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SCOTUS Strikes Down Gene Patents


Today’s Supreme Court ruling that naturally occurring human genes are not patentable may be the most important of the year so far. The unanimous decision reversed a lower court’s judgment that a company could hold patents on individual genes, effectively preventing anyone else from doing any research or testing on these genes without the patent holder’s permission. The Washington Post reports:

Justice Clarence Thomas, who wrote the court’s decision, said that Myriad’s assertion—that the DNA it isolated from the body for its proprietary breast and ovarian cancer tests were patentable—had to be dismissed because it violates patent rules. The court has said that laws of nature, natural phenomena and abstract ideas are not patentable.

“We hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” Thomas said.

This is a big deal. Patent protection for gene isolation would have made it very difficult for other companies to do genetic research or design tests of their own, and could have put a serious damper on one of the most promising areas of medical research. While the case was still making its way through the court system, Eric Hoffman wrote a piece in the American Interest profiling the damage that could be wrought by gene patents:

Myriad Genetics, for example, charges up to $4,000 for its breast cancer diagnostic test, a price too steep for many patients and health insurance providers. If allowed, labs could run the same genetic test for only a few hundred dollars.3 Myriad also sent cease-and-desist letters to researchers who were looking at the BRCA1/2 genes in their labs, providing diagnostic tests to patients and even providing patients second-opinion tests to confirm the test provided by Myriad.

Gene patents have a detrimental impact on health care and research.4 Gene patents can prevent more accurate, affordable and complex diagnostic tests from being developed.5 A survey of genetics labs found that 53 percent stopped doing research due to concerns about patented genes,6 and there has been a significant decline in published material on patented genetic information.7 The future of personalized medicine may be crushed by the weight of gene patent thickets if a company must ask permission from hundreds of patent holders to scan a single patient’s genome.

Gene patents also drive research towards gene-to-disease correlations and away from factors that actually cause disease, such as exposure to toxic chemicals. Most genetic tests offer only an estimate of the chances for developing a particular disease and fail to account for the influence of other genes and environmental factors that cause disease.8 The predictive power of the test for BRCA breast cancer mutations is high for persons from families with a history of particular kinds of breast or ovarian cancer, but very low for women without a family history of breast cancer; many women who test positive for a BRCA1 mutation do not get the disease.9 Gene patents lock-in our knowledge on these DNA sequences to only their potential correlation to a disease while preventing others from looking at how that gene may interact with other genes or the outside environment.

Although the court decision does still allow for the patenting of fully synthesized genes, it should undo most of the problems described above. When this ruling goes into effect, it should lead to improved medical research, more available procedures based on cutting-edge genetics, and lower costs. It’s a good day when the Supreme Court gets it right.

[Supreme Court image courtesy of Shutterstock]

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  • wigwag

    I agree with Via Meadia that the Supreme Court made the right decision in this case, but with that said, the issue is much less cut and dry than this post implies.

    BRCA1/2 are actually the easy cases because they confer a significant risk for breast cancer even though they are involved in only a very small percentage of breast cancer cases. For a variety of reasons, these two genetic mutations were relatively easy to discover.

    For most diseases, it is dramatically harder to identify mutations that confer susceptibility. Some diseases such as Huntington’s Disease, Fragile X or Cystic Fibrosis can be explained by mutations to a single gene. Unfortunately most diseases that have a basis in genetics aren’t that simple; susceptiblility to these diseases are explained by an unfortunate combination of rare mutations (the term of art is single nucleotide polymorphisms or SNPs-pronounced snips) to numerous genes. To give just one example, susceptibility to Type II diabetes (sometimes called adult onset diabetes) is probably related to a unfortunate combination of rare mutations to as many as 50 genes. As I mentioned earlier BRCA1/2 account for only small number of breast cancers; for the majority of people who get breast cancer but don’t have a bad version of BRCA, hundreds of other mutations could account for there susceptibility.

    Superimpose on all of this the fact that few diseases are caused by genes alone and things become complicated fast. Most diseases characterized by genetic susceptibility need an environmental trigger to activate the process that leads to illness. More often than not, these environmental triggers are neither known or obvious.

    The way that scientists find mutations that confer disease susceptibility is by harvesting DNA from the blood (or rarely saliva) of patients who have the disease and from control subjects who don’t have the disease. The DNA is then analyzed by extremely sensitive and extraordinarily expensive machines. Because most of the mutations associated with diseases are rare, thousands and sometimes tens of thousands of subjects with disease and control subjects without disease need to be induced to provide blood samples.

    Finding and collecting people willing to donate the necessary blood is really hard and very expensive. Making sure that your experimental subjects actually have the disease you are investigating is far harder and far more
    expensive than you might think. Extracting the DNA from the blood costs a lot of money and so does running the DNA through the expensive machinery. Once all of this is done,
    analyzing the data is highly complex, highly labor intensive (biological mathematicians who know how to do this don’t work cheap) and extraordinarily expensive.

    Who is going to bear the expense of making all of this work possible. Private companies including big pharma and biotech start-ups were willing to consider doing so as long as there was a potential payoff on the back end. Remove the protection for intellectual property protection as the Supreme Court just did and you eviscerate the motivation of private companies to invest the billions of dollars that will be required to move this field forward.

    That doesn’t mean this work will stop. The Federal Government thru the National Institues of Health spends hundreds of millions of dollars on research grants each year to scientists at hospitals, universities and medical schools to do exactly this kind of work. But we shouldn’t fool ourselves; the Supreme Court just eliminated the incentive that private companies had to invest in the search for disease susceptibility genes. That will slow the discovery of new disease causing genetic variants in a significant way.

    I still think the Supreme Court made the right decision, but the whole issue is far more complicated than Professor Mead’s post suggests.

    • rheddles

      A few points beyond what WW has said:

      We’re going to see the same effect in drugs. Big Pharma no longer supports huge research budgets. Between the low hanging fruit phenomenon, cost to bring a drug to market and the monopsony the federal government is seeking to establish, the returns aren’t there.

      We’re going to see this kind of research migrate to nations that will grant patent protection. Then there will be more medical tourism to take advantage of therapies unavailable in the US. Look for a Carribean nation to grant patent protection.

      • Corlyss

        What countries would those be?

        • rheddles

          Europe, Australia, etc. Countries that want to attract this type of research will grant protection. With this type of product there can also be significant trade secret content. They then sell product to practitioners in countries that recognize their patent.

    • Tom Chambers

      I agree with the essence of your comment, but just want to note that the purely technological costs of such research have come way down in recent years.

      • wigwag

        Absolutely. The day of the $1,000 genome is rapidly approaching. But the non-technical aspects of the search for susceptiblity genes are enormously expensive. Identifying patients and controls, formulating and maintaining bioinformatic data bases, insuring that your experimental population is as homogeneous as is reasonably possible, conducting quality control efforts (which are critical), collection the samples and finally, analyzing the data is all very expensive. Given genetic heterogeneity, some times this all needs to be done in several racial and ethnic groups.

        This all costs a fortune. After the Supreme Court ruling, the only source left to fund this work is the Federal Government.

  • Kavanna

    An excellent decision by the Supremos — for once, they got a clear-cut case completely right.

    The US patent system has been out of control for two decades and benefits only the lawyers and a few others. It’s demonstrably halting progress in many areas and diverting resources away from productive activities to nonproductive.

    Some people falsely think that patents are an example of “free markets” run amok. In fact, patents are a limitation on free activity, a temporary government-granted monopoly. They have their place. But the system has been greatly overextended into all sorts of dubious things, like business methods and software divorced from hardware implementation.

    This also creates a real problem with other countries, none of which has such broad patent coverage.

    • Corlyss

      You might enjoy the American Life program I linked to below. When suing companies for patent infringement and the threat of suit ends up being a means for rent-seekers to extort money from private enterprise, something needs to be done. I have little faith in Congress to act quickly enough (I mean, by your calculation the system has been out of whack already for 20 years), or to get the problem correct, or to get the solution correct. I can count on them to do the wrong thing slowly with a whole host of unintended consequences that will require future fixes they will be reluctant to make because “we just made a major revision and don’t want to touch it again so soon.”

  • Corlyss
  • ljgude

    I love the smell of a unanimous SCOTUS decision in the morning. Evidently I now enjoy a little more protection against Monsanto patenting my Grandmother’s genes and suing me. As much as I despise those who demonize private interest and the profit motive, I believe there is also a critical role for publicly funded research and the preservation of an intellectual and social commons.

  • wigwag

    Having now read the Eric Hoffman article in AI that Via Meadia links to in this post, I’m surprised how weak it is; the editor who decided to publish it must have concluded that AI readers weren’t entitled to a sophisticated review of the complicated issues involved.

    Hoffman gets the punch line right; genetic variants should not be patentable. The Supreme Court also made the right decision. But Hoffman’s decision to trivialize the arguments in favor of gene patenting make his article weaker, not stronger.

    Yes, allowing genes to be patented will make diagnostic tests that associate genetic mutations with disease far more expensive. But discovering genetic mutations associated with disease is an extraordinarily expensive process. Just to find all the susceptibility genes for one disease like Juvenile Onset Diabetes could easily cost north of $250 million and that for just one disease; where is all this money supposed to come from?

    The Supreme Court just removed any incentive the private sector had to invest in this area. The only funding that remains comes from governmental coffers that are severely depleted and unlikely to grow any time soon. This will dramatically slow the discovery of new disease susceptibility mutations.

    That Hoffman didn’t think that this fact should be mentioned is evidence of how weak his article was and how poorly it was edited. Trying to make your argument stronger by pretending countervailing arguments don’t exist is sloppy and just plain dumb.

  • lukelea

    OT but how SCOTUS rules on gay marriage will be its most important decision this summer. My bet is that they will leave it up to the people to decide rather than making it an irreversible constitutional right.

    Or maybe that’s just wishful thinking on my part.

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