By Jane Babin, Guest Columnist
Discussions surrounding kratom are heating up following the Food and Drug Administration’s public health advisory, and questions have appeared about whether kratom and its constituents are patented or could be.
The short answer is no.
Patents are important tools for protecting investment in innovation. Without patent protection, far fewer new drugs would be developed. An alternative is to keep details of an invention secret to ensure that no one will be able to copy it. However, this approach isn’t possible in the pharmaceutical industry, where regulations require extensive public disclosure.
To encourage inventors to share details about their inventions, the U.S. grants a patent right to prevent other people from making the same invention for a limited time, in exchange for publicly disclosing the details about the invention. The public can read patents and apply their disclosures to other situations, which immediately advances science and technology. After a patent expires, the invention itself can be made by anyone.
Patents Granted for a Limited Time
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”), were both granted to Smith Kline & French Laboratories.
FDA Commissioner Scott Gottlieb has ties to GlaxoSmithKline (the successor to Smith Kline & French) and some have suggested a conflict of interest motivated his warning about kratom.
If there is a conflict, it isn't over these patents, which were issued in the 1960's and have long since expired. Patents are granted for a limited time. Currently, patents expire 20 years after filing. Prior to 1995, a patent term was 17 years from the date of issuance.
Products of Nature are Not Patentable
Prior to their expiration, the two patents gave Smith Kline & French the right to prevent others from making, using, selling, and importing certain alkaloids isolated from kratom, but not the whole plant or leaf.
Plants themselves and other substances found in nature have never been patentable, unless they are changed substantially by an inventor. In the 1960s, isolating a substance from a plant was considered a substantial change to the substance. Today it isn’t.
Courts have held that substances found in nature, even in impure form, cannot be patented whether they are isolated from a natural source or synthesized in a lab. If a chemical has the same structure as a natural substance, it is not patentable.
Derivatives are Patentable
Derivatives of natural chemicals can be patented, however. As good as a natural chemical may be, changing it slightly may make it even better -- or worse. Scientists tweak a compound's structure to alter its properties, repurpose it, investigate interactions with other molecules, and design around compounds that are unpatentable.
Patents have been granted for derivatives of kratom alkaloids, particularly derivatives of mitragynine and 7-hydroxymitragynine (e.g. U.S. Patent Nos. 8,247,428 & 8,648,090), which potentially may become new drugs that are improved over natural alkaloids.
Even if they are never commercialized, studying how structural changes affect biological activity can lead scientists to modify other compounds to impart similar properties. For example, making non-addictive kratom derivatives may show scientists ways opioids could be made non-addictive.
U.S. patent law recognizes the importance of such inquiry and includes an exception under 35 USC §371(e), allowing scientists to use patented inventions in certain types of research. Unlike scheduling under the Controlled Substances Act, no permission or pre-approval is needed to take advantage of this exception.
Distinguishing a Patent from a Published Application
Another misconception about patents is that every document that looks like a patent is one. To obtain a patent, an inventor must first file an application, which doesn't become a patent until the Patent Office is satisfied that it meets all legal requirements. Whether granted or not, the application is usually published, and it looks very much like a granted patent.
There are two ways to distinguish a U.S. patent from an application:
- 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.
Foreign countries also issue patents and an inventor must obtain a patent in each country where he or she wants to enforce patent rights. Thus, there may be multiple patents covering the same invention in different countries. Each country has its own numbering system and may or may not publish applications prior to granting them. Instead of immediately filing multiple applications in foreign countries, inventors can initially file a single international application with the World International Patent Organization (WIPO) under the Patent Cooperation Treaty (PCT), which can be used as the first step toward patents in many countries.
Requirements for a Patent and Examination
Applications don't automatically become patents. They are first examined to see if a patentable invention that meets certain legal criteria is described and claimed. In addition to claiming patentable subject matter, an invention must be novel, non-obvious, and the application must disclose sufficient description that someone in the field would be able to make and use the invention.
Examination involves a dialogue between applicant and a patent examiner, often resulting in changes to the claims (the legally enforceable part of a patent). Some applications are never granted.
US 2010/0209542 is a kratom-related application that is frequently discussed. It claims a method for treating withdrawal from an addictive substance using a kratom extract. When this application was first examined, it was rejected because existing literature described kratom itself as being addictive. The applicant might have overcome this rejection by arguing that kratom is non-addictive or that other addictive substances are used to treat withdrawal. However, the inventors faced bigger challenges because they didn't actually treat anyone for withdrawal with a kratom extract and described no studies of their own showing the method actually worked.
Self-treatment using kratom had been reported, but that didn’t help the application because it meant that the applicant was not the first to "invent" the method and the invention was not novel. Facing an uphill battle, the application was abandoned and never matured into an enforceable patent.
There may be many obstacles on the path to general acceptance of kratom as a beneficial herbal supplement. Fortunately, patents are not one of them.
Jane Babin, PhD, is a molecular biologist and a biotechnology patent attorney in southern California. Jane has worked as a consultant for the American Kratom Association, a pro-kratom consumer group.
The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.