In Association for Molecular Pathology v. Myriad Genetics, Inc., the Supreme Court effectively reversed decades of U.S. Patent and Trademark Office (USPTO) practice by holding that claims to naturally occurring BRCA gene sequences are products of nature and therefore are not eligible for patent protection under 35 U.S.C. §101. On the other hand, the Supreme Court also held that manmade cDNA that differs from its native counterpart is patent eligible. The decision is a mixed result for the biotechnology industry, potentially putting at risk patents covering isolated genetic sequences that do not differ from native sequences, but giving some assurance to those companies whose patent portfolio includes claims to modified genetic sequences.
Patent Eligibility of Naturally Occurring DNA Segments
Writing for the Court, Justice Thomas recognized that patent
protection strikes a "delicate balance" between creating
incentives that foster invention and hindering the flow of
information necessary for innovation. Slip op. at 11. The Court
applied this standard to determine whether Myriad's patents
claimed no more than naturally occurring phenomena.
Turning first to naturally occurring DNA, the Court explained that
Myriad neither created nor altered the genetic information encoded
in the BRCA1 and BRCA2 genes. Recognizing that human genomic DNA
contains protein coding sequences interspersed with non-coding
sequences ("introns"), the Court focused on the fact that
the patent-ineligible isolated BRCA genes contain the same sequence
of nucleotides—including both coding and intron
sequences—as is found in nature. The Court therefore
characterized Myriad's contribution as simply determining the
precise location and genetic sequence of the BRCA1 and BRCA2
genes.
Looking to Diamond v. Chakrabarty, 447 U.S. 303 (1980),
Court distinguished the patented bacterium in Chakrabarty
from the claims to isolated BRCA1 and BRCA2 genes in Myriad's
patents. Unlike Chakrabarty, "Myriad did not create
anything" worthy of patent protection because separating a
gene from its surrounding environment "is not an act of
invention." Slip op. at 12.
The Court instead relied upon Funk Brothers Seed Co. v. Kalo
Inoculant Co., 333 U.S. 127 (1948), to find that isolated DNA
segments are ineligible subject matter under § 101. The Court
reasoned that Myriad's claims to naturally occurring DNA
imparted the same level of inventiveness as the mixed culture of
known bacteria strains in Funk Brothers. And although
Myriad's discovery of the location of the BRCA genes may be
helpful, the Court found that the usefulness of this information
did not render the genes eligible for patent protection. Looking to
Myriad's patent specification, the Court noted that
"[m]any of Myriad's patent descriptions simply detail the
'iterative process' of discovery by which Myriad narrowed
the possible locations for the gene sequences that it sought."
Slip op. at 14. This effort, while extensive, was not by itself
sufficient render the claims patent-eligible.
While the Court recognized that isolating DNA requires severing
chemicals bonds, it nevertheless concluded that those types of
changes are insufficient to satisfy the patent eligibility
requirements of § 101. The Court noted that Myriad's
claims are not "expressed in terms of chemical composition,
nor do they rely in any way on the chemical changes that result
from the isolation of a particular section of DNA. Instead, the
claims understandably focus on the genetic information encoded in
the BRCA1 and BRCA2 genes." Slip Op. at 14. The Court
therefore rejected the idea that merely excising the BRCA DNA from
the genome warranted patent protection. The Court suggested that
claims drawn to a unique chemical compound, as opposed to claims
focusing on the information contained in the genetic sequence,
might be patent eligible but would undoubtedly be easy to design
around.
Finally, the Court rejected Myriad's argument that it should
defer to the USPTO's practice of awarding gene patents. The
Court noted that, unlike the scenario in J.E.M. Agricultural
Supply, Inc. v. Pioneer Hi-Bred International, Inc., 534 U.S.
124 (2001), where Congress specifically enacted legislation
regarding patent protection for plants, Congress has not endorsed
the USPTO's practice of awarding gene patents. In addition, the
United States argued that isolated DNA is not patent eligible and
that the "PTO's practice was not a sufficient reason to
hold that isolated DNA is patent-eligible." Id. at
16.
cDNA Claims
In contrast to its decision regarding isolated genomic DNA, the
Court found that cDNA is patent eligible under §101 because it
contains only coding sequences, without introns, and thus are not
naturally occurring molecules. In removing the introns, "the
laboratory technician unquestionably creates something new when
cDNA is made." Id. at 17.
The Court recognized, however, that very short strands of cDNA
whose native counterparts lacked intervening introns may be
indistinguishable from natural DNA. In that situation, the cDNA
product would fall under the product of nature exception to §
101.
What Is Not Implicated by the Court's Decision
Finally, the Court expressly limited its decision, ostensibly leaving room for other claiming strategies for DNA-based inventions. The Court noted that its decision does not reach the patent eligibility of method claims, stating that "[h]ad Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent." Slip op. at 17. The Court also made clear that this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes, including the unchallenged claims in Myriad's patents. Nor did the Court express any opinion about the application of § 101 to alterations of the genetic code.
Justice Scalia's Concurrence
Justice Scalia concurred with the Court's opinion except for the portions discussing the details of molecular biology, which Justice Scalia was not able to affirm on his "own knowledge or . . . belief." Concurring op. at 1. In sum, Justice Scalia affirmed that "the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state; and that complementary DNA . . . is a synthetic creation not normally present in nature" by relying on the opinions and expert briefs in the record that he studied. Id.
Impact of the Decision
The decision could have an immediate effect on existing patent
portfolios of some biotech companies, particularly those in the
fields of diagnostics and personalized medicine. It may cause
biotech companies to reevaluate their existing patent portfolios,
and may presage a shift towards more reliance on trade secret
protection for DNA-based inventions. It is, however, a positive
development for companies that rely on cDNA for the development and
manufacture of novel therapeutic proteins. The decision's long
term effect on biotech and medical research remains to be
seen.
Please click here to read Association for Molecular
Pathology v. Myriad Genetics, Inc., No. 12-398 (Supreme Court
June 13, 2013) decision.
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