Certiorari Granted For A Second Time In Cancer Gene Patent Dispute

Certiorari Granted For A Second Time In Cancer Gene Patent Dispute

WASHINGTON, 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 Nov. 30 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.).

(Orders list available. Document #16-121217-001R.)

The high court granted a petition for certiorari submitted by the Association for Molecular Pathology, agreeing to address the question of whether human genes are patentable.

Products Of Nature

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.

In its 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 [2012]) [enhanced version available to lexis.com subscribers]. 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.


The Federal 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."

"They are 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."

The 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 not valid.

Unique, Fact-Bound

Myriad 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 [1980]) [enhanced version] and MedImmune, Inc. v. Genentech, Inc. (549 U.S. 118 [2007]) [enhanced version].

"The court's 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.

The 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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