What to think about the December 2014 USPTO Guidelines on Natural Products

By: Andreas Baltatzis & Thomas Powers  |   March 2, 2015




On December 16, 2014, the USPTO issued new Guidelines and Examples for the subject matter eligibility of “Nature-derived products” under Section 101 available at http://www.uspto.gov/patents/law/exam/interim_guidance_subject_matter_el....

These guidelines replace the much-derided March 2014 edition. We believe that the new guidelines are much improved from the previous version and represent movement in the right direction in view of the case law including Myriad. Most importantly, the new guidelines favorably address the issue of whether a nature-derived product is “markedly different” from a natural product. Specifically, the original Myriad guidelines set forth as a criteria “Claim is a product claim reciting something that appears to be a natural product that is not markedly different in structure from naturally occurring products.” The term “naturally occurring products” was then broadly interpreted to include any material containing natural compounds by many Examiners.

The new guidelines focus more broadly on functional or structural differences from a natural material. The December 2014 Interim Guidance, sets forth what constitutes a marked difference. While such marked differences include structural changes, they are expanded to include differences in biological or pharmacological function or activity, differences in chemical or physical properties. Further, changes in physical structure as well as chemical structure may constitute a marked difference.

The new examples offered by the USPTO appear to apply the above principles in a more sensible approach as consistent with the case law and are available at http://www.uspto.gov/patents/law/exam/mdc_examples_nature-based_products... Encouraging examples include Example 2, directed to pomelo juice. Here, a composition of pomelo juice and a preservative is held to be patent-eligible, because the preservative slows spoiling. The nature of the preservative is not treated in the analysis. Further, since a single preservative is sufficient to delay spoiling, there is no requirement for synergistic activity to obtain patent-eligible subject matter.

We also highlight Examples 6 and 10. Although Example 1 shows that synergism is not required to obtain patent-eligible subject matter, Example 10 makes it clear that the presence of synergism in a composition containing two naturally occurring materials which have been mixed by an applicant is sufficient to demonstrate a marked difference in functional characteristics. Example 6 shows that, while some combinations of bacteria may not be patent-eligible, combinations of bacteria which possess properties not afforded by either bacteria individually are patent-eligible. Patent-eligible claims recited in Examples 6 and 10, directed to mixtures of bacteria, may be distinguished from Funk Brothers (a patent-ineligible mixture of bacteria), on the grounds that Funk Brothers did not demonstrate synergistic or increased activity by the combined bacteria.

The Guidance could be additionally improved by better specifying what constitutes “marked differences.” It is presumed that changes in physical structure which constitute a marked difference include formation of polymorphs of compounds. Does fractionation of a natural material, e.g., plant or animal tissue, by extraction constitute a physical change rendering the product patent-eligible? Does a combination of natural materials which offers activity which is absent from, or enhanced from, either individual component necessarily have marked differences from the constituent materials? While we believe the guidelines and examples support these positions, an explicit statement of these principles would be beneficial.