Association for Molecular Pathology v. Myriad Genetics, Inc.
Headline: Court rules that naturally occurring human gene sequences cannot be patented when merely isolated, but allows lab-made cDNA patents, limiting companies’ exclusive control over genetic testing while permitting some synthetic DNA protection.
Holding:
- Stops patents on naturally occurring gene sequences, limiting exclusive control over genetic tests.
- Allows patents on lab-made cDNA used to create tests or therapies.
- Does not affect method patents or other patentability requirements.
Summary
Background
Myriad Genetics, a biotechnology company, found the location and sequence of the BRCA1 and BRCA2 genes and obtained patents on isolated gene segments, short 15-nucleotide fragments, and laboratory-made cDNA. Other laboratories offered BRCA testing, and a researcher, patients, and advocacy groups sued to declare Myriad’s composition claims invalid under the rule that natural phenomena are not patentable. The District Court ruled for the challengers; the Federal Circuit reached a divided result, and the challenger who filed suit was found to have standing.
Reasoning
The Court addressed whether isolating a natural gene makes it a new, patentable invention. It explained that Myriad did not create or change the genes’ genetic information but only located and isolated it. Under prior decisions barring patents on natural phenomena, the Court held that an isolated piece of naturally occurring DNA is a product of nature and not patent eligible merely because it was isolated. By contrast, cDNA, which labs create from messenger RNA and which lacks non‑coding sections, is not naturally occurring and therefore may be patented. The Court emphasized that merely breaking chemical bonds does not render a natural gene patentable.
Real world impact
The ruling removes patent protection for naturally occurring gene sequences and thus limits companies’ exclusive control over genetic tests based on those sequences. At the same time, laboratories can still seek patents on lab-created cDNA. The decision does not address method patents, altered genetic sequences, or other patentability requirements (such as novelty or obviousness), so some claims may remain protected or face other challenges.
Dissents or concurrances
The Federal Circuit judges split on whether isolation alone sufficed for patentability; all agreed cDNA could be patented. Justice Scalia joined most of the opinion while concurring in part, and the United States urged that isolated DNA is not patent eligible.
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