A federal judge sent shock waves through the biotechnology industry last October by reversing longstanding practice and ruling that human genes should not be patented. While the patentability of DNA sequences has a long history of controversy, U.S. courts have typically upheld gene patents, issuing thousands of patents since the 1990s.
In the United States, patents must meet the requirements of non-obviousness (an invention which in not trivial and contains obvious differences from existing products), utility , and novelty (the object being patented is something new). It is the requirement of novelty that has challenged the patentability of biological organisms and genetic sequences, as they exist naturally. The rationale behind the patentability of genetic matter stems from the Supreme Court’s landmark ruling in Diamond v. Chakrabarty. There, the court held that “anything under the sun made by man” was patentable, including the genetically modified oil-dissolving microbe in the case at hand. Since the ruling in 1980, the U.S. Patents and Trademark Office (USPTO) has extended this decision to justify patents on isolated DNA. It argues that the gene, through purification and isolation, is transformed from its original state through artificial means and thus qualifies as “man-made” and novel.
As a result, genes — including approximately 20 percent of the human genome — have been patented for over two decades without any challenge in the courts until a 2009 American Civil Liberties Union (ACLU) suit against Myriad Genetics and the USPTO. In the Association for Molecular Pathology v. United States Patent and Trademark Office (commonly referred to as ACLU vs. Myriad Genetics), the plaintiffs argued that Myriad’s patent on BRCA1 and BRCA2, two genes associated with breast and ovarian cancer, had impeded genetic research on the genes and screening in patients. Myriad is the currently the sole provider of the BRCA diagnostic test, which can be used to indicate increased risk of breast and ovarian cancer, and charges more than $3000 per test.
In an unexpected ruling in March 2010, federal Judge Robert W. Sweet of the U.S. District Court for Southern New York ruled Myriad’s patents to be invalid. In his decision, Sweet claimed that because “isolated DNA is not markedly different form native DNA as it exists in nature, it constitutes unpatentable subject matter.” While the decision grabbed headlines and the attention of the biotechnology industry, legal experts did not foresee it altering the permissive gene patenting policies that the USPTO have long followed. Not only was the decision inapplicable outside of New York’s southern district, but Myriad Genetics had appealed. The case, which will move to the Court of Appeals for the Federal Circuit in Washington, D.C., is likely to be decided in favor of Myriad Genetics, as the court has been known to favor patent holders.
That is, of course, until the recently filed amicus brief by the Department of Justice. An amicus brief, literally a “friend-of-the-court,” is a document filed in court by a party that is not directly related to the case at hand. It provides information that a judge may find useful in evaluating the case but is not legally binding. In the brief, the DOJ stated that “isolated, but otherwise unaltered genomic DNA is not patent-eligible subject matter,” categorizing isolated genes as a product of nature and not man.
So, what does this mean for Myriad Genetics, and more importantly, the patenting of genes, and the progression of science? Thus far, it is unclear how the decision will be applied, if at all, by the USPTO. The government claims that the decision will not drastically change the biotechnology industry, as altered genes and genetically modified organisms can still be patented. It is, however, a sign of a possible policy shift by the federal government on gene patenting.
And if the shift were to take place, it would undoubtedly invoke much protest from biotechnology companies. These companies claim that patents are essential for the development of drugs and diagnostic tests. If genes are indeed unpatentable matter, it is likely that diagnostic tests, such as the BRCA, would be more affordable for patients. But it is also likely that companies like Myriad would have less incentive to invest billions of research dollars in developing future diagnostic tests. Thus, it appears that the debate on gene patenting rehashes an old debate that the pharmaceutical industry has faced for decades. How do you incentivize intellectual creativity while also disseminating the results of that creativity? As such, perhaps gene patenting could learn from some of the intellectual property compromises reached in the pharmaceutical field. In one such compromise, companies are compelled by the government to license their intellectual property rights in exchange for royalties — an arrangement called compulsory licensing. Thus, instead of banning gene patents, the government can turn to tools such as compulsory licensing to strike the balance between incentivizing research and disseminating the results of that research to benefit humankind.
Jingyuan Luo, a senior at Rice University, is an intern for the Baker Institute Science and Technology Policy Program working under the supervision of Kirstin Matthews. In 2010, Luo was awarded Marshall Scholarship, which she will use to complete a Master of Science degree in biomedicine, bioscience and society at the London School of Economics and Political Science. She also will pursue a Master of Research in stem cell biology at Imperial College London.