On March 4, the US Patent and Trademark Office issued new guidelines and training materials to provide guidance to patent examiners on whether patent claims based on products of nature, natural laws, and natural phenomena may be allowed.

These materials are based on the US Supreme Court’s decisions in Mayo Collaborative Services v. Prometheus Laboratories, Inc. and Molecular Pathology v. Myriad Genetics.

In both of these cases, the Supreme Court held asserted claims to be invalid under 35 USC 101.

In the Mayo case, the court held that abstract ideas, natural laws, and natural phenomena are not patentable, and that that a method for measuring a patient’s blood level of a product of metabolism was not patentable as it did not do significantly more than describe the natural process.

In Myriad, the Court invalidated claims for isolated DNA sequences for genes that increase the risk of breast and ovarian cancer because the genes are products of nature.

According to the new guidelines, the proper test for patent eligibility is:

• “whether a claim reflects a significant difference from what exists in nature” (patent eligible), or
• “whether a claim is effectively drawn to something that is naturally occurring” (not patent eligible).

The PTO provided the following example:

The Amazonian cherry tree is a naturally occurring tree that grows wild in the Amazon basin region of Brazil. The leaves of the Amazonian cherry tree contain a chemical that is useful in treating breast cancer. However, to be effective, a patient must eat 30 pounds of the leaves per day for at least four weeks. Many have tried and failed to isolate the cancer-fighting chemical from the leaves. Applicant has successfully purified the cancer-fighting chemical from the leaves and has named it amazonic acid. The purified amazonic acid is structurally identical to the amazonic acid in the leaves, but a patient only needs to eat one teaspoon of the purified acid to get the same effects as 30 pounds of the leaves…

In the view of the Patent Office, a claim to the purified acid would not be accepted because:

• there is no structural difference between the acid in the leaves and the purified acid, and
• the claim does not include features to show that the purified product is markedly different from the natural one.