Source: http://blogs.kentlaw.iit.edu/islat/category/genetics/
Timestamp: 2019-04-22 22:11:42+00:00

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Today the U.S. Supreme Court held in Association for Molecular Pathology v. Myriad Genetics, Inc., that human genes were not patentable since they are products of nature and not inventions. This decision is great news for patients, doctors, and scientific researchers. Some biotechnology companies might grumble about the decision, but the decision will actually stimulate innovation by pharmaceutical companies and the new generation of biotech companies.
On April 15, the U.S. Supreme Court will hear the case Association of Molecular Pathology v. Myriad. The question before the court is: Are human genes patentable?
For 150 years, the Supreme Court has said that abstract ideas, laws of nature and products of nature are not patentable. Such patents would run afoul of the progress clause of the Constitution and section 101 of the Patent Act.
In 1980, the Supreme Court in Diamond v. Chakrabarty held that genetically modified living organisms are patentable if they are markedly different than what occurs in nature. That case reiterated that laws of nature like E = mc2 are not patentable, nor are products of nature such as plants from the wild or minerals from the ground.
Three decades after the Chakrabarty decision, the Supreme Court revisited the exception by taking a trilogy of cases. In the first one, Bilski v. Kappos, the Court held that an abstract idea–hedging in trading energy futures–could not be patented. In Mayo v. Prometheus, the Court held 9-0 that a law of nature–how the body responded to the administration of a drug–was not patentable.
In the Myriad case, the Court will be addressing the third part of the exception, dealing with products of nature. It will address whether an “isolated” breast cancer gene is an unpatentable product of nature. The patents at issue cover two isolated genes related to breast cancer, BRCA1 and BRCA2. The patents define the isolated gene to include a gene sequence “removed from its naturally occurring environment.” This claim gives Myriad the ability to control all uses of anyone’s breast cancer genes once they are removed from the body, giving Myriad the right to exert a monopoly over all BRCA1 and BRCA2 breast cancer gene testing and research.
What is a gene sequence? It’s a series of chemical letters known as nucleic acid bases–designated by A, T, C, and G. It is important because a single change in the letter–a typo in the sequence–can lead to a genetic disease. To diagnose a genetic disease, a physician or laboratory compares the patient’s genetic sequence to a normal gene sequence to see if there are differences that predispose the patient to breast cancer.
Myriad also argues that isolation of the gene “depended on an enormous amount of human judgment, including how to define the beginning and end of what came to be called the BRCA1 and BRCA2 genes, and then creating isolated DNA molecules corresponding to those particular defined genes.” Myriad also argues that by isolating the gene, it gave the gene new uses since genes in the body cannot be used for diagnosis. It also created copies of the gene in the lab.
In contrast, the petitioners in the case argue that what Myriad patented is not markedly different from nature. For Myriad’s gene sequence to work as a diagnostic tool, it must have the identical sequence to that of a breast cancer gene in nature. The petitioners argue that once the unpatentable product of nature, the gene sequence, was discovered, Myriad used routine means to create copies of it and to undertake diagnostic comparisons to patients’ genes. The Court is likely to look to a 1948 Supreme Court case, Funk Brothers Seed Co. v. Kalo Inoculant Co., in which the patent applicant combined six types of bacteria and the claimed invention was found to be an unpatentable product of nature because the bacteria “served the ends nature originally provided.” The petitioners argue that here the isolated gene sequence merely serves the ends nature intended.
In addition to extensive briefing about whether there is sufficient human ingenuity involved to consider an isolated human gene to be a patentable invention, the affidavits and amicus briefs in the case gathered all existing data on whether gene patents encourage or discourage innovation. Over 90 affidavits were filed, including those from Nobel Laureates. Briefs from over 102 amicus groups were filed, including briefs from medical organizations such as the American Medical Association and patient advocacy groups such as the March of Dimes arguing for the invalidation of gene patents, and briefs from industry organizations such as the Biotechnology Industry Organization and intellectual property associations such as the American Intellectual Property Law Association arguing that gene patents are valid. Also weighing in were prominent scientists, various companies and numerous law professors.
I filed an amicus brief in the case on behalf of medical organizations, including the American Medical Association, American College of Obstetricians and Gynecologists, and American Society of Human Genetics, providing evidence that patents on genetic sequences interfere with health care and research.
Medical organizations are concerned because gene patents increase the cost of the diagnosis and treatment of genetic diseases. For 20 years, a gene patent holder controls any use of “its” gene. The patent holder can charge whatever it wants for any test analyzing the patented gene–even if that test uses a technology that was not invented by the patent holder. Myriad, which holds the patent on the BRCA1 and BRCA2 genes, charges over $3,000 for its genetic test for breast cancer. One in four laboratories has stopped performing certain genetic tests because of patent restrictions or excessive royalty costs.
The ability of a patent holder to prevent health care providers from using a patented genetic sequence denies people crucial medical information. Most drugs only work on a percentage of patients who use them. An asthma inhaler might only work on seven of ten people to whom it is prescribed, causing the other three to suffer symptoms of asthma and pay for an inappropriate drug until the right medication can be found. Genetic testing can help to distinguish those people for whom a drug will work from those people for whom it will not work, but, if the same entity holds the patents on the drugs and the gene sequences, it may prevent use of the gene sequence because the identification of people for whom the drug will not work will limit the market for the drug.
One company has filed for patent protection on a genetic sequence that could be tested to determine the effectiveness of its asthma drug in a prospective patient. The company, however, has said that it will not develop the test–or let anyone else develop the test. While such a test would be crucial to doctors in determining which patients would benefit from the use of the asthma inhaler and which patients would benefit from a different drug or treatment, it would also diminish the market for the drug because a trial use of the asthma inhaler would no longer be needed to know if it would be an effective treatment.
For more information, listen to my interview with Minnesota Public Radio on the subject or view the video of an interview with me on the OYEZ website.
The recent phenomenon of “biohacking” has been quietly gaining momentum. In February 2010, Lori Andrews blogged about her experience at UCLA’s Outlaw Genetics conference. Just last week, the international scientific journal Nature published an article titled “Garage Biotech: Life Hackers” describing the growing trend. The steadily decreasing cost of molecular biology equipment has lead to a movement where amateur scientists, calling themselves biohackers, purchase equipment and set up their own molecular biology labs in their garages. Proponents of the movement liken it to the open source movement in software. The idea is that the “democratization of science” will bring fresh new talent to improve scientific instruments and uncover new applications for biotechnology. At the very least, the name “biohackers” sounds cool.
Biohackers and do-it-yourself biologists come in all forms. Geneticist Hugh Rienhoff created a home laboratory to study his ailing daughter’s rare genetic condition. Others, like Rob Carlson, simply became frustrated with the tedious process of annually filling out grant applications to secure funding at his academic lab. The real down-and-dirty biohackers, however, are simply hobbyists with little or no formal training in molecular biology. For example the article in Nature mentions Meredith Patterson, a computer programmer based in San Francisco California who created glow-in-the-dark yogurt by engineering a yeast strain in a garage lab. There are growing online communities such as DIYbio where biohackers come together to share protocols and instructions for making cheaper lab equipment. Other groups, such as the Silicon Valley-based BioCurious, are seeking to furnish a shared lab space where members of the club pay dues in exchange for classes taught by local graduate students and timeshares in the lab.
Myriad Offers to “Gift” Its Breast Cancer Patent to Australia: What’s the Logic?
Myriad Genetics, in mid-August, 2010, sent a letter offering to surrender its Australian BRCA1 breast cancer gene. The letter said, “Myriad wishes to gift Australian Patent No 686004 (the Patent) to the people of Australia.” On September 2, 2010, the Commissioner of Patents published notice of Myriad’s offer to surrender the Patent in the Australian Official Journal of Patents, and interested parties that want to be heard before the offer of surrender is accepted must submit a request within a month.
Myriad will surely claim its offer to surrender its patent is based on compassion and consideration for Australian women who have a family history of breast cancer and want genetic testing. Not enforcing their Australian patent will allow competing labs to open and provide BRCA1 testing—perhaps at a lower cost or at higher quality. The existence of more labs will give Australian women who wish to be tested the option of obtaining a second opinion before deciding to pursue radical surgeries, such when healthy, asymptomatic women have their breasts or ovaries removed based on a test result that suggests they are at a higher-than-normal risk of developing cancer.
Neuroscientist James Fallon has been studying behavioral disorders for 20 years at the University of California at Irvine, but he made his biggest discovery in his own backyard. At a family barbeque, James's 88 year-old mother recommended to him that he find out about his father’s relatives, saying "I think there were some cuckoos back there." What he found was a 300-year family history that included eight convicted and alleged murderers. Among his ancestors are a man who was sentenced to death by hanging for murder in 1667 and the infamous Lizzy Borden. Fallon was understandably concerned. As part of a family study to determine risk of Alzheimer’s disease, he had already convinced 10 of his family members and relatives to take a brain scan and give a blood sample. After years of studying the criminal brain, Fallon knew the signs associated with behavioral disorders, so he compared the brain scans. Only one of the family brain scans showed the pattern of what he calls a psychopath – his own.
Researchers studying Alzheimer’s disease have been using an approach to learning about the disease rarely used in the life sciences – cooperation. In 2003, the Alzheimer’s Disease Neuroimaging Initiative formed as a collaborative effort to find biomarkers that show the progression of Alzheimer’s disease in the brain. Researchers from the National Institute of Health, Food and Drug Administration, the drug and medical imaging industries, and universities and non-profits have been sharing all of their data and making every finding freely accessible to the public. The collaboration agreed that no one would either own the data or submit patent applications. Now in 2010, the collaboration is starting to bear fruit.
The Alzheimer’s collaboration is significant for two reasons. First, the collaboration of Alzheimer’s disease research is yielding promising results for the understanding and treatment of the disease. This collaborative approach looks to be effective – currently there are over 100 studies being conducted to test drugs that could slow the effects of the disease or cure it. Second, this type of collaboration in the life sciences is rare, as the practice of allowing patents on the results of basic scientific research (such as human gene sequences and correlations between genetic mutations and disease) in the life sciences fields has created an incentive to not share results, but instead withhold data. Dr. John Q. Trojanowski, an Alzheimer’s disease researcher at the University of Pennsylvania, describes how uncommon collaboration like this is in the life sciences: "It’s not science the way most of us have practiced it in our careers. But we all realized that we would never get biomarkers unless all of us parked our egos and intellectual-property noses outside the door and agreed that all of our data would be public immediately."
A group of scientists at the Beijing Genomics Institute has discovered the quickest example of human evolution to date. A study revealed that at least 30 genes have undergone evolutionary changes in Tibetans in the timeframe of 3,000-6,000 years. The discovery is interesting from a purely scientific standpoint, as an example of how quickly the human genome (and therefore, human body) can change and adapt to its environment. Tibetans, who have long sought to have Tibet to be a sovereign nation, could be tempted to use this discovery to argue that Tibet should be recognized by China, but the characterization of Tibetans as genetically distinct could have unwanted consequences.
These genes are responsible for Tibetans’ ability to live and work at high altitudes. The Tibetans live at altitudes of over 13,000 feet, where the air contains 40% less oxygen than at sea level, but Tibetans do not suffer from the effects of mountain sickness. The study found 30 gene variants that were rare among the 40 Hans Chinese in the study were much more common in the 50 Tibetans in the study. A variant of the gene hypoxia-inducible factor 2-alpha (HIF2a) appeared in 87% of Tibetans in the study, and only 9% of Hans Chinese. Tibetans with this variant of HIF2a had less red blood cells and therefore less hemoglobin in their blood, which would help explain less susceptibility to mountain sickness.

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