Narrative Opinion Summary
This case examines the patent eligibility of naturally occurring DNA segments and synthetic DNA (cDNA) under 35 U.S.C. § 101. Myriad Genetics, Inc. obtained patents for the BRCA1 and BRCA2 genes, associated with increased breast and ovarian cancer risk, claiming rights to isolate these genes and create cDNA. Challenged by petitioners as covering products of nature, the District Court ruled the patents invalid, but the Federal Circuit reversed. The Supreme Court ultimately held that naturally occurring DNA segments are not patent eligible as they are products of nature, while cDNA is patent eligible because it is not naturally occurring. The Court differentiated between Myriad's identification of gene locations, which falls under the law of nature exception, and cDNA, a synthetic creation. The ruling underscores that patents cannot monopolize natural phenomena but may protect new compositions of matter. The decision, partly affirming and reversing the Federal Circuit, emphasizes that the Patent Act excludes naturally occurring products from patentability, preserving innovation while preventing monopolization of essential scientific tools. Justice Thomas delivered the opinion, with Justice Scalia concurring in part, affirming some claims and invalidating others.
Legal Issues Addressed
Chemical Alteration Requirement for Patent Eligibilitysubscribe to see similar legal issues
Application: The isolation of DNA does not meet the requirements for patentability because it does not change the chemical composition or genetic information encoded, merely isolating it from its natural environment.
Reasoning: The substantial effort to discover these genes does not meet the requirements for patentability, as isolating DNA does not inherently change its chemical composition or the genetic information it encodes.
Comparative Analysis with Diamond v. Chakrabartysubscribe to see similar legal issues
Application: Unlike the modified bacterium in Diamond v. Chakrabarty, Myriad's act of isolating genes does not meet the threshold of invention required for patentability.
Reasoning: In Diamond v. Chakrabarty, 447 U.S. 303, the Supreme Court addressed patent eligibility, specifically whether Myriad Genetics' actions constituted a discovery that was 'new' with characteristics distinct from those found in nature.
Declaratory Judgment and Standingsubscribe to see similar legal issues
Application: The Court found sufficient grounds for a declaratory judgment in Dr. Ostrer's case, as he was affected by Myriad's infringement claims and intended to conduct BRCA testing.
Reasoning: The Court found sufficient grounds for a declaratory judgment in the case involving Dr. Ostrer, per the precedent set in MedImmune, Inc. v. Genentech, Inc.
Law of Nature Exceptionsubscribe to see similar legal issues
Application: Myriad's identification of the BRCA genes' locations and sequences falls within the law of nature exception, as it does not constitute a creation of new compositions of matter.
Reasoning: Myriad's contribution was primarily the identification of the genes' locations and sequences, which falls within the law of nature exception.
Patent Eligibility under 35 U.S.C. § 101subscribe to see similar legal issues
Application: Naturally occurring DNA segments are not patent eligible because they are considered products of nature, whereas cDNA is patent eligible because it is not naturally occurring.
Reasoning: The Supreme Court held that naturally occurring DNA segments are products of nature and not patent eligible solely due to isolation. However, cDNA is considered patent eligible as it is not naturally occurring.
Reliance on Past PTO Practicessubscribe to see similar legal issues
Application: The Court dismissed the argument that the PTO's previous practice of granting gene patents should influence the decision, noting no Congressional endorsement of such practices.
Reasoning: Myriad’s reliance on past practices of the Patent and Trademark Office (PTO) for gene patents was dismissed, noting that there was no Congressional endorsement of such practices in this case.