GMOs Demystified- Part 4: Biological Patents

Rural System, above all else, is an approach to land management that emphasizes reasonableness in making management decisions. “How much profit can be made?” is balanced with “How long will profit be made?” “What’s good for humans?” is balanced with “What is good for the ecosystem?” All management decisions are made according to the most recent scientific knowledge on the topic.

The debate over genetically modified food has been extensive and multi-faceted. Like many sensationalized issues, it can be difficult to sort out truth from bias. The series of posts before you is a guide to GMOs based on available science rather than uninformed opinion. Our fourth question: should biotech companies be able to patent genetic sequences?

Biological PatentsHere is where the issue of genetically modified crops departs from science and enters the much more difficult and hazy realm of politics. The question of patenting the genetics of an organism is one of money and power, not science. However, we can explore the various perspectives here and take a look at some of the sociological effects of biological patents.

We can start off by acknowledging the near monopoly four American companies have over American seed stock: Monsanto, DuPont, Syngenta, and Dow AgroSciences. These four companies have control of 70% of the corn seed market and 50% of the soybean seed market. This amounts to a lot of power, so much so that farmers find it difficult in some areas to come by conventional seed.

You have to wonder why adoption rates for GM crops are so high; if the crops weren’t beneficial to the farmers, why would they bother spending the extra money? Granted, the companies’ control would not be nearly so tenacious if farmers were legally allowed to harvest and save seeds from their GM crops. But then what incentive would they have to continue to research GM crops? One season likely wouldn’t be enough even to break even after all the money they spent on research & development, much less make a profit.

Is biotech simply too expensive? Should we look for alternatives to GM crops?

Farmers aren’t the only stakeholders in the decision on whether genes can be patented, however. The issue of biological patents is much larger than GM crops, encompassing medical research, medical testing, and whole-genome projects such as sequencing the human genome.

The earliest biological patents had nothing to do with GM crops. Rather, the earliest biological patents were for the human growth genome in 1978. The patents were immediately controversial, in large part because of Title 35 of the United States Code, which specifies that for something to be patentable, it must be a “new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” A sequence of DNA is not novel, so it is questionable whether it would qualify for a patent. Title 35 also states that the invention cannot be obvious to”a person having ordinary skill in the art to which said subject matter pertains.” Creating recombinant DNA is an increasingly common practice in genetics labs worldwide. Is the splicing of two pre-existing DNA sequences the creation of something novel? Is it beyond “ordinary skill” for a geneticist?

One study estimates that 20% of the human genome has been patented by various private firms and universities. About 10% is covered by patents owned by Incyte, a California-based drug company.

In 2010, the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) released the results of their study on the effects of biological patents. There had been concerns that patents on genes, particularly human genes, creates a situation in which the owner of that patent is the sole provider of tests relevant to that genetic sequence. For example, tests for mutations in breast tissue indicative of breast cancer have been in the hands of one sole provider for years. Of course, this means the tests are exorbitantly expensive, throwing equity into a grim light. The situation is worsened if the provider does not accept a patient’s insurance policy.

The study found that patents on genes restricted the ability of other biotech companies to research anything related to the patented gene. There was therefore no competition in the market, and worse, no further research to find better tests and alternatives. The quality of tests from a sole provider is quite suspect.

“The most robust method for assuring quality in laboratory testing is through the comparison of results obtained on samples shared between different labs. Moreover, the presence of multiples laboratories offering competing genetic testing for the same condition can also lead to improvements in the overall quality of testing through innovation in developing novel and more thorough techniques of testing. Neither sample sharing nor competition is possible when an exclusive-rights holder prevents others from providing testing. As a result, significant concerns about the quality of a genetic test arise when it is provided by a patent-protected sole provider.” SACGHS

It is no surprise that the Supreme Court ruled against biological patents on gene sequences in 2013. Now research can continue uninhibited. Also, biotech companies still have some measure of patent protection, in that cDNA still qualifies for patents. Anything that was engineered in a lab and is not exactly the same as its native form is still protected.

This means genetically modified organisms are still protected by patent laws. Monsanto has already won $23,675,820.99 in settlements from 72 recorded court cases over patent infringement. The most publicized of these cases was Bowman v. Monsanto in May of 2013. Bowman was an Indiana farmer who had purchased some mixed GM/non-GM seed from a grain elevator nearby. Because such a high percentage of American cropland is planted with GM crops, it was extremely likely that the seed had come from GM plants. Bowman wanted to plant the less expensive seeds for a late season crop, which is riskier. He did spray the plants with glyphosate, which would have killed them unless the plants were “Roundup Ready,” or glyphosate resistant. He had been doing this for 8 years before Monsanto sued him. His defense was that he had purchased the grain from a third party and so he claimed this was a case of patent exhaustion (such as when you buy a used book on Amazon). Ultimately the Supreme Court ruled in favor of Monsanto, partially to protect the thriving biotech industry and to protect the power of patents on all self-reproducing technology (including software).

Who was in the right? Monsanto, protecting their huge investment in the research & development of GM crops? Or Bowman, trying to make ends meet from year to year? How long and how far should patents protect biotechnology? What is reasonable?

There is plenty of information on the GMO controversy, but it is much easier to navigate with a guide. Our next post will address both sides of an argument: should products with GM ingredients be labeled?

Read the whole series, or pick a topic that interests you:

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About Laurel Sindewald

Laurel is an alumna of Warren Wilson College with a BS in Conservation Biology and a BA in Philosophy. She is a writer for Rural System, Inc.

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