The United States Patent & Trademark Office's Current View on Patent Eligibility

Abstract

Over the past few years, the Supreme Court of the United States has issued several decisions on the eligibility of natural methods and compositions for patent protection. In view of these decisions, the United States Patent and Trademark Office (USPTO) recently issued a guidance memorandum (Guidance) to implement new procedures that patent examiners must now use to determine whether claims to inventions that involve any natural principles, phenomena, and/or products are eligible for patent protection. This article briefly describes the holdings from the most recent Supreme Court decisions; two previous articles in this journal describe those holdings in more detail.^1,2 We then summarize the USPTO's Guidance on subject matter eligibility for natural methods and compositions and provide several strategies for obtaining patent protection under the Guidance.

Recent Supreme Court Decisions

The Supreme Court issued the unanimous Mayo v. Prometheus decision in early 2012 holding that Prometheus' claims to correlations between naturally produced metabolites and therapeutic efficacy and toxicity were not eligible for patent protection, because they covered laws of nature.³ The Court also decided that claiming the additional steps of “administering a drug” and “determining a level of” the metabolite did not transform the natural law into a patentable process. Rather, the Court held that those steps simply told doctors to treat patients using well-known methods and, therefore, did not add sufficient details to the statements of the natural correlation to qualify as a patent-eligible process that practically applies a natural law.

In Assoc. for Molecular Pathology v. Myriad, the Supreme Court unanimously held “that a naturally occurring DNA segment is a product of nature and not patent eligible.”⁴ Importantly, the Court found that isolated DNA claims could not be saved “by the fact that isolating DNA from the human genome severs the chemical bonds and thereby creates a nonnaturally occurring molecule.” On the other hand, the Court found that synthetic complementary DNA (cDNA) was patent eligible, “because it is not naturally occurring.” In Myriad, the Court did not address other types of biological substances and stated, “[w]e merely hold that genes and the information they encode are not patent eligible under § 101 simply because they have been isolated from the surrounding genetic material.”

The USPTO's Guidance

In March 2014, the USPTO issued its Guidance to all patent examiners on subject matter eligibility of claims reciting or involving laws or principles of nature, natural phenomena, and/or natural products in light of the Mayo and Myriad cases. The Guidance states that Myriad “re-affirmed the Office's reliance on Chakrabarty's criterion for eligibility of natural products (i.e., whether the claimed product is a non-naturally occurring product of human ingenuity that is markedly different from naturally occurring product).”⁵

The Guidance provides three questions that examiners must ask to determine whether a claim is directed to patent-eligible subject matter or should be rejected under 35 USC § 101.

Question 1: “Is the claimed invention directed to one of the four statutory patent-eligible subject matter categories: process, method, manufacture, or composition of matter?” If no, the claim should be rejected. If yes, go to Question 2.

Question 2: “Does the claim recite or involve one or more judicial exception [i.e., laws of nature/natural principles, natural phenomena, and natural products]?” If no, the claim is eligible. If yes, go to Question 3.

Question 3: “Does the claim as a whole recite something significantly different than the judicial exception(s)?” If no, the claim is patent ineligible. If yes, the claim is patent eligible.

Importantly, the Guidance goes far beyond the facts present in the Mayo and Myriad decisions and provides a list of types of claimed subject matter that must now be evaluated under Section 101. The list 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, sand, soils); nucleic acids; organisms (e.g., bacteria, plants and multicellular animals); proteins and peptides; and other substances found in or derived from nature.⁶

The Guidance describes how a claim could recite something significantly different from nature. For example, the claim may include elements or steps that practically apply the judicial exception in a significant way, or features or steps that demonstrate that the claim is markedly different from what exists in nature.

The Guidance then lists 12 factors to consider when deciding whether a claim is patent eligible under Question 3. A claim qualifies as eligible for patent protection if the “totality of the relevant factors” weighs toward eligibility. Once the claim has passed this initial hurdle of patent eligibility, it must still be examined on the technical merits to determine whether it covers an invention that is novel and nonobvious in view of the prior art, e.g., journal articles, patents, and other forms of public disclosure of the same or similar inventions. On the other hand, a claim will be rejected if the “totality of the relevant factors” weighs against eligibility. Such rejected claims are not examined with respect to the prior art.

Some of the 12 factors are paired as opposing facts of the same issue. For example, two of the factors look at whether something that may initially appear to be a natural product is actually non-naturally occurring and markedly different from what exists in nature. The Guidance explains that “a marked difference must be a significant difference, i.e., more than an incidental or trivial difference” and gives the example of isolating a nucleic acid as being insufficient to create a marked difference. The Guidance also states that the fact that merely routine activity or human manipulation of natural processes resulted in a marked difference does not prevent the marked difference from weighing in favor of eligibility, giving the examples of cDNA and hybrid plants being patent eligible even though the process of making cDNA and pollination/fertilization, respectively, are routine.

The remainder of the factors relate to when a claim recites elements or steps in addition to the naturally occurring method or composition and consider whether the additional elements/steps:

• Impose meaningful limits on claim (weighs toward eligibility) or must be used/taken by others to apply the judicial exception (weighs against eligibility)

• Relate to the judicial exception in a significant way (weighs toward eligibility) or are insignificant extra-solution activity, e.g., are merely appended to the judicial exception (weighs against eligibility)

• Do more than describe the judicial exception with general instructions to apply or use the exception (weighs toward eligibility) or are claimed at a high level of generality such that substantially all practical applications of the judicial exception are covered (weighs against eligibility)

• Include a particular machine or transformation of a particular article, where the particular machine or transformation implements one or more judicial exceptions or integrates one into a particular practical application (weighs toward eligibility)

• Add a feature that is more than well-understood, purely conventional or routine in the relevant field (weighs toward eligibility) or are well-understood, purely conventional or routine in the relevant field (weighs against eligibility)

• Amount to nothing more than a mere field of use (weighs against eligibility)

To illustrate how the three questions and 12 factors should be applied, the Guidance analyzes the factors for several exemplary claims, five of which we summarize here. As an example of a naturally occurring composition that is not eligible for patent protection, the Guidance recites a claim to “a stable energy-generating plasmid, which provides a hydrocarbon degradative pathway.” Because a plasmid is a composition (yes to Question 1) that is naturally occurring (yes to Question 2), Question 3's factors must be analyzed. The first two factors weigh against patent eligibility, because the claimed plasmid is not markedly different from what exists in nature. The other factors are not relevant because the claim does not include any elements in addition to the plasmid. Thus, the claim as a whole recites something that is not significantly different than what exists in nature and is not patent eligible.

An example of a composition that is patent eligible would be a claim described in the Guidance as “a bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway.” Again, the factors for Question 3 must be analyzed, because a bacterium is a composition (yes to Question 1) that is naturally occurring (maybe to Question 2). The Guidance notes that adding limitations regarding the structure and function of the bacterium is not enough to determine eligibility. Here, the first two factors weigh in favor of eligibility, because the claimed bacteria is markedly different from the naturally occurring Pseudomonas bacteria that has only a single plasmid and can degrade only a single hydrocarbon. The other factors do not apply because the claim does not include any elements in addition to the bacterium. Therefore, the Guidance concludes that this claim is eligible for patent protection.

The Guidance also concludes that a claim to a “purified amazonic acid” is not patent eligible if there is no structural difference between the purified acid in the claim and the acid in the leaves of the tree from which it is obtained. However, the Guidance concludes that a claim to “Purified 5-methyl amazonic acid,” which is described as a derivative of amazonic acid that is created in the laboratory, is patent eligible because the claim recites something that is structurally different from the naturally occurring acid found in leaves, and this structural difference results in functional differences.

The Guidance also discusses a claim to “a method of treating colon cancer, comprising: administering a daily dose of purified amazonic acid to a patient suffering from colon cancer for a period of time from 10 days to 20 days, wherein said daily dose comprises about 0.75 to about 1.25 teaspoons of amazonic acid.” The Guidance concludes that this claim recites something significantly different than the natural product, because it includes steps that add significantly more to the judicial exception. In particular, the step of administering a particular dosage for a particular length of time to a particular patient “meaningfully limits the scope of the claim to a particular application.”

Obtaining Patent Protection

The goal in preparing a new patent application to cover an invention that relates in some way to a natural product, law of nature, or a natural phenomenon should be to provide sufficient details and examples to support patent claims that include the types of additional elements or steps that will weigh in favor of patent eligibility. For example, specific limits, unconventional materials or steps, the use of a particular machine to carry out the invention, or a transformation that occurs when obtaining or using the invention can all help to render a claim eligible for patentability.

In addition, wherever possible one should describe in detail how the claimed invention is significantly different from the related natural law, phenomena, or product as actually found in nature. For example, a natural product may be used as a starting material to obtain a derivative product that might be sufficiently different to be patent eligible, but it is important to provide a thoughtful description of exactly how the derivative is different from the natural product and what changes in function arise as a result of the differences from the natural product. As another example, though not explicitly addressed by the Guidance, evidence of unexpected results or functions may also help support eligibility for natural products that are altered in some way from their natural state, because such results or functions may support a finding of a significant difference.

While the old idiom, “the devil is in the details,” has always been true for drafting patent applications, it is now more important than ever with respect to patent applications that involve laws or principles of nature, natural phenomena, and/or natural products. Thus, while the USPTO has made it clear that it will examine all such inventions with greater scrutiny, there will typically still be ways to protect such inventions with a US patent. In addition, inventors should not forget that patent protection for some of these types of inventions may still be somewhat easier in other countries, and the discussions in this article focus only on US patent laws and the USPTO's interpretations of those patent laws.

Footnotes

References

Fraser

, Rosen

. Patenting genes in a post-Myriad world. Ind Biotechnol, 2013; 9(4):163–164.

Reiter

, Fasse

JP.

Patent eligibility of biological methods and compositions. Ind Biotechnol, 2013; 9(3):90–92.

Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. __, 132 S. Ct. 1289 (2012).

Assoc. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 2111 (2013).

Guidance for Determining Subject Matter Eligibility of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products. Citing Diamond v. Chakrabarty , 447 U.S. 303 (1980) and Myriad, 133 S. Ct. at 2116-17. Available at www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf (Last accessed May 2014 ).

Guidance for Determining Subject Matter Eligibility of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products at pg 3. Available at www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf (Last accessed May 2014 ).