If you're wondering how to patent a natural product, the answer is that natural products are not eligible for patent protection. A controversial ruling by the United States Patent and Trademark Office was issued in March 2016 that denied a patent on isolated gene sequences linked to breast cancer. The court found that DNA is considered a natural product and thus cannot be patented.

Judicial Exceptions

Judicial exceptions were expanded by the USPTO ruling to include the term natural products. According to this ruling, "If the claim recites or involves a judicial exception, such as a law of nature/natural principle or natural phenomenon… and/or something that appears to be a natural product (e.g., a citrus fruit, uranium metal, nucleic acid, protein, etc.), then the claim only qualifies as eligible subject matter if the claim as a whole recites something significantly different than the judicial exception itself.”

Other non-patentable items considered judicial exceptions include abstract ideas, natural phenomena, and laws of nature. The new natural products exception applies to:

  • Products that use a natural product without significant variance in structure
  • Patents with processes that require a natural product or products
  • Patents that consist solely of a natural product

Although natural products could once be patented if they were synthesized, purified, or isolated, this is no longer the case under the new ruling. They do note that if a natural product is used to create a significantly different compound, the result may be eligible for patent protection.

Markedly vs. Significantly Different

The USPTO uses an analytical framework that asks whether any of the claims in a patent application apply to a judicial exception such as a natural product and whether the element or combination of elements amounts to more than the judicial exception in question. The first question requires the application of the "markedly different" test.

The language of the ruling describes a significantly different compound as follows: "“Claim recites elements/steps in addition to the judicial exception(s) that impose meaningful limits on claim scope, i.e., the elements/steps narrow the scope of the claim so that others are not substantially foreclosed from using the judicial exception(s).”

Based on this test, a marked difference can consist of either a functional or structural difference in the patent claim that distinguishes it from the natural product. Such differences must be significant, which means they are not conventional, routine, or well-understood in the field in which you are seeking a patent.

The ruling notes: “While a functional difference is not necessary in order to find a marked difference, the presence of a functional difference resulting from the structural difference makes a stronger case that the structural difference is a marked difference.”

For example, if a court is examining the patentability of a vaccine that is made from an adjuvant and an immunogenic protein must meet both parts of the analytical framework described above.

This test raises questions about whether functional differences in the product will be eligible for a patent if they are irrelevant to the invention if no structural differences are present.

Examples of Natural Products

Examples of eligible natural product patents include:

  • Natural products with a varied structure
  • Compositions made from a natural product and other structurally altered components
  • A natural product combined with an element that changes the way it functions
  • A natural product along with other components that pass the "significantly more" analysis described above
  • Devices that use a natural product with a new use that is not routine, conventional, or well-understood
  • Compositions of several natural products that create a new flavor profile or other relevant properties that are significantly different than any of the component parts
  • A natural product that has been made into a controlled-release formula
  • A natural product with specific physical attributes that support a distinguishable, relevant property of the invention

Items that may not pass the significant more analysis include:

  • Compositions made from a natural product with a carrier that is frequently used along with that type of natural product, even if the amounts of each substance are varied

Because your patent claims are evaluated on a case-by-case basis, you may want to consult with an experienced intellectual property attorney.

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