Association for Molecular Pathology v. Myriad Genetics, Inc

Date: June 13, 2013

Citation: 569 US ‗‗‗ (2013)

Issue: Patent eligibility of naturally occurring and artificially copied DNA

Significance: In a 9–0 decision the Supreme Court of the United States held that naturally occurring DNA sequences or segments within genes are not eligible for patents merely because they have been isolated, but that DNA sequences that have been copied from naturally occurring RNA are patent eligible.

Background

Mutations of two genes in human DNA called BRCA1 and BRCA2 drastically increase the risk of breast and ovarian cancer. Myriad Genetics, a company based in Salt Lake City, Utah, discovered the exact location and nucleotide sequence of the BRCA1 and BRCA2 genes, which in turn enabled the company to devise tests for mutations in the genes. Myriad was able to diagnose an increased risk for breast and ovarian cancer as a consequence of its discovery.

Myriad claimed patents on the two isolated genes as well as on composite DNA (cDNA), a synthetic composite "gene" that replicates the coding sections of the BRCA genes, and "primers" it used in its diagnostic tests. The company’s patents would give it exclusive rights to isolate a patient’s BRCA1 and BRCA2 genes and to create the synthetic DNA. However, the Patent Act defines what matter can be patented, and the United States Supreme Court had previously held that laws of nature, abstract ideas, and natural phenomena couldn’t be patented. Myriad Genetics claimed that they had isolated and modified the genes, and those genes could never occur naturally. Therefore, the genes can be patented.

The United States District Court for the Southern District of New York held that naturally occurring genes are not patentable. This decision was reversed by the Federal Circuit Court of Appeals, which found that both the isolated genes and cDNA were eligible for patents. The issue for the Association for Molecular Pathology (AMP) was that the patents meant that every naturally occurring variation on the BRCA1 and BRCA2 genes, including mutations, were now the exclusive property of Myriad Genetics. AMP members who typically used various genetic testing methods to examine genes were now barred from examining BRCA1 and BRCA2, which Myriad Genetics claimed to own. In short, only Myriad Genetics could test women for the mutations that dramatically increased the risk of breast and ovarian cancer.

The Supreme Court’s basic question revolved around whether or not human genes can be patented, but the Court noted that, in fact, three different kinds of genes were part of the question. Myriad Genetics’ patents covered the isolated human genes BRCA1/2 as well as alterations to those two genes. The Court concluded that the patent claims "relate to the isolated gene sequences and the methods used to determine whether a patient has these genes or mutations of these genes in their body."

The second gene involved was Myriad Genetics’ claim to have invented BRCA 1/2 cDNA, which is the so-called functional part of the gene—the part that includes coding. Creating the cDNA is a very complex process.

The third claim was for a patent on "primers," pieces of genetic code that are used to diagnose whether or not a patient has a particular gene and thus, as with the case of mutations to the BRCA1/2 genes, has an increased risk of a particular disease.

AMP argued that Myriad Genetics only isolated the genes without modifying them. Because the isolated genes have a similar function to the naturally occurring genes, AMP contended that they could not be patented. AMP represented a variety of individuals and groups who had been accused by Myriad Genetics of patent infringement.

The Supreme Court heard the case twice. In 2012 it vacated the Federal Circuit court decision and sent the case back to the Federal Circuit to be re-heard. The Court did this because it had ruled in a recent case that certain claims in medical diagnostic patents were not eligible to be patented. The Supreme Court expected the Federal Circuit to consider this precedent when it re-heard the case.

The Federal Circuit concluded that the precedent was not particularly relevant. AMP appealed to the Supreme Court.

The key question before the Supreme Court was quite straightforward: Are human genes patentable? It was coupled to questions about whether or not the Federal Circuit court was in error in its judgments, but the question that captured the public’s imagination was about patenting genes. Oral arguments were heard on April 15, 2013.

Opinion of the Court

The Court delivered its opinion on June 13, 2013. Justice Clarence Thomas wrote the opinion in which all other members of the Supreme Court joined, with the exception of Justice Antonin Scalia, who concurred in part and in the judgment. The 9-0 ruling retained part of Myriad Genetics’ patents disallowed others. Justice Thomas wrote:

• A naturally occurring DNA segment is a product of nature and not patent eligible simply because it is isolated, but cDNA is eligible because it is not naturally occurring.

In short, naturally occurring DNA cannot be patented simply because it has been isolated and identified, regardless of how much human intervention was required to do so. But composite DNA, which is not naturally occurring, may be patented.

Impact

This was a landmark case in gene patenting. Prior to the district court’s decision, isolated genes had been patented. When the Federal Circuit court reversed the district court’s ruling, it basically resumed the status quo. Its decision set off a certain amount of public outrage, however, because people could not understand how their genes, which they inherited from the parents, could become someone else’s private property. Even James Watson, one of the Nobel laureates who discovered the structure of the DNA molecule, had weighed in on the subject, arguing against patenting genes.

Those who supported patent-eligibility contended that the decision would limit research on genetic tests. This would be bad for patients because fewer tests would come to market. Those on the other side argued that the outcome would be better for patients because the tests would be less expensive.

Along with the precedent case that led the Supreme Court to send the case back to the Federal Circuit, the ruling in Myriad Genetics helped settle the issue. Diagnostic tests involving isolated gene sequences could not be patented if the patent applied to the genes.

Bibliography

Cartwright-Smith, Lara. "Patenting Genes: What Does ‘Association for Molecular Pathology v. Myriad Genetics’ Mean for Genetic Testing and Research?" Public Health Reports. National Center for Biotechnology Information, National Library of Medicine, May–June, 2014. Web. 25 January 2016.

"Case Study: Association for Molecular Pathology v. Myriad Genetics, Inc." @WashULaw. Washington University School of Law, 24 July 2014. Web. 25 January 2016.

Goddard, Jonathan, and Zachary Glantz. "Association for Molecular Pathology v. Myriad Genetics, Inc." Legal Information Institute. Cornell University Law School, n.d. Web. 25 January 2016.

Mamajuwalla, Salim, and Rochelle Seide, eds. Intellectual Property in Molecular Medicine. Cold Spring Harbor: Cold Spring Harbor Lab., 2015. Print.

Merges, Robert P. Intellectual Property New Technological Age: 2014 Case and Statutory Supplement. New York: Wolters Kluwer, 2014. Print.