"The human genome -- the vast set of DNA molecules conveying our genetic blueprint -- inspires wonder and amazement, not to mention entrepreneurial zeal. More than three decades ago, scientists embarked on a project to map the order of the genome's approximately three billion DNA "base pairs," which famously wind around each other in the shape of a twisted ladder. Dispersed in the genome are roughly 30,000 genes. These play a role in determining our physical characteristics, like eye and hair color, as well as our susceptibility to various health risks.
Even before the mapping of the genome was completed in 2003, biotech companies, universities and government labs were staking claims to parts of it by patenting certain genes, including those linked to particular diseases. By holding such a patent, a biotech company, say, could prevent a competitor from developing a cheaper diagnostic test or even from studying a particular gene.
By 2009, "it seemed like a matter of time until the entire human genome was parceled out to private owners like lots in a suburban housing development." So writes Jorge L. Contreras in "The Genome Defense," a compelling and thoroughly researched narrative history of a seminal lawsuit aimed not only at a provision of U.S. patent law but at the ethical question of whether anyone should be allowed to own human genes. The suit was initiated by the American Civil Liberties Union, an organization not otherwise known for patent disputes. As it happens, the ACLU, in 2003, had hired a science adviser named Tania Simoncelli, who convinced the organization's litigators that gene patents blocked the people's right to scientific knowledge. The ACLU's team followed her lead, viewing the lawsuit, beyond the precise patent matters at issue, as a forum for arguing that scientific knowledge is a public good to which individuals have a right to access.
To make its legal case and advance its broader cause, the ACLU cast about for a suitable defendant. It eventually settled on Myriad Genetics, a company that held the patents on two key genes, BRCA1 and BRCA2. Everyone has those genes, but women with certain mutations in their BRCA genes face higher risks of breast or ovarian cancer. Through its patents, Myriad had essentially cornered the market on BRCA testing. The company charged more than $3,000 for a test, and insurers didn't always cover it. Some women weren't able to get tested because they couldn't afford it. And the problem went beyond cost: One woman who joined the lawsuit as a plaintiff tested positive for a BRCA mutation but before undergoing surgical removal of her ovaries wanted a second opinion; because of Myriad's patents, no other lab could confirm the diagnosis.
The case went through many legal twists and turns before reaching the Supreme Court in 2013, and its scientific arguments were no less tortuous. The book's index includes a list of the metaphorical terms that were employed to argue for or against gene patenting. Justice Sonia Sotomayor allowed that someone might be able to get a patent on a new type of chocolate-chip cookie but not on the salt, flour, eggs and butter used to make it. Why were genes different from cookie ingredients? When the Myriad lawyer tried to answer, he ended up using another analogy. A baseball bat, he said, doesn't exist until it is isolated from a tree; the length of a bat is a "product of human invention" and thus would justify a patent.
Mr. Contreras, a law professor at the University of Utah, does a good job of explaining the legal case but also offers portraits of the participants. Before joining the ACLU, Ms. Simoncelli gave cello lessons and ran a nonprofit concerned with the ethics of genetic technologies. Chris Hansen, the ACLU lawyer who spearheaded the suit, is shown to be devoted to his work to the exclusion of nearly everything else.
Close to two months after hearing oral arguments, the Supreme Court issued its decision that Myriad's patents on the BRCA genes were invalid. Mr. Contreras, perhaps not wanting to slow down his narrative, leaves to an appendix his analysis of the court's reasoning. One aspect of the dispute turned on whether isolating DNA from the human cell -- determining in the lab the precise order of the base pairs -- made the gene significantly different from something found in nature. The Patent Office had been assuming it did. The court said that the gene itself remained a "product of nature" and not an invention of the sort that patents are intended to cover.
Mr. Contreras agrees with the court's decision to prohibit the patenting of human genes, but he concedes that patents can play a crucial role in scientific progress. He argues for a return to the roots of American patent law: the provision in the Constitution that authorizes Congress to grant patents to inventors for their discoveries. The invention in this case would not have been the genes themselves but rather Myriad's method of predicting a higher risk of breast or ovarian cancer by detecting mutations in BRCA genes. Limited access and high prices would still be the result.
In Mr. Contreras's view, the problem isn't the patent system but "systemic issues." Government grants help fund research used by drug companies. Many major scientific advances, such as Crispr gene-editing technology and the discovery of disease-related genes, are made at universities that benefit from public funds. Myriad and companies like it are often given the exclusive rights to patented technologies, with few conditions. Mr. Contreras thinks that the government and universities in particular must fight harder to ensure that scientific discoveries are fairly priced and accessible to the public -- an obligation, he says, implicit in the use of taxpayer money. The key legacy of the Myriad case may be the recognition that science is not only about achieving knowledge but about using it to advance the common good." [1]
1. Disputed Ownership
Marcus, Amy Dockser. Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 08 Dec 2021: A.17.
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