Supreme Court Addresses Product of Nature Doctrine Relating to Gene PatentsJune 13, 2013

The Supreme Court today handed down its decision in Association for Molecular Pathology v. Myriad Genetics, Inc. The Court held that isolated DNA is a product of nature and not patent eligible merely because it has been isolated, but that complementary DNA (cDNA) is patent eligible because it is not naturally occurring.

The Court limited its holding to the patentability of isolated genes and cDNA, concluding that DNA sequences that do not exist in nature (i.e. cDNA) are patent eligible under § 101, but that merely isolating a naturally occurring gene from the surrounding genetic material in not sufficient to render the gene patent-eligible. The Court also took care not to further limit patent-eligibility for innovative methods for manipulating genes, uses of newly discovered genes, or DNA molecules with altered sequences.

Myriad discovered the location and sequence of two genes—BRCA1 and 2. Mutations in these genes are linked to increased risk of developing breast and ovarian cancer. Myriad obtained several patents, which include numerous composition claims that cover the BRCA1 and BRCA2 genes, both as isolated DNA (i.e. the genetic sequence as it otherwise exists in the cell, but excised from the rest of the genome) and as cDNA (i.e. only the coding regions of the genomic DNA sequence; all non-coding regions have been removed). After the patents were granted, Myriad filed suit against a number entities that performed BRCA testing alleging infringement of the patents.

The case was originally filed in the Southern District of New York by a group of researcher, physicians, advocacy groups, and patients seeking a declaratory judgment that the Myriad patents were invalid under 35 U.S.C. § 101 because the claimed subject matter was ineligible for patent protection. The district court granted summary judgment to the declaratory judgment plaintiffs, holding the composition claims of the Myriad patents invalid because they covered products of nature. Myriad appealed to the Federal Circuit, which reversed the district court. The Supreme Court granted certiorari, but vacated the Federal Circuit decision and remanded the case to the Federal Circuit–without opinion–in light of the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories. On remand, the Federal Circuit held that Myriad’s claims to both isolated DNA and cDNA were patent-eligible, and the Supreme Court again granted certiorari.

In its decision, the Supreme Court affirmed in part and reversed in part the Federal Circuit. The Court separately addressed the patentability of isolated, naturally occurring DNA molecules and synthetically created cDNA. The Court framed its decision in terms of the “important implicit exception[s]” to patentability under § 101—laws of nature, natural phenomena, and abstract ideas. With respect to the claimed isolated DNA molecules, the Court concluded that Myriad did not create anything, but rather merely separated an important and useful gene from its surrounding genetic material, which did not constitute an act of invention. Because the location and order of the nucleotides existed in nature before Myriad found and separated them, and Myriad had not created or altered the genetic structure of the DNA, the claims to the compositions did not meet the requirements for patent-eligibility under § 101.

With respect to cDNA, the Court concluded that it did not present the same obstacles patentability as naturally occurring, isolated DNA. Because cDNA molecules do not exist in nature—due to the absence of non-coding intron regions, compared to the genetic DNA sequence—they are not products of nature, and constitute patent-eligible subject matter under § 101.

Ultimately, the Court concluded that Myriad is entitled to the exclusive right to synthetically create BRCA cDNA, but not the exclusive right to isolate an individual’s BRCA genes. However, the Court took special care to point out the limits of its decision. First, the Court emphasized that its decision did not reach any method claims, since those were not before the Court on appeal, but stated that the processes used by Myriad to isolate and generate the claimed DNA were well understood by geneticists at the time. Presumably, this would run afoul of the Court’s holding in Mayo Collaborative Services v. Prometheus Laboratories. However, the Court did note that Myriad “could possibly have sought a method patent” for some innovative method of manipulating genes, had it created any.

The Court also called attention to the fact that its decision in this case did not involve the patent-eligibility of new applications of genes, leaving open the possibility of protection for various uses of newly discovered genes or other DNA sequences, such as those claimed in the unchallenged claims of Myriad’s patents. These claims include kits for detecting mutations, methods for screening, and nucleic acid probes specifically hybridizable to mutated BRCA. Finally, the Court stated that its opinion did not address “DNA in which the order of the naturally occurring nucleotides has been altered,” concluding that this type of alteration constitutes a different inquiry.

The Court held “that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material,” but that DNA sequences that do not exist in nature (i.e. cDNA) are patent eligible under § 101, and left open the possibility of patent-eligibility for innovative methods for manipulating genes, uses of newly discovered genes, and DNA molecules with altered sequences. This case helps to define the boundaries of the Product of Nature doctrine after Mayo Collaborative Services v. Prometheus Laboratories, and in particular with respect to gene patents, but leaves many issues regarding the scope of the Product of Nature doctrine unresolved.

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