Science vs. Civil Liberties: The Legal Battles Over Gene Patenting
Updated: Feb 5, 2022
Gene patenting, per MedlinePlus, is "the exclusive rights to a specific sequence of DNA (a gene) given by a government to the individual, organization, or corporation who claims to have first identified the gene." The purpose of a patent is for a company to claim something like property and ensure that no one else steals or sells an invention belonging to the patent holder.
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The purpose of government-issued patents is to promote new ideas that hopefully turn into new inventions. However, obtaining a patent is a lengthy process with a detailed list of criteria. First, the item must be considered useful, novel, non-obvious, and detailed enough in the description that people within the field can comprehend and put to use. With the patient comes a 20-year term. During that term, extensive research takes place through extraction and manipulation to develop some invention. However, on the downside, other companies cannot do research on specific genes, which limits possibilities. There is also the monopolization of genes; the holder will not allow other companies to look at the genes. The tests also must be sent back to the patient holder, which means the results process takes much longer. On the positive side, companies can look at genes without competition from other companies and provide opportunities and encourage research.
All of this sounds like a big win for science. However, unfortunately, there is a vast, underlying problem. The gene patient holders have the final say over what happens to that gene, including research or tests. This leads to tests being unavailable for those with a life-threatening illness or private companies simply having complete ownership of testing, resulting in thousands of dollars raising the price. Another problem is that other laboratories have tests readily available but are legally forbidden to provide them due to the patient. The result has been undiagnosed deaths. Along with this, the denial of a third party puts restrictions on confirming negative or positive tests.
Gene patenting has some serious, life-threatening consequences. For example, in 2013, there was a case with Myriad Genetics, located in Salt Lake City, Utah, in which they patented BRCA 1 and BRCA 2. This was a big concern for individuals at risk for breast and ovarian cancer. Mutations coupled with both BRCA 1 and 2 are at higher risk for both diseases. A significant problem, in this case, was that Myriad Genetics was able to increase prices on testing from about $1,000 to over $4,000. In addition, there was also a problem with the accuracy of the tests they provided, as 12% of people tested received false-negative test results.
Kathleen Maxian is an individual who was explicitly affected by Myriad Genetics. She has the mutation coupled with BRCA 1 that leads to ovarian cancer. Unfortunately, due to her inability to get a test, her condition reached its late stages. In her case, she could have avoided cancer entirely if she had the resources available.
This case surrounded the concept of whether genes were a product of nature or simply compositions of matter. This is the most significant argument, as it ties into the Constitution. Article 1, Section 8 of the Constitution states that Congress has the power to "...promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries;" The interpretation of this was heavily debated. Among Myriad's motives, two reasons stand out: they claimed that the isolation of a gene makes it indistinguishable and that it could be patented because they discover the genes. The Supreme Court thought differently, which was reflected in their unanimous vote. Specifically, Justice Clarence Thomas claimed that Myriad did not create anything simply because they separated the gene from the original genetic material, not creating the gene itself. The decision was made as follows; naturally occurring genes and genetic sequences are not patentable because they are a product of nature and are not created by or belong to Myriad. As gene patenting grows, more legal battles will settle the blurred line of what is right and wrong in the scientific field.