Guidelines for Gene Patent Ruling

The USPTO offers guidance to its patent examiners on how to interpret the Supreme Court’s rulings in the recent Myriad and Prometheus cases.

Written byJef Akst
| 1 min read

Register for free to listen to this article
Listen with Speechify
0:00
1:00
Share

WIKIMEDIA COMMONS, GALLO & SPERO LLPLast summer, the US Supreme Court invalidated patents held by Salt Lake City, Utah-based Myriad Genetics on the BRCA1 and BRCA2 genes. A year earlier, the high court ruled that two diagnostic patents held by San Diego-based Prometheus were also not patent eligible. In both cases, the justices cited laws against patenting products or laws of nature or natural phenomena.

This week (March 4), the US Patent and Trademark Office (USPTO), whose role is to interpret court decisions on patentability into procedures for patent examiners to follow, issued guidelines on how to apply these new rulings. It all comes down to “whether a claim reflects a significant difference from what exists in nature and thus is [patent] eligible,” the USPTO described. Alternatively, if “a claim is effectively drawn to something that is naturally occurring,” then it is not patent eligible, according to the guidelines.

“In a new set of training materials, the USPTO has attempted to provide some concrete guidance to its examiners on determining whether claims improperly encompass laws of nature, natural principles, natural phenomena, or products of nature,” Dennis Crouch, an associate professor ...

Interested in reading more?

Become a Member of

The Scientist Logo
Receive full access to more than 35 years of archives, as well as TS Digest, digital editions of The Scientist, feature stories, and much more!
Already a member? Login Here

Related Topics

Meet the Author

  • Jef (an unusual nickname for Jennifer) got her master’s degree from Indiana University in April 2009 studying the mating behavior of seahorses. After four years of diving off the Gulf Coast of Tampa and performing behavioral experiments at the Tennessee Aquarium in Chattanooga, she left research to pursue a career in science writing. As The Scientist's managing editor, Jef edited features and oversaw the production of the TS Digest and quarterly print magazine. In 2022, her feature on uterus transplantation earned first place in the trade category of the Awards for Excellence in Health Care Journalism. She is a member of the National Association of Science Writers.

    View Full Profile
Share
Image of a woman with her hands across her stomach. She has a look of discomfort on her face. There is a blown up image of her stomach next to her and it has colorful butterflies and gut bacteria all swarming within the gut.
November 2025, Issue 1

Why Do We Feel Butterflies in the Stomach?

These fluttering sensations are the brain’s reaction to certain emotions, which can be amplified or soothed by the gut’s own “bugs".

View this Issue
Olga Anczukow and Ryan Englander discuss how transcriptome splicing affects immune system function in lung cancer.

Long-Read RNA Sequencing Reveals a Regulatory Role for Splicing in Immunotherapy Responses

Pacific Biosciences logo
Research Roundtable: The Evolving World of Spatial Biology

Research Roundtable: The Evolving World of Spatial Biology

Conceptual cartoon image of gene editing technology

Exploring the State of the Art in Gene Editing Techniques

Bio-Rad
Conceptual image of a doctor holding a brain puzzle, representing Alzheimer's disease diagnosis.

Simplifying Early Alzheimer’s Disease Diagnosis with Blood Testing

fujirebio logo

Products

Labvantage Logo

LabVantage Solutions Awarded $22.3 Million U.S Customs and Border Protection Contract to Deliver Next-Generation Forensic LIMS

The Scientist Placeholder Image

Evosep Unveils Open Innovation Initiative to Expand Standardization in Proteomics

OGT logo

OGT expands MRD detection capabilities with new SureSeq Myeloid MRD Plus NGS Panel