As many of you may have already heard, the U.S. Supreme Court recently issued a ruling on whether human genes could be patented. We had covered this issue at the stage of arguments in two guest posts, over
here and
here. One of our regular guest bloggers, Chris Ohly, a partner at a leading U.S. law firm has been kind enough to send us a guest post, analysing the latest opinion of the U.S. Supreme Court in this case. The full version of this post along with footnotes can be accessed over
here. The Court's opinion can be accessed over
here.
The Common Heritage of Mankind:
Isolated Genes
By D. Christopher Ohly[1]
“The human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity. In a symbolic sense, it is the heritage of humanity.”
[2]
On June 13, 2013, the United States Supreme Court authoritatively answered the question “Are human genes patentable?”
[3] and, in doing so, affirmed that at least in the United States the human genome is the common heritage of mankind.
[4]
Phrased more precisely, the question before the Supreme Court was “Whether human genes are patent-eligible subject matter under 35 U.S.C. § 101.”
[5]
In a unanimous opinion in
Association for Molecular Pathology,
et al., v.
United States Patent and Trademark Office, No. 12-398 (S.Ct. 2012), the United States Supreme Court held that an isolated segment of naturally occurring DNA segment is a product of nature and is not patent eligible merely because it has been isolated. In contrast, the Court held that, because “creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring,” it “does not present the same obstacles to patentability as naturally occurring, isolated DNA segments,” and is eligible for patenting in the United States.
[6]
Myriad has been the subject of attention since its commencement in 2010.
[7] In the Federal Circuit decision in
Myriad, which the Supreme Court reviewed, the majority opinion was founded on a “chemical” definition of genetic materials, in determining its eligibility for patenting, found that isolated DNA “is a free-standing portion of a native DNA molecule, frequently a single gene.” Isolated DNA, the Federal Circuit majority said, “has been cleaved (i.e., had covalent bonds in its backbone chemically severed) or synthesized to consist of just a fraction of a naturally occurring DNA molecule. …” The intermediate court held that, as a result of the severing of covalent bonds in the DNA backbone in order to obtain “isolated DNA,” that form of DNA is a “chemical species” that markedly differs from “native DNA,” and is therefore patent eligible subject matter.
[8]
The Supreme Court disagreed. “In this case,” the Court said, “Myriad did not create anything. To be sure, it found an important and useful gene,” the Court added, “but separating that gene from its surrounding genetic material is not an act of invention.”
[9] In more sweeping language, the Court said that “Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry.”
[10]
Myriad’s claims were not saved, the Court said, “by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a non-naturally occurring molecule." Indeed, “Myriad’s claims are simply not expressed in terms of chemical composition,” the Court noted, “nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA.” Instead, the Court said, “the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes.” The Court continued:
If the patents depended upon the creation of a unique molecule, then a would-be infringer could arguably avoid at least Myriad’s patent claims on entire genes (such as claims 1 and 2 of the ’282 patent) by isolating a DNA sequence that included both the BRCA1 or BRCA2 gene and one additional nucleotide pair. Such a molecule would not be chemically identical to the molecule “invented” by Myriad. But Myriad obviously would resist that outcome because its claim is concerned primarily with the information contained in the genetic
sequence, not with the specific chemical composition of a particular molecule.
[11]
The Supreme Court also rejected the argument, relied on by Judge Moore in the Federal Circuit, that “the PTO’s past practice of awarding gene patents is entitled to deference,” ultimately agreeing with the position of the United States Solicitor General, as
amicus curiae, that " PTO’s practice [is] not ‘a sufficient reason to hold that isolated DNA is patent-eligible.’”
[12]
The Supreme Court went to some length to describe what was not “implicated” in its decision. First, the decision said nothing about method claims, since the method claims at issue in Myriad were not before the Supreme Court.
[13] Second, the Court noted that Myriad did “not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes.” Some of Myriad’s “unchallenged claims were limited to such applications.”
[14] Third, the Court did not “consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.”
[15]
As narrow as the Court may have intended its holding in
Myriad to be, the decision will undoubtedly have significant implications, both jurisprudentially and practically. The decision will provide additional basis, in future cases, for distinguishing between “invention” and “mere discovery.” As a practical matter, the decision will affect the manner in which patent claims are written and examined,
[16] and may well impact patent claims that might have been asserted in future litigation over biosimilar medical products. There are still a myriad of possibilities.
[1] NOTE: The views expressed in this article are entirely my own and do not necessarily reflect the views of my law firm, or of any of its other attorneys or clients. Nothing in this article is intended to provide any form of legal advice.
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