In a unanimous decision with potentially widespread
ramifications, the US Supreme Court held today that "[a]
naturally occurring DNA segment is a product of nature and not
patent eligible merely because it has been isolated, but cDNA is
patent eligible because it is not naturally occurring." See
Association for Molecular Pathology v. Myriad Genetics,
Inc., No. 12-398 (June 13, 2013). Specifically, the Court
ruled that certain naturally occurring DNA segments claimed by
Myriad, relating to the breast and ovarian cancer-associated genes
BRCA1 and BRCA2, are not patentable under 35 U.S.C.
§101.
The Court explained that, whereas §101 provides that patents
may be granted to "[w]hoever invents or discovers any new and
useful . . . composition of matter, or any new and useful
improvement thereof," in this case "Myriad did not create
anything," and although Myriad "found an important and
useful gene, . . . separating that gene from its surrounding
genetic material is not an act of invention." Slip Op. at 12.
In addition, the court explained that although "Myriad found
the location of the BRCA1 and BRCA2 genes, . . . that discovery, by
itself, does not render the BRCA genes 'new . . .
composition[s] of matter' that are patent eligible."
Id. at 13, citation omitted. In reaching its decision, the
Court refused to give deference to the US Patent and Trademark
Office's practice of awarding such gene patents in the
past.
In contrast, the Court held that Myriad's claims to cDNA
sequences are patentable. These cDNA sequences correspond to the
naturally occurring DNA sequences except that certain non-coding
sequences, or "introns," are removed. The Court found
that such cDNA sequences are patent eligible because "the lab
technician unquestionably creates something new when cDNA is
made" because it is "distinct from the DNA from which it
was derived" and "not a 'product of
nature.'" Id. at 17.
Finally, although this decision will certainly lead to speculation
regarding additional limitations on the patentability of
biotechnology claims, the Court was careful to "note what is
not implicated by this decision," making clear that
"this case does not involve patents on new
applications of knowledge about the BRCA1 and BRCA2
genes" and that the Court did not consider "the
patentability of DNA in which the order of the naturally occurring
nucleotides has been altered." Id. at 17-18.
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