Thursday, June 13, 2013

The Supreme Court and Angelina Jolie

The United States Supreme Court, Actress Angelina Jolie, and human gene patents are three topics not usually mentioned in the same discussion, however, today's unanimous 9-0 ruling by the Supreme Court links all three in one of the most interesting and significant cases of this year.  The Court's ruling today in Association for Molecular Pathology v. Myriad Genetics establishes that isolated natural human genes may not be patented, and will significantly shape medical research and procedures surrounding breast and ovarian cancer.

To help better explain the decision handed down by the Supreme Court Justices today, I turn to Angelina Jolie and her inspiring revelation last month that she underwent double mastectomy surgery in a valiant effort to prevent breast cancer.  In a remarkable New York Times Op-Ed Jolie reveals she carries the gene BRCA1, while her doctors gave her an 87% chance of developing breast cancer and 50% chance of ovarian cancer.  After making the decision to have a double-mastectomy, Jolie explains, "My chances of developing breast cancer have dropped from 87 percent to under 5 percent."  Angelina Jolie took a remarkably courageous stance, one however, not all women are afforded.  The medical test which ONLY identifies the BRCA1 and BRCA2 genes costs patients and insurers between $3000 - $4000, a procedure that should cost around $100 if the two genes were not patented by Myriad Genetics.  So what exactly happened from today's ruling and what are the ramifications?! 

The Background:  The Association for Molecular Pathology and numerous other medical doctors, patients and associations sued the U.S. Patent and Trademark Office and Myriad Genetics to challenge the exclusively held patents of Myriad Genetics that covered the BRCA1 and BRCA2 genes and particular mutations indicating "high risk" of breast cancer.  Not only did Myriad Genetics have exclusive control over the BRCA gene patents, but they also had singular control over patents pertaining to the screening process in patients, which ultimately determines an individuals risk of developing cancer.  Myriad argued, once a gene has been "isolated", it becomes distinguishable from other genes in a person's DNA and therefore can be patented.  By patenting the genes, Myriad had sole control over the entire diagnostic testing and ALL scientific research pertaining to the genes.  The parties suing argued Myriad Genetics could not have a patent on the BRCA1 and BRCA1 genes and related genetic material because they were direct products of nature, while also arguing the exclusivity of the patents directly limits scientific progress and advances.

The Ruling:  The Supreme Court ruled 9-0 against Myriad Genetics with Justice Clarence Thomas writing the opinion and explaining, "A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated."  The Court held that the discovery of natural products is not patentable, while "It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes."  The Court found that Myriad Genetics in no way created either of the genes and therefore could not patent them nor the medical procedures involved with isolating them.  While the Supreme Court struck down the patents held by Myriad Genetics, the Justices did leave the door open for future patents on synthetic DNA, which would be patent eligible because synthetic genes are uniquely developed by humans in a lab and cannot be found naturally occurring in nature.     

My Take:  The manner in which this case relates to everyday families affected by cancer illustrates the immense power and influence of the Supreme Court.  The ruling today will affect every American seeking routine medical procedures surrounding the BRCA1 and BRCA2 genes and cancer prevention methods.  I believe the Supreme Court ruled correctly in striking down patents on human genes and their reasoning was founded in U.S. patent laws and the constitution.  Pharmaceutical companies cannot patent aspects of human DNA when they had no role in its creation or implication.  A corporation is not able to patent molecular structures found in nature, like H2O or elemental compounds, so basic components of a persons DNA is no exception.


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