ABSTRACT: In March 2010, the U.S. District Court in the Southern District of New York held in the Myriad case that patent claims directed to isolated DNA molecules were invalid under 35 U.S.C. § 101 for failing to claim patent-eligible subject matter, relying heavily on the so-called “product of nature” doctrine. Instead of a chronological order, this Note reviews the legal history of the “product of nature” doctrine in a brand new analytical framework, analyzing the application of the “product of nature” doctrine to relevant cases based on whether the claimed subject matter is an element, a molecule, or a microorganism. This Note then proposes an appropriate test for applying the doctrine to patent claims directed to molecules. Retroactive application of the proposed test to molecule-claim case law would have yielded results consistent with the vast majority of relevant cases. Application of the proposed test to the DNA-molecule claims-in-suit in Myriad leads to a legal conclusion that the claimed DNA molecules are patent-eligible, contrary to the conclusion of the Myriad court. This Note also makes an effort to address certain issues in the court’s opinion, and to provide some practical tips to patent practitioners in drafting DNA molecule claims.
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