CAFC decides Myriad; SDNY mostly reversed; "the difference between science and invention"
The punchline in an opinion by Judge Lourie:
On the merits, we reverse the district court’s decision that Myriad’s composition claims to “isolated” DNA molecules cover patent-ineligible products of nature under § 101 since the molecules as claimed do not exist in nature. We also reverse the dis- trict court’s decision that Myriad’s method claim to screening potential cancer therapeutics via changes in cell growth rates is directed to a patent-ineligible scientific principle. We, however, affirm the court’s decision that Myriad’s method claims directed to “comparing” or “analyzing” DNA sequences are patent ineligible; such claims include no transformative steps and cover only patent- ineligible abstract, mental steps.
As to standing, the CAFC noted:
Under the facts alleged in this case, we conclude that one Plaintiff, Dr. Ostrer, has established standing to maintain this declaratory judgment suit. (...) Dr. Ostrer clearly alleges a sufficiently real and imminent injury because he alleges an intention to actually and immediately engage in allegedly infringing BRCA-related activities. (...) Having found one plaintiff with standing to maintain this declaratory judgment action, see Horne v. Flores, 129 S. Ct. 2579, 2592-93 (2009), we may turn now to the merits of Myriad’s appeal of the district court’s summary judgment decision, which held all fifteen challenged composition and method claims invalid under § 101.
Of the major issue:
In this case, Plain- tiffs conclude that because isolated DNAs retain the same nucleotide sequence as native DNAs, they do not have any “markedly different” characteristics. Furthermore, ac- cording to Plaintiffs, the isolated DNA claims also have a preemptive effect, excluding anyone from working with the BRCA genes.
The government as amicus curiae does not defend the PTO’s longstanding position that isolated DNA molecules are patent eligible, arguing instead for a middle ground. Specifically, the government argues that DNA molecules engineered by man, including cDNAs,5 are patent-eligible compositions of matter because, with rare exceptions, they do not occur in nature, either in isolation or as contiguous sequences within a chromosome. In contrast, the government asserts, isolated and unmodified genomic DNAs are not patent eligible, but rather patent-ineligible products of nature, since their nucleotide sequences exist because of evolution, not man. (...)
In sum, although the parties and the government appear to agree that isolated DNAs are compositions of matter, they disagree on whether and to what degree such molecules fall within the exception for products of nature. As set forth below, we conclude that the challenged claims to isolated DNAs, whether limited to cDNAs or not, are directed to patent-eligible subject matter under § 101.
AND
The distinction, therefore, between a product of na- ture and a human-made invention for purposes of § 101 turns on a change in the claimed composition’s identity compared with what exists in nature. Specifically, the Supreme Court has drawn a line between compositions that, even if combined or altered in a manner not found in nature, have similar characteristics as in nature, and compositions that human intervention has given “mark- edly different,” or “distinctive,” characteristics. Id. Hartranft, 121 U.S. at 615; see also Am. Fruit Growers v. Brogdex Co., 283 U.S. 1, 11 (1931). Applying this test to the isolated DNAs in this case, we conclude that the challenged claims are drawn to patentable subject matter because the claims cover molecules that are markedly different—have a distinctive chemical identity and na- ture—from molecules that exist in nature.
AND
Isolated DNA, in contrast, is a free-standing portion of a native DNA molecule, frequently a single gene. Isolated DNA 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. For example, the BRCA1 gene in its native state resides on chromosome 17, a DNA molecule of around eighty million nucleotides. Similarly, BRCA2 in its native state is located on chromosome 13, a DNA of approximately 114 million nucleotides. In contrast, isolated BRCA1 and BRCA2, with introns, each consists of just 80,000 or so nucleotides. And without introns, BRCA2 shrinks to just 10,200 or so nucleotides and BRCA1 to just around 5,500 nucleotides. Furthermore, claims 5 and 6 of the ’282 patent cover isolated DNAs having as few as fifteen nucleotides of a BRCA sequence. Accordingly, BRCA1 and BRCA2 in their isolated state are not the same mole- cules as DNA as it exists in the body; human intervention in cleaving or synthesizing a portion of a native chromo- somal DNA imparts on that isolated DNA a distinctive chemical identity from that possessed by native DNA.
Linus Pauling comes up:
The dissent disparages the significance of a “chemical bond,” presumably meaning a covalent bond, in distinguishing structurally between one molecular species and another. But a covalent bond is the defining boundary between one molecule and another. The dissent’s citation of Linus Pauling’s comment that covalent bonds “make it convenient for the chemist to consider [the aggregate] as an independent molecular species” underlines the point. The covalent bonds in this case separate one chemical species from another.
The CAFC dispenses with the district court opinion AND "the magic microscope" :
The district court in effect created a categorical rule excluding isolated genes from patent eligibility. See SJ Op., at 228-29. But the Supreme Court has “more than once cautioned that courts ‘should not read into the patent laws limitations and conditions which the legislature has not expressed,’” Bilski, 130 S. Ct. at 3226 (quot- ing Diamond v. Diehr, 450 U.S. 175, 182 (1981)), and has repeatedly rejected new categorical exclusions from § 101’s scope, see id. at 3227-28 (rejecting the argument that business method patents should be categorically excluded from § 101); Chakrabarty, 447 U.S. at 314-17 (same for living organisms). We therefore reject the district court’s unwarranted categorical exclusion of isolated DNA molecules.
Because isolated DNAs, not just cDNAs, have a mark- edly different chemical structure compared to native DNAs, we reject the government’s proposed “magic microscope” test, as it misunderstands the difference between science and invention and fails to take into account the existence of molecules as separate chemical entities.
In partial dissent, Judge Bryson noted:
I respectfully dissent, however, from the court’s holding that Myriad’s BRCA gene claims and its claims to gene fragments are patent-eligible. In my view, those claims are not directed to patentable subject matter, and if sustained the court’s decision will likely have broad consequences, such as preempting methods for whole- genome sequencing, even though Myriad’s contribution to the field is not remotely consonant with such effects. (...) The essence of Myriad’s argument in this case is to say that it has not patented a human gene, but something quite different—an isolated human gene, which differs from a native gene because the process of extracting it results in changes in its molecular structure (although not in its genetic code). We are therefore required to decide whether the process of isolating genetic material from a human DNA molecule makes the isolated genetic mate- rial a patentable invention. The court concludes that it does; I conclude that it does not.
Of Linus Pauling: A chemical bond is merely a force between two atoms or groups of atoms strong enough “to make it convenient for the chemist to consider [the aggregate] as an independent molecular species.” Linus Pauling, The Nature of the Chemical Bond 6 (3d ed. 1960).
Lithium comes up: The government as amicus curiae argues that patenting the BRCA genes would be like patenting the element lithium. Isolated lithium does not occur naturally because it reacts with air and water and thus is found in nature only as part of a chemical compound, ionically bound to other elements. Robert E. Krebs, The History and Use of Our Earth’s Chemical Elements 48 (2d ed. 2006). Once isolated, lithium has many industrial applications, and in order to isolate lithium, it is necessary to break ionic bonds in the lithium compounds that are found in nature. But the majority acknowledges that elemental lithium (like other ele- ments) would not be patentable subject matter because it “is the same element whether it is in the earth or iso- lated.”
AND
The majority, however, does not agree that the cases are analogous, and indeed appears to have adopted the following rule: Isolated atoms are not patent eligible, but isolated molecules are.
Apart from the arbitrariness of such a rule, if we are to apply the conventional nomenclature of any field to determine whether Myriad’s isolated DNA claims are “new,” it would seem to make more sense to look to genetics, which provides the language of the claims, than to chemistry.
Of the USPTO:
First, as we have recognized, the PTO lacks substantive rulemaking authority as to issues such as patentability. Animal Legal Def. Fund v. Quigg, 932 F.2d 920, 930 (Fed. Cir. 1991). In areas of patent scope, we owe deference only commensurate with the “the thoroughness of its consideration and the validity of its reasoning.” Merck & Co. v. Kessler, 80 F.3d 1543, 1550 (Fed. Cir. 1996). The comments that the PTO issued at the time of its 2001 guidelines in response to suggestions that isolated human genes were not patentable are, frankly, perfunctory. See John M. Conley & Roberte Makowski, Back to the Future: Rethinking the Product of Nature Doctrine as a Barrier to Biotechnology Patents, 85 J. Pat. & Trademark Off. Soc’y 301 (2003). Because those comments, at least on their face, do not reflect thorough consideration and study of the issue, I do not regard them as worthy of much weight in the analysis of this complex question.
**Separately on Bilski:
from OPERATING EFFICIENTLY POST-BILSKI BY ORDERING PATENT DOCTRINE DECISION- MAKING
We take a different approach. Rather than try to cut through the complexity of Bilski, or predict how it will be applied, we talk about how to avoid it. We are interested in minimizing the cost and confusion that accompany a review of patents for § 101 subject-matter eligibility.2 We propose that the § 101 issue of Bilski be considered only when doing so is absolutely necessary to determine the validity of a claim or claims in a patent. We believe any claim that can be invalidated under one of the less controversial and less complex requirements for patentability—§§ 102, 103, and 112, for instance—ought to be disposed of without considering subject matter patentability.3 In other words, the Bilski issue should be avoided wherever it is not strictly necessary. To support this conclusion, we present a set of empirical data that indicates that the vast majority of patent claims challenged on subject matter eligibility grounds were also challenged on other patentability grounds.
On the merits, we reverse the district court’s decision that Myriad’s composition claims to “isolated” DNA molecules cover patent-ineligible products of nature under § 101 since the molecules as claimed do not exist in nature. We also reverse the dis- trict court’s decision that Myriad’s method claim to screening potential cancer therapeutics via changes in cell growth rates is directed to a patent-ineligible scientific principle. We, however, affirm the court’s decision that Myriad’s method claims directed to “comparing” or “analyzing” DNA sequences are patent ineligible; such claims include no transformative steps and cover only patent- ineligible abstract, mental steps.
As to standing, the CAFC noted:
Under the facts alleged in this case, we conclude that one Plaintiff, Dr. Ostrer, has established standing to maintain this declaratory judgment suit. (...) Dr. Ostrer clearly alleges a sufficiently real and imminent injury because he alleges an intention to actually and immediately engage in allegedly infringing BRCA-related activities. (...) Having found one plaintiff with standing to maintain this declaratory judgment action, see Horne v. Flores, 129 S. Ct. 2579, 2592-93 (2009), we may turn now to the merits of Myriad’s appeal of the district court’s summary judgment decision, which held all fifteen challenged composition and method claims invalid under § 101.
Of the major issue:
In this case, Plain- tiffs conclude that because isolated DNAs retain the same nucleotide sequence as native DNAs, they do not have any “markedly different” characteristics. Furthermore, ac- cording to Plaintiffs, the isolated DNA claims also have a preemptive effect, excluding anyone from working with the BRCA genes.
The government as amicus curiae does not defend the PTO’s longstanding position that isolated DNA molecules are patent eligible, arguing instead for a middle ground. Specifically, the government argues that DNA molecules engineered by man, including cDNAs,5 are patent-eligible compositions of matter because, with rare exceptions, they do not occur in nature, either in isolation or as contiguous sequences within a chromosome. In contrast, the government asserts, isolated and unmodified genomic DNAs are not patent eligible, but rather patent-ineligible products of nature, since their nucleotide sequences exist because of evolution, not man. (...)
In sum, although the parties and the government appear to agree that isolated DNAs are compositions of matter, they disagree on whether and to what degree such molecules fall within the exception for products of nature. As set forth below, we conclude that the challenged claims to isolated DNAs, whether limited to cDNAs or not, are directed to patent-eligible subject matter under § 101.
AND
The distinction, therefore, between a product of na- ture and a human-made invention for purposes of § 101 turns on a change in the claimed composition’s identity compared with what exists in nature. Specifically, the Supreme Court has drawn a line between compositions that, even if combined or altered in a manner not found in nature, have similar characteristics as in nature, and compositions that human intervention has given “mark- edly different,” or “distinctive,” characteristics. Id. Hartranft, 121 U.S. at 615; see also Am. Fruit Growers v. Brogdex Co., 283 U.S. 1, 11 (1931). Applying this test to the isolated DNAs in this case, we conclude that the challenged claims are drawn to patentable subject matter because the claims cover molecules that are markedly different—have a distinctive chemical identity and na- ture—from molecules that exist in nature.
AND
Isolated DNA, in contrast, is a free-standing portion of a native DNA molecule, frequently a single gene. Isolated DNA 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. For example, the BRCA1 gene in its native state resides on chromosome 17, a DNA molecule of around eighty million nucleotides. Similarly, BRCA2 in its native state is located on chromosome 13, a DNA of approximately 114 million nucleotides. In contrast, isolated BRCA1 and BRCA2, with introns, each consists of just 80,000 or so nucleotides. And without introns, BRCA2 shrinks to just 10,200 or so nucleotides and BRCA1 to just around 5,500 nucleotides. Furthermore, claims 5 and 6 of the ’282 patent cover isolated DNAs having as few as fifteen nucleotides of a BRCA sequence. Accordingly, BRCA1 and BRCA2 in their isolated state are not the same mole- cules as DNA as it exists in the body; human intervention in cleaving or synthesizing a portion of a native chromo- somal DNA imparts on that isolated DNA a distinctive chemical identity from that possessed by native DNA.
Linus Pauling comes up:
The dissent disparages the significance of a “chemical bond,” presumably meaning a covalent bond, in distinguishing structurally between one molecular species and another. But a covalent bond is the defining boundary between one molecule and another. The dissent’s citation of Linus Pauling’s comment that covalent bonds “make it convenient for the chemist to consider [the aggregate] as an independent molecular species” underlines the point. The covalent bonds in this case separate one chemical species from another.
The CAFC dispenses with the district court opinion AND "the magic microscope" :
The district court in effect created a categorical rule excluding isolated genes from patent eligibility. See SJ Op., at 228-29. But the Supreme Court has “more than once cautioned that courts ‘should not read into the patent laws limitations and conditions which the legislature has not expressed,’” Bilski, 130 S. Ct. at 3226 (quot- ing Diamond v. Diehr, 450 U.S. 175, 182 (1981)), and has repeatedly rejected new categorical exclusions from § 101’s scope, see id. at 3227-28 (rejecting the argument that business method patents should be categorically excluded from § 101); Chakrabarty, 447 U.S. at 314-17 (same for living organisms). We therefore reject the district court’s unwarranted categorical exclusion of isolated DNA molecules.
Because isolated DNAs, not just cDNAs, have a mark- edly different chemical structure compared to native DNAs, we reject the government’s proposed “magic microscope” test, as it misunderstands the difference between science and invention and fails to take into account the existence of molecules as separate chemical entities.
In partial dissent, Judge Bryson noted:
I respectfully dissent, however, from the court’s holding that Myriad’s BRCA gene claims and its claims to gene fragments are patent-eligible. In my view, those claims are not directed to patentable subject matter, and if sustained the court’s decision will likely have broad consequences, such as preempting methods for whole- genome sequencing, even though Myriad’s contribution to the field is not remotely consonant with such effects. (...) The essence of Myriad’s argument in this case is to say that it has not patented a human gene, but something quite different—an isolated human gene, which differs from a native gene because the process of extracting it results in changes in its molecular structure (although not in its genetic code). We are therefore required to decide whether the process of isolating genetic material from a human DNA molecule makes the isolated genetic mate- rial a patentable invention. The court concludes that it does; I conclude that it does not.
Of Linus Pauling: A chemical bond is merely a force between two atoms or groups of atoms strong enough “to make it convenient for the chemist to consider [the aggregate] as an independent molecular species.” Linus Pauling, The Nature of the Chemical Bond 6 (3d ed. 1960).
Lithium comes up: The government as amicus curiae argues that patenting the BRCA genes would be like patenting the element lithium. Isolated lithium does not occur naturally because it reacts with air and water and thus is found in nature only as part of a chemical compound, ionically bound to other elements. Robert E. Krebs, The History and Use of Our Earth’s Chemical Elements 48 (2d ed. 2006). Once isolated, lithium has many industrial applications, and in order to isolate lithium, it is necessary to break ionic bonds in the lithium compounds that are found in nature. But the majority acknowledges that elemental lithium (like other ele- ments) would not be patentable subject matter because it “is the same element whether it is in the earth or iso- lated.”
AND
The majority, however, does not agree that the cases are analogous, and indeed appears to have adopted the following rule: Isolated atoms are not patent eligible, but isolated molecules are.
Apart from the arbitrariness of such a rule, if we are to apply the conventional nomenclature of any field to determine whether Myriad’s isolated DNA claims are “new,” it would seem to make more sense to look to genetics, which provides the language of the claims, than to chemistry.
Of the USPTO:
First, as we have recognized, the PTO lacks substantive rulemaking authority as to issues such as patentability. Animal Legal Def. Fund v. Quigg, 932 F.2d 920, 930 (Fed. Cir. 1991). In areas of patent scope, we owe deference only commensurate with the “the thoroughness of its consideration and the validity of its reasoning.” Merck & Co. v. Kessler, 80 F.3d 1543, 1550 (Fed. Cir. 1996). The comments that the PTO issued at the time of its 2001 guidelines in response to suggestions that isolated human genes were not patentable are, frankly, perfunctory. See John M. Conley & Roberte Makowski, Back to the Future: Rethinking the Product of Nature Doctrine as a Barrier to Biotechnology Patents, 85 J. Pat. & Trademark Off. Soc’y 301 (2003). Because those comments, at least on their face, do not reflect thorough consideration and study of the issue, I do not regard them as worthy of much weight in the analysis of this complex question.
**Separately on Bilski:
from OPERATING EFFICIENTLY POST-BILSKI BY ORDERING PATENT DOCTRINE DECISION- MAKING
We take a different approach. Rather than try to cut through the complexity of Bilski, or predict how it will be applied, we talk about how to avoid it. We are interested in minimizing the cost and confusion that accompany a review of patents for § 101 subject-matter eligibility.2 We propose that the § 101 issue of Bilski be considered only when doing so is absolutely necessary to determine the validity of a claim or claims in a patent. We believe any claim that can be invalidated under one of the less controversial and less complex requirements for patentability—§§ 102, 103, and 112, for instance—ought to be disposed of without considering subject matter patentability.3 In other words, the Bilski issue should be avoided wherever it is not strictly necessary. To support this conclusion, we present a set of empirical data that indicates that the vast majority of patent claims challenged on subject matter eligibility grounds were also challenged on other patentability grounds.
posted by Lawrence B. Ebert at 9:13 AM
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