Several misconceptions exist when it comes to patenting natural products due to commonly held beliefs about them. Here are some key points that will help you understand whether an invention involving a natural product is patentable or not. The list will give you pointers in the right direction. It is important to note that we are only discussing patent eligibility i.e., whether your application is eligible to be considered for a patent in the first place. There are many other thresholds to overcome to get a patent granted.
Under patent eligibility, the first threshold is whether the claims in the patent application fall under any of the following four statutory categories: composition of matter, process, machine, and manufacture. They SHOULD fall into one of these categories, and most patent applications involving natural products often do. The second threshold is whether the claims in the application fall under judicial exceptions to the aforementioned four categories. These exceptions are laws of nature, natural phenomena, and abstract ideas. For inventions to be patentable, the claims SHOULD NOT fall under these exceptions.
For those unfamiliar with the term “claims”, they are a section in patent applications where the inventor states what exactly he/she is seeking a patent for. The rest of the application (termed “specification”) along with “figures” and an “abstract” provides supporting material for the claims that are made in an application. The main point to remember is that a patent is not just about the subject matter, a natural product in this case, but primarily the claimed subject matter, which is the matter that the inventors are seeking to exclude others from practicing. The claims ultimately determine patent eligibility.
One of the driving ideas behind creating patent eligible subject matter is to grant patent rights ONLY if the claims in the application are NOT so broad that they prevent everyone else from making further progress in that area. This is why natural phenomenon/laws, abstract ideas and mathematical equations are not patentable. The aforementioned exceptions’ list is more expansive and intends to ensure that the basic tools of scientific and technological work are not patented. When claims in a patent application are directed to one of the judicial exceptions, the threshold to overcome is whether the claim as a whole, amounts to significantly more than the exception itself. In other words, whether an inventive concept is present or not. Along similar lines, the assessment of patent eligibility of natural or nature-based products are performed by comparing what is covered in the claims to their naturally occurring counterparts, to determine if they have markedly different characteristics than their natural counterparts or not. The presence of markedly different characteristics is considered as evidence for the presence of inventive concept(s).
Natural products are NOT patent eligible if
- The claims are directed to their composition and they are identical to their natural counterparts.
- The claims are directed to their compositions although the inventor managed to synthesize them. This is because the composition remains the same whether the inventor isolated it or synthesized it.
- The claims are directed to formulations that merely combine two (or more) natural (or synthetic) products where they simply carry out their own actions without changing the property of one or the other or does not have an unexpected outcome as a result of combining them. In other words, they do not have markedly different characteristics than their natural counterparts.
- The claims are directed to a product made by a process, but the product is not different from its natural counterpart.
- The claims are directed to natural processes (Metabolic pathways, Signaling pathways) or natural correlations (insulin-sugar).
Natural products ARE patent eligible if
- The claims are directed to the composition that has been modified, for example, by changing the structure of the product to one that does not exist in nature, so that it is different from its natural counterpart (see how the product is not “natural” anymore).
- The claims are directed towards how to make/manufacture/synthesize them (see how the claims are not for the composition, but are directed towards making or manufacturing them, and the category shifts from composition to process/method or manufacture). Now, the protection being sought is not for the naturally occurring product itself, but for a new process that has been invented to synthesize it.
- The claims are directed to one or more methods for isolating them from their natural environment, for example, purification of a naturally occurring enzyme, drug etc. (see how the claims are now for the process and not the natural product itself).
- The claims are directed to their use. For example, CRISPR that exists naturally in some bacteria can be patented if you are NOT trying to patent CRISPR itself, but rather its use for doing the same (not exactly the same though; remember the characteristics have to be markedly different, so just moving from one species to another does not suffice, if there is a natural counterpart) thing in another environment or a different thing in the same environment (notice how the inventive process starts playing a role, making it different from its natural product or process counterpart). Methods patents like CRISPR are examples for this class of patent eligible subject matter (A method for editing genes in prokaryotes OR eukaryotes using CRISPR). Such patents may also include new compositions (for example, alterations in nucleic acid/protein sequence) that accomplish these new tasks.
- The claims are directed to formulations containing them and the formulations claimed have markedly different characteristics from a naturally occurring one or from one with a potential to occur naturally or in another formulation already known. For example, formulations that add desirable properties to a natural product will be patent eligible. An example that won’t make the cut is the formulation of a natural product in water, as it is very likely to exist in nature.
- The claims are directed to a product made by a process, and the product is different from its natural counterpart.
- The claims are directed to methods that modify or monitor natural processes, natural correlations, or natural laws, as they are likely to involve an inventive concept. Take CRISPR patents for example: all of them are for inventive concepts that exploit CRISPR/Cas9’s unique properties for something that was not obvious/natural.
Since there are many wrinkles to be carefully analyzed, getting a good patent professional involved right from the start would be a great idea for maximizing your chances of obtaining a patent for a natural product-based invention.
In essence, the key is what exactly does the patent application claim.
About the author
Dr. Syam Anand, PhD (Indian Institute of Science, IISc; Post doctoral research, University of Pittsburgh School of Medicine; Faculty, University of Pittsburgh School of Medicine, Founder and US Patent Agent, Mainline Intellectual Property LLC, Ardmore, Philadelphia USA). Syam has over 20 years of experience in diverse areas of science with domain knowledge in Life Sciences and Intellectual Property. Dr.Anand is also an inventor and budding entrepreneur. A rationalist, Dr. Anand enjoys science at all levels and advocates the use of scientific methods for answering all questions and solving all problems, and making common people curious and interested in understanding their worlds.
Arunima obtained her PhD from the University of Georgia, and is currently a postdoctoral researcher at the New York University. A computational structural biologist by training, she enjoys traveling, reading, and the process of mastering new cuisines in her spare time. Her motivation to move to New York was to be a part of this rich scientific, cultural, and social hub.
Paurvi Shinde is a recent PhD, in Biomedical Sciences (Immunology) with expertise in T cell activation pathways. She currently works as a Postdoctoral Fellow at Bloodworks Northwest in Seattle, where she studies the mechanism of how alloantibodies are formed against ‘non-ABO Red Blood Cell antigens’. Apart from science, she loves editing scientific articles to convey the message behind it, in a clear and concise form.
Conflict of interest: The author is a US patent agent
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