Association for Molecular Pathology v. Myriad Genetics, Inc.: Designer Genes

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Want to know what patent rights come between you and your naturally occurring DNA? According to a unanimous Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., the best fitting answer under § 101 is “nothing.” Reversing a divided Federal Circuit, the Myriad Court held that merely isolating the precise location and genetic sequence of a human gene does not meet the patent eligibility requirements of § 101 because, without more, that isolated DNA is still a product of nature. But the Court agreed with the lower court that the laboratory tailoring of synthetic or complementary DNA (known as cDNA) resulted in the creation of a new, patent eligible composition of matter. The Court’s decision means that overall narrowed patent protection remains in style and that gene patent holders in particular will need to embellish their discoveries or risk seeing patent rights bootcut.

In Myriad, the patents at issue centered on the discovery of BRCA1 and BRCA2, genes in which mutations were identified as increasing the risk of developing breast and ovarian cancer. This knowledge allowed patent holder Myriad to develop tests to assess the increased cancer risks created by the presence of mutations in those genes. Myriad’s patents, taken together, gave it the exclusive right to conduct BRCA screenings. Myriad actively enforced its patent rights against other medical providers conducting similar screening tests, but never filed a patent infringement lawsuit. Eventually, a group of doctors, other providers and patient advocacy groups filed for declaratory judgment to invalidate Myriad’s patents.

Following summary judgment motions, the district court invalidated Myriad’s composition patents—including its cDNA claims —on the grounds that all claimed molecules are unpatentable products of nature. On appeal, a divided panel of the Federal Circuit reversed. Though the Federal Circuit judges disagreed about the basis of their decision regarding the patentability of isolated DNA, they all agreed that the cDNA claimed was patent eligible. The Supreme Court then granted certiorari to determine whether human genes are patentable

The Court unanimously agreed that DNA that is simply isolated from its naturally occurring genomic context falls within the product of nature exception to patentability under § 101. Writing for the Court, Justice Thomas explained that Myriad’s discovery did nothing to alter or create the structure of a DNA sequence that existed in nature before Myriad found and described it. The Court also rejected Myriad’s argument that the PTO’s prior determination of patent eligibility was entitled to deference, especially because the United States filed an amicus brief arguing against the patentability of human DNA. Justice Thomas said concerns about industry reliance on past patent office practices are better directed to Congress, even though the PTO had been granting patents on genes for the past thirty years.

The Court, however, did see patent eligibility in Myriad’s claimed cDNA. Though cDNA is ultimately derived from and may share sequences that are indistinguishable from naturally-occurring genomic DNA, it is nonetheless distinct from that DNA and is a new composition rather than a product of nature. The Court also took the time to note that its decision did not impact new methods for manipulating or researching genes or new applications of knowledge related to genetic material. Both of those categories of DNA-related invention remain open to patentability―in the right circumstances, subject, of course, to the remaining patent statutory requirements.

Researchers will doubtlessly find that Myriad makes it harder to wiggle into § 101 patentability for claims on genes. As the understanding of the human genome continues to evolve, isolating and identifying particular genes will likely no longer be enough to confer patentability. Instead, at a minimum, human manipulation will be required. At least when it comes to asserting patent claims then, skinny genes will no longer be in style.

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