On June 13, the United States Supreme Court issued its decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. ___ (2013). The case concerned whether claims drawn to isolated DNA and cDNA were patent eligible subject matter under 35 U.S.C. § 101. The Supreme Court held that isolated DNA was not patent eligible, but that cDNA may be patent eligible.

In the early 1990s, Myriad identified the location and sequence of two genes, BRCA1 and BRCA2. Certain mutations in these genes are associated with a dramatic increase in a person’s risk of developing breast or ovarian cancer. Following the identification of these genes, Myriad developed diagnostic tests for determining whether an individual has mutations in these genes that are associated with an increased risk of cancer.

Myriad sought and obtained a number of patents related to BRCA1, BRCA2 and the diagnostic tests for detecting mutations associated with these genes. At issue before the Supreme Court were Myriad’s patent claims to isolated DNA and cDNA. A representative isolated DNA claim from Myriad’s patents reads: “An isolated DNA coding for a BRCA1 polypeptide,” which has “the amino acid sequence set forth in SEQ ID NO:2.” SEQ ID NO:2 is the amino acid sequence that is encoded by the BRCA1 gene. A representative cDNA claim from Myriad’s patents reads: “An isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.” SEQ ID NO:1 set forth the nucleotide sequence of the BRCA1 DNA coding region. In other words, the cDNA sequence of BRCA1, which contains only the coding exons (the non-coding introns are excluded). 

The Federal Circuit held that isolated DNA and cDNA were patent eligible subject matter under § 101. While all three judges held that cDNA was patent-eligible subject matter, only two of the judges found that isolated DNA was patent eligible. Judge Lourie found that the severing of the chemical bonds to isolate DNA created a non-naturally occurring molecule that was patent-eligible. Judge Moore concurred with Judge Lourie, and additionally relied on the United States Patent and Trademark Office’s (“PTO”) practice of granting patents on isolated DNA and the reliance of patent holders on the PTO’s practice. Judge Bryson concurred with Judge Lourie and dissented in part. Judge Bryson concluded that isolated DNA was not patent eligible because the “nucleotide sequences of the claimed molecules are the same as the nucleotide sequence found in naturally occurring human genes.”

The Supreme Court affirmed in part and reversed in part the Federal Circuit’s decision, holding that isolated DNA was not patent eligible subject matter, but that cDNA may be patent eligible subject matter. The Supreme Court first noted that it was undisputed that, with respect to the isolated DNA, “Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes.” Based on this fact, the Court distinguished Diamond v. Chakrabarty, 447 U.S. 3030 (1980), where scientists added four plasmids to a bacterium that enabled the bacterium to break down crude oil. In Chakrabarty, the Court found the modified bacterium patentable because the bacterium did not occur in nature. In distinguishing Chakrabarty, the Court noted that Myriad’s contribution was that “it found an important and useful gene” by pinpointing the exact location of the gene and identifying its genetic sequence. However, because the location and order of the nucleotides existed in nature before Myriad found them, Myriad’s patent claims to isolated DNA sequences were invalid.

The Supreme Court rejected the Federal Circuit’s reasoning that the isolated DNA was patent eligible because isolating the DNA severs chemical bonds thereby creating a non-natural substance. The Court reasoned that Myriad’s claims were not based on chemical composition or dependent on the creation of a new molecule. Rather, Myriad’s claims were based on the information encoded in the BRCA1 and BRCA 2 genes. As such, the Court did not find the breaking of chemical bonds sufficient to confer patent eligibility.

Additionally, the Supreme Court rejected the argument that the PTO’s practice of granting patents on isolated DNA was entitled to deference. The Court distinguished J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U.S. 124 (2001), because in that case, Congress had endorsed the PTO position of granting patents on new plant breeds in a subsequent Patent Act amendment. Here, in contrast, Congress has not endorsed the PTO’s practice of granting patents on isolated DNA sequences. Further, the United States had submitted an amicus curiae brief arguing that isolated DNA was not patent eligible under § 101. 

With respect to cDNA, however, the Supreme Court did not find the same obstacles to patentability. The Court emphasized that cDNA was not naturally occurring. Unlike the naturally-occurring DNA sequence, the cDNA sequence omits the non-coding introns. The Association for Molecular Pathology agreed that the cDNA sequence differed from the naturally occurring sequence, but argued that the cDNA was nonetheless patent ineligible because nature dictated the sequence. The Supreme Court found this argument unpersuasive because “the lab technician unquestionably creates something new when cDNA is made.” Because cDNA is not a “product of nature,” the Supreme Court held that it was patent eligible subject matter under § 101.

Although the Myriad decision answered the narrow question of whether isolated DNA sequences are patent eligible subject matter under § 101, the decision left many questions unanswered. As a practical consideration, how secure is patent protection on cDNA? Are cDNAs nonetheless obvious? Will patent protection be better afforded through claims to the manipulation of genes or applications of knowledge about genes? The Supreme Court pointedly noted that its opinion did not address method claims or new applications of knowledge about genes. Additionally, in a footnote, the Court stated that “The possibility that an unusual and rare phenomenon might randomly create a molecule similar to one created synthetically through human ingenuity does not render a composition of matter unpatentable.” This begs the question of how “unusual and rare” must a natural phenomenon be for a composition of matter to still be patent eligible? Finally, how far will the Myriad decision extend? Will Myriad be extended to other isolated and purified natural products? Will the Court’s decision, which addressed the question “Are human genes patentable?”, be extended to other organisms?