on capitalism and consumerism. In the U.S., we strive to discover and claim ownership.
    However, I also believe that there should be a limit on the role of these patents. Companies should be able to patent the location of a gene; however, this should not interfere with people's investigation of this gene within their own bodies. Therefore, caps on the amount a company can charge for "licensing" their patented genes should be limited. A woman interviewed in our in-class movie mentioned that Myriad charges two dollars or so for the use of the BRCA1/2 genes. This is an acceptable amount because the money will add up and profit Myriad for discovering the gene, though it is a relatively small amount to pay for each individual. People do not lose access to genetic testing because of the patent.

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  6. I also agree that companies, such as Myriad, have the right to patent genes, though I believe it should be done with certain moderations and considerations. I can understand why people are outraged by the thought of putting a patent of ownership on a gene- it is innate, biological, and naturally created. But the company is responsible for having located it with prospects of further research and potential application for medical purposes. Because they are the ones who supposedly did discover it, they should be entitled to credit of some sort. And as a business, though they have the goal of using their research to help others, they also have the incentive to profit. As long as the desire for profit does not hinder their true purpose, which is to enable genetic testing for the specific gene, it isn't necessarily bad for them to patent the gene. Allowing Myriad to keep the gene patents would also encourage research by other companies and increase competition. Though some companies may be doing so with hopes of patenting and profiting from their own gene, more research and discoveries will serve to benefit those who are in need of such new innovations and also provide new options for everyone.

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  7. I think the issue over patenting in some ways relates to ideas about keeping health care privatized and centered on a for profit model vs. a health care model that stresses equality of access, in the sense that patents are designed to allow certain researchers exclusive rights to what they have discovered and can control the market around that discovery largely for profit. There are other incentives to research science other than making huge profits, ie. helping people, in this case making genetic testing for prevention of genetic disorders more available. Researchers should certainly be protected from having ideas and work stolen, be given credit for being the person or team to make a discovery and be able to make a decent living in their line of work, but this can all be done without specific patents that inhibit others from working off of those ideas. It seems to me that patents encourage a monopoly in the market to form around the initial researchers of a discovery, and inhibits collaboration between different researchers to make innovation a faster process. Instead it centers on protecting profits and encourages competition for financial gain vs. competition for scientific/medical/social value.

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  8. By definition, a patent is "A grant made by a government that confers upon the creator of an invention the sole right to make, use, and sell that invention for a set period of time." Is Myriad the creator or inventor of this gene? no. This gene is a product of nature. I think it is not in the best interest of the people to put a patent on a gene that inhibits others from testing and researching for more information on the gene. To make facts and truths private property can only lead to impeded innovation and growth. I think the main interest here lies in profit, whereas myriad may be concerned with benefiting the people, it seems to me that they are just as, if not more, concerned with the financial benefits of monopolizing the gene. Patents are the domain of interest purely of business and not science. In the movie that we had watched in class, she asks why the price of the tests have not decreased in the past years and the head of Myriad was at a loss of words and could only agree that they should go down. Clearly, the money has become the interest. I disagree with Jess when she quotes "the race" as a drive for innovation. Although this did fuel competition, this was a race to obtain control, to obtain this patent, a race for financial monopoly. So the race was completed and won by Myriad and now that they have "won this race" they have limited competition and innovation. So, in the long run, was this "race" driven by the desire of ownership positive? Honestly, I think there are definitely two arguments to this question, but in my opinion, this was not for the benefit of the people, but for the benefit of the company.

    Although i find it hard to advocate for patents on genes, but if I were to be in the position of Myriad favoring a patent i would argue that if you deny those patents, you are potentially putting a lot of companies and their technologies at risk. This patent supplies funds for such testing.

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  9. I feel as though Myriad should have the right to patent their genetic test for the BRCA1/2 gene, since they were the ones to create and pioneer the test and their hard work should be rewarded. However, holding a patent over the gene itself is a different story. I found it a bit disheartening the way the Myriad representative handled the interview with Johanna in the documentary, overzealously congratulating himself and the company for having such authority over the genes, while seeming unsympathetic toward those individuals and their families who are highly susceptible to cancer due to those patented genes and undoubtedly think about how it will affect their future with each passing day. If the genes were not patented, perhaps researchers could make unprecedented advancements in the management and treatment of the resultant cases of cancer, without the barrier of a single company owning the rights to the genes. While it is important to promote healthy competition and innovation, in the process it's also necessary to consider whether or not you are stifling the healthiness of other more important components of society: people. It hardly makes sense that a success- and profit-driven corporation claim ownership over something that families all over the world could potentially carry in their own bodies.

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  10. I agree with what S. Walker said. I believe that a company does not have the right to patent a gene. When a company is doing research in trying to find a new gene, there incentive should not be to discover the gene first so they can patent it. But rather they should have the motivation to find these new genes because hopefully they will be helping or changing someone’s life. I think that the researchers should be recognized and given credit for that gene discovery but not receive extra money from a patent. We do not need to be adding to the profit making health care system that already exist. For instance, if researchers can patent a gene this is just going to lead to an inequality in the health care system where the people of higher SES are going to benefit from a genetic test because they can affordable it. Everyone else is left with nothing. Thus, starting off on the right foot by not allowing patents on genes will hopefully lead to people being able to afford to have genetic test.

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  11. I do not necessarily disagree with Myriad's position on gene patenting. I believe that there is something to say when individuals put their time and efforts into researching genes and other biological resources that potentially help the general public prevent, treat, and diagnose genome-wide diseases and mutations. Gene patenting gives incentive and provides a spark for innovation and hard work so that these researchers can get the recognition they are due. Otherwise, what merits are received for researchers to pour their hearts and time into their work?

    On the other hand, I do not believe it is a benefit for society and hence the overall research for companies to sell mutation testing for patented genes at unreasonable prices. Myraid currently "sells a test for more than $3,000 that detects mutations in the genes that confer a very high risk of breast or ovarian cancer" for the BRCA1 and BRCA2 genes. Individuals who are at most risk and in need of a genetic test should not have to pay $3,000 for a test that could potentially alter and change the course of their life. It is one thing for a company such as Myriad to receive the merit and recognition of discovery for the genes and it is another thing for them make their discoveries inaccessible and expensive for the individuals the genes affect the most. Mostly, I believe that although gene patenting is a good way to receive recognition and provide incentive for research, it should not be at such a price that makes it inaccessible to the general public.

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  12. I am in agreement with Lynese is regard to the pricing of specific genetic testing. The only reason to offer the BRCA 1/2 tests at such an expensive price is simply to make a profit. Myriad is clearly profiting from their market dominance for this specific test. While patents might increase motivation to develop certain genetic tests, I do not agree that one comapny should have the only right to use that certain genetic testing method. The purpose of genetic testing should be to help people and save lives, not just to make a financial profit. Typically, people have genetic testing to rule out or solidify an assumption about a disease. It seems highly unethical to charge outrageous prices for testing to this vulnerable population. To make getic testing more accessible to all patients, companies like Myriad should reevaluate pricing standards to accomodate the general public. How can a company have a patent over a gene that they did not create in the first place? Scientific research is costly and I understand that Myriad wants to protect their investment into the research, but they did not discover the gene. The gene was created by nature and not developed in a lab. It seems as though financial incentives have come in between the purpose of gentic testing, which companies must remember is to help people in need. This debate involves a great deal of ehtical problems that will only increase in the future. I think patents will continue to play a significant role in the research world as more genetic tests are developed.

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  13. Like the US government wants limits on gene patents, from an ethical perspective I strongly agree. Things found in nature should not be patentable. Patents are meant to protect inventions. No entity or person can lay such a claim to nature. Normally, companies who want to patent have commercial interest. Although, as T.Burks mentioned, the competition stance is not a strong argument since patenting a gene would only stimulate competition and innovation among other companies.
    In addition, patents are also not necessary for ensuring that genetic tests come to market. Myriad does not allow any other lab in the United States to perform full diagnostic testing on patients in order to tell them whether they are at increased risk of hereditary breast and ovarian cancer. Like Lynese mentioned, due to this monopoly, Myriad is able to charge more than $3,000 to perform the test, a high amount that keeps some women from being tested and making informed health decisions. If the women actually need the test, this amount is unfair and as a result, societal benefits are limited. Genes are an example of "basic knowledge"—the kind of knowledge that typically cannot and should not be patented.

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  14. Like the US government wants limits on gene patents, from an ethical perspective I strongly agree. Things found in nature should not be patentable. Patents are meant to protect inventions. No entity or person can lay such a claim to nature. Normally, companies who want to patent have commercial interest. Although, as T.Burks mentioned, the competition stance is not a strong argument since patenting a gene would only stimulate competition and innovation among other companies.
    In addition, patents are also not necessary for ensuring that genetic tests come to market. Myriad does not allow any other lab in the United States to perform full diagnostic testing on patients in order to tell them whether they are at increased risk of hereditary breast and ovarian cancer. Like Lynese mentioned, due to this monopoly, Myriad is able to charge more than $3,000 to perform the test, a high amount that keeps some women from being tested and making informed health decisions. If the women actually need the test, this amount is unfair and as a result, societal benefits are limited. Genes are an example of "basic knowledge"—the kind of knowledge that typically cannot and should not be patented.

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  15. I think Myriad should be allowed to keep their gene patents, because, after all, that has been official US policy for the past three decades. I think it is dangerous to deny Myriad, or for that matter any other company, the right to patent some product based on the reasoning that that product is an artifact of nature. There are many naturally occurring compounds (penicillin, antibiotics, proteins, etc) that have been patented, so it is not consistent to say that genes cannot be patented solely because they are "natural."

    The bottom-line for businesses, it can be argued, is in their profits. Companies like Myriad invest in research and development and so ought to be fairly rewarded for their innovation and creativity when they isolate some important gene variant. If the US Patent Office reverses itself and denies the granting of gene patents, I think it will be bad decision. Not only will research be stifled, but it is very likely that most of the innovation and development in genomics will be happening elsewhere and not in the US.

    Even though I think the rights of Myriad -with respect to BRCA1/2 gene patents- should be granted, I also agree with Lynese that, "individuals who are at most risk and in need of a genetic test should not have to pay $3,000 for a test that could potentially alter and change the course of their life." For this reason, I believe the US Patent Office and the National Institutes of Health ought to come up with a solution to the patent problem that allows companies to be rewarded for their effort and innovation without sacrificing the good of affordable public health care.

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  16. I agree with J. Grodman that Myriad should be allowed to keep their gene patents. I think that Myriad has the right to patent the genes because they were the first to discover them. Like Myriad said in the film we watched in class, "In the Family," when they discovered the BRCA1/2 genes, at the time it was a huge competition to see who could find it first. By allowing companies to patent genes would drive competition, which would benefit the study of genomics in the long run. However, I think patents on genes should have some barriers. Currently is very expensive to get a personal genome sequence, and patents could keep genetic testing unaffordable. Administration officials should find a middle ground where companies' research efforts can be rewarded and protected without keeping people from being able to easily access these benefits.

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  17. I concur with S. Marchese and J. Grodman in that it is an important driving factor in upholding the competition for genetic discoveries, to allow the first discovery to have rights to a patent. It's certainly a beneficial thing, however it is also a double-edged sword. With the patenting of genes, such as Myriad with the BRCA 1/2 we saw how they are the only people to offer a test for this mutation. Because of this, they are able to have direct control who gets tested, and the cost of the test.
    The pitfalls with the patenting is it will allow these companies such as Myriad to drive up the prices of their testing and have complete control over the costs, in a sense allowing them to gouge the prices and prevent those who really need the tests but may not be able to afford the test. Now, it is unclear whether insurance companies would be willing to cover the cost of the test, but let's say they did and you tested positive for the BRCA 1/2 mutation. This may then allow them to discriminate against you due to your increased risk of developing cancer and you may be dropped by your provider.
    Ideally, if there was a way to incorporate this competitive patenting industry driving idea with aa limitation on prices and perhaps other incentives for the patenter other than being able to rip people off, so to speak, then this would a situation where everyone won. Those who needed the tests would be able to get them for an affordable price and have the option of keeping the results confidential, the companies such as Myriad would be able to competitvely research for new genes with incentive and then perhaps this would allow for great growth and success in such a new and upcoming field. More guidelines and policies should be implemented as such, to prevent price gouging and monopolizing of gene patents, and allow for more universally affordable tests.

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  18. I think that a benefit to having a patent is that Myriad is able to have these tests done in a quick and organized manner, as they have the money from the patent to do so. If there were many companies running the tests, it is possible that people would go to some smaller places that may have cheaper tests but may also be much less accurate. Myriad is a large test center and I think because of that, they have gotten very good at what they do: analyze BRCA1/2 tests. However, I do think that this does restrict others from doing further research unless they are working for Myriad itself, but as long as Myriad does the best job they can to do as much research as is necessary, the patent may not be such a bad thing after all. One downside that S. Marchese mentioned and that I completely agree with, is that these patents make gene tests extremely expensive, limiting the people who are able to learn about their DNA if they choose to. There should definitely be something done about the cost per tests in order to have both Myriad making profit and patients getting quick, cheap, and organized test results.

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  19. It seems crazy that a company such as Myriad is able to claim ownership over a gene. How can something that is naturally existing able to have ownership over it? Myriad was the one who "discovered" the gene and so it is only fair that they have a gene patent for it. There are many things in our environment, besides genes, that are naturally existing and if someone is to find or see first it they are entitled to claim ownership over it. The benefit for allowing Myriad keep their gene patent is that it will allow other companies to compete with them and discover new findings in research medicine. Myriad has been very successful in their research and were intelligent in getting a patent for the gene that they found. Other research companies strive for the fame and fortune that Myriad has achieved thus far. I feel that as long as society is benefitting from the new gene findings and that people are experiencing improvements in health, then it is okay that a company profits from it. However, I think the line is crossed once a company starts to place limitations on their findings. It is morally wrong when the company charges costly prices for the genetic test that it offers. Myriad's genetic test for the BRCA1/2 gene is so expensive that it is driving away some of the people that are a high risk and should be getting the genetic test done. Having competition among research companies does promote for new findings to quickly occur, but I do not support research companies that take advantage of their discoveries and are negatively affecting the health status of the general population.

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  20. Although many consider it impossible to "own" a particular gene, I do believe it is possible for a company, such as Myraid, to have exclusive rights to a genetic sequence they discovered. The prospect of achieving notoritity for discovering a genetic sequence is terrific motivation to finding it. In this instance, however, I believe the real impetus for discovering a desired gene sequence is the promise of making money. The pharamaceutical industry, like any industry, is composed of big companies looking to stay on the vanguard of technological advance and creating products that many patients will need or want. As such, it requires a great deal of capital to fund the research and man hours to make the "discoveries" in genetics that will ultimately benefit patients and consumers alike. So in my opinion, why shouldn't these companies get paid for their advancements and their findings? One major issue with this however, is that there is little consumers can do to drive down the high prices of genetic screening tests, which is a deterant for many who want to have the test done, but cannot afford to do so.

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  21. Since the inception of gene patenting a generation ago, patent lawyers have taken the position that genes are just chemicals. Their information-carrying function is irrelevant to their patentability, the lawyers say. Because genes are chemically different in isolation, at least in a literal sense, they can’t be considered products of nature. The USPTO and the courts, including the Federal Circuit (the patent court of appeals), have uniformly acquiesced. Now a federal court has said that, no, genes aren’t just chemicals—precisely because they carry information. Genetic exceptionalism has become a principle of law, at least in Judge [Robert W.] Sweet’s court. Unfortunately for the Greenbergs, there has been legal precedent for patenting a gene since a landmark 1980 Supreme Court ruling, which established that living organisms altered or isolated by “the hand of man” could be patented, provided that the in­ventor did something new and useful with the discovery. Since then, about 500,000 gene patents have been granted or are pending, according to the advocacy group GeneWatch UK.

    And that's the question at the heart of the district court ruling, and today's arguments on appeal. If the genes in question are "chemicals," that's more favorable to Myriad. If they're "information," it's more favorable to the plaintiffs. If the ruling is upheld, I can't imagine it not going to the Supreme Court, because it's a significant sea change in the existing but nascent law.

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