Dr. Jane Babin Talks Patents and Kratom

With the recent attack on kratom from the FDA, a lot of misinformation is floating around within and without the kratom community. Molecular biologist and biotech patent lawyer, Dr. Jane Babin is luckily trying to clarify the situation. One of the concerns is how the FDA and DEA may work together to schedule the plant. As a result, some people are questioning whether kratom can be patented and if so how this would affect the availability of the plant. As for whether kratom and its constituents can be patented, Dr. Babin tells us the short answer is no.

Being an expert in molecular biology and patent law places <a href="https://www.painnewsnetwork.org/stories/2017/11/25/can-kratom-be-patented">Dr. Babin in a unique position to explicate the issue</a>. Patents exist as protection of one's investment into some sort of innovation. Patent protection is also a large part of the monetary impetus behind new drug research. Proprietary methods (trade secrets) are another option for protecting an invention secret, but in the case of the pharmaceutical industry, public disclosure is necessary by law. Patent protection exists for a limited amount of time, however, in exchange for the protection the details of the invention are publicly disclosed. Patented technologies are available for the public to peruse at their leisure online. This allows for new discoveries to build on previous. Once a patent has expired, the invention can be made or altered by anyone.

<blockquote class="twitter-tweet" data-lang="en"><p lang="en" dir="ltr"><a href="https://twitter.com/TheEllenShow?ref_src=twsrc%5Etfw">@TheEllenShow</a> <a href="https://twitter.com/VICE?ref_src=twsrc%5Etfw">@VICE</a> <a href="https://twitter.com/vicenews?ref_src=twsrc%5Etfw">@vicenews</a> <a href="https://twitter.com/Montel_Williams?ref_src=twsrc%5Etfw">@Montel_Williams</a> <a href="https://twitter.com/WPBF25News?ref_src=twsrc%5Etfw">@WPBF25News</a> <a href="https://twitter.com/hashtag/help?src=hash&amp;ref_src=twsrc%5Etfw">#help</a>! Someone <a href="https://twitter.com/hashtag/please?src=hash&amp;ref_src=twsrc%5Etfw">#please</a> share the <a href="https://twitter.com/hashtag/truth?src=hash&amp;ref_src=twsrc%5Etfw">#truth</a> so many won&#39;t lose their <a href="https://twitter.com/hashtag/righttochoose?src=hash&amp;ref_src=twsrc%5Etfw">#righttochoose</a>! <a href="https://twitter.com/hashtag/plantsnotpills?src=hash&amp;ref_src=twsrc%5Etfw">#plantsnotpills</a> <a href="https://twitter.com/hashtag/IAMKRATOM?src=hash&amp;ref_src=twsrc%5Etfw">#IAMKRATOM</a> <a href="https://twitter.com/hashtag/stoptheFDA?src=hash&amp;ref_src=twsrc%5Etfw">#stoptheFDA</a> <a href="https://twitter.com/hashtag/STOPSCOTTGOTTLEIB?src=hash&amp;ref_src=twsrc%5Etfw">#STOPSCOTTGOTTLEIB</a> <a href="https://t.co/Vq1lOhUDSk">https://t.co/Vq1lOhUDSk</a></p>&mdash; danielle fortier (@danifortier728) <a href="https://twitter.com/danifortier728/status/933537126133714944?ref_src=twsrc%5Etfw">November 23, 2017</a></blockquote>

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There have been some patents that involve preparations of Mitragyna speciosa (kratom) or derivatives of the plant or its constituents. 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”), is owned by Smith Kline & French Laboratories. Since FDA Commissioner Scott Gottlieb has ties to GlaxoSmithKline (the successor to Smith Kline & French) and is even on their new drug investment advisory board, some suspect a conflict of interest may behind the most recent attack on kratom.

Until 1995, patent terms were 17 years, currently, patent protection lasts for two decades. Many of these patents involving kratom and kratom preparations are from the 1960's and are far past expiring. In addition, plant products can't be patented. Borax is one of the best tools for killing bugs. It slowly dehydrates the bugs and manages to get rid of the pest problem despite being non-toxic to pets and toddlers. Why isn't Borax advertised as one of the best pest control solutions? Because it is just boron, the 5th element and elements and plants can't be patented. As a result, some of the most effective potential solutions to our problems may exist around us in nature, but without monetary motive to invest in research, advancements are often stalled. The Smith Kline and French patent would have prevented the making, selling, use and importing of certain alkaloids isolated from kratom, but not affected the legality of the whole leaf.

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Unless a plant is changed substantially through some process it can't be patented. Courts have ruled that no substance in nature, even in impure form, can be patented. This includes isolates or synthetic extracts. If the isolate or extract contains the same chemical structure as what appears in the natural substance it is not subject to patent protection. Derivatives of natural chemicals are patentable, however. In some cases, by altering the molecular structure in specific ways, scientists are able to coax some additional benefit or specific property from an existing natural chemical compound. There have been some patents granted for kratom alkaloid derivatives. Most involve the two primary active constituents, mitragynine and 7-hydroxymitragynine (e.g. U.S. Patent Nos. 8,247,428 & 8,648,090), these patents do have a potential for becoming a new drug and may have some advantages for specific conditions over the natural form.

<blockquote class="twitter-tweet" data-lang="en"><p lang="en" dir="ltr">If you want a scientist&#39;s perspective on <a href="https://twitter.com/hashtag/kratom?src=hash&amp;ref_src=twsrc%5Etfw">#kratom</a>, watch this. The evidence presentated by the <a href="https://twitter.com/US_FDA?ref_src=twsrc%5Etfw">@US_FDA</a> is incomplete and lacking data like the other factors in these 36 deaths. Correlation doesn&#39;t equal causation. Making leaps in judgement is bad science. <a href="https://t.co/QSSgLXHtpj">https://t.co/QSSgLXHtpj</a></p>&mdash; Ahna Foxe (@AhnaFoxe) <a href="https://twitter.com/AhnaFoxe/status/931335337237815296?ref_src=twsrc%5Etfw">November 17, 2017</a></blockquote>

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One advantage of this line of research is advancing the field of understanding. Scientists studying non-addictive kratom extracts might find ways to make non-addictive, but effective forms of opioids. In a case like this, U.S. patent law allows an exception under 35 USC §371(e), allowing scientists to use patented inventions in research. This differs from scheduling under the Controlled Substances Act in that no permission or pre-approval is required to take advantage of the exemption.

<a href="https://thegoldwater.com/news/12348-Dr-Jane-Babin-Weighs-In-On-Kratom-Safety">Dr. Babin explains</a> another misconception spreading through the kratom community, not all documents that appear to be patents actually are. A patent application isn't a patent. The applications for a patent, when published, appear similar to actual patents but are not valid until the Patent Office has ruled on it. Dr. Babin explains how to discern an actual patent.

<blockquote>U.S. Patents have the words "US Patent" at the top of the first page, while applications have "US Patent Application Publication." Current patents are identified by a 7 digit number. Published applications numbers have eleven digits beginning with a 4 digit year. For example, 9,458,426 is a US patent, while 2014/0186948 is a published application.</blockquote>

According to Dr. Babin, of the many obstacles that stand between us currently and the normalization and guarantee of availability of kratom, patents are not one of them.