How do you determine if a characteristic is “markedly different”?

Determining whether a characteristic is “markedly different” is a critical part of the analysis for patent eligibility of nature-based products. The MPEP provides guidance on this evaluation:

“The courts have emphasized that to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart.“

Key points to consider:

• The characteristic must be changed as compared to the natural counterpart.
• The change must be caused by the inventor’s efforts or influences.
• Inherent or innate characteristics of the natural counterpart cannot be considered markedly different.
• Incidental changes are not sufficient to establish a marked difference.

Examples of markedly different characteristics include:

• A bacterium with additional plasmids that give it the ability to degrade multiple hydrocarbons (as in the Chakrabarty case).
• cDNA with a different nucleotide sequence than its natural DNA counterpart (as in the Myriad case).

Examples of characteristics that were not considered markedly different include:

• Isolated genes that have the same nucleotide sequence as natural genes (Myriad case).
• Primers with the same nucleotide sequence as portions of natural DNA (Ambry Genetics case).
• Cloned animals with the same genetic material as their donors (Roslin case).

It’s important to note that the analysis is case-specific, and the determination of whether a characteristic is markedly different depends on the nature of the claimed product and its relationship to the natural counterpart.

To learn more:

• markedly different characteristics
• nature-based products
• patent eligibility
• product characteristics