More and
`Better
`Choices for
`Farmers:
`Promoting Fair
`Competition and
`Innovation in Seeds
`and Other
`Agricultural Inputs
`
`A report directed by President
`Biden’s Executive Order
`Number 14036: “Promoting
`Competition in America’s
`Economy”
`
`March 2023
`
`Inari Ex. 1009
`Inari Agric. v. Corteva Agriscience
`PGR2023-00022
`Page 00001
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`

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`This report was prepared by the U.S. Department of Agriculture's Agricultural
`Marketing Service in consultation with relevant offices, agencies, and teams at
`USDA, as well as the Director of the United States Patent and Trademark Office
`and her team and other Federal partners. This collaboration was led by AMS
`academic cooperators Dr. Julie Dawson and Ms. Paulina Jenney of the
`University of Wisconsin-Madison, under the direction of Senior Advisor for Fair
`and Competitive Markets Mr. Andy Green. Its findings are comprehensively
`informed by the public input under a Request for Information issued in March
`2022 as well as listening sessions, meetings, and other forms of consultation
`with farmers, seed businesses and trade associations, plant scientists, patent
`and competition experts, and other stakeholders. This report represents our
`best efforts, to date, to grapple with certain longstanding challenges associated
`with promoting competition and protecting intellectual property in relation to
`agriculture. USDA invites and encourages all stakeholders to continue the
`dialogue with us and with all our Federal partners to promote vibrant
`competition, a robust and reliable intellectual property system, and a
`continuing respect for science across all Federal policymaking.
`
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`Executive Summary
`
`A well-functioning economy depends on businesses competing based on the merits of their
`products, including price, innovation, quality, privacy, and diversity. For years, American
`farmers and independent seed businesses have voiced concerns to the USDA about
`concentration and the consolidation of market power in agriculture, including in seeds and
`other agricultural inputs, and the resulting decline in healthy competition.1 Competition in
`food and agricultural markets promotes the types of diversity farmers need to thrive: a
`diversity of choices that respond to the particular needs and priorities of farmers; a diversity
`of options to meet changing business, climatic, societal, and scientific needs; and a diversity
`of companies that are committed to the localities and regions they serve and can weather the
`storms and shocks of today and the future.
`
`In the seed market, promoting fair and vibrant competition involves considerations of
`intellectual property (IP) law, antitrust and other fair business practices law, and public
`investment in our food system. These are complex and often confusing areas even for the
`most experienced farmers, plant breeders, small businesses, and others. Partly that flows
`from the nature of current varieties, where, building off of complex biological material,
`American ingenuity has produced incredibly advanced innovations. Adding to the complexity,
`business developments arising from multiple decades of mergers and acquisitions have led to
`an increasingly consolidated marketplace with complicated legal relationships among
`companies. Greater transparency, fairness, and investment—facilitated through better
`coordination and communication by government partners—are areas of progress that will
`benefit all in the marketplace.
`
`To make that happen, on July 9, 2021, President Biden issued a historic Executive Order titled
`“Promoting Competition in the American Economy,”2 which creates a whole-of-government
`approach to competition and includes initiatives across federal agencies to tackle some of
`the most pressing issues across our economy. Among other things, the Executive Order
`directs the Secretary of Agriculture, in consultation with the Under Secretary of Commerce for
`Intellectual Property and Director of the U.S. Patent and Trademark Office, to submit a report
`to the Chair of the White House Competition Council on concerns and strategies for ensuring
`“that the intellectual property (IP) system, while incentivizing innovation, does not also
`unnecessarily reduce competition in seed and other input markets beyond that reasonably
`contemplated by the Patent Act.”3
`
`1. As defined in Federal Register Notice requesting for public comment on “Competition and the Intellectual
`Property System: Seeds and Other Agricultural Inputs,” 87 Fed. Reg. 15198 (March 17, 2022), at
`www.regulations.gov/document/AMS-AMS-22-0025-0001.
`2. Executive Order Number 14036, “Promoting Competition in America’s Economy,” at
`https://www.whitehouse.gov/briefing-room/presidential-actions/2021/07/09/executive-order-on-promoting-
`competition-in-the-american-economy/.
`3. See 35 U.S.C. 100 et seq. and 7 U.S.C. 2321 et seq.
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`As a response to the Executive Order, on March 17, 2022, the USDA-AMS published a request
`for public comments and information that included 25 multi-part questions about
`competition and market power, intellectual property, and other business practices in the
`seed industry that might be affecting the American farmer’s ability to participate in a fair and
`competitive market.4 After a 90-day comment period, we (USDA staff and cooperators)
`collected comments, hosted a public listening forum,5 and heard from an array of interested
`parties to ensure that as many perspectives as possible were represented in this report.6
`
`Comments and input were diverse, nuanced, and multifaceted. Many commenters agreed
`that a system that fairly protects IP is critical to continued innovation and investment in seed
`systems.7 Because plant breeding takes time and resources, many plant breeders and seed
`companies need a return on their investment. At the same time, we heard concerns that the
`current system and practices for protecting and enforcing IP rights for plant innovations may
`not be promoting fair competition. Those concerns broadly fall into several areas.
`
`First, some commenters expressed concerns about the difficulty in accessing information on
`existing IP rights associated with a particular plant variety. Due to the various IP systems for
`protecting plant-related innovations, a lack of a consolidated source of information was
`noted as a contributing factor.
`
`Second, several commenters focused on the application of patentability standards on the
`examination of plant-related innovations. To determine whether a claimed invention is novel
`and non-obvious, the USPTO must conduct a thorough search of the existing prior art. For
`plant technologies, this often requires searching numerous non-patent sources, such as
`publicly available scientific literature and datasets. These commenters believe incomplete
`searching has led to patents that covered existing plant varieties, characteristics, and
`methods of breeding.
`
`Third, several commenters raised concerns with how IP rights for plant-related inventions are
`being used and enforced, noting the growing use of licenses that override research and
`breeding exemptions guaranteed by certain types of IP rights. Some plant breeders expressed
`having difficulty determining whether their ongoing work would infringe upon a newly
`granted IP right. These commenters noted that if faced with a lawsuit, small to mid-sized
`plant breeding programs may be led to discontinue those lines of innovation even if they
`believed they would likely not be found liable in court.
`
`4. 87 Fed. Reg. 15198 (March 17, 2022), www.regulations.gov/document/AMS-AMS-22-0025-0001.
`5. Competition and the Intellectual Property System: Seeds and Other Agricultural Inputs, (Aug. 2022),
`www.zoomgov.com/rec/play/h4r0AJXwFkYRbfUr6zDMELCKte7_77Meo-W1fnl9VrbKFGdr0QIig-
`qAovK4WqxAuiq8HDNkOnTPxXW8.WwQpath9AqKkafH_?continueMode=true.
`6. In this report, we use “commenters” to refer to people who submitted public comments, people who
`participated in listening forums, or people who participated in interviews.
`7. In this report, when we refer to seed, we also include other planting stock for crops not propagated by seed
`(tubers, bulbs, cuttings, etc.).
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`
`Commenters that primarily license IP from larger companies were concerned about the
`effects of consolidation on their choice of products. These commenters described farmer,
`plant breeder, and seed retailers’ increasing dependence on the few companies that control
`most of the IP for seed. They also observed that this dependence is more pronounced for
`farmers, plant breeders, and retailers in commodity crops than in specialty crops.
`Commenters described situations in which companies on whom they are dependent for seed
`or technology could impose contractual terms that seem to extend patent rights beyond the
`scope contemplated by law. Small businesses expressed concern that these companies may
`offer retail incentives that disadvantage competitors, new entrants, farmers, and consumers.
`
`Finally, many commenters called for greater investment in public infrastructure around seed
`systems and plant breeding. This public infrastructure, largely a partnership between the
`states and federal government, involving USDA research locations, Land Grant Universities,
`and State Agricultural Experiment Stations, has long supported fair competition among
`private entities by releasing cultivars that small and mid-sized companies can use, and by
`being a key provider of traits and varieties for underserved crops and geographies. Decades
`of underinvestment have significantly reduced that capacity. With fewer choices, and without
`varieties tailored to local circumstances, farmers may lose potential revenue. In addition, the
`loss of decentralized capacity for variety development and production of seeds and other
`planting stock means that supply chains are vulnerable to disruption. Commenters pointed
`out that increased investments could mitigate climate-related disruptions to food and
`agricultural systems, could encourage new market entrants, and could establish a fairer and
`more competitive market.
`
`Addressing these concerns is not a straightforward task (see methodological note below). The
`concerns of farmers, businesses, plant breeders, and market participants—those who grow
`the food we eat, as well as the general public—span IP law, antitrust law, and public
`investment in our food system. Moreover, federal authorities that tackle these issues are
`complex and overlapping. Ultimately, the following report defines three key topic areas in
`which the Executive Order’s “whole of government” approach to promoting competition can
`be used to address these challenges:
`
`1. ensure robust and reliable IP rights that enhance innovation and promote competition
`2. ensure that IP owners exercise their rights within the scope of fair competition provided
`by law, and
`3. rebuild critical national infrastructure for variety development and the provision of seed
`and other planting stock to create resilient seed supply chains.
`In each of these sections, we analyze the current situation and make recommendations for
`the U.S. Government to promote fair competition and innovation, focused on actions
`available to the executive branch and leaders of involved federal agencies, including the
`Department of Agriculture (USDA), Patent and Trademark Office (USPTO), the Department of
`Justice (DOJ), and the Federal Trade Commission (FTC). Our goal is to improve fair
`competition in the seed industry, enhance the resiliency of America’s food and agricultural
`
`
`
`
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`supply chains, and provide economic opportunity and choice for America’s agricultural
`communities.
`
`Methodological note. The commentary discussed in this report represents views that existed
`at the time the comments were submitted. Where, in the intervening months, USDA, the
`USPTO, or other agencies, under the Biden Administration, has made a number of
`improvements, we make note of that progress while preserving the commenters’ views.
`Additionally, some comments may represent the commenter’s perspective which may be in
`conflict with others’ views, data, or market understanding. We have preserved the comments
`as presented and provide additional clarification as needed without seeking to conclusively
`evaluate their relationship to existing law, practices, or data in all circumstances. Our
`purpose is simple: the USDA, USPTO, and other Federal partners take seriously the concerns
`of all involved in the seeds and other agricultural input markets and are committed to taking
`a “whole of government” approach to addressing any and all concerns.
`
`Summary of key recommendations
`This is a brief summary of the recommendations given in the report. Detailed, complete
`recommendations are given in specific sections of the full report.
`
`• A voice for farmers and plant breeders. To enhance transparency, reduce confusion,
`and otherwise help farmers, small and mid-sized seed businesses and plant breeders
`successfully navigate a complex seed system, AMS is establishing a Farmer Seed Liaison.
`Among its responsibilities will be to facilitate communication between farmers, plant
`breeders, and relevant agencies that touch on the IP system, more generally coordinate
`implementation of the recommendations described in this report, and otherwise
`promote fair competition in the seed industry. In consultation with the USPTO and
`modeled on AMS’s Transportation Services Division, the Farmer Seed Liaison will
`particularly facilitate engagement and public input into existing public USPTO input
`processes regarding prior art.
`• A new partnership between USDA and USPTO. A new Working Group on Competition
`and Intellectual Property will focus on a number of initiatives such as, 1) to explore joint
`USPTO-USDA opportunities for collecting broader stakeholder input from researchers,
`plant breeders, farmers, and others in the seed and agricultural input markets, 2) to
`explore initiatives to enhance the quality of the patent examination process for
`innovations related to agricultural products and processes, including opportunities for
`enhancing prior art search capabilities and providing additional training and guidance to
`patent examiners, 3) to collaborate on initiatives that enhance the transparency of IP
`information for agricultural-related innovations and assess availability and viability of
`patented and off-patented germplasm, and 4) to consider and evaluate new proposals
`for incentivizing and protecting innovation in the seed and agricultural-related space,
`including the addition of research or plant breeders’ exemptions for US utility patents.
`• Enhanced transparency for farmers. Enforce label requirements under the Federal
`Seed Act (FSA), to ensure that farmers have access to all legally required information at
`
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`the earliest opportunity, usually at the time of purchase and no later than the
`commencement of shipment. Additionally, enforce false advertising provisions under the
`FSA to avoid representations that may claim or give the impression that seed brand
`names add diversification for a grower when that representation is false or misleading.
`Enhance the accessible filing of complaints and tips on potentially unlawful seed
`practices.
`• Interagency coordination to promote fair competition. USDA and USPTO, together
`with the Department of Justice (DOJ) and the FTC, contemplate a number of actions to
`promote fair competition in the seed industry, including 1) expand farmerfairness.gov to
`include seeds and other inputs, 2) assess the impact of seed business consolidation and
`IP on pricing, choice, and availability of adapted varieties and the impact of reduced
`competition on food security, genetic diversity, and regional production capacity, and 3)
`coordinate and consult on actions related to practices in the seed industry that may
`harm competition.
`• Investment in innovative and resilient local and regional food systems. Every day
`USDA invests in science and innovation in agriculture. Following the pandemic, USDA has
`already begun pivoting to meet the needs of a more diverse and resilient food system,
`which incorporates equity and respects Indigenous food systems. More can be done to
`create enhanced diversity and resiliency in seeds and other agricultural inputs, including
`1) explore and highlight opportunities where additional funding, if provided, may
`encourage public sector plant breeders to work in crops or regions that are currently
`underserved by the private sector and where innovation is needed for farmer choice and
`resilience, 2) promote broader adoption of IP strategies that enable continued research
`and breeding with commercialized cultivars from federally funded research, 3)
`encourage and strengthen partnerships between public entities, small and mid-sized
`businesses, and non-profit organizations, and ongoing outreach and support to
`historically underserved groups, including indigenous peoples who originally stewarded
`and continue to care for important varieties, and 4) explore options to invest in
`education around agriculture, plant breeding, and seed systems at all levels.
`
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`Contents
`Executive Summary .................................................................................. 3
`Summary of key recommendations .......................................................................................... 6
`
`Introduction ............................................................................................ 10
`Glossary ..................................................................................................................................... 14
`Plant Breeding ........................................................................................................................ 14
`Crop groups ............................................................................................................................ 15
`Plant-related Intellectual Property Rights and Business Practices .................................... 15
`
`1. Intellectual Property in the Seed Industry ................................................. 18
`Patents Are Used Widely Across Crop Markets ........................................................................ 20
`Plants Pose Unique Challenges for Patent Examination ........................................................ 22
`Challenges: novelty and non-obviousness ........................................................................... 22
`Challenges: disclosure ........................................................................................................... 25
`Post–Issuance Proceedings for Challenging Patent Validity .............................................. 26
`Continued Innovation as Impacted by Disclosure, Germplasm Accessibility, Research and
`Breeding Exemptions ............................................................................................................... 28
`Continued innovation: disclosure ......................................................................................... 28
`Continued innovation: germplasm accessibility .................................................................. 29
`Continued innovation: research and breeding exemptions ................................................ 30
`International IP protection for plant varieties ..................................................................... 30
`Continued innovation: Access to protected varieties and traits after IP rights expire ...... 34
`Enhanced Transparency for a More Level Playing Field ......................................................... 35
`Recommendations On Intellectual Property Protections in The Seed Industry ................... 38
`
`2. Competition and Innovation ................................................................... 41
`Increased Prices are Felt Acutely by Independent Small to Mid-Sized Companies .............. 47
`Loss of Independent Small to Mid-Sized Companies Raises Concerns about Farmer Choice
`and Access to Independent Product Information ................................................................... 48
`Potential Loss of Innovation Due to Changing IP Landscape and Reduction of Small to Mid-
`Sized Businesses ....................................................................................................................... 50
`Public Availability of Patented Innovations after IP Protection Expires ................................ 53
`Patent-holding firms may delay competition after patents have expired ......................... 53
`Plant breeders encounter difficulty accessing off-patent seed from public repositories . 54
`Biotechnology regulation may delay commercialization of new products and generics. 55
`Recommendations To Improve Competition and Innovation ............................................... 56
`
`3. Seed System Resilience ........................................................................ 58
`Risks of Declining Public Investment in Our Seed System ..................................................... 61
`Infrastructure and Capacity Building to Strengthen Seed System Resilience ....................... 64
`Recommendations to Improve Seed System Resilience ........................................................ 65
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`Conclusion ............................................................................................. 67
`
`Appendix A. History of IP for Plants in the US ............................................... 68
`
`Appendix B. Methods of analysis of IP ownership ......................................... 74
`
`Appendix C: Seed Industry Diagrams .......................................................... 82
`Diagram Color Chart (left) and Vertically Integrated Seed Company (right) ..................... 82
`Vertically and Horizontally Integrated Seed Company ....................................................... 83
`Trait Developer ....................................................................................................................... 84
`Cultivar Developer .................................................................................................................. 84
`Seed Dealer ............................................................................................................................. 85
`Seed Retailer........................................................................................................................... 85
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`Agricultural Marketing Service
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`
`
`Introduction
`
`American agriculture has undergone significant transformation over the past one hundred
`years. Plant breeding innovation has contributed to this transformation, delivering improved
`varieties to farmers across crops, regions, and production systems. Variety development and
`seed systems engage a wide range of innovators, including farmers, universities and research
`organizations, seed and nursery businesses of all sizes, independent plant breeders, and
`large vertically integrated companies. Over the same time period, the opportunities, limits,
`and challenges of intellectual property (IP) rights have come to play a central role in plant
`breeding. Robust and reliable IP rights and their fair enforcement are a critical component to
`ensure equitable opportunities for all actors engaged in variety development. This, in turn, is
`key to sustaining ongoing innovation to ensure the resilience of America’s agricultural
`production in the face of new and evolving challenges.
`
`The U.S. Constitution grants Congress the power “to promote the progress of science and
`useful arts, by securing for limited times to authors and inventors the exclusive right to their
`respective writings and discoveries.”8 In response, Congress has crafted a patent system to
`provide adequate incentives to individual inventors while encouraging innovation for public
`benefit. The system strikes this balance in three important ways. First, stringent requirements
`for patent protection seek to assure that ideas and inventions already in the public domain
`remain available for the public to use. Then, patents incentivize innovation by granting a
`period during which no one else can make, use, offer to sell, sell, or import an invention
`without the permission of the patent owner. Finally, in exchange for this exclusive right, the
`inventor fully discloses the invention in their application and grants public access to the
`patented invention for further innovation, so long as the patent is not infringed upon during
`the limited duration of the patent. By design, this system provides limited-in-time exclusivity
`to the claimed invention in order to deliver innovations to the public. By requiring disclosure
`of the methods of creating innovations, it allows for others to build on them.
`
`Research shows that the patent system, generally, spurs innovations in the private sector. A
`recent economic study published by the U.S. Patent and Trademark Office (USPTO) shows
`that IP-intensive industries play a significant role in the U.S. economy in terms of both
`output—measured as gross domestic product (GDP)—and employment.9 IP protection may
`be especially important to new market entrants, individual inventors, and small businesses
`that do not have market share and rely on their IP to compete. Research and development
`spending and new plant variety introductions by the private seed industry have generally
`grown in recent decades. At the same time, some have expressed concerns that dominant
`companies in research-intensive markets, such as pharmaceuticals, technology, and
`
`
`
`8. U.S. Constitution, art. 1, sec. 8, cl. 8.
`9. USPTO, IP and the U.S. Economy: Third Edition, by Andrew A. Toole, Richard D. Miller, Nicholas Rada, (2022).
`www.uspto.gov/sites/default/files/documents/uspto-ip-us-economy-third-edition.pdf
`
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`agriculture, are tipping the careful balance struck by Congress to use the intellectual property
`system in ways that protect market power at the public's expense.
`
`In agriculture, ongoing consolidation has resulted in a global seed industry dominated by just
`a few companies.10 Farmers, plant breeders, businesses, and others have expressed growing
`concern about the implications of this continuing consolidation. Their concern has been
`heightened given the potential interplay between industry consolidation, anticompetitive
`behaviors, and the exclusive rights conferred by the utility patent system, which has
`increasingly been used for seed-related IP following court decisions expanding the scope of
`patentable material.11 The tension is due in part to the fact that the IP system, which provides
`a limited-in-time exclusivity to claimed inventions, coexists with antitrust laws, which
`prohibit specific behaviors that restrict competition in the marketplace.12
`
`On July 9, 2021, President Biden issued an Executive Order titled “Promoting Competition in
`the American Economy,” which creates a White House Competition Council and directs
`Federal agency actions to enhance fairness and competition across America's economy.
`Among other things, the Executive Order directs the Secretary of Agriculture, in consultation
`with the Director of the USPTO, to submit a report on concerns and strategies for ensuring
`that the intellectual property (IP) system, while incentivizing innovation, does not also
`unnecessarily reduce competition in seed and other agricultural input markets. As a response
`to the Executive Order, on March 17, 2022, the USDA’s Agricultural Marketing Service (AMS)
`published a request for public comments and information that included 25 multi-part
`questions about competition and market power, intellectual property, and other business
`practices in the seed industry that might be affecting the American farmer’s ability to
`participate in a fair and competitive market. After a 90-day comment period, we (USDA staff
`and cooperators) collected comments, hosted a public listening forum, and heard from an
`
`10. In its 2018 assessment of global seed markets, OECD writes that “Bayer-Monsanto is the largest player, with
`roughly equal shares of sales coming from seeds and biotech versus agricultural chemicals. ChemChina-Syngenta is
`second, at about a third smaller than Bayer-Monsanto, but mostly focused on agricultural chemicals. DowDuPont
`is the third major player, with a roughly equal split between seeds and biotech. Following the acquisition of Bayer
`assets, BASF has become the fourth player in the sector, although its total sales are less than half of those of
`Bayer-Monsanto. Finally, both Limagrain/Vilmorin and KWS, while important players, are small in comparison with
`the market leaders. Each firm has less than one-tenth the sales of Bayer-Monsanto.” OECD, “New Evidence on
`Market Concentration,” Concentration in Seed Markets: Potential Effects and Policy Responses, (OECD Publishing,
`Paris, 2018), 57.
`11. See, e.g., Department of Justice (DOJ). Competition and Agriculture: Voices from the Workshops on Agriculture
`and Antitrust Enforcement in our 21st Century Economy and Thoughts on the Way Forward. 2012.
`www.justice.gov/atr/page/file/1534736/download.
`12. The Sherman Act of 1890 authorizes the Department of Justice to prohibit all contracts, combinations and
`conspiracies that unreasonably restrain interstate and foreign trade. The Sherman Act also makes it a crime to
`monopolize any part of interstate commerce. The Clayton Act (1914) further prohibits mergers or acquisitions that
`are likely to lessen competition, as well as other business practices, such as discriminatory pricing and exclusive
`dealing, that may harm competition under certain circumstances. The Federal Trade Commission, established
`through the FTC Act (1914), is empowered to prevent unfair methods of competition and deceptive practices
`affecting commerce, and joins the DOJ in enforcing the Clayton Act.
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`array of interested parties to ensure that as many perspectives as possible were represented
`in this report.
`
`Public comments generally addressed concerns about consolidation and market power; IP
`mechanisms and how they are used; business practices that may restrict competition
`including trait stacking, bundling, and licensing terms; information resources including
`farmer access to information and farmer rights to data collected by digital platforms; and
`additional matters including right-to-repair and regulatory burdens for bringing new
`products to market. The comments submitted to the Federal Register reflected a range of
`commenter types. Forty comments were submitted by individuals, including anonymous
`commenters, the public-at-large, farmers, independent plant breeders, and university-
`affiliated researchers. Nine comments were submitted by private entities, ranging in size from
`small businesses to multinational corporations. Twenty-six comments were submitted by
`groups or organizations. Ten of these were nonprofits or advocacy groups, ten were trade
`associations, and six were farmers’ organizations. Groups that claimed to represent
`individuals claimed anywhere from one thousand to two million members; however, because
`not all groups explicitly stated their membership, these numbers could not be accounted for
`in a systematic way.
`
`Of the public comments posted to the Federal Register, the majority expressed concern about
`the negative effects of business consolidation and market power of large companies. Some of
`these comments were from individuals and focused on single aspects of the inquiry, such as
`consolidation, patents, or prices of seeds and other inputs. Some comments that described
`concern about concentration detailed licensing practices they consider anticompetitive.
`Others voicing concern about these issues included farmers’ organizations such as the
`National Farmers Union. In addition, this group of comments included organizations
`representing consumer, economic, and environmental advocates such as the American
`Antitrust Institute, the Center for Food Safety, Friends of the Earth, and the Open Markets
`Institute.
`
`Many commenters