Myriad after remand: isolated genes still patentable
In Association for Molecular Pathology v. Myriad, decided by the Court of Appeals for the Federal Circuit on August 16, one again has three opinions by the three judges.
The first, by Judge Lourie, includes the text:
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 because each of the claimed molecules represents a nonnaturally occurring composition of matter. We also reverse the district court’s decision that Myriad’s method claim to screening poten- tial cancer therapeutics via changes in cell growth rates of transformed cells is directed to a patent-ineligible scien- tific principle. We affirm the court’s decision, however, 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.
Footnote 2 relates to standing:
On July 27, 2011, two days before we issued our initial, now-vacated decision in this case, Myriad notified the court that Dr. Ostrer was leaving NYU to assume a position at the Albert Einstein College of Medicine and Montefiore Medical Center, effective August 29, 2011. In response, Plaintiffs submitted a supplemental declaration from Dr. Ostrer stating that, in his new position, he still seeks to undertake BRCA diagnostic testing, still has the resources and expertise to conduct such testing, and would immediately do so if Myriad’s patents were invali- dated. Following remand from the Supreme Court, we have also received from Myriad a related “suggestion of mootness” and motion to remand or dismiss. We declined the suggestion and denied the motion. We now review this case on the facts and arguments briefed and pre- sented to us.
Later in the opinion:
Under the facts alleged in this case, we conclude that one Plaintiff, Dr. Ostrer, has established standing to maintain this declaratory judgment suit.
Of the policy issues:
We would further note, in the context of discussing what this case is not about, that patents on life-saving material and processes, involving large amounts of risky investment, would seem to be precisely the types of sub- ject matter that should be subject to the incentives of exclusive rights. But disapproving of patents on medical methods and novel biological molecules are policy questions best left to Congress, and other general questions relating to patentability and use of patents are issues not before us. As will be seen, on the limited questions before us, we conclude that the composition claims and the screening claim involving growing a transformed host cell meet the standards for patent eligibility, while the claimed methods for “analyzing” or “comparing” do not.
There is reference to the previous magic microscope argument:
At the first oral argument, the government illustrated its position by way of a so-called “magic microscope” test (an invention in and of itself, although probably not patent-eligible). Oral Arg. at 46:50-47:50. According to the government’s test then, if an imaginary microscope could focus in on the claimed DNA molecule as it exists in the human body, the claim covers ineligible subject matter. The government thus argued that because such a microscope could focus in on the claimed isolated BRCA1 or BRCA2 sequences as they exist in the human body, the claims covering those sequences are not patent eligible. In contrast, the government contended, because an imaginary microscope could not focus in vivo on a cDNA sequence, which is engineered by man to splice together non-contiguous coding sequences (i.e., exons), claims covering cDNAs are patent eligible.
There was discussion of Funk Brothers:
n Funk Brothers, the patentee discovered that certain strains of nitrogen-fixing bacteria associated with leguminous plants do not mutually inhibit each other. 333 U.S. at 129-30. Based on that discovery, the patentee produced (and claimed) mixed cultures of nitrogen-fixing species capable of inoculating a broader range of leguminous plants than single-species cultures. Id. The Court held that the bacteria’s cooperative quali- ties were, “like the heat of the sun, electricity, or the qualities of metals,” the “work of nature,” and thus not patentable. Id. at 130. The Court also held that applying the newly discovered bacterial compatibility to create a mixed culture was not a patentable advance because no species acquired a different property or use.
As to isolated DNA:
One distinction, therefore, between products of nature and 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 arrayed in useful combinations or harnessed to exploit newly discovered properties, have similar characteristics as in nature, and compositions that human intervention has given “markedly different,” or “distinctive,” character- istics. Id. (citing 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, the challenged claims are drawn to patent-eligible subject matter because the claims cover molecules that are mark- edly different—have a distinctive chemical structure and identity—from those found in nature.
AND
As the above description indicates, isolated DNA is not just purified DNA. Purification makes pure what was the same material, but was combined, or contaminated, with other materials. Although isolated DNA is removed from its native cellular and chromosomal environment, it has also been manipulated chemically so as to produce a molecule that is markedly different from that which exists in the body. Accordingly, this is not a situation, as in Parke-Davis & Co. v. H.K. Mulford Co., in which purifica- tion of adrenaline resulted in the identical molecule, albeit being “for every practical purpose a new thing commercially and therapeutically.” 189 F. 95, 103 (C.C.S.D.N.Y. 1911). Judge Learned Hand’s opinion for the district court in that oft-cited case held the purified “Adrenalin” to be patent-eligible subject matter. Id. The In re Marden cases are similarly inapposite, directed as they are to the patent ineligibility of purified natural elements—ductile uranium, 47 F.2d 957 (CCPA 1931), and vanadium, 47 F.2d 958 (CCPA 1931)—that are inher- ently ductile in purified form. While purified natural products thus may or may not qualify for patent under § 101, the isolated DNAs of the present patents constitute an a fortiori situation, where they are not only purified; they are different from the natural products in “name, character, and use.” Chakrabarty, 447 U.S. at 309-10.
Linus Pauling is invoked:
But a covalent bond is the defining boundary between one molecule and another, and 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” under- lines the point. The covalent bonds in this case connect different chemical moieties to one another.
Policy arises again:
Under the statutory rubric of § 101, isolated DNA is a tangible, man-made composition of matter defined and distinguished by its objectively discernible chemical structure. Whether its unusual status as a chemical entity that conveys genetic information warrants singular treatment under the patent laws as the district court did is a policy question that we are not entitled to address. Cf. Nat’l Fed’n of Indep. Bus. v. Sebelius, 132 S. Ct. 2566, slip op. at 6 (2012) (“[W]e possess neither the expertise nor the prerogative to make policy judgments. Those decisions are entrusted to our Nation’s elected leaders, who can be thrown out of office if the people disagree with them.”). Congress is presumed to have been aware of the issue, having enacted a comprehensive patent reform act during the pendency of this case, and it is ultimately for Congress if it wishes to overturn case law and the long practice of the PTO to determine that isolated DNA must be treated differently from other compositions of matter to account for its perceived special function. We therefore reject the district court’s unwarranted categorical exclu- sion of isolated DNA molecules.
There is consideration of Mayo:
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. Plaintiffs argue here that they are preempted from using the patented DNA mole- cules. The answer to that concern is that permitting patents on isolated genes does not preempt a law of nature. A composition of matter is not a law of nature.
AND
The remand of this case for reconsideration in light of Mayo might suggest, as Plaintiffs and certain amici state, that the composition claims are mere reflections of a law of nature. Respectfully, they are not, any more than any product of man reflects and is consistent with a law of nature. Everything and everyone comes from nature, following its laws.
The lithium analogy arises:
But the isolation here is not a simple separation from extraneous materials, but conversion to a different molecular entity. And again, these facts are not before us, so we do not attempt to evaluate the patentability of one form of lithium over another. Courts decide cases; they do not draft comprehensive legal treatises. Suffice it to say, however, that if lithium is found in the earth as other than elemental lithium because it reacts with air and water to form, for example, lithium oxide or lithium hydroxide, it is a different material. A lithium compound is not elemental lithium.
As to settled expectations:
Finally, our decision that isolated DNA molecules are patent eligible comports with the longstanding practice of the PTO and the courts. The Supreme Court has repeatedly stated that changes to longstanding practice should come from Congress, not the courts.
Of method claims:
We turn next to Myriad’s challenged method claims. This court in its now-vacated decision of July 29, 2011, had held method claims 1 of the ’999, ’001, and ’441 patents, as well as method claims 1 and 2 of the ’857 patent—all of which consist of analyzing and comparing certain DNA sequences—not to be patent-eligible subject matter on the ground that they claim only abstract men- tal processes. In light of the Supreme Court’s decision in Mayo, we reaffirm that prior holding. The Court made clear that such diagnostic methods in that case essentially claim natural laws that are not eligible for patent.
BUT
In our prior decision, however, we reversed the dis- trict court’s holding that claim 20 of the ’282 patent was not eligible for patent. We did so on the ground, inter alia, that, in addition to the step of comparing the cells’ growth rates, the claim also recites the steps of growing transformed cells and determining those growth rates. We relied on the fact that those steps were transforma- tive. Although the Court has now held that certain trans- formative steps are not necessarily sufficient under § 101 if the recited steps only rely on natural laws, we once again, even in light of Mayo, arrive at the same conclusion of patent-eligibility because at the heart of claim 20 is a transformed cell, which is made by man, in contrast to a natural material.
Of growth rates:
Lastly, we turn to claim 20 of the ’282 patent, directed to a method for screening potential cancer therapeutics via changes in cell growth rates of transformed cells. The parties agree that those transformed cells arose from human effort; i.e., they are not natural products. Plain- tiffs nonetheless challenge claim 20 as directed to the abstract idea of comparing the growth rates of two cell populations and as preempting a basic scientific princi- ple—that a slower growth rate in the presence of a poten- tial therapeutic compound suggests that the compound is a cancer therapeutic. Plaintiffs therefore contend that claim 20 is indistinguishable from the claims held ineligi- ble in Mayo. We disagree.
Judge Moore's concurring opinion begins:
I join the majority opinion with respect to standing and the patentability of the method claims at issue. I join the majority with respect to claims to isolated cDNA sequences, and concur in the judgment with respect to isolated DNA sequences. I write separately to explain my reasoning.
Judge Moore also referenced Funk Brothers:
Even when an invention does not exist in nature in the claimed state, it may still be directed to subject matter that is not patentable. For example, in Funk Brothers, the Supreme Court held a patent to a combination of multiple naturally occurring bacterial strains was not patentable. Although there was “an advantage in the combination,” which was apparently “new and useful,” none of the bacterial strains “acquire[ed] a different use” in combination. Funk Bros., 333 U.S. at 131-32. The aggregation of the bacterial strains into a single product produced “no new bacteria, no change in the six species of bacteria, and no enlargement of the range of their utility. Each species has the same effect it always had. The bacteria perform in their natural way. . . . They serve the ends nature originally provided and act quite independ- ently of any effort of the patentee.” Id.
AND
Prometheus did not, however, overturn Funk Brothers or Chakrabarty; cases clearly more analogous to the one before us. Using the framework of Funk Brothers and Chakrabarty in conjunction with the direction of Prometheus, the applicable principles are: (1) laws of nature/manifestations of nature are not patentable; (2) a composition of matter with “markedly different characteristics” from that found in nature with the potential for significant utility is directed to patentable subject matter.
Does the isolation process change the DNA from an unpatentable manifestation of nature into a patentable composition of matter? Id. at 1299. Does the claimed isolated DNA have markedly different characteristics with the potential for significant utility, e.g., an “enlargement of the range of . . . utility” as compared to nature? Chakrabarty, 447 U.S. at 309-310; Funk Bros., 333 U.S. at 131.
Of interest:
If I were 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. The scope of the law of nature/manifestation of nature excep- tion was certainly enlarged in Prometheus. But we do not decide this case on a blank canvas. Congress has, for centuries, authorized an expansive scope of patentable subject matter. Likewise, the United States Patent Office has allowed patents on isolated DNA sequences for dec- ades, and, more generally, has allowed patents on purified
natural products for centuries. There are now thousands of patents with claims to isolated DNA, and some un- known (but certainly large) number of patents to purified natural products or fragments thereof.5 As I explain below, I believe we must be particularly wary of expand- ing the judicial exception to patentable subject matter where both settled expectations and extensive property rights are involved.
Link to decision: http://www.cafc.uscourts.gov/images/stories/opinions-orders/10-1406.pdf
See also Myriad Wins U.S. Appeal Over Ability To Patent Isolated DNA
The first, by Judge Lourie, includes the text:
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 because each of the claimed molecules represents a nonnaturally occurring composition of matter. We also reverse the district court’s decision that Myriad’s method claim to screening poten- tial cancer therapeutics via changes in cell growth rates of transformed cells is directed to a patent-ineligible scien- tific principle. We affirm the court’s decision, however, 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.
Footnote 2 relates to standing:
On July 27, 2011, two days before we issued our initial, now-vacated decision in this case, Myriad notified the court that Dr. Ostrer was leaving NYU to assume a position at the Albert Einstein College of Medicine and Montefiore Medical Center, effective August 29, 2011. In response, Plaintiffs submitted a supplemental declaration from Dr. Ostrer stating that, in his new position, he still seeks to undertake BRCA diagnostic testing, still has the resources and expertise to conduct such testing, and would immediately do so if Myriad’s patents were invali- dated. Following remand from the Supreme Court, we have also received from Myriad a related “suggestion of mootness” and motion to remand or dismiss. We declined the suggestion and denied the motion. We now review this case on the facts and arguments briefed and pre- sented to us.
Later in the opinion:
Under the facts alleged in this case, we conclude that one Plaintiff, Dr. Ostrer, has established standing to maintain this declaratory judgment suit.
Of the policy issues:
We would further note, in the context of discussing what this case is not about, that patents on life-saving material and processes, involving large amounts of risky investment, would seem to be precisely the types of sub- ject matter that should be subject to the incentives of exclusive rights. But disapproving of patents on medical methods and novel biological molecules are policy questions best left to Congress, and other general questions relating to patentability and use of patents are issues not before us. As will be seen, on the limited questions before us, we conclude that the composition claims and the screening claim involving growing a transformed host cell meet the standards for patent eligibility, while the claimed methods for “analyzing” or “comparing” do not.
There is reference to the previous magic microscope argument:
At the first oral argument, the government illustrated its position by way of a so-called “magic microscope” test (an invention in and of itself, although probably not patent-eligible). Oral Arg. at 46:50-47:50. According to the government’s test then, if an imaginary microscope could focus in on the claimed DNA molecule as it exists in the human body, the claim covers ineligible subject matter. The government thus argued that because such a microscope could focus in on the claimed isolated BRCA1 or BRCA2 sequences as they exist in the human body, the claims covering those sequences are not patent eligible. In contrast, the government contended, because an imaginary microscope could not focus in vivo on a cDNA sequence, which is engineered by man to splice together non-contiguous coding sequences (i.e., exons), claims covering cDNAs are patent eligible.
There was discussion of Funk Brothers:
n Funk Brothers, the patentee discovered that certain strains of nitrogen-fixing bacteria associated with leguminous plants do not mutually inhibit each other. 333 U.S. at 129-30. Based on that discovery, the patentee produced (and claimed) mixed cultures of nitrogen-fixing species capable of inoculating a broader range of leguminous plants than single-species cultures. Id. The Court held that the bacteria’s cooperative quali- ties were, “like the heat of the sun, electricity, or the qualities of metals,” the “work of nature,” and thus not patentable. Id. at 130. The Court also held that applying the newly discovered bacterial compatibility to create a mixed culture was not a patentable advance because no species acquired a different property or use.
As to isolated DNA:
One distinction, therefore, between products of nature and 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 arrayed in useful combinations or harnessed to exploit newly discovered properties, have similar characteristics as in nature, and compositions that human intervention has given “markedly different,” or “distinctive,” character- istics. Id. (citing 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, the challenged claims are drawn to patent-eligible subject matter because the claims cover molecules that are mark- edly different—have a distinctive chemical structure and identity—from those found in nature.
AND
As the above description indicates, isolated DNA is not just purified DNA. Purification makes pure what was the same material, but was combined, or contaminated, with other materials. Although isolated DNA is removed from its native cellular and chromosomal environment, it has also been manipulated chemically so as to produce a molecule that is markedly different from that which exists in the body. Accordingly, this is not a situation, as in Parke-Davis & Co. v. H.K. Mulford Co., in which purifica- tion of adrenaline resulted in the identical molecule, albeit being “for every practical purpose a new thing commercially and therapeutically.” 189 F. 95, 103 (C.C.S.D.N.Y. 1911). Judge Learned Hand’s opinion for the district court in that oft-cited case held the purified “Adrenalin” to be patent-eligible subject matter. Id. The In re Marden cases are similarly inapposite, directed as they are to the patent ineligibility of purified natural elements—ductile uranium, 47 F.2d 957 (CCPA 1931), and vanadium, 47 F.2d 958 (CCPA 1931)—that are inher- ently ductile in purified form. While purified natural products thus may or may not qualify for patent under § 101, the isolated DNAs of the present patents constitute an a fortiori situation, where they are not only purified; they are different from the natural products in “name, character, and use.” Chakrabarty, 447 U.S. at 309-10.
Linus Pauling is invoked:
But a covalent bond is the defining boundary between one molecule and another, and 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” under- lines the point. The covalent bonds in this case connect different chemical moieties to one another.
Policy arises again:
Under the statutory rubric of § 101, isolated DNA is a tangible, man-made composition of matter defined and distinguished by its objectively discernible chemical structure. Whether its unusual status as a chemical entity that conveys genetic information warrants singular treatment under the patent laws as the district court did is a policy question that we are not entitled to address. Cf. Nat’l Fed’n of Indep. Bus. v. Sebelius, 132 S. Ct. 2566, slip op. at 6 (2012) (“[W]e possess neither the expertise nor the prerogative to make policy judgments. Those decisions are entrusted to our Nation’s elected leaders, who can be thrown out of office if the people disagree with them.”). Congress is presumed to have been aware of the issue, having enacted a comprehensive patent reform act during the pendency of this case, and it is ultimately for Congress if it wishes to overturn case law and the long practice of the PTO to determine that isolated DNA must be treated differently from other compositions of matter to account for its perceived special function. We therefore reject the district court’s unwarranted categorical exclu- sion of isolated DNA molecules.
There is consideration of Mayo:
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. Plaintiffs argue here that they are preempted from using the patented DNA mole- cules. The answer to that concern is that permitting patents on isolated genes does not preempt a law of nature. A composition of matter is not a law of nature.
AND
The remand of this case for reconsideration in light of Mayo might suggest, as Plaintiffs and certain amici state, that the composition claims are mere reflections of a law of nature. Respectfully, they are not, any more than any product of man reflects and is consistent with a law of nature. Everything and everyone comes from nature, following its laws.
The lithium analogy arises:
But the isolation here is not a simple separation from extraneous materials, but conversion to a different molecular entity. And again, these facts are not before us, so we do not attempt to evaluate the patentability of one form of lithium over another. Courts decide cases; they do not draft comprehensive legal treatises. Suffice it to say, however, that if lithium is found in the earth as other than elemental lithium because it reacts with air and water to form, for example, lithium oxide or lithium hydroxide, it is a different material. A lithium compound is not elemental lithium.
As to settled expectations:
Finally, our decision that isolated DNA molecules are patent eligible comports with the longstanding practice of the PTO and the courts. The Supreme Court has repeatedly stated that changes to longstanding practice should come from Congress, not the courts.
Of method claims:
We turn next to Myriad’s challenged method claims. This court in its now-vacated decision of July 29, 2011, had held method claims 1 of the ’999, ’001, and ’441 patents, as well as method claims 1 and 2 of the ’857 patent—all of which consist of analyzing and comparing certain DNA sequences—not to be patent-eligible subject matter on the ground that they claim only abstract men- tal processes. In light of the Supreme Court’s decision in Mayo, we reaffirm that prior holding. The Court made clear that such diagnostic methods in that case essentially claim natural laws that are not eligible for patent.
BUT
In our prior decision, however, we reversed the dis- trict court’s holding that claim 20 of the ’282 patent was not eligible for patent. We did so on the ground, inter alia, that, in addition to the step of comparing the cells’ growth rates, the claim also recites the steps of growing transformed cells and determining those growth rates. We relied on the fact that those steps were transforma- tive. Although the Court has now held that certain trans- formative steps are not necessarily sufficient under § 101 if the recited steps only rely on natural laws, we once again, even in light of Mayo, arrive at the same conclusion of patent-eligibility because at the heart of claim 20 is a transformed cell, which is made by man, in contrast to a natural material.
Of growth rates:
Lastly, we turn to claim 20 of the ’282 patent, directed to a method for screening potential cancer therapeutics via changes in cell growth rates of transformed cells. The parties agree that those transformed cells arose from human effort; i.e., they are not natural products. Plain- tiffs nonetheless challenge claim 20 as directed to the abstract idea of comparing the growth rates of two cell populations and as preempting a basic scientific princi- ple—that a slower growth rate in the presence of a poten- tial therapeutic compound suggests that the compound is a cancer therapeutic. Plaintiffs therefore contend that claim 20 is indistinguishable from the claims held ineligi- ble in Mayo. We disagree.
Judge Moore's concurring opinion begins:
I join the majority opinion with respect to standing and the patentability of the method claims at issue. I join the majority with respect to claims to isolated cDNA sequences, and concur in the judgment with respect to isolated DNA sequences. I write separately to explain my reasoning.
Judge Moore also referenced Funk Brothers:
Even when an invention does not exist in nature in the claimed state, it may still be directed to subject matter that is not patentable. For example, in Funk Brothers, the Supreme Court held a patent to a combination of multiple naturally occurring bacterial strains was not patentable. Although there was “an advantage in the combination,” which was apparently “new and useful,” none of the bacterial strains “acquire[ed] a different use” in combination. Funk Bros., 333 U.S. at 131-32. The aggregation of the bacterial strains into a single product produced “no new bacteria, no change in the six species of bacteria, and no enlargement of the range of their utility. Each species has the same effect it always had. The bacteria perform in their natural way. . . . They serve the ends nature originally provided and act quite independ- ently of any effort of the patentee.” Id.
AND
Prometheus did not, however, overturn Funk Brothers or Chakrabarty; cases clearly more analogous to the one before us. Using the framework of Funk Brothers and Chakrabarty in conjunction with the direction of Prometheus, the applicable principles are: (1) laws of nature/manifestations of nature are not patentable; (2) a composition of matter with “markedly different characteristics” from that found in nature with the potential for significant utility is directed to patentable subject matter.
Does the isolation process change the DNA from an unpatentable manifestation of nature into a patentable composition of matter? Id. at 1299. Does the claimed isolated DNA have markedly different characteristics with the potential for significant utility, e.g., an “enlargement of the range of . . . utility” as compared to nature? Chakrabarty, 447 U.S. at 309-310; Funk Bros., 333 U.S. at 131.
Of interest:
If I were 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. The scope of the law of nature/manifestation of nature excep- tion was certainly enlarged in Prometheus. But we do not decide this case on a blank canvas. Congress has, for centuries, authorized an expansive scope of patentable subject matter. Likewise, the United States Patent Office has allowed patents on isolated DNA sequences for dec- ades, and, more generally, has allowed patents on purified
natural products for centuries. There are now thousands of patents with claims to isolated DNA, and some un- known (but certainly large) number of patents to purified natural products or fragments thereof.5 As I explain below, I believe we must be particularly wary of expand- ing the judicial exception to patentable subject matter where both settled expectations and extensive property rights are involved.
Link to decision: http://www.cafc.uscourts.gov/images/stories/opinions-orders/10-1406.pdf
See also Myriad Wins U.S. Appeal Over Ability To Patent Isolated DNA
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