In Part One of this series, we looked at the Court’s decision in Monsanto, where the court rejected the applicability of the exhaustion doctrine to self-replicating products. Today, we will look at the court’s recently released opinion in Myriad, in which the Court held that naturally occurring human genes are not patentable. The case was brought by the American Civil Liberties Union in an effort to block the patenting of human genes, a strategy many hope will lower costs of genetic testing, making it more accessible to the general public.
Plaintiffs contended that Myriad has not “created” something capable of being patented; rather, these genes are present in the human body and Myriad merely reveals them. Opponents of human gene patenting claimed that “snipping” portions from the larger gene sequence is the equivalent of snipping of leaf from a tree and attempting to procure a patent for inventing a leaf.
Myriad countered that analogies like the one above are oversimplifications of the process necessary to uncover genes like BRCA-1 and BRCA-2. The more apt analogy, they contended, is that of a scientist who isolates a useful molecule in an Amazonian plant. While the plant and the molecule are not new or patentable, they can become so through the isolation process. Rather than a mere snipping, the isolation of genes requires a purification process that involves human creativity and ingenuity. The Supreme Court explicitly rejected this argument, holding that Myriad could not patent human genes that they had isolated because the isolation of a gene fails to create something new. The Court relied on its precedent that natural phenomena cannot be patented, reasoning “the company actually did not create anything at all, but simply extracted the genetic material from its location in human blood, and setting it apart for study.”
Supporters of Myriad argued that both additive and subtractive creations should be patentable, and that, logically, there is no difference between the two. Benjamin Jackson, Senior director of Legal Affairs at Myriad, explained that:
“Many easily accept that combining two chemical entities creates a man-made, patentable invention, but become instantly skeptical if a single molecule is separated into two parts that do not exist in nature. This surfaced in the Myriad argument as well, but from a chemical, biological, genetic, and even legal perspective there is no defensible distinction between addition and subtraction. A molecule created by removing parts that interfered with its new utility is just as much a product of human ingenuity, and can have just as important a new utility, as a molecule created by addition.”
Much of the policy underlying Myriad supporters’ argument focused on the deleterious effects that reversing 30 years of patent precedent would have on the biotech industry. As noted by Nina Totenberg’s coverage of the case on National Public Radio each side of the case “sees the future of science threatened.” Those opposing Myriad worry that allowing the patenting of human genes will hinder innovation and limit research and access to potentially life-saving information. On the other side, many in the biotech industry counter that, without patents to protect the efforts of companies like Myriad Genetics and Genentech, companies will not be able to “garner the investment and support needed to develop those new treatments and bring them to patients.” This is especially true when so much of the investment for research into the isolation of human genes takes years to recoup. Patents that merely cover the processes involved will not be sufficient, Myriad supporters contended, and without the exclusivity that a patent on the actual gene guarantees, innovation will be stymied. The ACLU’s Christopher Hansen countered by noting “A patent isn’t a reward for effort. A patent is a reward for invention. And Myriad didn’t invent anything. The gene exists in the body. All Myriad did is find it.”
While the Court accepted Hansen and the ACLU’s argument with regard to the isolation of human genes, they may have provided a small victory for Myriad. Justice Thomas’ opinion seemed to suggest that when biotech companies synthesized DNA—creating something that does not exist independently in nature—they create something new. However, the Court did not explicitly say that synthesized DNA (more commonly known as companion DNA or cDNA) was capable of being patented, and noted that the federal government had raised objections to composition patents for cDNA as well.
Myriad’s shares fell 5.6% after the Supreme Court delivered its decision. Shares had initially bumped up slightly as many commentators feared that the Court would issue a broad ruling that precluded the patentability of cDNA as well. Other commentators had raised concerns that the Court would split the baby with a decision that attempted to reach a compromise but ultimately failed to give biotech companies a clear sense of the future of gene patenting. The decision in Myriad has left both sides of the debate claiming victory. Those opposed to human gene patenting see a strong decision prohibiting the ownership of naturally occurring DNA while the biotech industry seemed to take solace in the Court’s indication that the process of synthesizing DNA to produce cDNA creates something new and patentable. Bloomberg reported that Jim Greenwood, chief executive officer of the Biotechnology Industry Organization, said in a statement. “cDNA is the commercially most important form of DNA used in biotechnology . . . Today’s decision offers urgently needed certainty for research-driven companies that rely on cDNA patents for investment in innovation.”