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Association for Molecular Pathology v. Myriad Genetics, Inc.

Myriad Genetics first identified and isolated the BRCA1 and BRCA2 genes responsible for diagnosing an elevated risk of breast and ovarian cancer. Myriad claims patents on the isolated BRCA genes along with cDNA, which is a synthetic product that mirrors the coding sections of the BRCA genes, and "primers" used in diagnostics. The Patent Act defines the scope of patentable subject-matter in 35 U.S.C. § 101; however, the Supreme Court has consistently held that laws of nature, abstract ideas, and natural phenomenon cannot be patented. Myriad claims that the isolated and modified genes that they hold patents for never occur in nature, and subsequently are patentable subject-matter. Conversely, the Association for Molecular Pathologists contends that Myriad only isolated, and did not modify, a gene already existing in nature and that this isolated gene performs a similar function as the gene in natural form. The district court held that naturally-occurring genes were not patentable subject-matter, but the Federal Circuit court reversed. How the Supreme Court decides this case will greatly impact the scope of patentable subject-matter. A narrowing or a broadening of current subject-matter eligibility will have significant effects on the incentives for inventors as well as what information is available for and usable by the general public.

Questions as Framed for the Court by the Parties

Many patients seek genetic testing to see if they have mutations in their genes that are associated with a significantly increased risk of breast or ovarian cancer. Respondent Myriad Genetics obtained patents on two human genes that correlate to this risk, known as BRCA1 and BRCA2. These patents claim every naturally-occurring version of those genes, including mutations, on the theory that Myriad invented something patent-eligible simply by removing ("isolating") the genes from the body. Petitioners are primarily medical professionals who regularly use routine, conventional genetic testing methods to examine genes, but are prohibited from examining the human genes that Myriad claims to own. This case therefore presents the following questions:

  1. Are human genes patentable?
  2. Did the court of appeals err in upholding a method claim by Myriad that is irreconcilable with this Court's ruling in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012)?
  3. Did the court of appeals err in adopting a new and inflexible rule, contrary to normal standing rules and this Court's decision in MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), that petitioners who have been indisputably deterred by Myriad's "active enforcement" of its patent rights nonetheless lack standing to challenge those patents absent evidence that they have been personally threatened with an infringement action?

LIMITED TO QUESTION 1 PRESENTED BY THE PETITION.

Issue

Whether Myriad’s claimed invention, the sequence of certain human genes in both isolated and purified forms, falls within the scope of inventions for which a patent may be granted.

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Acknowledgments

The authors would like to thank Professor Oskar Liivak for his insight into this case.

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Laboratory Corporation of America Holdings v. Metabolite Laboratories, Inc. and Competitive Technologies, Inc.

Issues

To what extent can an inventor patent a method for detecting vitamin deficiency when the patent seeks to grant the inventor exclusive rights to a natural scientific principle?

 

Three medical school professors from the University of Colorado and Columbia University developed a method to diagnose low levels of cobalamin and folate, two vitamins found in the blood serum of warm-blooded animals. After patenting this process, the patent was assigned to Competitive Technologies, Inc. and Metabolite Laboratories for distribution. Competitive Technologies, Inc. and Metabolite Laboratories in turn sublicensed the patent to Laboratory Corporation of American Holdings. Competitive Technologies and Metabolite Laboratories filed suit against Laboratory Corporation of American Holdings for induced infringement of the patent and contributory infringement. Judgment was rendered against Laboratory Corporation of American Holdings at trial and was affirmed by the Court of Appeals for the Federal Circuit. Laboratory Corporation of American Holdings in turn appealed to the United States Supreme Court in an effort to seek clarification about the substantive scope of method patents. The Supreme Court's decision in this case has the potential to alter the balance of the patent system.

Questions as Framed for the Court by the Parties

Whether a method patent setting forth an indefinite, undescribed, and non-enabling step directing a party simply to 'correlat[e]' test results can validly claim a monopoly over a basic scientific relationship used in medical treatment such that any doctor necessarily infringes the patent merely by thinking about the relationship after looking at a test result.

Three medical school professors from the University of Colorado and Columbia University developed a method to diagnose low levels of cobalamin and folate, two vitamins found in the blood serum of warm-blooded animals. Brief for Respondents at 1-2, 6.

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