The United States Supreme Court held in Association for Molecular Pathology v. Myriad Genetics, Inc. that isolated DNA sequences are not patent eligible under Section 101 of the Patent Act. The court held that cDNA is patent eligible under the circumstances of this case. While the court acknowledged that a new molecule was created by isolating the DNA, Myriad’s patent was focused on a sequence of information, not the molecular structure. In light of this, the court held that the isolated DNA implicated the “product of nature” common law exception to patent eligibility. In my opinion, this case would have been better decided via an improved pre-emption analysis that would have avoided this awkward characterization of Myriad’s claims.
This case began when the Association for Molecular Pathology (AMP) challenged several claims from patents belonging to Myriad Genetics, Inc. (Myriad).
At issue before the Supreme Court were nine of Myriad’s composition claims: claims 1, 2, 5, 6, and 7 of U.S. Patent 5,747,282, claim 1 of U.S. Patent 5,693,473, and claims 1, 6, and 7 of U.S. Patent 5,837,492.1
Representative of Myriad’s claims are claims 1 and 2 of the ’282 patent. Claim 1 claims “[a]n isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2”.2 Claim 2 claims “[t]he isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.”3
Claim 2 differs from claim 1 in that the DNA code in claim 2 at SEQ ID NO:1 gives only the cDNA exons.4 Claim 1 is a claim on an isolated DNA sequence. Claim 2 claims a cDNA sequence.
The district court found that all the challenged claims were drawn to subject matter ineligible for patent under §101.5 This included several method claims. This case was then argued at the Federal Circuit in 2011, which largely reversed that decision, with the exception that the Federal Circuit affirmed the ineligibility of some of the method claims relating to “analyzing” and “comparing”.6 The Supreme Court vacated that judgement and remanded the case for review in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc.7(Mayo invalidated a method of administering a drug to a patient, monitoring the response, and adjusting the dosage on the grounds that it fell under the “law of nature” exception to subject matter eligibility.8) On remand, the Federal Circuit again held that both the isolated DNA and cDNA were patent eligible under §101. However, the court was split as to the rationale.
Judge Lourie found the isolated DNA to be eligible because the act of separating the sequence of nucleotides from the chromosome creates a nonnaturally occurring molecule.
Judge Moore found the isolated DNA to be eligible, not because of the molecular difference between the non-isolated and isolated forms of the sequence, but because of deference to decades of practice by the United States Patent Office.9
Judge Bryson found the isolated DNA to be ineligible, because the “naturally occurring genetic material thus has not been altered in a way that would matter under the standard set forth inChakrabarty”.10
All of the judges found cDNA to be patent eligible.
The question before the Supreme Court was whether or not each of these forms of isolated human DNA are patent eligible under Section 101 of the Patent Act.
Justice Thomas began by quoting the broad language of Section 101 of the Patent Act:
“Whoever invents or discovers any new and useful…composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”11
The opinion then provides a brief history of the three common law exceptions to this expansive subject matter eligibility: laws of nature, natural phenomena (or products of nature), and abstract ideas.
Thus, the §101 analysis turns whether or not isolated DNA and cDNA are products of nature.
We are reminded that “The rule against patents on naturally occurring things is not without limits, however, for “all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas,” and “too broad an interpretation of this exclusionary principle could eviscerate patent law.”12
The court looked to Chakrabarty13 for guidance on this issue. In Chakrabarty the court held that human-modified bacterium was patentable. The bacterium was found to have “markedly different characteristics from any found in nature”.14
The court acknowledges the effort and novelty of the discovery of the location of the BRCA1 and BRCA2 genes, but says, “but extensive effort alone is insufficient to satisfy the demands of 101.”15
The court also acknowledges that “isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule”.16 However, Myraid’s “claims are simply not expressed in terms of chemical composition” and instead, “the claims understandably focus on the genetic information encoded [in the genes]”.17
The court held that isolated DNA did not meet the test set out by Chakrabarty and is not eligible for patent. cDNA (at least the cDNA claimed by Myriad in this case) was found to result in “an exons-only molecule that is not naturally occurring”18 and is eligible for patent.
Information or Molecule?
The court acknowledges that Myriad created a non-naturally occurring molecule. Without further reasoning, that would be sufficient to render isolated DNA sequences patent-eligible. They are new compositions of matter that don’t fall under any of the common law exceptions. The court relied on the form of the claim to establish §101 invalidity. Justice Thomas wrote:
Myriad’s claims are simply 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.19
I find this a perplexing interpretation of the claim. What did the court believe was being claimed if not for the chemical composition? Did the court interpret this as a claim on the genetic information? If so, the subject matter does not even fall under the broad categories listed in §101. Information is not a “process, machine, manufacture, or composition of matter”.20 If the court believed what was being claimed was an information sequence, it could have rejected the claim for falling outside of §101.
Does this leave room for the draftman’s art to save such claims in the future? If Myriad had instead explicitly claimed the molecular form of the isolated DNA instead of just the information sequence, would it have been patentable? I doubt this is the case. The court didn’t only look to the form of the claim, but also the lack of reliance on the molecular difference. Further, as I explain below, I believe a pre-emption analysis would have also resulted in isolated DNA being found ineligible for patent, regardless of the form of the claim.
Also interesting was the complete lack of discussion of Mayo as part of this decision. Perhaps the court wanted to step back from its conflation of inventiveness with §101 analysis.
The court didn’t completely avoid this issue, however: “To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention”.21 §101 uses the language “[w]hoever invents or discovers…”.22 A §101 analysis does not depend upon the manner in which an individual happens upon their new and useful thing. This decision could have simply applied the natural phenomenon exception, without reference to inventiveness, a question covered by §102 and §103.23
An improved pre-emption analysis
If the court was making a pre-emption argument, it didn’t make it clearly. The pre-emption doctrine has been established in a line of cases involving §101 subject matter eligibility: Gottschalk v. Benson,24 Diamond v. Diehr,25 and Bilski v. Kappos.26
Benson considered a patent on a process for converting binary coded decimal into pure binary numbers.27 The concern was that “the patent would wholly pre-empt the mathematical formula and in practical effect would be a patent on the algorithm itself.28
Diehr considered the use of a well-known mathematical equation as part of a process for curing synthetic rubber. This patent was held to be valid, because while “[t]heir process admittedly employs a well-known mathematical equation, [...] they do not seek to preempt the use of that equation.”.29 Because the abstract idea (the mathematical equation) was not preempted, the patent was found to be drawn to eligible subject matter.
Bilski considered a business method for hedging risk.30 The concept of hedging was held to be an abstract idea, and “[a]llowing petitioners to patent risk hedging would pre-empt use of this approach in all fields, and would effectively grant a monopoly over an abstract idea.”31
The court doesn’t draw a clear line from the isolated DNA sequence to a product of nature that is being pre-empted. The isolated piece of DNA itself is not a product of nature (“isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule”32). It must be the information sequence in the isolated DNA that the court interprets as being a product of nature. That, however, relies on a awkward claim construction.
In my opinion, this case would have been better decided using the following pre-emption analysis instead of focusing on the similarity between the information content of the isolated and non-isolated DNA sequences. This allows a more intuitive construction of Myriad’s claims, while preserving the result that isolated DNA sequences are not patent eligible. A non-isolated DNA sequence is clearly a product of nature that is not patent eligible. However, “[i]solation is necessary to conduct genetic testing.”33 Thus, any claim on an isolated DNA sequence is “coextensive” with a product of nature, no matter if the isolated DNA itself is a product of nature. Allowing Myriad to patent an isolated DNA sequence would pre-empt use the non-isolated sequence, and would effectively grant a monopoly over a product of nature.
1Association for Molecular Pathology v. Myriad Genetics, Inc. 569 U.S. (slip op.) 2013, at footnote 2.
2Myraid Genetics, Inc. “17Q-linked breast and ovarian cancer susceptibility gene”. U.S. Patent 5747282.
4Association for Molecular Pathology v. Myriad Genetics, Inc. Supra note 1, at 5.
5Association for Molecular Pathology v. United States Patent and Trademark Office. Fed. Cir. Docket 2010-1406. 2012.
6Association for Molecular Pathology v. United States Patent and Trademark Office. 653 F.3d 1329. 2011.
7Mayo Collaborative Services v. Prometheus Laboratories, Inc. 566 U.S. (slip op.) 2012.
9Association for Molecular Pathology v. United States Patent and Trademark Office, supra note 5, at 14-20, Judge Moore’s opinion.
10Ibid., at 14, Judge Bryson’s opinion.
1135 U.S.C. §101.
12Association for Molecular Pathology v. Myriad Genetics, Inc. Supra note 1, at 11, quoting Mayo Collaborative Services v. Prometheus Laboratories, Inc. Supra note 7
13Diamond v. Chakrabarty. 447 U.S. 303. 1980.
14Ibid., at 310.
15Association for Molecular Pathology v. Myriad Genetics, Inc. Supra note 1, at 14.
16Ibid., at 14.
17Ibid., at 14.
18Ibid., at 16.
19Ibid., at 14-15.
20Supra note 11.
21Association for Molecular Pathology v. Myriad Genetics, Inc. Supra note 1, at 12.
22Supra note 11.
2335 U.S.C. §102; 35 U.S.C. §103.
24Gottschalk v. Benson. 409 U.S. 63. 1972.
25Diamond v. Diehr. 1981.
26Bilski v. Kappos. 561 U.S. (slip op.) 2010.
27Gottschalk v. Benson, supra note 24.
28Ibid., at 72.
29Diamond v. Diehr, supra note 25, at 586.
30Bilski v. Kappos, supra note 26.
31Ibid., at 15.
32Association for Molecular Pathology v. Myriad Genetics, Inc. Supra note 1, at 14.
33Ibid., at 7.