One of our clients recently contacted The Bowen Law Group with reference to seeking a commercial patent, thus it was with great interest that I learned that the United States Supreme Court recently heard arguments over whether human genes can be patented. As with most high profile Supreme Court cases, this is a hotly-contested issue with important ethical and financial consequences, not just for the healthcare industry, but also for millions of sick people across the world.
The question before the justices is straightforward on the surface: can human genes be patented? The oral arguments, however, revealed just how scientific and complex it will be try to answer that question. Arguments revolving around DNA fragments, BRCA1 and 2 and the nature of human identity appeared to puzzle several justices and had them struggling to reframe questions in more accessible terms involving baseball bats and chocolate chip cookies.
The High Court agreed to hear the case regarding whether Myriad Genetics & Laboratories is allowed to patent two genes linked to hereditary breast and ovarian cancer. Back in August of last year, the D.C. Federal Circuit Court of Appeals ruled by a 2-1 margin that Myriad was allowed to patent the detection of two genes, BRCA1 and BRCA2, which have been linked to a heightened risk of breast and ovarian cancer in women.
While Myriad and other major bio-tech firms argue that such gene patenting is necessary to protect their investment and innovation, critics warn that it could actually have the opposite effect. They claim that patents will allow Myriad and other companies to prohibit standard clinical testing of the BRCA1 and BRCA2 genes and restrict scientific research and access to medical care.
Peter Meldrum, Myriad’s chief executive, said that his company’s test has helped nearly 1 million people learn of their risk for cancer. Women who test positive using Myriad’s genetic test, BRACAnalysis, have an 82% higher risk of developing breast cancer and 44% higher risk of developing ovarian cancer in their lifetimes. The value of the test came at an enormous cost to the company in time and money that went into the mapping the gene, some estimates peg the number at around $500 million. Meldrum believes the U.S. patent system was designed to help protect the companies willing to pour so much money into cutting edge technology.
However, many outside groups including the AARP, the American Medical Association, the American Society of Human Genetics, the March of Dimes Foundation, the National Breast Cancer Foundation and, most recently, Angelina Jolie, disagree. They argue that giving a company a legal monopoly over something as basic as genes is inherently wrong. They claim that genes are owned by everyone and that to allow a patent for a gene would commoditize an element of the human body.
When the case was heard in April, the majority of the Court appeared reluctant to allow these kinds of genes to continue being patented. However, the justices also appeared to be wary of dealing a painful financial blow to the industries that rely on such patents to fund valuable scientific research. Experts who have been asked their opinion on the case believe that the majority of justices will choose to invalidate those patents based on isolated segments of human DNA, including those owned by Myriad. These same experts also say that they think the Court will allow continued patent protection for complementary DNA, essentially synthetic DNA used for medical and agricultural purposes.
Given the enormous financial implications of the case--the biotech industry is valued at around $83 billion--you can bet that big pharmaceutical, biomedical and agricultural companies will be anxiously awaiting word from the Court. A final decision is expected in the coming days.