A Genetically Modified Garden of Eden: The Role Patents Play in U.S. Food Production

Written by Liberty Smith

When we were children, having “too much of a good thing” may have seemed like an illogical warning aimed solely at restricting quantities of dessert. As adults, however, the wisdom of this aphorism unfolds once we arrive at the unfortunate conclusion that many widely held human values exist in opposition to one another when exercised to their fullest extent. Thus, it is no surprise that the U.S. struggles to achieve this moderation when it comes to incentivizing and regulating innovation. [1] With the birth of a new nation, especially one empowered by revolution, comes a desire for change; however, coupled with the Age of Enlightenment and the Industrial Revolution [2], intellectual property changes occurred quickly in the U.S. during the 18^th and 19^th Centuries. [3] Despite the novel industrial landscape, the U.S. forged onward, and in an effort to ensure that corporations would prioritize the discovery, application, and publication of new technology, it adopted U.S. Patent System [4], which is regarded as rather liberal when compared to other countries. Congress, in support of the U.S. Patent System, enacted various laws which authorized the issuance of limited monopolies on new inventions in order to encourage perpetual industrial progress and economic growth. [5]

When most people think of patents, they tend to envision machinery, computers, medications, tools, and communication devices, because these are inventions well-known to the public. However, as our scientific knowledge rapidly evolves, patentable subject matter has become less discernable to the masses. [6] For example, many do not realize that a big reason most food in the U.S. is considered heavily processed [7], unhealthy [8], or unnatural [9], is that processed foods are not only cheaply produced [10], but also easily patented [11], and patents are one of the main ways large food corporations make their profit. [12] Kellogg’s patent for flaked cereal and the process for preparing it was issued in 1896. [13] Kellogg’s original patent has long since expired; however, slight but novel changes in the recipes and manufacturing processes have allowed Kellogg to own 739 active patents as of 2022. [14] With the relatively recent ability for food giants to patent more naturally occurring foods by genetically modifying them, the stakes have been raised. [15] In 2013, 95% of the canola crops planted and 99.9% of sugar beets harvested were genetically modified organisms (or “GMOs”), and in 2020, 94% of soybeans, 96% of cotton, and 92% of corn crops planted were GMOs. [16] The initial investment cost in biotechnology is worth it for large corporations looking to turn a heavier profit as opposed to producing more natural food products, which, without genetic modification, are not themselves eligible for patent protection (though various processes by which they are sourced or prepared may be). [17]

Federal patent law states that “whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor.” [18] The term “composition of matter” is especially applicable to food patents, as it includes “mixtures of ingredients” and “new chemical compounds.” [19] These inventions must actually be created and reduced to practice before a patent can be granted; a discovery or the “idea or suggestion” itself is not patentable. [20] In the U.S., utility patents are active for twenty years, during which time the patent owner may “exclude others from making, using, offering for sale, or selling the invention throughout the U.S. or importing the invention into the U.S.” [21] Thus, patents are temporary government-authorized monopolies over inventions and are lucrative assets. [22] While “laws of nature, physical phenomena, and abstract ideas” cannot be patented– novel, asexually reproduced varieties of plants are patent eligible. [23] This essentially means that any product or process which requires human innovation to occur or is man-made is potentially patentable provided it is novel and non-obvious. [24] It was the 1980 Supreme Court case of Diamond v. Chakrabarty, which determined that living, human-engineered bacterium “was patentable subject matter because (1) it was a product of creative human agency containing characteristics ‘markedly different’ from those found in nature and (2) possessed potential for significant utility.” [25]

Food patents are considered utility patents, a class of patents that are considered useful and capable of providing an identifiable benefit. [26] Food products; compositions in foods; and processes that: alter the physical appearance of food, create new combinations, improve flavor or texture, increase longevity, create a new health benefit, or reduce preparation time tend to be eligible for patenting. [27] U.S. citizens are often criticized as valuing convenience over quality, but perhaps this is merely because the U.S. Patent System monetarily incentivizes companies to create novel products, and novelty often results from adding elements of convenience. The enormous monetary value of producing and distributing a patented food product or utilizing a patented food production process presents itself to corporations at many stages and will be further examined. [28]

First, there are monetary incentives at play before the product even hits the shelves. Patentable food products and food production processes, especially those involving genetic modification, typically result in end products that possess higher resistance to pesticides, herbicides, diseases, and parasites. [29] One of the first instances of high-resistance food product patents arose in 1996 when Monsanto patented Roundup Ready soybeans. [30] Monsanto mixed the soybean plant cells with bioengineered bacteria so that farmers could use the herbicide Roundup to kill weeds that threatened soybean plants without killing the plants themselves, due to the plants’ genetically modified herbicide resistance. [31] These types of innovations allow for fewer food products to be lost during the sourcing and production stage. [32] Patented innovations also typically allow for products to be produced more efficiently, which creates a higher yield, and require less careful or immediate transportation during distribution. [33] These shortcuts and advantages allow companies to cut costs and losses and sell their products in more locations at lower prices. [34]

Second, patentable food products and food production processes typically result in products with more desirable appearances, tastes, and longevity. Variations of shellac, resin [35], and wax coatings [36], used to keep apples shiny and seal in their moisture; diphenylamine compounds [37], used to prevent oxidation or scald on apples [38]; and ethylene and carbon dioxide [39], used to ripen fruit, are just three examples of patentable ways to make a natural product present as fresher or more appealing than competing products.

Finally, because patents secure a limited-time monopoly, they allow the patent owner to exclude others from using the patented product or process without paying to secure a license. [40] Because of the inexpensive and enticing nature of patented products and products which benefit from patented processes, competitors have little choice but to license those patents which guarantee continued competition against their counterparts in the industry. [41]

In 2021, after battling the FDA and U.S. Congress for over two decades, AquaBounty Technologies began distributing their new AquAdvantage Atlantic salmon,  genetically modified with a growth hormone gene taken from the Pacific Chinook salmon and a promoter gene sequence taken from an ocean pout, allowing the genetically modified salmon to mature quicker. [42] While the patent for the fish was issued in 1996, and expired in 2013 [43], the company did not obtain FDA approval until 2015, and the FDA’s approval was followed by Congress’ immediate ban on genetically engineered salmon in 2016. Although the ban was lifted in 2019 [44], due to the pandemic and years of inability to generate a commercial profit [45], the company was unable to begin distributing the salmon until 2021. [46] As a result, in 2022, the FDA finally required all bioengineered foods to be labeled. [47] So long as the label requirement does not deter food companies, this will likely result in an increase in genetically modified animal products. [48]

The primary health concerns based on the ever-mounting research of GMO consumption are GMOs’ antibiotic resistance [49], allergen transference [50], impact on non-target species [51], instability leading to toxicity, links to cancer, and inadequate safety evaluation standards used by the FDA. [52] Researchers have also pressed the importance of continued studies, as the long-term effects of consuming GMOs are relatively unknown even if, in the short term, they appear innocuous. [53] However, GMOs have a tight hold on U.S. agricultural giants. Roundup Ready seeds are so prevalent that in 2021, Roundup was still farmers’ preferred weedkiller, despite the company paying billions in settlements due to the product’s link to cancer. [54] Environmental scholars have their own batch of legitimate concerns about GMOs such as the loss of naturally occurring biodiverse food sources, citing the Irish Potato Famine as a warning [55], and food sources that have survived the natural selection process due to their abilities to withstand environmental threats. [56] Changes in agriculture production and genetic modification of animals are additional factors that can throw ecosystems out of balance. [57]

As the U.S. federal government struggles to balance the vastly competing interests of businesses, patent law, antitrust law, the FDA, and the EPA, reformation of the U.S. patent system itself is needed in order to protect both innovation and the public interest. European Union Patent Law requires that any invention contrary to “ordre public,” or morality, be specifically excluded from patentability. [58] This morality exclusion also prohibits patents on genetically modified animals. [59] Further, the European Patent Office has stated that patents cannot be granted to plant and animal varieties that are biological in nature [60], though innovative processes applicable to more than one variety are. [61] This protects organic breeders and their classically bred varieties, which are better at adapting to changes that occur in the natural world. [62] The adoption of a morality clause similar to the European Union’s could be a gateway to restructuring U.S. patent law and incentivize innovation which promotes public, economic, and environmental health [63], or at least provide a basis for the federal government to inquire further into the hazardous consequences of patent-eligible innovations before indirectly funding them. [64]

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References

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[18] 35 U.S.C. § 101.

[19] USPTO, supra note 17.

[20] Id.

[21] 35 U.S.C. § 154(a).

[22] Dratler, supra note 8.

[23] USPTO, supra note 17.

[24] Id. 

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[26] Upcounsel, supra note 17.

[27] Id.

[28] Dratler, supra note 8.

[29] Rowe, supra note 25, at 867.

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[31] Id.

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[37] U.S. Patent No. 2,820,829 (issued Jan. 21, 1958).

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[39] U.S. Patent No. 3,924,010A (issued Dec. 2, 1975).

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[43] U.S. Patent No. 5,545,808 (issued Oct. 13, 1996).

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[54] NSAC, supra note 41.

[55] Heather Landry, Challenging Evolution: How GMOs Can Influence Genetic Diversity, SITN (Aug. 10, 2015), https://sitn.hms.harvard.edu/flash/2015/challenging-evolution-how-gmos-can-influence-genetic-diversity/#:~:text=A%20major%20concern%20of%20genetically,between%20individuals%20of%20a%20species[https://perma.cc/8799-EAL4].

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[58] Guidelines Examination Eur. Pat. Off., Pts. G-II, § 4.1; F, § 7.2, https://www.epo.org/law-practice/legal-texts/html/guidelines/e/g_ii_4_1.htm [https://perma.cc/WR8M-VYFL] (last visited Apr. 16, 2023).

[59] Eur. Pat. Convention, R. 28(1)(d) (2000) (amended by the Enlarged Board of Appeal G 2/06 (Annex I, 2008)), https://www.epo.org/law-practice/legal-texts/html/epc/2020/e/r28.html [https://perma.cc/YA82-TALD] (last visited Apr. 16, 2023); Rowe, supra note 25, at 882.

[60] Eur. Pat. Convention, R. 28(2) (2000) (amended by the Enlarged Board of Appeal G 3/19 (Annex I, 2020)), https://www.epo.org/law-practice/legal-texts/html/epc/2020/e/r28.html [https://perma.cc/BJ39-R3ML] (last visited Apr. 16, 2023).

[61] Global 2000, supra note 12, at 4.

[62] European Patent Office: No Patents on Conventionally Bred Varieties, IFOAM ORGANICS EUR. (Mar. 6, 2020), https://www.organicseurope.bio/news/european-patent-office-no-patents-on-conventionally-bred-varieties/[https://perma.cc/V8F5-QNFF].

[63] Enrico Bonadio, The Case for Incentivizing Healthy Food by Using Patents, 20 MARQ. INTELL. PROP. & INNOVATION L. REV. 241, 246 (2016), https://scholarship.law.marquette.edu/cgi/viewcontent.cgi?article=1295&context=iplr[https://perma.cc/8DZ4-KWKQ].

[64] Bagley, supra note 4, at 474.