• Myriad Genetics: The Supreme Court Rules That Isolated DNA Is Not Patent Eligible
  • July 1, 2013 | Authors: Amy DeCloux; Kathleen Madden Williams
  • Law Firm: Sunstein Kann Murphy & Timbers LLP - Boston Office
  • “The very first official thing I did in my administration - and it was on the very first day of it, too - was to start a patent office; for I knew that a country without a patent office and good patent laws is just a crab, and couldn’t travel any way but sideways or backways.”

    Mark Twain, A Connecticut Yankee in King Arthur’s Court

    The Patent Act of 1793, authored by Thomas Jefferson and clearly a favorite of Mark Twain’s, defined patent-eligible subject matter as “any new and useful art, machine, manufacture, or composition of matter, or any new useful improvement [thereof].” The Act embodied Jefferson’s philosophy that “ingenuity should receive a liberal encouragement.”

    It is upon Jefferson’s carefully crafted definition of patent-eligible subject matter (codified in §101 of the Patent Act) that the U.S. Supreme Court rested its considerable weight in its ongoing effort to define patent-eligible subject matter.

    The court’s long-anticipated decision in Association of Molecular Pathology. v. Myriad Genetics Inc., published on June 13, unanimously supported the premise that a gene in its isolated form cannot be the subject of a U.S. patent:

    “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.” (emphasis added).

    The word “merely” is a key to understanding the overall effect-and narrowness-of the decision.

    The Myriad litigation was begun by a group of plaintiffs, including the American Civil Liberties Union, who challenged Myriad’s patents by asserting isolated DNA to be a product of nature and thus not patent-eligible subject matter. The plaintiffs sought to invalidate all existing gene patents, to prevent the future issuance of patents claiming human genes, and thereby to eliminate barriers to competition for genetic tests.

    While the ACLU achieved its nominal objectives, the Myriad decision should not significantly impede patent protection of genetic tests or commercialization of discoveries in human diagnostics and personalized medicine.

    The science of predicting or diagnosing human disease has moved towards identifying mutation in many genes, no one of which on its own is predictive or dispositive. Thus, new diagnostics have moved beyond the isolation of individual genes and incorporate inventions that involve combinations of gene segments, where each gene segment has a naturally occurring sequence but the combination of sequences does not occur in nature.

    In Myriad, the court made two key observations, neither of which reflects the realities of scientific discovery: (1) the apparent ease (per the court) of identifying a gene such as BRCA1 or 2 and separating it from the remaining approximately 20,000 genes in a human cell genome, and (2) the apparent identity of a “natural” gene and one in “isolated” form as to their informational content.

    The court acknowledged that Myriad discovered an important and useful gene, but it trivialized the way in which Myriad found the BRCA1 and BRCA2 genes and genetic mutations, characterizing the discovery process as “well understood, widely used, and fairly uniform” at the time of Myriad’s patents:

    “The location and order of the nucleotides existed in nature before Myriad found them. . . Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13. The question is whether this renders the genes patentable.”

    The Myriad patent’s specification described the genes’ isolation process in detail, emphasizing its extensive and iterative nature. The court implied that it was obvious to identify the chromosomal location of the BRCA1 and BRCA2 genes, given both the keen interest in identifying and isolating gene mutations at that time and the reliance on known scientific techniques to isolate the genes. The identification and isolation of these genes do not add up to a “true discovery,” in the court’s view.

    Also central to the decision was that Myriad “did not create or alter the genetic information encoded in the BRCA1 and BRCA2 genes” and “did not alter the genetic structure of DNA.” It follows that the severing of chemical bonds that naturally hold genes together is an insufficient structural change to confer patent eligibility.

    The lower court had taken the opposite view of this consideration, concluding that the fact that chemical bonds are different in isolated DNA than they are in naturally occurring DNA supports the patent eligibility of isolated DNA. The Federal Circuit had reasoned:

    “The claimed isolated DNA molecules are distinct from their natural existence as portions of larger entities, and their informational content is irrelevant to that fact. We recognize that biologists may think of molecules in terms of their uses, but genes are in fact materials having a chemical nature.”

    In contrast, the Supreme Court believed that, because the information content of naturally occurring DNA is identical to that of the isolated DNA, patent eligibility is precluded.

    A gene’s nucleotide sequence[1], said the court, is critical to its function of encoding a gene product, and the isolated gene contains the identical nucleotide sequence as naturally occurring DNA. The court dismissed as inconsequential the structural distinction that the isolated gene was not chemically linked to the remaining ~20,000 genes of the human genome.[2]

    The Myriad ruling suggests that a full gene sequence, cut out of a cell’s complete gene set, cannot be the subject of a patent, but leaves open the prospect of patent eligibility for other forms and uses of DNA. As we predicted after the oral argument in April, the court has, rather inexplicably, justified patent eligibility of cDNA, which is synthetically produced using trivial and common synthetic processes.

    This result is puzzling because, with respect to their information content, BRCA1 and BRCA2 cDNAs are essentially direct offspring DNAs of the naturally occurring RNA products of the BRCA1 and 2 parent genes, containing all critical sequence information to encode the gene product. The court chose to ignore this inconsistency when it relied on the sequence information content of the BRCA1 and 2 isolated DNAs as the basis for precluding their patent eligibility[3].

    While the court hinted that other forms of DNA may be patent-eligible, its reasoning left little room for drafting claims to “an isolated gene” which recites an entire gene sequence. At the same time, the court reiterated the principle of preserving the “delicate balance of creating incentives that lead to creation, invention, and discovery and impeding the flow of information to the public.”

    How far does the Myriad ruling reach? Not very far, as diagnostics pertaining to genetics and human diseases has reached a level of sophistication which involves analyzing tens, hundreds, if not thousands of gene mutations at once. As a consequence, holding a patent on a single gene is unlikely to preclude competitors from commercializing diagnostics aimed at hundreds of genes, only one of which is that single gene.

    In addition to specifying that cDNA is patent-eligible, the court left open the patent eligibility of almost any other form of DNA, including (i) isolated DNA where the claim language is expressed in terms of chemical composition, (ii) DNA having structure and/or sequence changes, or (iii) patents on new applications of an isolated gene.

    [1] This sequence is known to scientists as its primary structure.

    [2] Though not mentioned in the decision, structural differences which characterize a gene found in nature also include distinct secondary and tertiary structures, as well as many proteins that are required to maintain the natural gene’s structure and are critical to its function. All of these are inherently absent in an isolated gene, and the court therefore implies that those structural differences are also inconsequential to determine patent eligibility.

    [3] A cell produces (and thus contains) a naturally occurring nucleic acid (RNA) having a nucleotide sequence identical to the gene’s critical coding sequences. A cDNA is an identical nucleotide-sequence copy of a naturally occurring RNA, yet, in the court’s view, it is patent-eligible despite possessing the same critical information defining its gene product.