The development, testing, and regulation of genetically engineered crops usually takes a significant investment of time and resources, and it comes as no surprise that these crops are patented so that their developers can recoup their investments. Farmers who grow these crops usually pay licensing fees for the use of the technology, and sign license agreements that restrict their ability to save the seeds. Now, a variety of GMO herbicide-tolerant soybeans has been released by the University of Arkansas with no technology fees, and no license agreements to sign. The farmers are free to save the seeds and replant them ad infinitum. This is possible because the patent for the first genetically engineered trait in soybeans – Roundup Ready – has expired. The world of “generic” or Open Source GMOs is upon us, however, there are still some practical challenges ahead.
The University of Arkansas tells the story of this new variety.
The University of Arkansas System Division of Agriculture has released its first soybean variety that features Roundup Ready® technology.
Division soybean breeder Pengyin Chen said the new variety, called UA 5414RR, offers the weed control advantages of Roundup Ready® soybeans without the added cost of technology fees. He said growers could also save seed from each harvest for planting the following year.
Monsanto’s patent on the first generation of Roundup Ready® products expires in March 2015, Chen said, and the company shared the breeding material with public breeding programs, including the Arkansas program directed by Chen. He said UA 5414RR fills a niche for growers who want to use the Roundup system of weed control but don’t want to pay the higher cost of the next generation Roundup Ready 2 Yield® technology.
They then go on to explain that this variety yields about 7% lower than the top varieties in the area, however, the benefit to the farmer is the same weed control technology but without the licensing fees. The ability to save seed is also an attractive prospect for some farmers, particularly for marginal areas.
Last year, a high-profile Supreme Court case was fought over whether a farmer could purchase genetically engineered soybean seeds from a grain elevator and plant them without a license agreement. Bowman v. Monsanto was decided unanimously in favor of Monsanto’s position, meaning that this practice was not legal. Bowman had argued that he only did this for a second planting of soybeans, which may or may not reach harvest-able maturity before winter sets in. The high cost of GMO soybeans would make this too expensive for him to do. The arrival of this new variety means that for farmers like Bowman who wish to reduce their planting costs for risky or low-profit soybean crops can now do so – with the same weed control that they have grown accustomed to.
The goal of patents is to encourage investment in the development of new technologies by allowing an inventor to have a temporary monopoly on profiting from their inventions. But when applied to self-reproducing organisms (and other replicating inventions) it can lead to issues that are independent of the technology itself.
It is not common that you will find a patented computer chip technology accidentally landing in another company’s products, but with patented seeds, this can happen with pollination, admixture, and wind. There has been no verifiable case of any farmer anywhere being sued for accidental mixture of GMO crops in their fields at a low level, and it would be quite silly for a company to attempt to do so. Nevertheless, it is frequently brought up as a risk of GMOs. Restrictions on research and development with a company’s patented products also feature widely in the current meta-debate over this technology. This new soybean variety has the potential to separate the issues with the technology itself and the patent system we use to incentivize the development of the technology.
The kind of patents that are used with GMOs (and a few conventionally-bred varieties) are “utility patents.” Many of the issues over patents and GMOs may stem from the fact that utility patent violations are judged on the basis of strict liability. That means it doesn’t matter how the patent violation occurred, or how much – just that it did. Some critics of GMOs and patents on them want to end strict liability to prevent these kinds of lawsuits. (Ironically, some of the same organizations also argue for strict liability on the part of a company that develops a GMO crop that you find on your land and don’t want.) It is patently obvious that a few stray plants in another farmer’s field do not affect the goal of patents to encourage innovation, and we should take steps to ensure that no one abuses the technicalities of patent laws in the future.
But utility patents are not the only kind of intellectual property in the plant breeding world. There are also plant patents and Plant Variety Protections (PVPA) which protect the work of the plant breeder who crosses, selects, and develops the genetic background of the plants themselves. PVPA allows for seed saving by farmers, which is what the press release at the University of Arkansas mentions – and nothing more. It is likely, but not yet verified, that the new soybean variety will be protected under PVPA, so using these seeds for breeding purposes may still require a license from the breeders at the University of Arkansas. This new soybean variety demonstrates that off-patent GMOs can be useful for the development of new varieties with benefits, however, it would be necessary to have someone release a public variety with this off-patent transgenic trait for there to be truly Open Source GMOs.
The Real Challenge for Public, Open Source GMOs
The prospect of off-patent Open Source GMOs for public benefit is an exciting one, and is the right and intended outcome of the patent system. However, the enthusiasm for these off-patent GMOs must be reigned in by a looming threat that could jeopardize their continued use – the expiration of approvals in export markets. It is not widely known, but if Open Source GMOs are to become a reality this issue must be addressed head-on.
The greatest impediment to saving seeds once the patent on the trait expires is not the technology developers, it is the regulatory systems in other countries. Many of the key US ag export markets approve a trait for a limited number of years. Once that approval expires, the trait developer must go through the regulatory approval process all over again – which means spending money to do more research and submit data to the regulators. Similarly, the EPA requires renewals and the submission of new data as well for crops such as Bt crops.
So once the patent expires and farmers start saving seed, who is going to maintain those regulatory approvals in the export markets? Who will continue to provide data to the EPA for the continued use of traits when they go off-patent? Without regulatory approvals in export markets, and maintaining the EPA registrations, we may see these traits wither on the vine.
The same thing goes for any public research project to develop GMO crops. While initial development, regulation, and approvals can be achieved for such projects, maintaining them perpetually can be a challenge.
While public resources are stretched thin as it is, the collective resources of farmers – the primary beneficiaries of the current round of traits – could make it possible to maintain these approvals. Currently, Monsanto – the developer of the Roundup Ready trait, has pledged to maintain the approval status of the first Roundup Ready trait in soybeans through 2021, which gives about 7 years of time.
Coming back to the goal of patents, as Ramez Naam puts it, “The inventor gets a temporary monopoly to reward them for their research and development, and in exchange, society gets the permanent benefit of their invention.” But in the current state of affairs, the permanent benefit may be curtailed by the expiration of approvals elsewhere. If we are to turn GMOs that go off-patent into public, open source, and new proprietary varieties of crops that will endure, this is the challenge that we face.
Farmers will have to consider some costs when saving seed. The beans used for seeding the next crop will need to be cleaned before being put in a seeder. Pods, dirt, bugs, and bits of stems will be presented in the harvest. Clean enough for sale on the commodity market, but not good enough to plant. These off patent beans are a good thing, but it won’t be as easy a dumping them in a planter straight of of the combine.
We regularly double crop soybeans behind wheat harvest. We often are able to purchase RR soybeans that late in the season for half price. Just my farmer $.02.
I can’t wait to see how this plays out. I think this is a real game-changer.
Spot on with regard to renewals of marketing authorizations.
The issue has already arisen in the European Union in relation to minor uses of pesticides, leaving some crops orphaned.
Assuming the anti-GMO hysteria continues, there will also be some practical problems. Will for instance grain elevators be prepared to separate a small crop from a farmer who would have preferred using an old technology over paying a royalty for the state-of-the art one?
As regards patents, it is high time to deconstruct the extraordinary assertion that a patentee might sue an innocent (alleged) infringer.
Strict liability may be the driving legal principle in the United States for patent infringement. Yet there is no certainty that a court would apply it in the case of an accidental contamination.
And it is not the driving principle in many other States. Actually, when it comes to patents, and intellectual property, the United States is on another planet. It is very important to make this point, time and again, as the scaremongering in other, particularly developing, countries is based on the hypothetical case of the United States.
What about the US situation in a case of « contamination » ?
« 35 U.S.C. 271 Infringement of patent.
(a) Except as otherwise provided in this title, whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States, or imports into the United States any patented invention during the term of the patent therefor, infringes the patent. »
Has the alleged infringer « made » the invention? No. Has he « used » it? Either patently no or without his knowledge, in respect of a tiny amount of his crop.
« 35 U.S.C. 283 Injunction.
The several courts having jurisdiction of cases under this title may grant injunctions in accordance with the principles of equity to prevent the violation of any right secured by patent, on such terms as the court deems reasonable. »
Courts are unpredictable, but can anyone figure out an injunction in a case of « contamination »?
« 35 U.S.C. 284 Damages.
Upon finding for the claimant the court shall award the claimant damages adequate to compensate for the infringement but in no event less than a reasonable royalty for the use made of the invention by the infringer, together with interest and costs as fixed by the court. »
How much for « contamination »?
Any court decision finding for the patentee in the case of such a de minimis would, rightfully so, cause an uproar and trigger some proposals to introduce the concept of innocent infringement (existing in the copyright laws) into the patent laws.
Moreover, any action for infringement would be countered by an action, against the patentee, for liability for the contamination and the resulting action for infringement.
As regards the PVPA, you erred. A PVPA protected variety may be freely used as source material for the purpose of breeding new varieties.
« Sec. 114. Research Exemption.
The use and reproduction of a protected variety for plant breeding or other bona fide research shall not constitute an infringement of the protection provided under this Act. (7 U.S.C. 2544.) »
I should add that, upon expiry of the relevant patent(s) on the invention(s) incorporated into the relevant RR soybeans, all existing relevant RR varieties become freely available for further breeding.
Why this triple « relevant »? The statement only applies to what is now becoming public domain. If a new (and presumably better) RR system is developed and patented, the patent saga will of course start again, but only in relation to that system.
A final thought:
« If we are to turn GMOs that go off-patent into public, open source, and new proprietary varieties of crops that will endure, this is the challenge that we face. »
Your excellent analysis should serve as a call for caution to all those who would be tempted to produce GM varieties based upon off-patent traits just for the cause of countering the patent-based proprietary varieties and seed industry. Any breeding program on RR soybeans starting today faces the risk of irrelevance in 2021.
I think that breeders exemption- using competitors variety as a parent in crossing is accoording to UPOV. 1991 differently allowed in US and in Europe.
I believe we already got a taste of what happens when a GMO would go off patent. Bt cotton has been shamelessly copied and crossbred in India for years now. Illegal, yes, but it’s real tough to enforce such things in the hinterlands of India.
No. The Plant Variety Protection Act mirrors the provisions of the 1991 UPOV Convention.
Interesting article, worth reading against the background of 10 further years of experience. But it is shaky as regards intellectual property.
There was no patent protection in Argentina and India. Bt cotton could therefore be “copied and crossbred in India” without it being illegal in terms of intellectual property.
Similarly, Argentinian producers could legally save seeds.
There was a patent in Brazil (under the pipeline protection provisions), so the arrangement between Monsanto and the grain elevators operators had a legal backing. By and large, the soybean producers were also conscious of the need to finance plant breeding activities for the purpose of developing varieties suiting their agroclimatic conditions.
Overall, I would also submit the “Wild, Wild West” period of the early 2000’s is over. What will no happen will be a different story.
Yes, good point about other countries and the diversity of IP laws for plants in them. We do certainly know that India has had an underground seed trade, and Brazil has had no patent protections for transgenic crops as well. I’m not saying that breeding with off-patent (or on-patent) traits won’t happen somewhere, but it may be hindered somewhat by the other IP protections in the varieties.
True, but farmers had to consider costs when saving seed prior to RR soybeans also, so at least in terms of the RR1 trait we are, in essence, back to square one – if farmers want to save seed they are no longer prohibited from doing so due to the presence of the RR1 trait – indeed they should simply be able to do whatever bean farmers did prior to RR being a thing, whether that is buy more beans with RR1 (and no tech fee) or save beans with RR1 in them directly from their own fields.
“Old technology” instead of “state of the art one”? Do you call natural seeds with original genetics “technology”?
For many people, it’s not the “patented GMO” that’s exclusively troubling. It’s the roundup, and other pesticides and herbicides. Roundup-drenched soils, over-fertilization, and any other massive chemical injection in soils are, however you spin it, poisons. From bacterial soil organisms to pollinating insects and birds.
Second, for any sane person, the danger of cross-breeding real original genetics of any organism with “biotech” ones is real. Because of the extinction of the original genetics in the future, and the “no-way-back” nature of this change. Biotechnology seeds should only be grown in labs. Period. it’s born in labs, it’s grown in labs. Controlled environment all the way. Anything else is vandalism and bullying 🙂
That may be, but a necessary condition to entice people to develop them in the first place. However, my post was simply to indicate we may already have a model as to what will happen when GMO’s go off patent. Basically, there’s no holding them back with farmers willing to revolt if they’re taken away.
One of the issues that occurs to me is the ability of public domain ht and pip traits to police resistance management. One of the benefits of patent protection and the prohibition of seed saving is the ability of patent holders to hold licensees to resistance management rules, refuge planting, etc. through the tech use agreement. I am wondering if PVPA patent is sufficient to enforce resistance management rules on seeds that may be saved and replanted.
…or buy beans with RR2 (assuming there is one) – RR2 being possibly covered by a patent; or buy beans with RR1 combined with another trait; etc.
Unrelated: the latest opinion from ANSES on Seralini (2014):
Ummm, you are aware that the “GMO-ness” of an organism involves one or few of many many thousands of genes, aren’t you?
The mutation rate generation-to-generation is comparable or larger.
Yup, and so they take away the tech that is our best hope of doing without all those chemicals. That’s why it make no sense at all to be across-the-board anti-GMO.
Roundup drenched? Application rate of glyphosate is about 12 ounces to the acre. That’s a can of soda spread out over 43560 square feet. GMO’s require fertilizer just as non-gmo crops do. Neither grow out of thin air and, yes, the greater the yield, the more fertilizer it needs for the very same reason, gmo or not.
There has been extensive work in the ag industry to address post-patent regulatory responsibilities. Here is a website that discusses GEMMA and DUCA, two aspects of the Accord:
yes there is a RR2 which is still under patent. RR1 experiences a yield drag because it is still slightly affected by glyphosate. Your probably further ahead to just buy the RR2
I guess not much of a changer they are not going to allow it . because old seed canit be certified for export unless it has gone through another government hoop again . My experience has shown me the government doesn’t care if a product is legal to use in Canada and it is legal to sell the Canadian crop in the USA . If it is illegal to use this product on a US crop The government forced my neighbor to destroy his crop . that was exactly the same as the legal crop grown in Canada that was legal to sell in the USA The government wants their rules obeyed and they may not bend their rules if you disobey . The most important thing for the government is that the farmers obey . They don’t care if their rule is stupid , The government will do the thinking and you must do the obeying .
I think Monsano did collect off the terminals when the boats were loaded in Brazil or Argentina . I bet it wasn’t as much as we paid though ..
Hell, forget cleaning them, just auger them out of the bin into a spin spreader and sling them out in the field stems pods and all, then come back with a disk set to run about 1.5″ deep with a cultipacker behind it. My grandad planted his beans that way for 50+ years. Everyone in the neighborhood used to laugh at that old geezer out sewing soybeans with a spin spreader on the back of his 1959 poppin johnny but his beans yielded just as well as our beans grown from expensive Asgrow, and Pioneer bean seed planted with my dad’s expensive Deere 750 drill. I honestly never would have believed it myself, but I cut some of grandad’s beans for him and the yield monitor doesn’t lie.
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