US Supreme Court Rethinks the Patentability of Human Genes

Article  \  13 Jul 2013

The United States Supreme Court has made a U-turn on the patentability of DNA. In AMP v Myriad, the Court held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated”. Previously, naturally occurring DNA could be claimed in isolated form.

The case relates to two genes, known as BRCA1 and BRCA2, discovered by Myriad. Women with mutations in these genes face significantly increased risks of developing breast and ovarian cancers.  Screening tests for these mutations, which Myriad offers for about US$3,000, has obvious value to women who have a family history of these cancers.

Despite the extensive research required to discover the genes, the Supreme Court was critical that “Myriad did not create anything.” The Court acknowledged the genes were important and useful, “but separating [the genes from the] surrounding genetic material is not an act of invention”.

A significant part of the human genome has already been mapped and therefore fewer patents are being filed for isolated forms of naturally occurring DNA. The Supreme Court did confirm that cDNA is not a product of nature and therefore patentable. Therefore, its decision on isolated DNA will probably have little impact on biotechnical research. However, there may be major implications for inventions based on other naturally occurring compounds, since the “did not create anything” reasoning could be applied to them.

Researchers are now free to conduct experiments using the naturally occurring BRCA genes. However, Myriad’s screening tests are still patented because the tests use transformed host cells, which do not occur in nature. Myriad actively enforces its exclusive right to the tests and refuses to grant any licenses to them.

Even if the screening tests were not patentable (and many are not since the decision in Mayo v Prometheus), it is doubtful whether tests will be more available to the public in the future. The Court has arguably removed the financial incentive for companies to invest in research inherent to the patent system. The decision may also force companies to resort to trade secrets to protect their intellectual property, and potentially some information will never be in the public domain, and consequently under perpetual monopoly.

Most of the world, including New Zealand, Australia and Europe, allow claims to isolated forms of naturally occurring DNA. In fact, the Federal Court of Australia recently confirmed that Myriad’s claims to the isolated BRCA genes were valid, applying the “artificially created state of affairs” test from NRDC v Commissioner of Patents. The same test for patentability is used in New Zealand.