The United States Supreme Court, on April 15, heard oral argument in Association for Molecular Pathology v. Myriad Genetics, No. 12-398. This case is to decide a profoundly important question, namely whether human genes are patent-eligible.

Background

Myriad’s composition claims generally relate to DNA isolated from the genes BRCA 1 and BRCA 2. Mutations in these genes create a hereditary predisposition to developing breast and ovarian cancers. Myriad uses some of the claimed DNA sequences as part of its diagnostic testing services to determine a patient’s risk for developing these hereditary breast and ovarian cancers.

A panel of the Federal Circuit has twice held, 2-1, that composition claims to isolated natural DNA molecules are patent-eligible subject matter, and twice held unanimously that composition claims to cDNA molecules are patent-eligible. The Supreme Court limited the issue before it to the patent-eligibility of “human genes.” Specifically, the Court is considering the patent-eligibility of the isolated natural DNA sequences and cDNA sequences claimed by Myriad. By way of background, the isolated natural DNA sequence contains the natural sequence of the DNA of a gene as it exists in humans, isolated from the chromosome. cDNA, however, is not the same as the natural sequence. While isolated natural DNA contains sequences that code for proteins (exons) intermixed with non-coding domains (introns), cDNA contains the coding exons without the introns. Myriad’s claims encompass both isolated natural DNA sequences and cDNA sequences of BRCA1 and BRCA2.

The Oral Argument

AMP’s Argument

Plaintiff-Respondent Association for Molecular Pathology (AMP) argued that isolated natural DNA and cDNA are not patent-eligible because they are products of nature. In its view, only recombinant DNA—DNA whose sequence is decided by scientists— is patentable.

Justices Kagan, Scalia and Kennedy questioned AMP’s counsel about the incentives to innovate and invest in the expensive and time-consuming process of isolating genes. AMP’s counsel referred to scientists’ general desire to learn and create as providing such incentive.

AMP faced substantial questioning about cDNA. Conceding that cDNA does not exist in nature, AMP nevertheless argued that cDNA is not patentable because it is a product of nature. AMP argued that “[t]he question is whether there was a human invention involved, whether it is markedly different from what is found in nature.”

The Justices nonetheless generally seemed disposed in favor of the patent-eligibility of cDNA. For example, although Justice Sotomayor seemed receptive to AMP’s arguments about the unpatentability of isolated natural DNA sequences, she seemed disinclined to accept that cDNA also was unpatentable, and at one point commented that “that whole gene without the introns [cDNA] is just not found in nature.”

The Solicitor General’s Argument

The Solicitor General argued for the government as amicus in support of neither party. The government argued that isolated natural DNA sequences are not patentable, but “cDNA is patent eligible because we think, unlike the isolated DNA which is just taken from your body, cDNA is an artificial creation in the laboratory that doesn’t correspond to anything in your body.” The government acknowledged that it had changed its position and was advocating a different position from that of the USPTO, which had been granting gene patents for over 30 years.

Myriad’s Argument

Myriad argued that both isolated natural DNA and cDNA are patentable, because it takes human ingenuity and innovation to discover and isolate them. Myriad’s counsel relied heavily on the existence of settled expectations of persons in this field, given that it was now 33 years after Diamond v. Chakrabarty, 31 years after the first isolated gene molecule patents issued, and 12 years after the USPTO issued its Utility Guidelines confirming the patent-eligibility of isolated gene molecules (and also 16 years since Myriad's patents began to issue).

Myriad also argued that the USPTO was entitled to deference, despite the change of position expressed by the government in its appeal brief.

The Justices seemed to have difficulty distinguishing isolated natural DNA from analogous examples in nature, such as a seemingly patent-ineligible new plant isolated from the Amazon, or a chromosome, or a portion of an organ. For example, Justice Sotomayor asked “I mean, if you cut off a piece of the whole in the kidney or liver, you're saying that's not patentable, but you take a gene and snip off a piece, that is? What's the difference between the two?” Myriad’s counsel argued that obviousness is a better doctrine to disallow such a claim.

The Justices again asked about incentives. Justice Kennedy asked: “If we were to accept the Government's position that the DNA is not patentable but the cDNA is, would that give the industry sufficient protection for innovation and research? And if not, why not?” Myriad’s counsel indicated that the line between the two might not be as clear as was suggested, and that recognizing a legal distinction between them could create another litigable area.

Conclusion

The Justices seemed skeptical about the patent-eligibility of isolated natural DNA but less skeptical about the patent-eligibility of cDNA. The bar now awaits the opinion of the Court to see whether it will overturn the USPTO’s 30-year practice of allowing claims to human gene patents.