Patent Eligibility of Traditional Chinese Medicine in the United States: Section 101 Guidelines

In the United States, patentable or “patent-eligible” subject matter is defined by §101 of the Patent Act as “any new and useful process, machine, manufacture, or composition of matter[.]” These four categories have historically been applied very broadly by the U.S. courts to “include anything under the sun that is made by man.” But exceptions to patent eligibility under §101 exist, described as “laws of nature, physical phenomena, and abstract ideas” in important U.S. Supreme Court decisions as recently as Bilski in 2010, Mayo Collaborative Services v. Prometheus Laboratories, Inc. (“Prometheus”) in 2012, and Ass’n for Molecular Pathology v. USPTO/Myriad (“Myriad”) in 2013.

In the Prometheus case, claims to a medical diagnostic method were held to be patent-ineligible subject matter because they were construed as reciting a method for observing natural phenomena. The claims at issue in Myriad case were composition claims to cDNA, method claims to screening potential cancer therapeutics, and method claims directed to “comparing” or “analyzing” DNA sequences. The Supreme Court addressed only the composition claims, and concluded that genes and the information they encode are a product of nature and not patent-eligible under §101 simply because they have been isolated from the surrounding genetic material. According to the Supreme Court, the isolated portion of DNA sought to be patented in this case is identical to that portion in its natural state. Synthetically created DNA, (complementary DNA or cDNA), on the other hand, is patent-eligible because it is not naturally occurring.

On December 16, 2014, the USPTO issued Interim Guidelines on Subject Matter Eligibility. These Guidelines instruct examiners to focus on whether the claims recite subject matter that fits in the “product of nature” exception.

Specifically, the Guidelines provide a two-step test: 

    1. Is the claim to a process, machine, manufacture, or composition of matter? 

    2A. Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (judicially-recognized exceptions)? 

    If yes, then 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?

This analysis compares a nature-based product in the claim to its naturally occurring counterpart to identify markedly different characteristics based on structure, function, and/ or properties. The analysis proceeds to Step 2B, only when the claim is directed to an exception (when no markedly different characteristics are shown).

Extracts of Traditional Chinese Medicine (TCM), particularly important in China, where Chinese companies presently seek U.S. FDA approval of plant extracts, are not naturally occurring. Rather, the extracts are new compositions of matter with different percentages of markers than existed in the plant pre-extraction. Such TCM extracts are not identical to those which exist in the plant. Instead they differ from the natural plants in properties, character, and often-times use, and should fall within the scope of patent-eligible subject matter.

TCM extracts often have a great many components, so the claims recite identifying markers with certain percentages. For example, a hypothetical U.S. patent claim of a TCM extract is: 

    An extract of Lucky Leaf for treating effectively cancer in a subject in recognized need thereof, comprising: 1-30% by weight compound A, 

    0.5 to 10% by weight compound B, and further comprising in said extract for treating effectively said cancer, 1-15% by weight compound C.

This claim is directed to a composition of matter, so the answer to Question 1 of the two-part test is “yes.” The key, under the Guidelines, will be clearly explaining the “markedly different” structural, property, and functional distinctions of the claimed extract from its pre-extraction form, as well as the methods required to transform the extract from its pre-extraction state to a useful therapeutic product. In this way, the answer to 2A in the two-part test is “no” because the TCM extract is not a judicial exception and the claim qualifies as eligible subject matter under §101. In this patent claim, the extract clearly differs in structure, property, and functions from Lucky Leaf.

It is important to remember that in the USPTO, the claims will be construed according to their “broadest reasonable interpretation.” The Guidelines specifically instruct the examiners to establish the broadest reasonable interpretation of the claim before evaluating it for patent-eligible subject matter.

It is also important to remember that determining if the claim recites patent-eligible subject matter under §101 is a threshold test. Even if the claimed subject matter is found patent-eligible, the claim must also meet the statutory patentability requirements of novelty (§102), nonobviousness (§103), and a full, clear, and enabling description (§112).

*Stacy Lewis is a law clerk at Finnegan.