Association for Molecular Pathology v. Myriad Genetics, Inc.

Summary

In the 1990s scientists at Myriad Genetics, a Salt Lake City company, determined the location and nucleotide sequence of two human genes, BRCA1 and BRCA2. Certain mutations in these genes greatly raise a woman's risk of breast and ovarian cancer, and knowledge of the sequences allowed Myriad to build tests that detect those mutations. Myriad obtained patents claiming isolated DNA molecules corresponding to the genes and also synthetic complementary DNA, or cDNA, which copies only the protein-coding portions. It then sent letters asserting infringement to other laboratories, including one at the University of Pennsylvania, and most stopped testing, leaving Myriad as the only provider of BRCA analysis in the United States. Harry Ostrer, a geneticist whose samples could no longer be tested elsewhere, joined the Association for Molecular Pathology, other physicians, researchers and patients in a suit asking courts to declare the composition claims invalid. The question was whether a naturally occurring DNA segment becomes patent eligible under Section 101 of the Patent Act once it has been isolated from the rest of the genome, and whether cDNA stands on a different footing. The challengers argued that genes are products of nature, which the Court had long held cannot be patented, and that locking them up would hinder research and patient care. Myriad answered that isolation breaks chemical bonds and yields a molecule that does not exist in the body, that its discovery took years of costly work, and that the Patent and Trademark Office had granted gene patents for decades, a practice on which investors relied. The United States, as amicus curiae, argued that isolated DNA was ineligible but cDNA was not. On 13 June 2013 the Court decided the case unanimously, 9–0. Justice Thomas reasoned that Myriad had found an important and useful gene but had not created or altered the genetic information it carries, and that discovery alone, however brilliant, does not satisfy the statute. Breaking chemical bonds did not save the claims, since they were framed around genetic information rather than chemical structure. Deference to the Patent Office was unwarranted because Congress had not endorsed its practice. cDNA, by contrast, is an exons-only molecule made in the laboratory and is therefore not a product of nature, except perhaps for very short sequences. Thomas closed by listing what the Court was not deciding: method claims, new applications of knowledge about the genes, and DNA in which the order of nucleotides has been altered. Justice Scalia joined the judgment and most of the opinion but declined to endorse its detailed account of molecular biology, which he could not affirm from his own knowledge. The library text contains both opinions; the notes that accompany them in the official reports have been left out. Within days of the ruling several other laboratories announced BRCA tests. The following year, in Alice Corp. v. CLS Bank International (2014), the Court applied the Mayo framework for natural laws and abstract ideas to computer-implemented inventions.

Top Lessons

• Finding versus making

  The decision turns on an old distinction in patent law between what a person discovers in the world and what a person makes. Thomas grants that locating the BRCA genes was valuable work, yet he holds that patents reward the creation of new things, not the uncovering of what already exists in every human cell.

• Information or chemistry?

  Myriad argued that an isolated gene is a distinct chemical because bonds are broken when it is removed. The Court answered that the claims were drawn to the genetic sequence, the information the gene carries, and that this information was unchanged. How a patent claim is written can decide its fate.

• A line drawn through the middle

  The Court did not hand either side a full victory: natural gene sequences were not patentable, but cDNA was. Drawing that line let the justices respect the product-of-nature rule while still protecting laboratory creations, the kind of incentive the patent system exists to provide.

• Judges and scientific detail

  Scalia's brief concurrence raises a question every court faces in technical cases: how far should judges vouch for science they cannot check for themselves? He relied on the expert briefs for the essential facts while declining to adopt the fuller explanation in the opinion.

Verified Quotes

Medical Lens

The case concerns inherited cancer risk and who may test for it. Thomas sets out the population figures on BRCA mutations and records how Myriad's infringement letters ended testing at an academic laboratory, so that patients had a single source for analysis and no independent second opinion; the challengers framed the patents as a barrier to clinical care and research. For a history-of-medicine reader the decision marks a turn in the long story of heredity, from speculation about inherited constitution to sequence-level knowledge that could be owned, licensed and contested in court.

• Opinion of the Court, Part I–B, at the sentence beginning The average American woman has a 12- to 13-percent risk

  Thomas gives the Court's figures for the lifetime cancer risk associated with BRCA mutations, the medical stakes that made Myriad's test valuable.

• Opinion of the Court, Part I–C, at the sentence beginning After learning of GDL

  The opinion recounts how Myriad's letters led the University of Pennsylvania laboratory to stop testing and to refuse a physician's patient samples, the factual basis for the challengers' claim that patents restricted clinical access.

• Opinion of the Court, Part III, at the sentence beginning First, there are no method claims

  Thomas notes that patents on methods of testing and on new applications of BRCA knowledge were not before the Court, leaving room for diagnostic innovation to be patented in other forms.