DNA Patents: Everything You Need to Know
DNA sequences preserve information in a way that other biomolecules don't.4 min read
DNA sequences preserve information in a way that other biomolecules don't. Unlike other substances, destroying a DNA sample doesn't prevent the sequences from providing information in a database.
Our genes are uniquely ours, and we regard this information differently than the results and information from other types of medical testing. Our DNA defines us on a fundamental level, unlike results from an x-ray, mammogram, or cholesterol test. We have an emotional attachment to our genomes, which is why the patentability of the BRCA1 and the BRCA2 cancer-susceptibility genes has been frequently reviewed in court.
The Prometheus Laboratories patents measured levels of a metabolite to decide whether a dosage of 6-mercaptopurine is appropriate for treating inflammatory bowel disease. Testing was used to determine if the dosage was ineffective at low doses or could cause adverse effects at high doses, and this testing was deemed by the court to “add nothing specific to the laws of nature other than what is well-understood, routine, conventional activity.” This led to the patents being invalidated on March 20, which sparked a debate over DNA patents.
Patents for cancer genes as diagnostic tools have little to do with determining the dosage of metabolites, but rather share a lack of “non-obviousness,” which is one of the key components of a patentable invention. The U.S. Patent Act of 1790 defined a patentable invention as novel, useful, and non-obvious to experts. This is clear with many patents and inventions, but not so much with DNA. Ideas, laws of nature, or products of nature can't be patented, but Parke-Davis claimed adrenaline in 1911 since the chemical can be isolated from nature and is different than what's produced inside the body.
U.S. patent law went further in biology in 1980, when General Electric claimed “oil eater” bacterium, which combines DNA rings from four microbes. The individual parts exist in nature, but not the combination. Then, in 1990, the patent office allowed the claim of DNA sequences. In under a year, Amgen patented the first gene, erythropoietin, which is used to treat anemia and commonly used as a performance-enhancing drug. Soon after, the European Union allowed genes to be patented in 1998.
A gene's DNA sequence, without the non-protein-encoding parts, renders it patentable because it's no longer a product of nature, as argued by Myriad. The court agreed that this makes it a novel "composition of matter,” because it corresponds to the RNA sequence that excludes the non-protein-encoding parts. Isolating a gene renders it patentable since it's no longer in its natural form, it's separate from its chromosome, and its non-essential parts are removed. What remains is a composition of matter.
Controversial DNA Patent Issues
Canavan disease is a condition that strips brain cells of their insulation, myelin, in infancy. It can be lethal before adulthood. A genetic test is essential to confirm diagnosis of Canavan disease because it can closely mimic other leukodystrophies. The specific enzyme isn't typically found in the blood, and urinalysis is inconclusive. Though it typically affects Jewish individuals, anyone can acquire this condition.
In 1997, the Canavan gene sequence was patented by four researchers and Miami Children's Hospital. Other labs were using it, but they were forced to stop once it was patented. Patient advocacy groups were finally making progress with the availability of testing programs for the entire Jewish community, which was then halted by the patent. The Canavan genetic test became expensive, even for parents who had donated their affected children's brains to research and wanted to test their other children.
The case, Greenberg et al. vs. Miami Children's Hospital et al. was settled out of court, due to the plaintiffs running out of funds, and the price for the test plummeted. Researchers were then able to use the gene. Three years after the Canavan gene patent was issued, the first Myriad Genetics BRCA patent was issued, which sparked outrage every since.
Conversely, genetic testing and sequencing has led to the discovery of many genes that contribute to common diseases. DNA profiling has also led to the exoneration or conviction of hundreds of people, and many states have expanded their forensic DNA databases.
DNA patents and genetic testing are still rapidly evolving and hotly debated topics in the legal and scientific communities. At this point, gene patents are no longer approved, but synthetic DNA can be patented. This is a complex issue that usually requires the help of a professional lawyer who specializes in patents and intellectual property.
If you need help with DNA patent, you can post your legal need on UpCounsel's marketplace. UpCounsel accepts only the top 5 percent of lawyers to its site. Lawyers on UpCounsel come from law schools such as Harvard Law and Yale Law and average 14 years of legal experience, including work with or on behalf of companies like Google, Menlo Ventures, and Airbnb.