The United States Patent Office (USPTO) has issued a new set of training materials to provide guidance to patent examiners on whether patent claims improperly encompass laws of nature, natural phenomena and principles, or products of nature.
The training materials are based on the US Supreme Court’s recent decisions in Molecular Pathology v. Myriad Genetics and Mayo Collaborative Services v. Prometheus Laboratories, Inc.
The new guidelines will have an impact on patent applications now pending.
According to the USPTO, the proper test for patentability 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 a flowchart to illustrate the analysis and included an 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 USPTO’s view, a claim to the purified acid would not be patent-eligible 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.
Commentators have questioned why the USPTO is apparently seeking to make patent-ineligible purified or isolated natural products that have been considered patentable in the US for at least 100 years and are patentable in many other countries.
If you have questions about patentability, contact our office to arrange a free initial consultation with one of our patent attorneys.
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