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    By Elizabeth Winogra... | October 15th 2009 05:03 PM | Print | E-mail
    When a patient takes a pain killer, she doesn't usually care what it's made of.  As it enters her bloodstream, she's not aware of the chemical interactions that cause her fever to go down, the molecular components that combine to relieve her pain.  But she doesn’t have to know everything about the drug to feel the effects; she just has to swallow a pill.  A pharmaceutical company has a patent on that drug, on the chemical responsible for alleviating her symptoms.  This kind of patent is generally acknowledged to foster innovation by providing a monetary incentive.

    What happens when the chemical that a company wants to patent is actually a gene? DNA itself (deoxyribonucleic acid) is certainly a chemical, like the pain reliever, but nobody "takes" DNA as a drug.  Researchers use a gene for its information, its sequence and resulting protein product, not its chemical nature, in order to figure out how it works in a cell.  Similarly, medical patients who want to know whether they have a mutated copy of a cancer gene, for example, can use the information from their DNA to assess their cancer risk.  The basic knowledge, the sequence of your genes, will come at additional cost or not at all while genes can be patented.

    DNA chemicals are like letters that spell out the words, or genes, that make up the book that is each individual’s genome.  Imagine patenting the word “Because.”  Everyone uses this word, but now it is a patent violation even to read in your own genome, your own “book,” let alone researching how it is used in other genomes.  This sounds ridiculous because it is.  Genes should be patented no more than words should.

    In an effort to prevent the random and wonton patenting of large DNA sequences, like those coming from The Human Genome Project1 and ENCODE2, the US Patent Office says for a gene sequence to be patented, it must be deemed “novel” and given “a stated purpose”3.  But these criteria do nothing to stem the flood of patents on genetic information being snatched up by biotech companies.  For example, if you are looking for a gene that contributes to breast cancer, its usefulness is obvious: use it to determine whether a patient has an increased risk for breast cancer.  And how “novel” is a mutated gene if it shows up in enough people to make it worth patenting?

    A woman whose mother had breast cancer at a young age may want to know if she has the dangerous forms of the BRCA1 or BRCA2 genes, which have been shown to increase a woman’s risk of breast and ovarian cancer4.  Myriad Genetics&Laboratories holds the patents on these genes, so while any scientist could take some of her DNA and use common tools and techniques to see which form of these genes she has, doing so without a license from Myriad Genetics would constitute patent infringement, and the doctor could be sued.  Using Myriad’s test is expensive, about $3000 to test for the mutations, and as the New York Times reported in May 2009, what if the woman wants a second opinion5?  For the twenty years the patent exists, there can be no legal second opinion.

    While it may seem that Myriad’s test would give a simple yes or no answer, something for which no second opinion would be necessary, biological systems are rarely so simple.  The patented test uses PCR, or polymerase chain reaction, to amplify just a small, incredibly specific section of DNA that includes the gene of interest.  This is done by starting, or “priming,” the DNA sample with small bits of DNA around the section you want to see.  Once this section alone is amplified, then you can determine the sequence to see which form of the gene, normal or mutated, is in your DNA.  The patent on PCR has expired and so is free for anyone to use, and this means any properly equipped lab could perform this test.  However, legally, only labs licensed to use Myriad’s test can perform this PCR, and they have to use Myriad’s protocol.  This extends to, for example, their “primers,” the bits of DNA that make the PCR specific, even though every person is different and some samples may respond differently to different primers.  So what stops another lab from performing this test using different primers?  By owning the patent on these genes, Myriad can sue anyone that screens for BRCA1 or BRCA2 without their license.  Anyone who wants to know the sequence of these genes has to use Myriad’s primers and PCR conditions, which may or may not be best for that individual.  Why not allow the patent to extend to the primers, the specific technique, but leave the gene open for others to develop different ways to test for these mutations?  In other words, patent the magnifying glass you use to see the word on the page, but leave the word itself for anyone to look at using other techniques.

    Beyond developing tests for medically important genes, many researchers are also engaged in projects with the intention of creating improved food crops for distribution to poor farmers around the world.  Say a researcher finds a gene for flood tolerance in a simple-to-research organism like Arabidopsis thaliana, a weedy mustard-like plant of no agricultural importance.  This gene, or a very similar one, may also exist in more lucrative crop plants like wheat, corn, or rice, but the average researcher doesn’t have the resources to clone and patent all of them.  Even if the researcher chooses to patent this Arabidopsis gene, that will not prevent a biotech company from using that sequence information to find and patent the others.  If this promotes the availability of more flood-resistant crops, then perhaps the patent was prudent.  However, there is no law to prevent a biotech company that may already have a less effective flood-resistant product from getting the patent and then sitting on it for twenty years to prevent competition.  Moreover, university researchers regularly make genetically improved crop plant seeds available for free to impoverished farmers worldwide6, but if a biotech company uses this publicly available information to patent and clone these genes in agriculturally important plants, they likely will not be giving these crop seeds away.  It is much more likely that this company will only market to farmers who can afford their premiums.  Worse, once the gene is patented, even publicly-funded researchers infringe on the patent just by looking at the genes7.

    In 1930, Congress passed the Plant Patent Act, which first allowed the patenting of living organisms, specifically, plants that are usually propagated asexually, like roses8.  The idea was that a gardener could cultivate a wild plant, that is, something naturally occurring, and the work he puts into his cultivar should ultimately be protected from someone else buying a cutting from him and then selling it herself.  Could anyone with access to that wild flower have been able to produce that exact cultivar?  Probably not.  But two scientists with legal access to the same flood resistance gene can produce the same flood resistance in a plant.  The flood resistance gene is the information needed to make the flood-resistant rice, as opposed to the gardener’s rosebush, a finished product in itself.

    Surgical procedures are a similar type of “information” that has been patented.  However, as fewer and fewer surgeons used potentially life-saving procedures for fear of violating a patent, a 1996 “medical exemption” was instituted to allow doctors to use the most state-of-the-art methods without fear of patent infringement, surely saving many lives8. Are genes a patentable combination of molecules?  Yes, but like a surgical procedure, they are also truly life-saving information, both in the eyes of scientists and in the way they are used by the public.  Allow patents on the BRCA test, the rosebush, the flood-resistant crop, and all the other products that took real ingenuity to create, but leave the genetic information available to all.