Do Pharmaceutical Compositions Have Patent Subject Matter Eligibility Under The New USPTO Guidelines?

The USPTO's new patent subject matter eligibility guidelines (the "Guidelines") include examples that apply the multi-factored analysis mandated by the Guidelines to compositions that include one or more "natural products" as a component. Do these examples indicate that pharmaceutical compositions with an active ingredient that can be obtained from a natural source no longer can be patented?

The USPTO's Definition of "Natural Product"

The Guidelines provide this information on the meaning of "natural product":

[N]atural product includes, but is not limited to: chemicals derived from natural sources (e.g., antibiotics, fats, oils, petroleum derivatives, resins, toxins, etc.); foods (e.g., fruits, grains, meats and vegetables); metals and metallic compounds that exist in nature; minerals; natural materials (e.g., rocks, sands, soils); nucleic acids; organisms (e.g., bacteria, plants and multicellular animals); proteins and peptides; and other substances found in or derived from nature.

The Guidelines take the position that "a product claim reciting something that initially appears to be a natural product" is directed to patent eligible subject matter only if the claimed product "is determined to be non-naturally occurring and markedly different in structure from naturally occurring products."

Drawing from the Myriad Supreme Court decision, the Guidelines explain that not all structural differences rise to the level of "markedly different," because while "isolating a nucleic acid changes its structure (by breaking bonds)" isolated DNA "is not markedly different from the chromosomal DNA because its nucleotide sequence has not been changed." On the other hand, the guidelines note that "[t]he fact that a marked difference came about as a result of routine activity or via human manipulation of natural processes does not prevent the marked difference from weighing in favor of patent eligibility."

(Please see this article for a more detailed review of the Guidelines and the factors to be considered when assessing patent eligibility.)

The USPTO Examples of Composition Claims Reciting Multiple Natural Products

Examples D and E of the Guidelines relate to composition claims reciting multiple "natural products."

Example D (based on Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948)):

Claim: An inoculant for leguminous plants comprising a plurality of selected mutually non-inhibitive strains of different species of bacteria of the...