Those who are not patent attorneys may be surprised to learn that it is possible to patent the human genetic code.
In fact, approximately 20% of all human genes are patented.
The US Patent and Trademark Office (PTO) has granted patents on genes and their DNA building blocks since the early 1980s, but this practice has recently reentered public awareness due to a lawsuit (Association for Molecular Pathology v. US Patent & Trademark Office) by a breast cancer survivor against Myriad Genetics, a company that has obtained patents on two genes closely associated with increased risk for breast and ovarian cancer, BRCA1 and BRCA2. These patents make Myriad the sole provider of tests to detect those genes, at a cost of over $3,000 per test.
Patents give their owners exclusive rights to use, manufacture, or sell the patented invention for 20 years from filing of the application. In order to qualify for a patent, an invention must be new, useful, and non-obvious to an expert in the field. However, patents cannot be granted on laws of nature or theoretical phenomena, for example the Theory of Relativity. Prior to the 1980s, the PTO considered that life forms were equivalent to the laws of nature, and therefore not patentable subject matter.
However, the Supreme Court ruled in Diamond vs. Chakrabarty (1980) that a scientist could obtain a patent on a lab-created bacterium that could consume oil slicks, on the grounds that the organism did not occur in nature, and therefore was a “manufacture” or “composition of matter” under 35 USC Section 101, and not equivalent to a law of nature. (more…)