Keith Mack
The patent eligibility of natural products is a complex issue that has been the subject of much debate and litigation. The courts have identified laws of nature, natural phenomena, and abstract ideas as exceptions to patent eligibility, but the precise scope and interpretation of these terms remain uncertain. While naturally occurring substances are generally not patentable, combinations of natural products that do not exist in nature may be eligible for patent protection if they exhibit markedly different characteristics or functions compared to their naturally occurring counterparts. The determination of patent eligibility in these cases is made on a case-by-case basis, and the specific facts of each situation must be carefully considered.
| Characteristics | Values |
|---|---|
| Patent eligibility | Section 101 of the United States Patent Act |
| Judicial exceptions | Laws of nature, natural phenomena, and abstract ideas |
| Patent-eligible subject matter | The claim must include additional limitations that are significantly more than the exception |
| Examples of judicial exceptions | Gravity, the heat of the sun, extracted metals, isolated DNA segments, bacterial mixtures |
| Patent-eligible natural products | Living organisms (plants, animals, bacteria) that satisfy the "markedly different" characteristics analysis |
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What You'll Learn
Natural phenomena
The patent eligibility of natural phenomena is a complex issue that has been the subject of much debate and litigation. The courts have identified natural phenomena as one of the three specific exceptions to patent protection, along with laws of nature and abstract ideas. This means that natural phenomena are generally not considered patent-eligible subject matter.
However, the courts have also acknowledged that many inventions embody, use, or apply natural phenomena in some way, and have cautioned against a strict interpretation of this exclusionary principle, as it could potentially invalidate all patent law. As a result, the courts have recognised that not every claim describing a natural ability or quality of a product or process necessarily recites a natural phenomenon. For example, in Rapid Litig. Mgmt. v. CellzDirect, Inc., the Federal Circuit held that a process for fractionating, recovering, and cryopreserving hepatocytes was patent-eligible because it was not focused merely on observing or detecting the ability of hepatocytes to survive multiple freeze-thaw cycles.
The courts have also considered whether combinations of natural products that do not exist in nature can be patented. In Ex parte Calvin, the PTAB determined that a combination of natural products that do not exist as a combination in nature qualified for patent protection. Similarly, in Ex parte Hennen, the PTAB noted that while the individual components of the claimed invention may be naturally occurring, the combination of all the claimed elements does not occur naturally.
To determine whether a claimed invention is directed to a natural phenomenon, examiners use the markedly different characteristics analysis. This analysis evaluates whether the claimed invention has markedly different characteristics compared to what occurs in nature. If the claimed invention has significantly different characteristics or functionality compared to its natural counterpart, it may be eligible for patent protection. However, it is important to note that the determination of "markedly different" is made on a case-by-case basis and can depend on the specific facts and technology involved.
Overall, while natural phenomena are generally excluded from patent protection, there are exceptions and complexities to this rule. The eligibility of a claimed invention depends on its specific characteristics and the interpretation of the relevant laws and principles by the courts.
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Judicial exceptions
The Supreme Court has held that Section 101 contains an implicit exception for "laws of nature, natural phenomena, and abstract ideas," which are "the basic tools of scientific and technological work." However, the Court has cautioned that "at some level, all inventions embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas," and that this exclusionary principle should not be construed so broadly as to swallow all of patent law. This means that for a claim reciting a judicial exception to be eligible, the claim as a whole must include additional limitations amounting to significantly more than the exception.
The four "judicial exception" categories, to be used in patentability decisions, are (1) abstract ideas, (2) laws of nature, (3) natural phenomena, and (4) natural products. The courts have interpreted these terms in various ways, and there is no bright line between the types of exceptions. For example, the Supreme Court has cited gravity, the heat of the sun, and extracted metals as true examples of "natural laws," "phenomena," and "products." However, an examination of scientific philosophy demonstrates that these concepts may not be accurate representations of "natural laws," "phenomena," and "products."
The patent eligibility of natural products has been a source of confusion, with recent changes by the Supreme Court and analyses by tribunals contributing to this uncertainty. For example, the Supreme Court held that isolated segments of DNA were products of nature and not eligible for patent protection, reversing the long-standing practice of the United States Patent and Trademark Office (USPTO). Despite this, the USPTO has continued to issue patents claiming combinations of natural products. When reviewing such patent applications, the USPTO considers whether these combinations have markedly different characteristics from any naturally occurring counterparts in their natural state.
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Scientific philosophy
The philosophy of science is a complex and multifaceted field that explores the underlying principles, methods, and implications of scientific knowledge. At its core, it seeks to understand the nature of science, the validity of scientific claims, and the relationship between science and society. One of the fundamental aspects of scientific philosophy is the concept of "natural laws," "natural phenomena," and "products of nature."
In the context of patent law, the interpretation of these terms has significant implications for determining patent eligibility. It is generally accepted that "laws of nature," "natural phenomena," and "abstract ideas" are not eligible for patent protection. These exceptions are based on the understanding that they are the "basic tools of scientific and technological work" and that allowing patents on such fundamental concepts could hinder innovation and progress.
However, the precise definition of these terms has been a subject of debate and uncertainty. The Supreme Court, for example, has not provided a clear framework or explanation for these "natural" terms. Instead, they have relied on scientific tropes such as gravity, the heat of the sun, and extracted metals as examples of "natural laws" and "phenomena." This has led to confusion and inconsistencies in patent eligibility decisions, especially in fields like life sciences.
To address these complexities, some scholars have suggested adopting strategies from scientific problem-solving, such as "decomposition" and "localization." By breaking down the complex system of patent eligibility into manageable subparts and understanding their functions within the overall system, it may be possible to develop a more coherent and consistent approach to patent eligibility, particularly when dealing with "laws of nature."
Additionally, the concept of "markedly different characteristics" has been introduced to distinguish between eligible and ineligible nature-based products. This concept considers whether a claimed invention has significantly different characteristics compared to what occurs in nature. For example, in Seed Co. v. Kalo Inoculant Co., the court held that a combination of naturally occurring bacterial strains was not patentable as it did not result in a marked change in function or activity.
In conclusion, the scientific philosophy of "laws of nature" and their patent eligibility is a complex and evolving field. While there are established exceptions for "laws of nature" and "natural phenomena," the interpretation and application of these terms continue to be a subject of debate and uncertainty. A deeper engagement with scientific philosophy and the utilization of problem-solving strategies may help navigate the complexities of patent eligibility and ensure a more coherent and consistent approach.
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Patent eligibility
The courts have recognised that all inventions, to some degree, embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas. As such, caution must be exercised when considering patent eligibility to avoid inadvertently invalidating all patent law.
The judicial exceptions to patent eligibility are abstract ideas, laws of nature, and natural phenomena, including products of nature. These exceptions are subject matter that the courts have found to be outside of, or exceptions to, the four statutory categories of invention. For a claim to be eligible, it must include additional elements or limitations that amount to significantly more than the exception.
In the context of natural products, the courts have clarified that not every claim describing a natural ability or quality of a product or a natural process recites a law of nature or natural phenomenon. For example, in Rapid Litig. Mgmt. v. CellzDirect, Inc., the court held that a process of fractionating, recovering, and cryopreserving hepatocytes was eligible for patent protection because it was not focused merely on observing or detecting the ability of hepatocytes to survive multiple freeze-thaw cycles. Similarly, the human body's natural response to aspirin is not considered a law of nature, nor is the inability of cancer cells to survive chemotherapy.
Additionally, combinations of natural products that do not exist as a combination in nature may qualify for patent protection if they produce a marked change in function or activity. For example, in Ex parte Calvin, the PTAB determined that a combination of constituents that do not coexist in nature must be an artificially constructed combination and not a natural phenomenon excluded from patentability. However, the standard for "significantly different" is still unclear and will be determined on a case-by-case basis.
In conclusion, while laws of nature are generally not patent-eligible, the patent eligibility of specific applications involving natural products or processes will depend on the specific facts and circumstances of each case.
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Natural products
The patent eligibility of natural products has been a subject of debate and discussion. The concept that natural products may not be patentable is not new. In Funk Bros. Seed Co. v. Kalo Inoculant Co. (1948), the Supreme Court held that a combination of naturally occurring strains of bacteria was not patentable, explaining that the claimed bacteria were "manifestations of laws of nature".
In 2013, the U.S. Supreme Court's Myriad decision significantly shifted intellectual property rights for "natural products" industries. The decision clarified that merely isolating a natural product does not make it patentable, and that the inventor must introduce a change that makes the invention "markedly different" from its natural counterpart. This decision reversed the United States Patent and Trademark Office's (USPTO) long-standing practice of issuing patents for isolated DNA segments.
Following the Myriad decision, the patent eligibility of natural products will be determined on a case-by-case basis. The USPTO's Guidance states that what is claimed should be "non-naturally occurring and markedly different in structure from the naturally occurring products". However, the level of difference required for patent eligibility remains uncertain. One strategy suggested is to include multiple claims with varying degrees of modifications relative to the naturally occurring product.
In the natural food industry, innovation and novelty often drive the "patentability" of a product. Even if a natural food product itself does not meet the patent eligibility requirement, a patent directed to the method of making or using the product may be eligible. For example, one may be able to secure a patent for manufacturing kelp-based food packaging, assuming it is made in a new way that differs from existing prior art.
Overall, while natural products may be afforded patent protection, it requires outside-the-box thinking and a thorough understanding of patent law and its requirements.
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Frequently asked questions
The US Patent Act prohibits patents on laws of nature, natural phenomena, and products of nature. However, the Supreme Court has not provided a clear framework for these terms, and recent decisions have created uncertainty in this area of law.
Examples of laws of nature that cannot be patented include gravity, the heat of the Sun, and extracted metals.
Combinations of natural products that do not exist in nature may be eligible for patent protection. For example, in Ex parte Hennen, the PTAB noted that the combination of transfer factor derived from animal sources with herb or plant extracts does not occur naturally and therefore qualified for patent protection.
