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Isolated DNA Compositions Are Not Patent Eligible: Association for Molecular Pathology v. Myriad Genetics

Marylee Jenkins and Kristi Nicholes Burton

©2013. Published in Landslide, Vol. 6, No. 2, November/December 2013, by the American Bar Association. Reproduced with permission. All rights reserved. This information or any portion thereof may not be copied or disseminated in any form or by any means or stored in an electronic database or retrieval system without the express written consent of the American Bar Association or the copyright holder.

For over 30 years, the United States has been grant- ing patents relating to DNA molecules for many useful applications, such as diagnosis and treatment of disease.1 While there is much debate about whether patents relating to DNA molecules have advanced innovation and progress in the field of medicine or, alternatively, created a substantial barrier to research and adequate health care, it is readily apparent that the biotechnology industry and its corresponding patent filings have grown tremendously over the past three decades.

Since patents were first granted on DNA molecules, there has been extensive controversy over their patentability due to the nature of the technology, particularly as it relates to human DNA molecules. It is, therefore, not surprising that a challenge to the patent eligibility of DNA molecules eventually appeared before the courts.

In Association for Molecular Pathology v. USPTO (Myriad I), the U.S. District Court for the Southern District of New York ruled that patent claims for isolated DNA and cDNA compositions and methods of analyzing gene sequences were categorically ineligible.2 The U.S. Court of Appeals for the Federal Circuit reversed the district court’s decision and found that the claims directed to both isolated DNA and cDNA were patent eligible.3

The U.S. Supreme Court ultimately decided the controversy, and in Association for Molecular Pathology v. Myriad Genetics, Inc. (Myriad IV), reversed the Federal Circuit in part, holding that the composition claims directed to isolated DNA were not patent eligible under 35 U.S.C. § 101, but affirmed the Federal Circuit’s holding that cDNA was patent eligible.4

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