Patent Eligibility of Natural Products Under New USPTO Guidance
Takeaway: The USPTO has offered new guidance as to what "natural products" might be patentable.
There are two new examples added in the USPTO patent eligibility examples for “natural products” based inventions. The new examples add Examples 28-33 to the USPTO’s body of patent eligibility examples, of which Examples 28 and 30 relate to natural products. One example relates to vaccines and the other relates to nature-based sweetener compositions.
For vaccines, the following are the USPTO examples of what satisfies and what does not satisfy patent subject matter eligibility.
[S]tructurally-altered variants of natural products satisfy § 101; no “significantly more” analysis is required.
[C]ompositions comprising a natural product (or a fragment of a natural product, such as a peptide antigen) and other components that are structurally-altered as compared to their naturally-occurring counterparts (e.g., a cream, emulsion, gel, liposome, nanoparticle, or ointment carrier) satisfy § 101; no “significantly more” analysis is required, but it could be important that the other components impact properties of the composition as a whole in a relevant way.
[C]ompositions comprising a natural product (or a fragment of a natural product) and another component that impacts the function of the natural product (e.g., an effective amount of an adjuvant) satisfy § 101; no “significantly more” analysis is required.
[C]ompositions comprising a natural product (or a fragment of a natural product”) and other components (e.g., a pharmaceutically acceptable carrier) do not satisfy § 101 if the components do not impart a different structure or function to each other, unless the claims can survive a “significantly more” analysis.
[D]evices (e.g., microneedles) comprising a natural product (or a fragment of a natural product”) do not satisfy § 101 unless the use of the device with the natural product was not well-understood, routine or conventional (e.g., unless the claims can survive a “significantly more” analysis).
For nature-based sweeteners, the following are the USPTO examples of what satisfies and what does not satisfy patent subject matter eligibility.
[C]ompositions comprising specified amounts (or ranges of amounts) of a natural product (e.g., a small molecule) and a carrier (e.g., water) do not satisfy § 101 where it was well-understood, routine and conventional to use that type of carrier with that type of product and to vary the relative amounts of each (e.g., where the claims do not survive a “significantly more” analysis).
[C]ompositions comprising a natural product and other naturally-occurring components satisfy § 101 if the combination as a whole has properties that are different in a way that is “relevant to the nature of the invention” (e.g., organoleptic properties or flavor profile); no “significantly more” analysis is required.
[C]ompositions comprising a natural product having specific physical characteristics (e.g., a specific particle size distribution) satisfy § 101 if the physical characteristic is associated with a different property that is “relevant to the nature of the invention”; no “significantly more” analysis is required.
[C]ompositions comprising a natural product in a controlled release formulation satisfy § 101 if the controlled release is “relevant to the nature of the invention”; no “significantly more” analysis is required.
The examples indicate the additional component(s) at issue must not be “well-understood, routine or conventional” in the field of the invention in order to satisfy § 101 and be patentable subject matter.