Key Takeaways

  • The "nature of patent" doctrine excludes natural products, abstract ideas, and natural phenomena from patent eligibility.
  • Patents on natural products may be allowed if the product is modified to be "markedly different" from its natural state, either structurally or functionally.
  • Processes, methods, or compositions using natural products may still qualify for patents if they demonstrate significant innovation.
  • U.S. law emphasizes that naturally occurring substances, even if isolated or purified, are generally not patentable unless transformed into something significantly different.
  • The scope of what can be patented under this doctrine continues to evolve through USPTO guidelines and key court decisions.

If you're wondering how to patent a natural product, the answer is that natural products are not eligible for patent protection. A controversial ruling by the United States Patent and Trademark Office was issued in March 2016 that denied a patent on isolated gene sequences linked to breast cancer. The court found that DNA is considered a natural product and thus cannot be patented.

Judicial Exceptions

Judicial exceptions were expanded by the USPTO ruling to include the term natural products. According to this ruling, "If the claim recites or involves a judicial exception, such as a law of nature/natural principle or natural phenomenon… and/or something that appears to be a natural product (e.g., a citrus fruit, uranium metal, nucleic acid, protein, etc.), then the claim only qualifies as an eligible subject matter if the claim as a whole recites something significantly different than the judicial exception itself.”

Other non-patentable items considered judicial exceptions include abstract ideas, natural phenomena, and laws of nature. The new natural products exception applies to:

  • Products that use a natural product without significant variance in structure
  • Patents with processes that require a natural product or products
  • Patents that consist solely of a natural product

Although natural products could once be patented if they were synthesized, purified, or isolated, this is no longer the case under the new ruling. They do note that if a natural product is used to create a significantly different compound, the result may be eligible for patent protection.

Understanding the Nature of Patent Eligibility

The concept of the "nature of patent" revolves around what subject matter can legally be protected under patent law. According to the United States Patent and Trademark Office (USPTO), not every discovery or invention is eligible for patent protection. The foundational rule is that laws of nature, natural phenomena, and abstract ideas are not patentable. This principle prevents individuals from monopolizing fundamental truths that exist independently of human invention.

However, an invention that integrates these excluded elements into an innovative process, composition, or application may still qualify for patent protection. For instance, while a naturally occurring mineral or plant cannot be patented on its own, a process for extracting or using it in a novel way might be eligible.

Understanding the nature of patent law is crucial when considering whether a natural product or process qualifies for patent protection. Inventors should evaluate whether their claim involves human ingenuity that transforms the natural product into something demonstrably new and useful.

Markedly vs. Significantly Different

The USPTO uses an analytical framework that asks whether any of the claims in a patent application apply to a judicial exception such as a natural product and whether the element or combination of elements amounts to more than the judicial exception in question. The first question requires the application of the "markedly different" test.

The language of the ruling describes a significantly different compound as follows: "Claim recites elements/steps in addition to the judicial exception(s) that impose meaningful limits on claim scope, i.e., the elements/steps narrow the scope of the claim so that others are not substantially foreclosed from using the judicial exception(s).”

Based on this test, a marked difference can consist of either a functional or structural difference in the patent claim that distinguishes it from the natural product. Such differences must be significant, which means they are not conventional, routine, or well-understood in the field in which you are seeking a patent.

The ruling notes: “While a functional difference is not necessary to find a marked difference, the presence of a functional difference resulting from the structural difference makes a stronger case that the structural difference is a marked difference.”

For example, if a court is examining the patentability of a vaccine that is made from an adjuvant and an immunogenic protein must meet both parts of the analytical framework described above.

This test raises questions about whether functional differences in the product will be eligible for a patent if they are irrelevant to the invention if no structural differences are present.

Factors That Influence Patentability of Natural Products

The USPTO and U.S. courts apply several key factors when determining whether a product derived from nature qualifies for patent protection. These factors include:

  • Structural Modification: Alterations at the molecular or chemical level that result in a product not found in nature.
  • Functional Difference: Changes that lead to new properties or uses that are not inherent in the original natural product.
  • Combination with Other Elements: The inclusion of additional components that modify the behavior, functionality, or characteristics of the natural product.
  • Innovative Processes: Use of new or unconventional methods in deriving or applying the natural product.

For example, in the landmark case Association for Molecular Pathology v. Myriad Genetics, the Supreme Court ruled that isolated DNA sequences are not patentable because they are products of nature. However, complementary DNA (cDNA), which is synthetically created and not naturally occurring, was deemed patent-eligible.

This illustrates how important it is for inventors to show a "marked difference" that distinguishes their product from its natural counterpart.

Examples of Natural Products

Examples of eligible natural product patents include:

  • Natural products with a varied structure
  • Compositions made from a natural product and other structurally altered components
  • A natural product combined with an element that changes the way it functions
  • A natural product along with other components that pass the "significantly more" analysis described above
  • Devices that use a natural product with a new use that is not routine, conventional, or well-understood
  • Compositions of several natural products that create a new flavor profile or other relevant properties that are significantly different than any of the component parts
  • A natural product that has been made into a controlled-release formula
  • A natural product with specific physical attributes that support a distinguishable, relevant property of the invention

Items that may not pass the significant more analysis include:

  • Compositions made from a natural product with a carrier that is frequently used along with that type of natural product, even if the amounts of each substance are varied

Because your patent claims are evaluated on a case-by-case basis, you may want to consult with an experienced intellectual property attorney.

Key Court Cases Shaping the Nature of Patent Law

Several high-profile legal decisions have shaped the understanding of the nature of patent eligibility for natural products:

  • Diamond v. Chakrabarty (1980): The Supreme Court ruled that a genetically engineered bacterium capable of breaking down crude oil was patentable, as it was not naturally occurring.
  • Mayo Collaborative Services v. Prometheus Laboratories (2012): The Court held that a diagnostic method based on observing natural biological responses was not patentable, emphasizing that mere application of natural laws without significant innovation does not meet patent standards.
  • Association for Molecular Pathology v. Myriad Genetics (2013): The Court confirmed that isolated genes are not patentable, but synthetic DNA (cDNA) is eligible because it does not occur naturally.

These decisions highlight that while the basic laws of nature cannot be patented, meaningful human intervention and innovation can lead to patent eligibility.

Frequently Asked Questions

  1. Can natural products ever be patented?
    Natural products themselves generally cannot be patented unless they have been modified or combined in a way that makes them markedly different from their natural state.
  2. What does "nature of patent" mean?
    The "nature of patent" refers to the types of inventions and discoveries that qualify for patent protection under U.S. law, excluding laws of nature, natural phenomena, and abstract ideas.
  3. Are isolated or purified natural products patentable?
    Isolated or purified natural products may not qualify for patent protection if they retain the same structure and function as they do in nature. However, if the isolation process imparts new properties, eligibility may be possible.
  4. Can methods using natural products be patented?
    Yes, methods and processes that use natural products may be patentable if they involve new, non-obvious steps that transform or apply the product in an innovative way.
  5. What role does structural difference play in patent eligibility?
    A structural difference between the claimed invention and the natural product is a critical factor in determining patent eligibility, especially when it results in new functionality or properties not found in nature.

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