Academic journal article American University Law Review

Take off Your Genes and Let the Doctor Have a Look: Why the Mayo and Myriad Decisions Have Invalidated Method Claims for Genetic Diagnostic Testing

Academic journal article American University Law Review

Take off Your Genes and Let the Doctor Have a Look: Why the Mayo and Myriad Decisions Have Invalidated Method Claims for Genetic Diagnostic Testing

Article excerpt

Ass'n for Molecular Pathology v. U.S. Patent & Trade Office sent shockwaves through the legal community, when the U.S. District Court for the Southern District of New York rejected a series of patents held by Myriad Genetics, Inc. The court invalidated all of Myriad's compositional patents for human genes and its method patents for diagnosing genetic predispositions to breast cancer. While commentators have discussed the ethical implications of allowing patent rights to human genes in great detail, the Court's ruling on Myriad's method claims went by comparatively unnoticed.

The ability to test a patient's genetic profile for predisposition to cancer and other diseases is an incredible achievement in the field of personalized medicine. Whether these tests deserve patent protection is a hotly debated issue that involves weighing the interests of both incentivizing research and making these tests available to the general public. This Comment analyzes the legal framework established by the Supreme Court and U.S. Court of Appeals for the Federal Circuit to decide patent eligibility for genetic diagnostic tests. It concludes that, while the world was spellbound by the ethical quandary of compositional claims on human genes, the recent Supreme Court and Federal Circuit decisions have surreptitiously eliminated genetic diagnostic tests as patentable subject matter under § 101 of the United States Patent Act.

"We are on the leading edge of a true revolution in medicine, one that promises to transform the traditional 'one size fits all' approach into a much more powerful strategy that considers each individual as unique and as having special characteristics that should guide an approach to staying healthy."1

INTRODUCTION

On March 3, 1986, the U.S. Department of Energy announced the Human Genome Project: an unparalleled endeavor to decode the entire human genome and one day develop "new diagnostic, preventative and therapeutic tools."2 Nearly thirty years later, humanity has finally begun to harvest the fruits of this mammoth endeavor.3 New technology, made possible by genetic research, allows doctors to use a patient's unique genetic profile to prevent, diagnose, and treat disease.4 As research efforts continue, this practice-known as "personalized medicine"5-continues to promise cheaper, more effective healthcare and incredible diagnostic capability.6

Despite the benefits personalized medicine has already produced, the field remains in its infancy.7 Unfortunately, courts have struggled with encouraging the growth of this industry while simultaneously ensuring equitable access to its benefits.8 This tension between encouraging innovation and maintaining accessibility-which mirrors the central conflict of patent law itself9-has resulted in a heated debate as to whether human genes and genetic diagnostic tests ought to receive patent protection.10 Supporters of patent protection for genes and genetic tests argue that, without protection, researchers will no longer be incentivized to invest in personalized medical research.11 Opponents respond that patent monopolies impede access and have a chilling effect on cooperative research efforts.12

In 2011, this conflict came to a head in Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office13 (Myriad I). Myriad Genetics, Inc. (Myriad), a genetic researcher, held patents on two genes associated with a high incidence of breast and ovarian cancer as well as patents for genetic diagnostic tests, which identified a predisposition to these cancers in a patient.14 On an initial remand from the Supreme Court, the U.S. Court of Appeals for the Federal Circuit held that (1) isolated genetic sequences remained eligible for patent protection,15 and (2) Myriad's diagnostic method patents were not eligible for patent protection.16 The Supreme Court vacated and remanded the case for further consideration17 in light of its holding in Mayo Collaborative Services v. …

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