Great post. I've been aware of this information for awhile, and I've explained it to my family to no avail. Maybe non-Christards can understand better.
https://www.upcounsel.com/how-to-patent-a-natural-product
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"Not only are processes patentable, but the use of a material for a particular application may be patentable in some cases; a new use for a known material may thus represent patentable subject matter."
Updated November 10, 2020:
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.
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.
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.
https://www.upcounsel.com/how-to-patent-a-natural-product
Quotehttps://www.science.org/content/blog-post/can-you-patent-natural-product-prepare-different-answer
Can You Patent A Natural Product? Prepare For a Different Answer
So, can you patent naturally occurring substances, or not? That's a rather complicated question, and some recent Supreme Court decisions have recomplicated it in US patent law. Mayo v. Prometheus and Assoc. Mol. Pathology v. Myriad Genetics. The latter, especially, has sent the PTO (and the IP lawyers) back to staring out their respective windows, thinking about what to do next.
The Patent Office has now issued new guidelines for its examiners in light of these rulings, though, and things may be changing. Previous standards for patenting naturally occurring compounds have been tightened up - if I'm reading this correctly, no longer is the process of isolation and purification itself seen as enough of a modification to make a case for patentability. 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. And examiners are specifically asked to determine if a patent application's claims recite something "significantly different" than these.
Here's the blog of an IP firm that thinks that the USPTO has gone too far:
Now we learn that grant of these and similar patents were mistakes, that 100 years of consistent practice in the field of patents was wrong, that what was invented was no more than products of nature without significant structural difference from the naturally-occurring materials, and that the USPTO will endeavour to avoid such mistakes in future. . .
. . .Whatever workable rule of law is derivable from Prometheus, it is apparent from the opinion of Justice Breyer that it was not the Court's intention to bring about a radical change in pharmaceutical practice. The opinion gives a warning against undue breadth:
"The Court has recognized, however, that too broad an interpretation of this exclusionary principle could eviscerate patent law. For all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas."
The problem (and it's the usual problem with fresh patent law) is that we really don't know what the phrases in the decisions or guidance mean, in practice, until there's been some practice. This is going to be thrashed out application by application, lawsuit by lawsuit, until some new equilibrium is reached. Right now, though, if you're trying to patent something that could be considered an isolated natural product, your life has become much more complicated and uncertain. Here's another IP law firm:
What is the "significantly different" standard? With respect to natural products, the Guidance offers that what is claimed should be "non-naturally occurring and markedly different in structure from the naturally occurring products". Again, it is unclear at this point how different "markedly different" will be. How different it needs to be will be worked out on a case-by-case basis, beginning at the level of the patent examiner at the USPTO.