After years of uncertainty about the patent eligibility of DNA under §101, the Supreme Court in Ass'n for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (U.S. June 13, 2013), has held that "a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated."1 However, complementary DNA ("cDNA"), which is synthetic DNA created from mRNA, is patent eligible when the cDNA sequence "is distinct from the DNA from which it was derived."2
In the mid-1990s, Myriad Genetics ("Myriad") discovered the location and sequence of two cancer susceptibility genes: BRCA1 and BRCA2. Mutations in these genes correlate strongly to breast and ovarian cancer. Myriad subsequently developed a test for detecting mutations in these genes and obtained patents covering isolated genomic BRCA DNA and synthetic BRCA cDNA. The Association for Molecular Pathology challenged several of Myriad's claims under §101, arguing that genomic DNA and cDNA were unpatentable natural products. The District Court found all of Myriad's asserted DNA claims invalid because they covered products of nature.3 But on appeal, the Federal Circuit reversed.4 The Supreme Court granted certiorari, vacated the judgment, and remanded the case in light of Mayo Collaborative Servs. v. Prometheus Labs., Inc., 130 S. Ct. 3543 (2010).5
On remand, the Federal Circuit again held that genomic DNA and cDNA are patent eligible under §101.6 However, the Federal Circuit's decision included divergent opinions from the three sitting judges, raising questions about the exact contours of DNA patent eligibility. Writing for the Court, Judge Lourie reasoned that "isolating a particular strand of DNA creates a nonnaturally occurring molecule" because "[i]solated DNA has been cleaved ( ... covalent bonds in its backbone [have been] chemically severed) or synthesized to consist of just a fraction of a naturally occurring DNA molecule."7 Judge Moore concurred that isolated DNA is patentable, but argued that "the chemical differences between genomic and isolated DNA (breaking the covalent bonds)" are not sufficient to hold that the claims to human genes are directed to patentable subject matter.8 However, she went on to explain that her position was based on the history of the Patent and Trademark Office's practice of granting such patents and on the reliance interests of patent holders. In dissent, Judge Bryson focused on the genetic information rather than the chemical structure, arguing that the "nucleotide sequences of the claimed molecules are the same as the nucleotide sequences found in naturally occurring human genes," and "structural similarity dwarfs the significance of the structural differences between isolated DNA and naturally occurring DNA."9 These divergent positions set the stage for the appeal to the High Court that followed.
A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated
The Supreme Court's holding rests on "an important implicit exception" to §101: "Laws of nature, natural phenomena, and abstract ideas are not patentable."10 In explaining that isolated BRCA genes are not new compositions of matter, the Court relied on its two previous decisions concerning "laws of nature" and "natural phenomena": Diamond v. Chakrabarty, 447 U.S. 303 (1980) and Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U. S. 127 (1948). In Chakrabarty, scientists added four plasmids to a bacterium that enabled it to break down crude oil. The Court held that the modified bacterium was patent eligible, because the patent claim was "not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter," and the bacterium was new "with markedly different characteristics from any found in nature."11 The Court reached a different conclusion in Funk Brothers, where the patent applicant claimed a mixture of naturally occurring strains of bacteria that can be used to help leguminous plants take nitrogen from the air and fix it in the soil. The Court held that the combination of the bacteria "was not patent eligible because the patent holder did not alter the bacteria in any way."12 Rather, the combination "fell squarely within the law of nature exception."13
The Supreme Court acknowledged that Myriad had made an "important and useful discovery" in identifying the precise location and genetic sequence of the BRCA1 and BRCA2 genes.14 But the Court nevertheless made clear that separating genes "from its surrounding genetic material is not an act of invention."15 Specifically dismissing Judge Lourie's argument that isolating genomic DNA creates a non-naturally occurring molecule, the Court observed that the claims at issue are "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."16 Instead, the Court insisted that the claims focus on the genetic information coded within the isolated genes. The Supreme Court also challenged Judge Moore's position that the PTO's past practice of awarding gene patents should be entitled to deference. The Court observed that Congress has not endorsed the views of the PTO in legislation and pointed out that the United States, as amicus curiae, argued against the PTO's practice.
cDNA is patent eligible when it is not "naturally occurring"
Using the same reasoning that found isolated DNA patent ineligible, the Supreme Court found that "exons-only" cDNA is not "naturally occurring,"17 and is therefore patent eligible. Although the cDNA is derived from genomic DNA, the Court observed that a "lab technician unquestionably creates something new when cDNA is made."18 However, the Court went out of its way to note that not all cDNA segments will be patent eligible: some cDNA segments are short, and "may have no intervening introns to remove" when cDNA is created.19 Because such short segments are "indistinguishable from natural DNA,"20 the Court explained, they are patent ineligible.
The Myriad decision's impact may be smaller than expected
Myriad will undoubtedly impact the pharmaceutical industry. Many pharmaceutical companies hold patents claiming isolated DNAs and many transactions depend on these patents. Just a few hours after the decision, the USPTO published its preliminary guidance relating to nucleic acid-related technology:
As of today, naturally occurring nucleic acids are not patent eligible merely because they have been isolated. Examiners should now reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not, as being ineligible subject matter under 35 U.S.C. § 101.21
Despite this apparently dim proclamation, the Myriad decision does not affect "nonnaturally" occurring cDNA claims, method claims directed toward cDNA or isolated genomic DNA, or "new applications of knowledge" concerning specific genes.22 The USPTO's abrupt policy announcement also stands in stark contrast to the current practice in Europe where "[a]n element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element."23 The legality in Europe of patenting isolated genetic materials from the human body has been confirmed by the highest court, the European Court of Justice, in 2001.24
Another issue regarding the Myriad decision is that biologics, or even certain small molecules, may be construed as "naturally occurring" molecules that are ineligible for patent protection. Only future cases will tell, but a broad invalidation of a wide variety of such claims seems unlikely, given the limited scope of the decision. Myriad's holding merely concerns the patentability of "naturally occurring DNA segment[s]"25 and does not lay down a categorical rule that any substance derived from naturally occurring molecules is patent ineligible. In fact, the patent eligibility of biologics often depends on the holding in Merck,26 in which the Court ruled that the patent eligibility turns on whether it is "a new thing commercially and therapeutically."27 The Supreme Court made no mention of Merck's holding in finding that Myriad's DNA claims were patent ineligible. However, the Court recognized the need for patent eligibility of a broader class of chemical entities - i.e., biologics and small molecules - when it emphasized how important the genetic sequence was to Myriad's claims:
If the patents depended upon the creation of a unique molecule, then a would-be infringer could arguably avoid at least Myriad's patent claims on entire genes (such as claims 1 and 2 of the '282 patent) by isolating a DNA sequence that included both the BRCA1 or BRCA2 gene and one additional nucleotide pair. Such a molecule would not be chemically identical to the molecule "invented" by Myriad. But Myriad obviously would resist that outcome because its claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.28
The Court's reasoning suggests that claims that depend not on the information carrying aspect of a given molecule, but on a molecule's "specific chemical composition", should be analyzed differently. Consequently, the Myriad decision should not significantly affect the patent eligibility of biologics or small molecules.
Recommendations for protecting biotechnology inventions
Going forward, inventors should consider the following four strategies. First, patent applications should provide a greater number of method claims, such as methods of use, treatment, diagnosis, and manufacture. Second, patent applications should exclude short cDNA segments that contain no splice site. Third, inventors can avoid patent eligibility problems by claiming host cells or expression vectors that contain a desired heterologous DNA sequence. Finally, inventors may choose to avoid the risks of disclosure by treating the fruits of research as trade secrets. The AIA's expanded protection for prior-users makes this option particularly attractive. Thus, many options still exist for protecting biotechnology inventions even though isolated genomic DNA is no longer patent eligible.