On November 30, 2012, the Supreme Court granted certiorari–in what portends to be one of the most
impactful decisions in patent law history–to end the “gene patenting” debate, an issue that lower courts have
measured over the past three years in Association for Molecular Pathology v. Myriad Genetics, Inc. et al.
(informally styled as the “Myriad gene patenting” case). The sole question before the Court concerns whether
human genes qualify as patentable subject matter pursuant to 35 U.S.C. § 101 (“§ 101”), which recites that
“any new and useful process, machine, manufacture, or composition of matter, or any new and useful
improvement thereof …” is eligible for patent protection.
Patent eligible subject matter, moreover, has been apophatically defined by the Supreme Court in previous
decades. See e.g., Diamond v. Diehr, 450 U.S. 175 (1981). These “exceptions” to patent eligibility, i.e., abstract
ideas, laws of nature, and natural phenomena (also referred to as the “products of nature” exception), are
coterminous with the statutory categories outlined above, but serve as “carve-outs” which proscribe patent
Within this framework, it is not surprising that the Supreme Court decided to revisit the Myriad gene
patenting question at least in view of their recent docket. While the issues in Myriad were taking shape in a
New York district court, and later at the Federal Circuit, the Supreme Court respectively granted certiorari in
Bilski v. Kappos, 130 S. Ct. 3218 (2010) (holding that “purely abstract” business method patent claims, which
pose no meaningful limits, are precluded from patent eligibility) and Mayo Collaborative Services v. Prometheus
Laboratories, Inc., 132 S. Ct. 1289 (2012) (holding that naturally occurring pharmacological correlations are
not eligible for patent protection) to clarify the scope of the exceptions concerning abstract ideas and laws of
The Supreme Court therefore appears to be “rounding out” the patent eligibility exceptions with Myriad, at
least insofar as the “products of nature” carve-out could potentially encompass human genes. While we hesitate
to prospectively opine on any particular aspect of this case, it is relevant to note that recent Supreme Court
decisions regarding the exceptions to §101 have significantly circumscribed the scope of patent eligibility, as
In this respect, the question presented to the Supreme Court (or more appropriately, the issue selected by the
Court) for review may impart the fate of Myriad. To this end, in their brief in opposition to certiorari, Myriad
Genetics, Inc., the corporate owner of patents claiming isolated DNA sequences that can be used for identifying an individual’s susceptibility to breast and/or ovarian cancer, asserted that the proper question for review concerned whether isolated DNA molecules–identified and defined by human inventors–were patent eligible. Myriad’s position in this regard was expected in view of the Federal Circuit’s August 16, 2012 decision, which recited that:
The isolated DNA molecules before us are not found in nature. They are
obtained in the laboratory and are man-made, the product of human ingenuity.
While they are prepared from products of nature, so is every other composition
of matter. All new chemical or biological molecules, whether made by synthesis
or decomposition, are made from natural materials.
Ass’n for Molecular Pathology v. USPTO, 689 F.3d 1303, 1325 (Fed. Cir. 2012).
In contrast, but predictable nonetheless, the petitioner’s framed a broader and more provocative question, as
entitled above. By accepting the petitioner’s query-based premise for review, and apparently conflating in vitro
results (isolated DNA) with in vivo manifestations (human genes), the Supreme Court seems to have set the
stage for an paradigmatic shift with respect to defining the limits of certain DNA-based inventions. Indeed, if
the Court determines that isolated DNA molecules are tantamount to genetic products of nature, many, if not
all, claims in the more than 30,000 issued patents directed to such subject matter will be at risk.
Should the Court venture down that road, however, there is a possible silver lining at least with respect to issues
regarding the eligibility of cDNA, modified nucleotide sequences, and non-obvious variants thereof, all of
which were favorably discussed by the lower courts, albeit in a tangential context. At a minimum, it can be said
with certainty that the Federal Circuit’s previous determinations in Myriad (see Phillips Lytle LLP Client Alert:
Federal Circuit Renders Decision in “Gene Patenting” Case, published August, 2012), which confirmed subject
matter eligibility for isolated DNA sequences, will be refitted in accordance with the Supreme Court’s recent
desire to engage in § 101 jurisprudence.
Likewise, because the Court did not grant certiorari to hear the remaining questions presented on appeal,
which concerned screening methods using genetically transformed cells and issues surrounding a plaintiff ’s
standing, it appears that the law is settled with respect to these concerns, at least for the foreseeable future.
Finally, we may not have to wait long for resolution of the gene patenting question. Many in the patent law
community believe that the Supreme Court will provided a decision in Myriad before the end of the spring
term, in June. Stay tuned.
If you have any questions, or for additional information, please contact Randy V. Clower, Ph.D., J.D. at (716)
847-5421 or email@example.com.