By Ralph “Donnie” Turlington, Research Analyst  

On March 19, 2013 the U.S. Supreme Court decided in favor of the chemical and agricultural biotechnology company Monsanto in the case Bowman v. Monsanto Co.[1]  The case revolved around a farmer named Hugh Bowman.  Mr. Bowman had purchased mixed soybean seeds from a grain elevator that sold seeds as commodities, not for planting.  Testing some of the seeds, he found them to be transgenic seeds resistant to glyphosate, an herbicide commonly known as Roundup, sold by Monsanto.  He replanted seeds from these plants in later harvests, he informed Monsanto of what he was doing.[2]

Monsanto sued Mr. Bowman and held the position that Mr. Bowman had infringed on their patents because the soybeans he purchased were new products and he had not been given a license from Monsanto to use them.  The Supreme Court ruled in favor of Monsanto, and found that patent exhaustion does not allow a farmer to plant patent seeds without the patent holder’s permission even if the seeds are a later generation seed.  The scope of the ruling is narrow, avoiding a broad precedent and makes the overall impact of the case small.  However, the precedent only applies when the next generation of seeds being utilized is identical to the original seeds that were patented.  What happens when later generations of patented seeds have a slightly mutated (slightly different DNA sequences)?  Are these the same seeds carrying the same patent protection, or are these seeds different and are they free from patent protection?

This issue is more likely to occur in biotechnology applications dealing with microorganisms that produce a product, or microorganisms that are used in an industrial application.  These microorganisms reproduce many times and due to large number of organisms are more likely to undergo mutations.  Are these mutated organisms protected by the same patents as the original organism?

As far as patentability, any new sequences (created on purpose or not) are treated like any other chemical entity and may be patentable as long as they meet the standard criteria: novel, nonobvious, and useful.  The mutated sequence is clearly novel if its sequence differs from the original sequence and if the mutated sequence holds some properties not present in the original sequence.

This issue may be coming sooner rather than later.  A new technology called CRISPR/Cas-9 is a tool to perform large scale but exact genomic editing.[3]  If a patent holder spends resources to develop an organism performing a specific function, can that organism’s genetic code simply be copied by another and modified using CRISPER/Cas-9 and then used without the original patent holder’s permission, possibly even patented by another party?  This would mean that the original patent holder would not gain financially from their invention.  This might lead to a lack of resources in developing new and novel organisms, and may create an advantage to be a “second mover” or someone who simply copies and slightly modifies an existing system without having to spend large amounts of resources.[4]

How can the current patent system deal with these advances?  What changes could be done to the current system to ensure that there are financial rewards for developing new biotechnologies?  When applying for a patent for a genetic sequence in the current U.S. system the applicant is able to claim a sequence that has some percentage match to the listed sequence.  This means that a sequence could be 50%, 60%, 70%, etc. identical to a claimed sequence and still be protected by the original patent.  The Patent Cooperation Treaty and the European Patent office hold similar rules.[5]  If holders of patents with a specific sequence begin to claim a percentage match to their original sequences, it would make slight modification of these sequences useless.  Someone attempting to gain a second mover advantage would have to devote resources to modifying the original sequence and then determining what improvements have been gained from the modifications.  The U.S. Patent and Trademark Office could also change how they judge patent applications containing sequences, using a percentage match, or the end product match.

Biotechnology is a rapidly changing area.  The patent system dealing with biotechnology needs to be able to keep up with the ability of researchers to create new sequences with new and novel properties.  In addition, it needs to ensure that original sequences are protected and that their owners are able to profit from their discoveries.