Intellectual Property, Pages 660–666

Association for Molecular Pathology v. Myriad Genetics, Inc.

Supreme Court of the United States, 2013

Facts:

Respondent Myriad discovered two human genes that increase the risks of breast and ovarian cancer, and obtained patents thereupon.

Procedural History:

  • The district court concluded that respondent's claims were invalid because they covered products of nature.

  • Page 662–663The Federal Circuit affirmed in part and reversed in part. It held that one of the petitioners did not have standing, but that both DNA and cDNA were patentable, although every judge had a different view on whether isolating the DNA was an inventive act entitling one to a patent.

Issues:

  • Can naturally-occurring segments of DNA be patented for being isolated from the rest of someone's DNA?

  • Can cDNA, synthetically-created DNA which is based on natural DNA but omits parts that do not code for proteins, be patented?

    Explanation:

    When DNA creates proteins, it creates RNA, an inverse copy of DNA; the RNA is spliced to just the parts that code for proteins, the exons; and this mRNA is then read by ribosomes. cDNA just takes this natural mRNA and inverts it again to get DNA spliced to just the exons. Respondent did not create or alter any genetic information.

Reasoning:

  • Being innovative alone is not enough for a patent.

    While respondent spent extensive effort on discovering these DNA segments, extensive effort alone is insufficient to satisfy the demands of § 101.

    Just isolating DNA cannot be a patentable invention. If this unique section was a valid patent, then theoretically a competitor could just include one more nucleotide and have its own invention. The information is what is important, not the molecule, and respondent did not create the information.

    Although the Patent and Trademark Office has awarded gene patents before, this has not been endorsed by Congress. The United States argued that the Patent and Trademark Office's practice was not a sufficient reason.

  • cDNA contains the same information, but it is not naturally-occurring. It therefore is protectable by patent.

  • Respondent never claimed an innovative method of manipulating genes. Such a method possibly could have been patented. Respondent just used widely-used methods to isolate these sections.

    Respondent also does not apply the genes. It could have also claimed applications of such knowledge.

    Modified DNA is also not at issue.

Holding:

  • Naturally-occurring DNA segments are products of nature and therefore not patent-eligible.

  • cDNA is not naturally-occurring and therefore is patent-eligible.

Judgment:

Affirmed in part; reversed in part.

Concurring Opinion:

Scalia: I do not understand molecular biology enough to join the judgment about that, but isolated DNA is natural and not patentable, while cDNA is man-made and patentable.

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