08/12/13

SCOTUS on Myriad: Isolated DNA Ineligible, cDNA Eligible

Category: 101 
  
 
By: Jesus Hernandez, Blog Editor/Contributor  
 
TitleAsso. for Molecular Pathology v. Myriad Genetics, Inc., No. 12–398 (June 13, 2013).
Issue“This case […] requires us to resolve whether a naturally occurring segment of deoxyribonucleic acid (DNA) is patent eligible under 35 U. S. C. §101 by virtue of its isolation from the rest of the human genome. We also address the patent eligibility of synthetically created DNA known as complementary DNA (cDNA), which contains the same protein-coding information found in a segment of natural DNA but omits portions within the DNA segment that do not code for proteins.” Myriad, at *1.
Holding“[W]e hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring.” Myriad, at *1.
 


Procedural History"The District Court […] granted summary judgment to petitioners on the composition claims at issue in this case based on its conclusion that Myriad’s claims, including claims related to cDNA, were invalid because they covered products of nature. 702 F. Supp. 2d, at 220– 237. The Federal Circuit reversed […] and this Court granted the petition for certiorari, vacated the judgment, and remanded the case in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___ (2012). […] On remand, the Federal Circuit affirmed the District Court in part and reversed in part, with each member of the panel writing separately. All three judges agreed that only petitioner Ostrer had standing. […] With respect to the merits, the court held that both isolated DNA and cDNA were patent eligible under §101.” Myriad, at *7-8.
 
 
 
 
Legal Reasoning
On Isolated DNA Sequences
Claim 1"1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2." U.S. Patent No. 5,747,282 (Claim 1).
Claim 1 Interpretation"The first claim asserts a patent on '[a]n isolated DNA coding for a BRCA1 polypeptide,' which has 'the amino acid sequence set forth in SEQ ID NO:2.' App. 822. SEQ ID NO:2 sets forth a list of 1,863 amino acids that the typical BRCA1 gene encodes. See id., at 785–790. Put differently, claim 1 asserts a patent claim on the DNA code that tells a cell to produce the string of BRCA1 amino acids listed in SEQ ID NO:2." Myriad, at *5.
Ineligibility of Isolated DNA Sequences
Distinction from Chakrabarty“The Chakrabarty bacterium was new ‘with markedly different characteristics from any found in nature,’ 447 U. S., at 310, due to the additional plasmids and resultant ‘capacity for degrading oil.’ Id., at 305, n. 1. In this case, by contrast, Myriad did not create anything. 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. Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry.” Myriad, * 12.

Broad Claim Language“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.“ Myriad, * 12.
No PTO Deference“Finally, Myriad argues that the PTO’s past practice of awarding gene patents is entitled to deference, citing J. E. M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U. S. 124 (2001). See Brief for Respondents 35–39, 49–50. We disagree. J. E. M. held that new plant breeds were eligible for utility patents under §101 notwithstanding separate statutes providing special protections for plants […] While Myriad relies on Judge Moore’s view that Congress endorsed the PTO’s position in a single sentence in the Consolidated Appropriations Act of 2004, see Brief for Respondents 31, n. 8; 689 F. 3d, at 1346, that Act does not even mention genes, much less isolated DNA. §634, 118 Stat. 101 […] Further undercutting the PTO’s practice, the United States argued in the Federal Circuit and in this Court that isolated DNA was not patent eligible under §101, Brief for United States as Amicus Curiae 20–33, and that the PTO’s practice was not 'a sufficient reason to hold that isolated DNA is patent-eligible.' Id., at 26. See also id., at 28–29. These concessions weigh against deferring to the PTO’s determination.” Myriad, at * 15-16.
On cDNA
Claim 2"2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1." U.S. Patent No. 5,747,282 (Claim 2).
Claim 2 Interpretation"Claim 2 of the ’282 patent operates similarly. It claims '[t]he isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.' Id., at 822. Like SEQ ID NO:2, SEQ ID NO:1 sets forth a long list of data, in this instance the sequence of cDNA that codes for the BRCA1 amino acids listed in claim 1. Importantly, SEQ ID NO:1 lists only the cDNA exons in the BRCA1 gene, rather than a full DNA sequence containing both exons and introns. See id., at 779 (stating that SEQ ID NO:1’s 'MOLECULE TYPE:' is 'cDNA')." Myriad, at *5-6.
Eligiblity of cDNA"cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments. As already explained, creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring. […] cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a “product of nature” and is patent eligible under §101 […]" Myriad, at *16-17.
Caveat
"It is important to note what is not implicated by this decision. First, there are no method claims before this Court. […] Similarly, this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. […] Nor do we consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. Scientific alteration of the genetic code presents a different inquiry, and we express no opinion about the application of §101 to such endeavors. We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material." Myriad, at *17-18.
 
 
"JUSTICE SCALIA, concurring in part and concurring in the judgment." Myriad, Scalia Op. at *1.
"I join the judgment of the Court, and all of its opinion except Part I–A and some portions of the rest of the opinion going into fine details of molecular biology. I am unable to affirm those details on my own knowledge or even my own belief. It suffices for me to affirm, having studied the opinions below and the expert briefs presented here, that the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state; and that complementary DNA (cDNA) is a synthetic creation not normally present in nature." Myriad, Scalia Op. at *1.
 
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