Isolated DNAs: "Products of Man" - Federal Circuit Repeats Decision in AMP v. USPTO and Myriad on Remand

August 17, 2012

By: N. Scott Pierce

Hamilton Brook Smith Reynolds Alert

The Decision on Remand
 
The Court of Appeals for the Federal Circuit yesterday decided the case of The Association for Molecular Pathology (AMP) v. the United States Patent and Trademark Office (USPTO) and Myriad Genetics, Inc. on remand from the Supreme Court in view of Mayo v. Prometheus, (566 U.S. ___, 132 S.Ct. 1289 (2012)) (Mayo). The majority opinion, by Judge Lourie, upheld jurisdiction, and upheld claims directed to isolated DNAs and method claims directed to screening potential cancer therapeutics by observing changes in cell growth rates of transformed cells. The court invalidated method claims directed to "comparing" and "analyzing" gene sequences.
 
In upholding claims to isolated DNAs, the court stated that "the Supreme Court in Mayo focused on its concern that permitting patents on particular subject matter would prevent use by others of, in Mayo, the correlation recited in the method claims." The court held that "permitting patents on isolated genes does not preempt a law of nature," and stated that "a composition of matter is not a law of nature." Relying on the Supreme Court's earlier decision in Diamond v. Chakrabarty, 447 U.S. 303 (1980), requiring that claimed subject matter be "markedly different" than what is found in nature, Judge Lourie stated that "it is the distinctive nature of DNA molecules as isolated compositions of matter that determines their patent eligibility rather than their physiological use or benefit," and that the "patent eligibility of an isolated DNA is not negated because it has similar informational properties to a different, more complex natural material." According to the court, "informational content is irrelevant" to patent eligibility of isolated DNA molecules as statutory subject matter under 35 U.S.C. § 101.  Judge Lourie stated that isolated DNAs are "not natural products," but, rather, "the products of man."
 
Similarly, the court upheld the patent eligibility of a method for screening potential cancer therapeutics by observing changes in cell growth rates of transformed cells (i.e., cells that have been manipulated genetically), and distinguished the method of screening from the methods that were held to be not patent eligible in Mayo. The court held that, in contrast to the claimed methods in Mayo, the screening method "is based on a man-made, non-naturally occurring transformed cell," and that the "transformed, man-made nature of the underlying subject matter...makes the claim patent eligible."

On the other hand, the Federal Circuit found Myriad's claims directed to "comparing" and "analyzing" sequences to be "indistinguishable from the claims the Supreme Court found invalid under § 101 in Mayo." Like the claimed methods in Mayo, the court found the claimed methods for "comparing" and "analyzing" nucleic acid sequences to be a matter of "mere inspection." These claims were held to be "directed to the abstract mental process of comparing two nucleotide sequences" and, therefore, invalid under 35 U.S.C. § 101 as claiming patent-ineligible processes.
 
Concurrence-in-Part by Judge Moore
 
Judge Moore concurred in part in a separate opinion stating that, while the Supreme Court's decision in Mayo "does not control the outcome in this case, it is nonetheless instructive regarding the scope of the law of nature exception." She differed from the majority by stating that "the chemical differences between genomic and isolated DNA (breaking the covalent bonds)...is [insufficient]...to hold that claims to human genes are directed to patentable subject matter." Rather, for Judge Moore, her decision that the claimed isolated DNA were eligible for patent protection was based on the utility of those sequences apart from the same sequences in a state of nature. As in her previous concurring opinion accompanying the July, 2011 decision by the Federal Circuit, Judge Moore stated that, were she "deciding this case on a blank canvas, I might conclude that an isolated DNA sequence that includes most or all of a gene is not patentable subject matter," but that the court should be "particularly wary of expanding the judicial exception to patentable subject matter where both settled expectations and extensive property rights are involved."

Concurrence-in-Part and Dissent-in-Part by Judge Bryson
 
Judge Bryson, as he did in the previous decision by the Federal Circuit, concurred in part and dissented in part.  Applying his own "common-sense point of view," Judge Bryson drew a direct parallel with the Supreme Court's decision in Mayo, stating that, "a patent involving the product of nature should have an inventive concept that involves more than merely incidental changes to the naturally occurring product."  According to Judge Bryson, isolated DNA sequences do not meet the requirements of 35 U.S.C. § 101 because the "informational content of nucleotide sequences is the critical aspect of these molecules," and is unchanged from nucleotide sequences that have not been isolated.  Therefore, the "structural similarity dwarfs the significance of the structural differences between isolated DNA and naturally occurring DNA, especially where the structural differences are merely ancillary to the breaking of covalent bonds, a process that is itself not inventive."  On the other hand, Judge Bryson concurred with the court that claims to complementary deoxyribonucleic acid (cDNA) sequences, which differ from naturally-occurring and isolated nucleotide sequences by the absence of non-coding regions, are patent eligible subject matter, and concurred with the majority with respect to the method claims.  Regarding arguments that decisions by the Federal Circuit should not upset settled expectations of patent eligibility of genetic material, Judge Bryson stated that "there is no collective right of adverse possession to intellectual property, and we should not create one."
 
Litigation is Expected to Continue
 
Commentators widely expect that this case will be reheard en banc or that certiorari will be granted by the Supreme Court.
 
 

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August 17, 2012

By: N. Scott Pierce

Hamilton Brook Smith Reynolds Alert

The Decision on Remand
 
The Court of Appeals for the Federal Circuit yesterday decided the case of The Association for Molecular Pathology (AMP) v. the United States Patent and Trademark Office (USPTO) and Myriad Genetics, Inc. on remand from the Supreme Court in view of Mayo v. Prometheus, (566 U.S. ___, 132 S.Ct. 1289 (2012)) (Mayo). The majority opinion, by Judge Lourie, upheld jurisdiction, and upheld claims directed to isolated DNAs and method claims directed to screening potential cancer therapeutics by observing changes in cell growth rates of transformed cells. The court invalidated method claims directed to "comparing" and "analyzing" gene sequences.
 
In upholding claims to isolated DNAs, the court stated that "the Supreme Court in Mayo focused on its concern that permitting patents on particular subject matter would prevent use by others of, in Mayo, the correlation recited in the method claims." The court held that "permitting patents on isolated genes does not preempt a law of nature," and stated that "a composition of matter is not a law of nature." Relying on the Supreme Court's earlier decision in Diamond v. Chakrabarty, 447 U.S. 303 (1980), requiring that claimed subject matter be "markedly different" than what is found in nature, Judge Lourie stated that "it is the distinctive nature of DNA molecules as isolated compositions of matter that determines their patent eligibility rather than their physiological use or benefit," and that the "patent eligibility of an isolated DNA is not negated because it has similar informational properties to a different, more complex natural material." According to the court, "informational content is irrelevant" to patent eligibility of isolated DNA molecules as statutory subject matter under 35 U.S.C. § 101.  Judge Lourie stated that isolated DNAs are "not natural products," but, rather, "the products of man."
 
Similarly, the court upheld the patent eligibility of a method for screening potential cancer therapeutics by observing changes in cell growth rates of transformed cells (i.e., cells that have been manipulated genetically), and distinguished the method of screening from the methods that were held to be not patent eligible in Mayo. The court held that, in contrast to the claimed methods in Mayo, the screening method "is based on a man-made, non-naturally occurring transformed cell," and that the "transformed, man-made nature of the underlying subject matter...makes the claim patent eligible."

On the other hand, the Federal Circuit found Myriad's claims directed to "comparing" and "analyzing" sequences to be "indistinguishable from the claims the Supreme Court found invalid under § 101 in Mayo." Like the claimed methods in Mayo, the court found the claimed methods for "comparing" and "analyzing" nucleic acid sequences to be a matter of "mere inspection." These claims were held to be "directed to the abstract mental process of comparing two nucleotide sequences" and, therefore, invalid under 35 U.S.C. § 101 as claiming patent-ineligible processes.
 
Concurrence-in-Part by Judge Moore
 
Judge Moore concurred in part in a separate opinion stating that, while the Supreme Court's decision in Mayo "does not control the outcome in this case, it is nonetheless instructive regarding the scope of the law of nature exception." She differed from the majority by stating that "the chemical differences between genomic and isolated DNA (breaking the covalent bonds)...is [insufficient]...to hold that claims to human genes are directed to patentable subject matter." Rather, for Judge Moore, her decision that the claimed isolated DNA were eligible for patent protection was based on the utility of those sequences apart from the same sequences in a state of nature. As in her previous concurring opinion accompanying the July, 2011 decision by the Federal Circuit, Judge Moore stated that, were she "deciding this case on a blank canvas, I might conclude that an isolated DNA sequence that includes most or all of a gene is not patentable subject matter," but that the court should be "particularly wary of expanding the judicial exception to patentable subject matter where both settled expectations and extensive property rights are involved."

Concurrence-in-Part and Dissent-in-Part by Judge Bryson
 
Judge Bryson, as he did in the previous decision by the Federal Circuit, concurred in part and dissented in part.  Applying his own "common-sense point of view," Judge Bryson drew a direct parallel with the Supreme Court's decision in Mayo, stating that, "a patent involving the product of nature should have an inventive concept that involves more than merely incidental changes to the naturally occurring product."  According to Judge Bryson, isolated DNA sequences do not meet the requirements of 35 U.S.C. § 101 because the "informational content of nucleotide sequences is the critical aspect of these molecules," and is unchanged from nucleotide sequences that have not been isolated.  Therefore, the "structural similarity dwarfs the significance of the structural differences between isolated DNA and naturally occurring DNA, especially where the structural differences are merely ancillary to the breaking of covalent bonds, a process that is itself not inventive."  On the other hand, Judge Bryson concurred with the court that claims to complementary deoxyribonucleic acid (cDNA) sequences, which differ from naturally-occurring and isolated nucleotide sequences by the absence of non-coding regions, are patent eligible subject matter, and concurred with the majority with respect to the method claims.  Regarding arguments that decisions by the Federal Circuit should not upset settled expectations of patent eligibility of genetic material, Judge Bryson stated that "there is no collective right of adverse possession to intellectual property, and we should not create one."
 
Litigation is Expected to Continue
 
Commentators widely expect that this case will be reheard en banc or that certiorari will be granted by the Supreme Court.
 
 

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