To laypeople, the idea of having a gene patented may sound impossible. However, an amendment to federal patent legislation could allow pharmaceutical and biotech companies to patent genes, a decision that would have significant consequences for a variety of industries, medical care providers, and patients.
New Amendment Could Change Legal Precedent
Legal precedent was established in 2013 when Myriad filed a patent for BRCA1 and BRCA2 genes. These genes are utilized in diagnostic tests for breast and ovarian cancer. The company argued that they had the right to patent these genes because they were the company to isolate them. The U.S. Supreme Court ruled that human genes cannot be patented, since they are a product of nature.
This new bill, which was introduced in Congress in May of 2019, would allow companies to patent human genes and associations between diseases and genes.
What This Means for Researchers, Companies, and Patients
If this bill passes, it could seriously impact the pharmaceutical industry, as well as companies that specialize in biotech and medical research. A company that patents a gene would have full rights to any experimentation on that gene, as well as the development of diagnostic tests and treatment options. In some situations, perhaps this would be advantageous. Companies with a truly philanthropic interest in the treatment of specific diseases could potentially have more resources to dedicate to the isolation of genes and the subsequent development of testing and treatment options.
The more likely scenario, however, is far less palatable for consumers and biotech development as a whole. Large companies with extensive funding could essentially dominate the field by focusing exclusively on gene isolation and securing patents. Once they successfully patent various genes and connections with diseases, they would be able to conduct research on their own schedule and at their leisure. In the meantime, other companies—including companies that could possibly develop cutting-edge testing and treatment options—would be unable to do any research with the patented gene. This is disastrous for smaller biotech companies and research facilities. It’s likely that they’d be unable to isolate genes as quickly as much larger companies, which would significantly limit the type and amount of research they could do. Consequently, they’d have a difficult time hiring talented researchers who want to discover new treatment options. Larger pharmaceutical and biotech companies could quickly develop a monopoly in several diseases.
Perhaps the most disastrous implication of this legal decision would be the effect on patients. Patients with debilitating or even fatal diseases do not have extra time to wait for a patent-holding company to decide that their disease is profitable enough to research. By limiting who can study and experiment on specific genes, legislators could leave thousands of patients waiting for cures or treatment options that may not come or may come too late.
Opinions Across Various Industries
Lawyers representing professionals across many different industries have voiced their opposition to this measure. At least 169 different organizations representing medical professionals, patients, and researchers have come out in strong opposition to the bill. The ACLU is one organization that has expressed concern over this bill. Kate Ruane, senior legislative counsel for the ACLU, said, “Congress should not upend years of settled law to grant corporations exclusive rights to examine our genes and hinder much-needed genetic research, testing and treatments for a range of diseases.”
Attorneys have outlined the potential fallout of this bill. They note that BRCA gene patents caused significant issues in the past, with Myriad’s monopoly on testing protocols leading to the shutdown of other labs that also conducted ovarian and breast cancer screenings. Myriad dramatically increased its testing prices when it held the patent, leading to serious issues for patients.
This bill could go one of several ways. It could pass if it gets the necessary votes or it could die on the legislative table if it doesn’t receive enough votes. If it passes, it’s likely that numerous advocacy groups and professionals organizations will fight it, possibly leading to another Supreme Court case.