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INVENTIONS

Association for Molecular Pathology, et al. v. Myriad Genetics, Inc.

in
Oral argument: 
April 15, 2013
Court below: 
United States Court of Appeals for the Federal Circuit

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 Presented: 

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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Written by: 
Jonathan Goddard
Zachary Glantz
Edited by: 
Brandon Bodnar
Acknowledgments: 

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

Additional Resources: 

Bilski v. Kappos (08-964)

in

Oral argument: Nov. 9, 2009

Appealed from: United States Court of Appeals for the Federal Circuit (Oct. 30, 2008)

PATENT LAW, PATENTABLE SUBJECT MATTER, INVENTIONS, INTELLECTUAL PROPERTY, MACHINE-OR-TRANSFORMATION TEST

In 1997, the United States Patent and Trademark Office denied Bernard Bilski's patent application for a method of hedging risk in commodities trading. Affirming the rejection on appeal, the Federal Circuit held that a process must be tied to a particular machine or transform an article into a different state to be patentable. The Supreme Court will consider the validity of the machine-or-transformation test for patentability. This case will have implications for the validity of current process patents as well as the availability of future patent protection for business methods. If the court decides that business-methods are not patentable, this would invalidate numerous patents and may curb innovation in the biotechnology and software industry. If, however, the court overturns the machine-or-transformation test and declares that Bilski’s idea is patent-eligible, expensive litigation may continue and uncertainty will mount regarding business-method patents.

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