Can human genes be monopolized? -Association for Molecular Pathology v. Myriad Genetics

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Introduction 

Anyone who has taken any type of biology course would know that our DNA is part of what makes us, us. DNA can be found in nearly all human cells, and contains the instructions to make proteins for cellular growth, reproduction and ultimately cellular survival. Even the simplest of changes in a nucleotide, which is the building block for DNA can have devastating effects on human life. And again, anyone who has taken any level biology class would know that DNA is the result of molecular reactions that occurred billions of years ago. DNA is a product of nature that was created prior to and independent of human touch.    

Biologists and modern medicine have made groundbreaking discoveries in the field of human genetics. From the general structure of DNA, to specific diagnostic tests, innovation and exploration of the human genome has vastly improved our quality of life. But what if all of this came to a halt? What if someone could make a profit off a shared gene? What if someone could make a profit off your genes? The 2013 Supreme Court case Association for Molecular Pathology v. Myriad Genetics put this into question. 

Scientific Background

In order to understand the court's decision, you should understand the science behind the case. Myriad Genetics, a molecular diagnostic company, had patents on the BRCA1 and BRCA2 (breast cancer susceptibility) genes, and several other genetic mutations. BRCA1 and BRCA2 are genes that code for tumor suppressor proteins and are inherited from both parents, one copy of each gene from the biological mother and the other from the biological father. Breast and ovarian cancer occurs when there is a mutation in both alleles, so the person does not have any functional copies of the BRCA1 and BRCA2 genes. The second mutated gene would not be inherited, and would only be found in cancerous cells. Mutations can occur when there was an uncorrected error during DNA replication, or because of environmental factors like UV radiation and exposure to chemicals. These mutations can result in an increased likelihood of breast, ovarian and other cancers. You can learn more about BRCA1 and BRCA2 here and here. Because Myriad had a patent on BRCA1 and BRCA2, they had complete control over who has access to testing and researching those genes and the mutations within those genes.   

    

Risk of breast cancer from mutations in the BRCA1/2 genes ²

Case Background

The plaintiffs, The Association for Molecular Pathology and several other genetic associations, doctors, and patients sued Myriad Genetics and the US Patent and Trademark Office regarding these patents. Myriad Genetics argued that the patented genes were isolated and mutated, making them distinguishably different from any other naturally occurring genes. Myriad Genetics cited SCOTUS case Diamond v. Chakrabarty, in which the court upheld that live man-made bacteria are unique in nature, therefore patentable. Applying the same logic to their case; because the BRCA1 and BRCA2 genes (and other mutations) are distinguishable from nature they can be patented. 

The Association for Molecular Pathology argued that Myriad's patents violated section 101 of the Patent Act. The section reads as follows: "Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain  a patent therefor, subject to the conditions and requirements of this title". This seems pretty broad, but there are a few limitations. The court established in Diamond v. Chakrabarty and then later upheld in Mayo Collaborative Servs. v. Prometheus Labs, Inc. that laws of nature, natural phenomena and abstract ideas are not patentable. The plaintiffs also argued that patents on genetic information would inhibit scientific research and progress. 

Justice Clarence Thomas gave the court's unanimous opinion June 13th, 2013. The court ruled in favor of The Association for Molecular Pathology and held that naturally occurring genetic sequences, their mutations and other derivatives could not be patented. Because the BRCA1 and BRCA2 genes were not lab made, and their mutations were not synthetic they could not be patented. If those genes and their mutations were created and altered by man, they could then be patent allegeable. Justice Scalia concurred in part, disagreeing with the notion that cDNA (DNA composed of only the exons because the introns were removed in the lab) is naturally occurring, therefore unpatentable.     

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Analysis

You are probably wondering why any of what I wrote is remotely relevant to you. The short answer is that gene monopolies are bad. We all know the Gilded Age robber barons. They monopolized major and new industries, giving them the power to set and regulate the price and supply of goods. You could argue that their actions had a positive influence on American life. Because they controlled the markets and destroyed competition, they cut the price of their goods and pushed for expansion. You could even say that because they treated and payed their employees so poorly, they paved the way unionization and the protection of worker's rights. But the biggest difference between Rockefeller's Standard Oil and the potential for a genetic monopoly is human life. 

Love it or hate it, there are alternatives to high steel prices. There are not many alternatives for genetic testing. If companies can patent genetic information, they can control who has access to said information. The company would have exclusive rights to this information and could create an inverse relationship between availability and price. They can adjust the market in their favor by increasing the price of diagnostic tests and make it more difficult for other scientists to research, thus thwarting scientific progress. A lot of this sounds worse case scenario, but we've seen it happen in history.  People should not have to pay an arm and a leg to see their genetic makeup. Scientists should not have to go above and beyond to have access to information that could substantially improve our quality of life. Scientific progress occurs as we disseminate information. Life altering science and innovation that remains a secret, is for all intent, void of any purpose.

    

Image Credits

¹- Chris Madden and published by Biopoliticaltimes.com