Patents on Genetically Modified Organisms

            There are countless uses for the manipulation of genes in plants, animals, and humans.  Whether to create a disease-resilient food source, enhance nutrition, create larger meat livestock, shorten growing seasons for crops, or repelling certain types of insects (Purdue University College of Agriculture, n.d.).  People against genetic modification of organisms argue that the effects are unknown when genetically modified organisms are introduced to the environment, including the effects on the ecosystem, the food chain, and human health.  People for genetic modification of organisms argue that their outcomes are needed by humanity, whether higher crop yields to feed the world, or a disease-resistant plant seed that avoid infestation, crop loss, and possible famine.  Food is a common target for genetic modification, but so are houseplants like blue roses (Purdue University College of Agriculture, n.d.), pets like GloFish that glow in the dark, insects, and human traits such as diseases, defects, and cancers.  What about the business behind this modification and their rights to the product they have modified?

            Activist Jeffrey Smith, author of a book about the genetic engineering industry called Seeds of Deception, explains that many of the companies engineering organisms (such as mosquitos in his example) have not undergone significant testing (Smith, 2020).  This means that companies are patenting and releasing genetically altered organisms into the environment where they have effects on nature as well as humans, with almost no testing to know whether there will be some other catastrophic effect created by their custom organism.  Jeffrey Smith also explains that companies in the industry want to patent everything they create with DNA because the gene editing process is so expensive that they want to protect their investment (Smith, 2020).  While this is true, there are scientists and people in the genetic industry that believe that genetically modified organisms are safe, such as the National Academy of Sciences, which released a report in 2016 on the science, safety, and regulation of genetically modified food (Haspel, 2016).  It is interesting to note that while performing research for this paper, it became visible that almost ever university agriculture department has information which argues that genetically modified foods are safe, so the academic viewpoint is clear:  genetic modification is okay.  Should the genetic modification be patentable, though?

Defending the Patents of Engineered Organisms:  New and Useful Invention

            In Canada, there are instances of the courts ruling that no life form can be patented, such as in a mouse in Harvard College v. Canada, but in other cases, the courts ruled that certain life forms are patentable, such as in genes in plant cells in Monsanto Canada Inc. v. Schmeiser (Trademarks Patents Lawyers, 2017).  The distinction seems to be in what patent subjects the courts determine to be higher life forms.  Canada will patent genes, bacteria, fungi, and cells, but full animals and plants are not patentable in Canada (Trademarks Patents Lawyers, 2017).

            In the United States, patents can be applied to new plant breeds down to the cells and genes (Lau, 2011, p.268).  The whole organism or any of its parts are patentable.  In the 1980 decision Diamond v. Chakrabarty, the U.S. Supreme Court ruled that a “live artificially-engineered microorganism” is patentable as well as the processes and composition of it, if it is a new and useful invention and not a discovery (Diamond v. Chakrabarty, 1980).

            Harvard explains that patents are needed to encourage innovation by protecting inventors with a 20-year window of exclusive rights to their invention, and that GMO plants cost an average of 8 years (Haggarty-Weir, 2019) and $136 million to develop, so companies would not be willing to embark on the innovation without protecting investment with patents (Zhou, 2015).  In other words, without patents to protect their research and development efforts, companies would not risk innovating in those areas.  Patents give inventors room to capture market share due to their innovation, so they are a necessity in order to continue to spur growth.  Twenty years in the fast-paced modern age seems ridiculously long.  After that twenty years, the invention becomes public and other companies have access to reproduce it (Zhou, 2015).

            So, patents allow companies to research their genes and further develop and innovate their product without competition, which opens up investment opportunities (Genetics Generation, 2015).  Investors are willing to invest in a genetically engineered organism with a patent because it has potential in the market without competition for up to twenty years.  The right investments in research and product development can help a small company with a patent grow and become profitable before bigger companies compete with them.

            From an ethical point of view, genetically modified organisms are a necessity in a world of climate change and increased diseases on crops, and the patents are crucial in allowing researchers to develop and test the best ways to create disease-resistant, safe crops to feed the world (Genetics Generation, 2015).  Since humankind has the technology to improve the world and avoid famine, they should, and patents enable them to continue their research uninhibited.

            Beyond food, there are a lot of other genetically engineered organisms such as genes for cancer treatment that need to be protected.  Companies working on cures for diseases need to be able to protect their work so that they can continue to work on the cures for new drugs and treatments, which may include gene therapy or gene modification on animal or human cells.  In order to protect their rights and continue research toward cures, patents are needed.  Without those patents, investors may not invest in the new medicine or treatment (Schwartz, 2011).

Against the Patents of Engineered Organisms: Product of Nature

            Those against the patents of engineered organisms are usually in one of two camps:  those who say it is unethical or say it is environmentally irresponsible, and those who are against patents in the first place.  Most visible in these are activists like Greenpeace, who typically cite environmental impact for arguments against genetically modified organisms (Watts, 1992).  Citing that the GMOs will affect plant populations, insect populations, animals, and humans due to lack of testing is a common argument on the environmental irresponsibility camp.  Greenpeace also bring up that GMOs can elevate cancer risk or increase allergic reactions, does not actually increase yield nor solve hunger issues, and introduce toxins to the environment, and should not be patented nor produced and distributed (Cotter, 2011).

            One camp is the anti-GMO camp which believes that altering the genes of plants and animals is either unethical or dangerous.  There is a religious argument tied to the ethical argument which argues that people should not be tampering with nature and playing god or that life itself is sacred.  This side of the argument has a completely valid point:  there is never sufficient testing to know every possible expression of a gene, the impacts on the entire environment, and the impacts on human health.  Since nature is a complex system, there is no way to know whether a genetically engineered organism will be invasive or introduce other side effects on the world as a whole. 

            The other camp is the anti-patent camp that believes that patents inhibit innovation and hurt small inventors and farmers while being strongly in favor of big business (Haggarty-Weir, 2019).  Patents can hinder research because a company is not likely to innovate and research something that another company has exclusive rights on (Genetics Generation, 2015).  This means that there are potential innovation opportunities that are being missed because the exclusive rights to an organism may block researches from researching it.

            The anti-patent camp includes the farmers that want to save seed for next year but are not allowed to since the gene in that plant is exclusively owned by the patent holder.  For instance, a farmer buys genetically engineered seed and grows GMO corn.  The farmer harvests a small part of their corn as seed stock for next year.  This is illegal, since the patent-holder owns the patent to that seed variety, and the farmer must pay royalties to the patent holder.  This is the concept behind the 2008 Monsanto Co. v. David, the farmer Loren David saved seeds from the previous year’s harvest to sow for the following year.  The argument is that the ability of a farmer to save seeds per the Plant Variety Protection Act does not break the protection of patented organisms under the Patent Act.  As a result, the farmer Loren David was sued for total damages of $786,989.43 by Monsanto (Finnegan, n.d.).  Although this is a huge win for big business, the protection stops farmers from doing what they have done for thousands of years:  save seeds for future crops.

            The farmers also have a financial responsibility to the patent holder (often Monsanto) in the event that their other seed cross-pollinates and breeds with a patented crop.  The plants created from this cross-pollination, if they contain the genes of the patented crop, still belong to the patent holder.  This means that a farmer has a responsibility for their crops cross-breeding with the patented GMO crop and can be sued for patent infringement (Lau, 2011, p.270).  Many farmers are not big businesses and do not have great margins, so keeping them from seed saving is extremely painful.  This is an example of why genetically modified organisms should not be protected by patents.

            Outside of food, there are other places where genes are being patented.  Myriad Genetics, for instance, patented a human gene involved in a cancer study.  The courts ruled against patenting human genes since they are a “product of nature,” not an invention.  Patents in this case would limit innovation and testing rather than creating an environment that fosters invention (Schwarts, 2010).  After all, in a race for a cure, what is the point of limiting the research to only one company?

Conclusion

            There are ethical arguments on both sides of the genetically modified organism patent discussion.  Do companies really need a patent to protect their research and get funding, or would the world be better served by keeping the playing field level and allowing competition.  In trying to feed the world with higher crop yields and disease-resistant varieties, or in trying to fight cancer, there is significant investment from the research company that they wish to protect with a patent.  This research and innovation probably never would have been undertaken the investment.  In search of a profit, are these corporations really considering public safety and the welfare of the environment?  In the end, patents are there to protect the inventor’s rights to their invention.  This is a good thing.  There are some cases, like with human DNA and working toward a cure for cancer, when holding onto a gene for twenty years is an edge case that does not work for humanity, and the patent gets in the way of research and innovation.

References

Cotter, Janet. (2011). Busting the GM myths: a view from Greenpeace. Retrieved from https://theconversation.com/busting-the-gm-myths-a-view-from-greenpeace-3610

Diamond v. Chakrabarty. (1980). Oyez. Retrieved July 20, 2020, from https://www.oyez.org/cases/1979/79-136

Finnegan. (n.d.).  Planting Seed Containing a Gene Sequence Infringes a Patent Covering That Sequence.  Retrieved from https://www.finnegan.com/en/tools/monsanto-v-david/analysis.html

Genetics Generation. (2015). Patenting Genes: Pros and Cons. Retrieved from https://knowgenetics.org/patenting-genes-pros-and-cons/

Haggarty-Weir, Christopher. (2019). Arguments For and Against GMO Patents. Retrieved from https://mostlyscience.com/2019/03/arguments-for-and-against-gmo-patents/

Haspel, Tamar. (2016). Scientists Say GMO Foods Are Safe, Public Skepticism Remains. Retrieved from https://www.nationalgeographic.com/culture/food/the-plate/2016/05/17/scientists-say-gmo-foods-are-safe-public-skepticism-remains/

Lau, T. & Johnson, L. (2011). The Legal and Ethical Environment of Business (Vol. 1). Flat World Knowledge.  Retrieved from https://resources.saylor.org/wwwresources/archived/site/textbooks/The%20Legal%20and%20Ethical%20Environment%20of%20Business.pdf

Purdue University College of Agriculture. (n.d.). Why do we use GMOs? The Science of GMOs.  Retrieved from https://ag.purdue.edu/GMOs/Pages/WhyGMOs.aspx

Schwartz, John. (2010). Judge Invalidates Human Gene Patent. Retrieved from https://www.nytimes.com/2010/03/30/business/30gene.html

Smith, Jeffrey. (2020). They Want to Patent Everything With DNS. Should We Be Concerned About Genetically Engineered Insects. [Video] Youtube. The Real Truth About Health. Retrieved from https://youtu.be/7CL6LNVuw3A

Trademarks Patents Lawyers. (2017). Can You Patent Life Forms in Canada? Retrieved from http://trademarkspatentslawyer.com/can-you-patent-life-forms-canada/

Watts, Susan. (1992). Greenpeace warns of threat from crop patent deal. Retrieved from https://www.independent.co.uk/news/uk/greenpeace-warns-of-threat-from-crop-patent-deal-1565928.html

Zhou, Wen. (2015). The Patent Landscape of Genetically Modified Organisms.  Retrieved from http://sitn.hms.harvard.edu/flash/2015/the-patent-landscape-of-genetically-modified-organisms/

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