Kratom is a South East Asian tree related to the coffee shrub. It has been used safely for centuries in the countries where it is indigenous. Last year, the kratom community faced an extra-judicial scheduling by the Drug Enforcement Agency. Bipartisan support from both houses of Congress as well as the vocal support of leading scientists, clinical researchers, medical professionals and addiction experts led to an unprecedented backdown of the DEA. Around a year out from the kratom communities literally historic win, the FDA seems to have picked up where the DEA left off.
After an advisory by Food and Drug Administration (FDA) commissioner Scott Gottlieb warning against the use of kratom, the kratom community mobilized once again. With the recent attack, there has been ample misinformation both within and outside of the kratom community at large. Dr. Jane Babin is a molecular biologist, biotech patent lawyer, doctor of jurisprudence and kratom advocate. She recently wrote a guest column for Pain News Network to clarify the situation regarding the patentability of kratom and what that would mean for the kratom community. Many within the kratom community have expressed concerns that the FDA may work with the DEA to schedule the plant. Rumors that kratom may show up as an investigative new drug (IND) have further confused the matter. As for whether the plant kratom can be patented, Dr. Babin assures us that the short answer is no.
As an expert in molecular biology and patent law Dr. Babin is in a unique position to explain the issue.Patents are issued as protection of one’s investment into an invention or innovation. Without patent protection, the new drug research we see wouldn’t be as profitable. In the pharmaceutical industry, regulations require full disclosure of contents, so proprietary methods or trade secrets don’t apply. Patent technologies are available to read online, but provide protection for a period of 20 years. Once the patent has expired, the invention or process can be used, appropriated or adapted by anyone.
Some patents involving preparations of Mitragyna speciosa (kratom) or derivatives of the plant have existed. For instance, U.S. Patents 3,256,149 (“Compositions Compromising an Alkaloid of Mitragyna Speciosa and Methods of Using Same”) and 3,324,111 (“Speciofoline, an Alkaloid from Mitragyna Speciosa”), was the source of some rumblings in the kratom community when it was discovered the patent was owned by Smith Kline & French Laboratories. FDA Commissioner Scott Gottlieb has ties to GlaxoSmithKline which is the successor to Smith Kline & French. He is even on a board of GSK. Dr. Babin pointed out that the patent that GSK holds has long since lapsed.
As of 1995, patent protection lasts for a period of two decades. Before that, the patent held for 17 years. Several patents and patent applications have existed that involve kratom or its derivatives. Many of them, however, date back to the late 1960s. Plant products cannot be patented. The same is so for other natural compounds. Boric acid, for instance, is touted as an excellent solution for pest control. You don’t see many major companies investigating in advertising its potential however because as a form of Boron (the fifth element) it is not patentable. Patents provide not only protection in an investment in some form of innovation, but a monetary motive for investing in research and advertising. As for concern for how the Smith Kline and French patent would affect the whole kratom, Dr. Babin explains that though the patent would have prevented the sale, manufacture, use, and import of certain alkaloids isolated from kratom, it would not affect the legality or availability of whole or powdered leaf material.
In order to be eligible for patent protection, a plant must be substantially altered through some process. Courts have previously ruled that no substance in nature may be patented as is. This also includes isolates and extracts of natural compounds. If the extract is unaltered from that appearing in nature, it can not be patented. By slightly tweaking the molecular structure of a natural compound, scientists can often change the properties of the chemical itself. Studying kratom could potentially lead to the development of non-addictive opioids, Dr. Babin hopes. As for the potential of new drugs derived from kratom, Dr. Babin points out that the two primary active constituents, mitragynine and 7-hydroxymitragynine show up in U.S. Patent Nos. 8,247,428 & 8,648,090. There is some potential in her opinion for these patents to become a new drug which may have some advantages in specific situations over the natural form.
@TheEllenShow @VICE @vicenews @Montel_Williams @WPBF25News #help! Someone #please share the #truth so many won’t lose their #righttochoose! #plantsnotpills #IAMKRATOM #stoptheFDA #STOPSCOTTGOTTLEIB https://t.co/Vq1lOhUDSk
— danielle fortier (@danifortier728) November 23, 2017
Dr. Babin also expressed a hope that research into kratom could lead to the development of new drugs. As for how that might affect the kratom community, she explains that U.S. patent law provides an exemption under 35 USC §371(e), which allows scientists to use patented inventions in research. Unlike scheduling under the Controlled Substances Act, no permission or pre-approval is required to take advantage of the exception. Another misconception Dr. Babin explains is that not everything that appears to be a patent is actually a patent. Patent applications are nearly indistinguishable to the untrained eye from patents. U.S. Patents will have the words “US Patent” at the top of the first page. If the first page reads “US Patent Application Publication” it may not yet be approved by the U.S. Patent and Trademark Office. Current patents will have a 7-digit identification number, whereas published applications feature an 11-digit identification number followed by a 4-digit year. As far as Dr. Babin is concerned, though we are not out of the woods as far as kratom’s continued availability goes, fears regarding patent protection should not be a concern.
If you want a scientist’s perspective on #kratom, watch this. The evidence presentated by the @US_FDA is incomplete and lacking data like the other factors in these 36 deaths. Correlation doesn’t equal causation. Making leaps in judgement is bad science. https://t.co/QSSgLXHtpj
— Ahna Foxe (@AhnaFoxe)