What is the “markedly different characteristics” test for patent eligibility of living matter?

This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice.

The “markedly different characteristics” test is a key criterion for determining the patent eligibility of living matter. This test originates from the Supreme Court’s decision in Diamond v. Chakrabarty.

According to the MPEP, “The Supreme Court in Chakrabarty held a claim to a genetically engineered bacterium eligible, because the claimed bacterium was not a ‘product of nature’ exception. As the Court explained, the modified bacterium was patentable because the patent claim was not to a ‘hitherto unknown natural phenomenon,’ but instead had ‘markedly different characteristics from any found in nature,’ due to the additional plasmids and resultant capacity for degrading oil.”

This test is used to determine whether a nature-based product, such as living subject matter, is eligible for patent protection. If the claimed invention possesses characteristics markedly different from those found in nature, it may be eligible for patent protection.