D.C. - (Mealey's) Less than a year after it returned to the Federal Circuit U.S. Court of
Appeals a patent lawsuit over diagnostic test kits for determining hereditary
risk of breast and ovarian cancer, the U.S. Supreme Court on Friday announced
it will again take up the case (The Association for Molecular Pathology et
al. v. Myriad Genetics Inc., No. 12-398, U.S. Sup.; See 8/20/12, Page 4).
(Orders list available. Document #16-121217-001R.)
court granted a petition for certiorari submitted by the Association for
Molecular Pathology, agreeing to address the question of whether human genes
In a divided
August 2012 ruling, the Federal Circuit reversed a determination by a judge in
the U.S. District Court for the Southern District of New York that composition
claims related to isolated DNA molecules are patent-ineligible products of
nature and scientific principles pursuant to Section 101 of the Patent
Act. At issue in the dispute are several patents owned by respondent
Myriad Genetics Inc. for diagnostic tests for mutations along BRCA1 and BRCA2 -
the genes responsible for most cases of hereditary breast and ovarian
cancer. The association and several other national organizations of
physicians and health professionals sued Myriad in 2009, alleging patent
invalidity under Section 101 of the Patent Act. Specifically, the
petitioners maintained that because the test kits cover products of nature,
laws of nature and abstract ideas, they are patent ineligible; in addition, the
petitioners asserted that the patents in suit preempt scientific inquiry and
medical care to the detriment of patient health and scientific advancement.
initial ruling in the dispute, issued in July 2011, the Federal Circuit deemed
one of the disputed patents - No. 5,747,282 - valid. After a motion for
rehearing was denied, the association sought certiorari before the
Supreme Court; in March 2012, the petition was granted but for the limited
purpose of vacating and remanding in light of Mayo Collaborative Servs. v. Prometheus Labs., Inc. (132 S. Ct.
1289  [enhanced version available to lexis.com subscribers]; See 12/19/11, Page 6). In that case, the Supreme
Court found that processes claimed by patents that recite laws of nature are
not themselves patentable absent the presence of "additional features" that
"transform" natural correlations into patentable applications.
Circuit held oral arguments in the remanded dispute in July, and in August it
again reversed the U.S. District Court for the Southern District of New York,
reaffirming its earlier ruling upholding the validity of certain challenged
composition claims and one method claim. Additionally, the appellate
panel found that isolated DNA molecules are "not found in nature."
obtained in the laboratory and are man-made, the product of human ingenuity,"
the panel majority said. "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. For example, virtually every medicine utilized by today's medical
practitioners, and every manufactured plastic product, is either synthesized
from natural materials (most often petroleum fractions) or derived from natural
plant materials. But, as such, they are different from natural materials,
even if they are ultimately derived from them. The same is true of
isolated DNA molecules."
association filed a second petition for certiorari which largely
mirrored its first, arguing that Supreme Court review is needed to resolve
vastly conflicting interpretations of the scope of Section 101 as it applies to
compositions of matter and DNA. Additionally, the association noted that
the instant dispute is the only dispute fully litigated before the Federal
Circuit in which the only claim asserted arises under Section 101 and that
longstanding Supreme Court precedent counsels that patents on isolated DNA are
responded on Oct. 31, telling the high court that "the Federal Circuit has
twice correctly applied § 101 and this Court's decisions in" Mayo,
Diamond v. Chakrabarty (447 U.S. 303 ) [enhanced version available to lexis.com subscribers] and MedImmune, Inc. v. Genentech, Inc. (549 U.S.
118  [enhanced version available to lexis.com subscribers]; See 1/22/07, Page 5).
decision is also consistent with the policy goal of the Patent Act, the
considered judgment of the PTO, and longstanding practice. Further, the
issues presented are unique and fact-bound, and in order to even reach the §
101 issues, the Court would have to take up antecedent jurisdictional questions
and preempt percolation in the Federal Circuit, the appellate court statutorily
vested with unifying and clarifying U.S. patent law. The Court should
deny the petition," Myriad added.
In granting certiorari,
the Supreme Court indicated that it will address only the first question raised
by the association - whether human genes are patentable. The association
presented the high court with two additional questions that will not be
presented during oral argument.
petitioners are represented by Christopher A. Hansen, Steven R. Shapiro, Sandra
S. Park, Aden J. Fine and Lenora M. Lapidus of American Civil Liberties Union
Foundation in New York and Daniel B. Ravicher and Sabrina Y. Hassan of Public
Patent Foundation, Benjamin N. Cardozo School of Law, in New York.
Gregory A. Castanias and Jennifer L. Swize of Jones Day in Washington and Brian
M. Poissant and Laura A. Coruzzi of Jones Day in New York represent Myriad.
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