Supreme Court Draws the Line on Genes and Patents
Jun 25, 2013
Naturally-occurring DNA is not, in itself, patentable. So said the U.S. Supreme Court in its unanimous opinion in Association for Molecular Pathology v. Myriad Genetics, Inc. While the Court’s decision has drawn both ire and praise from scattered pockets of the biotech community, the Myriad decision is not the game-changer that the popular press would have you believe. Although the Court held that naturally-occurring DNA is not patentable, the decision will have a limited effect on biotechnology as it exists in the real world and agriculture, in particular.
The Supreme Court has used the 2012-13 term to more clearly define the boundaries of how federal law treats patents. In Bowman v. Monsanto Co., the court analyzed whether patent rights extended to subsequent generations of patented seeds. In Bowman, the Court held that patent rights extended to subsequent generations of patented soybean seeds, even if the seeds were acquired from a grain elevator. With the Myriad decision, the Court has established another bright-line rule – isolated, but naturally-occurring DNA is a "product of nature" and not patentable.
In Myriad, the plaintiffs challenged three of Myriad’s patents related to BRCA-testing. The BRCA test, recently made famous by Angelina Jolie, allows a patient to determine whether she carries a gene for an increased risk of breast cancer. Myriad held a patent on the isolated DNA sequence for the BRCA1 and BRCA2 gene. Myriad also held a patent on complimentary DNA, known as cDNA, for these genes, which was synthetically-replicated based on the isolated DNA sequence in question.
The difficult question Myriad posed to the Court was whether the act of discovering and isolating a naturally-occurring gene, an expensive and time-consuming breakthrough that could save millions of lives, was patentable. Patent protection would give Myriad the right to determine how the gene was used and could allow it to recoup the cost it invested in discovering the gene. However, one problem that was ultimately fatal to Myriad’s case is that "products of nature" cannot be patented. The Court invalidated Myriad’s patents in the isolated DNA because it was a naturally-occurring product of nature that Myriad had discovered, but not made. At the same time, the Court held that cDNA was patentable subject matter because its existence came about by human intervention, not nature.
In other words, scientists that identify and isolate a useful gene or DNA segment cannot patent their discovery. Instead, they must take an additional step beyond identification and isolation of DNA and "make" something to qualify for a patent. Up to this point, many biotech companies have made it a practice to patent naturally-occurring DNA. However, they have also patented the technologies that they developed using the naturally-occurring DNA. After the Myriad decision, only the patents on subsequent technology utilizing the DNA will be valid.
The net effect for those of us in agriculture is limited. All of the patented biotechnology that we encounter is something "made" from naturally-occurring DNA. For instance, Roundup Ready soybean technology uses genes from a bacteria that are inserted into the soybean’s DNA sequence. By placing the gene from one species into another, Monsanto "made" a unique plant that qualifies for patent protection. Similarly, the DNA-based Red Factor Test to determine whether cattle are "homozygous black" remains patentable so long as the test itself, and not the underlying red/black gene, is patented.
Biotechnology has made waves in the patent world ever since the Supreme Court affirmed that living things are eligible for patent protection in 1980 with the Diamond v. Chakrabarty opinion. Myriad is certainly a landmark case that places some boundaries on Chakrabarty. However, in practice, its effect will be limited.
John Dillard is an attorney with Olsson Frank Weeda Terman Matz P.C. (OFW Law), a Washington, DC-based firm that serves agricultural clients and clients with issues before federal and state courts, EPA, FDA, USDA, and OSHA. John focuses his practice on agricultural and environmental law. He occasionally tweets at @DCAgLawyer.