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HORTSCIENCE 54(4):763–765. 2019. https://doi.org/10.21273/HORTSCI13528-18 Act of 1930, later codified in 35 U.S.C. §161–164 (U.S. Patent and Office, 2018). Utility Patent applications are examined To Protect or Not to Protect: Guide for at the USPTO under the authority found in Art. 1, §8, cl.8 of the U.S. Constitution and later Deciding on Public Release or codifiedin35U.S.C.(U.S.PatentandTrade- mark Office, 2000). Intellectual Protection of New In addition to these mechanisms, some aspects of , such as breeding methods, could be protected as a trade secret, and Plant and Germplasm names could be protected under trademark Mojdeh Bahar and Robert J. Griesbach1 law (Nirwan, 2017). Unlike the three pre- Office of Transfer, U.S. Department of Agriculture, Agricultural viously mentioned IP protection mecha- nisms, trade secrets are not time limited. Research Service, 5601 Sunnyside Avenue, Beltsville, MD 20705-5131 For example, two unique parents, one plant Additional index words. , , plant patent, plant variety protection with small purple flowers and the other with large red flowers, when crossed together can Abstract. The U.S. Department of Agriculture’s Agricultural Research Service (ARS) result in novel and uniform progeny (i.e., and universities have a long and successful history of developing enhanced germplasm plants with large blue flowers). Progeny of and cultivars that are transferred through public release. Today, nonprotected public the large blue-flowered plants are not uni- release may not be the most appropriate mechanism. (IP) pro- form. So, the cross results in plants with large tection as it pertains to the plant germplasm and cultivars is involved and complex. red flowers, small purple flowers, small red Unlike other scientific areas, in the United States there are three distinct mechanisms to flowers, large purple flowers, and so on. In protect plants—namely, utility , plant patents, and plant variety protection this instance, the original parent plants that certificates. Each of these mechanisms offers different criteria for protection and covers produce the desirable progeny can be kept as different types of plants. This article is a practical tool to help research institutions and a trade secret. No one can create the novel scientists decide when to consider releasing a germplasm or , which factors to plants with large blue flowers without know- consider, who should be involved, and whether IP protection is appropriate. ing the genetic identity of the parents. Some institutions may also choose to pro- tect the plant name by registering the name as a The public sector has a long and success- propagated plants are covered by plant pat- trademark, such as Pink LadyÒ apple, WaveÒ ful history of developing enhanced germ- ents, but sexually propagated crops are cov- petunia, Blue SkiesÒ lilac, and EncoreÒ azalea. plasm and finished cultivars that are ered by PVPCs. An example of a cultivar In many instances, the trademarked plant may transferred through public release. For sev- protected by a PVPC is Capsicum annum L. also have a conventional cultivar name; for eral reasons, such as maintaining genetic ‘Black Pearl’ pepper (Stommel and Gries- example, Blue SkiesÒ lilac is Syringa vulgaris integrity, public release may not now be the bach, 2005); an example of a cultivar pro- L. ‘Monroe’. It can also be a little more most appropriate mechanism (Shelton and tected with a PP is Rubus subg. Rubus complex. Apples sold as Pink LadyÒ can be Tracy, 2017). IP protection of plants is involved Watson ‘Onyx’ (Finn et al., 2011). either Malus domestica L. Borkh ‘Cripps and complex (Batur and Dedeurwaerdere, Traits, genes, plant parts, and methods of Pink’, ‘Rosy Glow’, or ‘Lady in Red’. Two 2014; Clark, 2011). The International Society producing or using man-made plant cultivars of the cultivars (‘Cripps Pink’, PP7880; and for Horticultural Science held two symposia could be protected through a utility patent. ‘Lady in Red’, PP18787) are also protected on the topic in 2014 and 2018 (Hale et al., Utility patents can protect both sexually and through PPs (Luby and Bedford, 2015). 2014). The American Society for Horticul- asexually reproducing plants. An example of Although any one or combination of tural Science also has held many workshops a cultivar protected with a utility patent is PVPC, PP, utility patent, or trade secret can on the topic. There is still quite a bit of Capsicum annum L. ‘Medusa’. The utility be used to afford plants IP protection, many confusion on when and how to protect new patent (US 7,087,819) covers all nonpungent public institutions, be they governmental or plant cultivars (Pardey et al., 2013). In and ornamental pepper plants that have all the academic entities, may choose to release their addition, trade secrets and can morphologic and physiologic characteristics new plant cultivars and novel germplasms also be used to protect new plant cultivars. of Capsicum annuum L. ‘96P611’. Yet, at publicly without IP protection. What follows This article is a practical tool to help research times, more than one type of IP protection describes the plant release process used by institutions and scientists decide when to could be afforded to a single plant species. the U.S. Department of Agriculture’s ARS consider releasing a germplasm or cultivar, For example, in addition to utility patent (Plowman, 1993). Although the point of de- which factors to consider, who should be protection, Capsicum annum L. ‘Medusa’ is parture is ARS’s plant release procedures, the involved, and whether IP protection—and also protected with a PVPC (200000140). It aim is to make the procedures generic so they what type of protection—is appropriate. is important to note that some mechanisms could also encompass some of the procedures Unlike other scientific areas, in the United are more permissive than others. A summary used by our university partners. States there are three distinct mechanisms to of these three types of protection and their protect plants themselves—namely, utility exceptions are presented in Table 1. Ready or Not: How to Decide Whether a patents, plant patents, and plant variety pro- Two distinct government agencies are in- New Cultivar or Enhanced Germplasm Is tection certificates. Each of these mecha- volved in intellectual property in the plant Ready for Release nisms offers different criteria for protection kingdom. Plant Variety Protection applications and covers different types of plants. Cultivars are examined by the Plant Variety Protection It is the primary responsibility of the can be protected by a Plant Variety Protec- Office (PVPO), Agricultural Marketing Ser- individual plant breeder to decide whether tion Certificate [PVPC (Chen, 2005)] or a vice, U.S. Department of Agriculture, under the potential cultivar or germplasm is ready plant patent [PP (Fowler, 2000)]. Asexually the authority of the Plant Variety Protection for release. It is essential that the germplasm Act of 1970, codified in 7 U.S. Code of Laws or cultivar do the following: (U.S.C.) §2321 et seq. (U.S. Department of  Received for publication 24 Aug. 2018. Accepted Agriculture, 2013). Plant patent applications Represent a useful advance in genetic re- for publication 20 Dec. 2018. are examined at the U.S. Patent and Trademark sources 1Corresponding author. E-mail: robert.griesbach@ Office (USPTO), an agency of the Department  Be adequately evaluated ars.usda.gov. of Commerce, under the authority of the Plant  Offer benefits to users

HORTSCIENCE VOL. 54(4) APRIL 2019 763  Be new, distinct, uniform, and stable other languages must not be used for ‘culti- (whether PVPC is sought) var.’’’ In general, germplasm is released under a Breeding exemption Approval processes for cultivar or germ- number; cultivars are given a cultivar name. plasm releases are particular to each institu- Cultivar names need to follow the rules tion. In some universities, technology of the International Code of Botanical No- transfer offices may play a role in this pro- menclature. A trademark search through the cess. At ARS, after the previously listed USPTO website (www.uspto.gov) should criteria have been met, the breeders must also be conducted to make sure the proposed discuss their desire to release the germplasm name has not been trademarked. In case of or cultivar with both line and program man- No No No No seed-propagated plants, the PVPO website Yes Yes agement. (http://www.ams.usda.gov/AMSv1.0/pvpo) After there is general agreement to re-

seed exemption should also be searched to determine Crop/farm saved lease a new cultivar or enhanced germ- whether the name has been used before for plasm, the breeder usually drafts a release that crop. notice (Supplemental Fig. 1). In addition to the institutional release notice, most Who Is the Breeder/Inventor of a New breeders also publish their release in one Cultivar? of two scientific, peer-reviewed journals: HortScience for horticultural crops and The legal definition of a breeder of a new Journal of Plant Registrations for agro- cultivar is slightly different than the com- nomic crops. In addition, breeders should

erusalem artichoke. monly accepted genetic definition. The Plant also register their cultivar, if there is regis- Variety Protection Act in 7 U.S.C. §2401 tration authority for that crop, with the

hile retaining the expression of the essential characteristics that result from defines a breeder as a ‘‘person who directs the International Cultivar Registration Author- final breeding creating a cultivar or who embryos. Excluded by statute are plants in which the part of the plant used for ity (International Society for Horticultural discovers & develops a cultivar. If the actions Science, 2018). Many university and all are conducted by an agent on behalf of a ARS germplasm releases are deposited in principal, the principal, rather than the agent, date date or vines) from the date of issue the U.S. National Plant Germplasm System shall be considered the breeder.’’ The statu- 20 years from earliest effective filing 20 years from earliest effective filing 20 years (most plants) 25 years (trees (U.S. Department of Agriculture, 2018) to tory language suggests that final breeding enable further dissemination. means not only the genetic component, but also the selection component of cultivar de- How Is the Name for a New Cultivar or velopment. Germplasm Release Selected? The Plant Patent Act in 35 U.S.C. §161 further defines the inventor (breeder): ‘‘If one

that are The International Code of Nomenclature person discovered or selected (emphasis that are z

y for Algae, Fungi, and Plants (International added) a new and distinct plant, and a second

x Association for Plant Taxonomists, 2012) person asexually reproduced the plant and defines a ‘‘variety’’ (abbreviated var.) as a ascertained that the clone(s) of the plant below that of species and were identical to the original plant in every subspecies but above that of form (abbreviated distinguishing characteristic, the second fm.). A ‘‘cultivar’’ is defined by the Interna- person would properly be considered a co- tional Code of Nomenclature for Cultivated inventor. However, an inventor may direct Plants (International Society for Horticultural that the step of asexual reproduction be nonobvious, definite and enabled new, distinct, and completely described new, distinct, uniform, stable and nonessentially derived Science. 2009) as an assemblage of plants that performed by a custom propagation service 1) has been selected for a particular character or tissue culture enterprise. Those performing or combination of characters; 2) is distinct, the service would not be considered co- uniform, and stable in those characters; and 3) inventors, as they are performing these tasks when propagated by appropriate means, re- as the agent of the inventor.’’ tains those characters. For example, the name of a petunia would be Petunia (genus) integ- Should a New Cultivar Be Protected? rifolia (species) var. integrifolia (variety) fm. alba (form) (Fries) Smith et. Down ‘White Although ARS’s default position is to re- Glory’ (cultivar name). The genus, species, lease new cultivars and enhanced germplasm variety, and form are in italics; the cultivar lines publicly without IP protection, there are name is in single quotes, without italics. exceptions to this policy. There can be several It is important to note that the botanically reasons for protecting new cultivars: defined ‘‘variety’’ should not be confused with Legal authority Criteriathe legally defined ‘‘variety.’’ Length of Protection Although they  IP protection better facilitates technology both use the same term (‘‘variety’’), the desig- transfer. nations are not the same. The legally defined  Can allow broader adoption than public re- ‘‘variety’’ is equivalent to the botanically de- lease. For example, a cultivar of a new plant/ fined ‘‘cultivar.’’ species not already in the market will not The Plant Variety Protection Act defines likely get widely accepted by consumers ‘‘variety’’ in §41 as ‘‘a plant grouping within without a marketing campaign. A patent- a single botanical taxon of the lowest known license allows a commercial grower to re- rank.’’ The lowest botanical rank is not cover the cost of marketing. ‘‘variety,’’ but ‘‘cultivar.’’ The International  Provides incentive for investments by the Code of Nomenclature for Cultivated plants private sector in getting the cultivar in the states in §2.2: ‘‘The English words ‘variety,’ hands of farmers or growers. For example, Included by statute are asexuallyEssentially derived propagated variety plants is in derived which predominantly from the another part variety of or the from a plant variety used that for is asexual derived predominantly reproduction from is the a initial tuber variety w food part, as with potato or j Rooting cuttings, grafting and budding, apomictic seeds, bulbs, division slips, layering, rhizomes, runners, corms, tissue culture, and nucellar asexual reproduction is a tuber food part, as with potato or jerusalem artichoke. the genotype or combination ofU.S.C. genotypes = of U.S. the Code initial of variety. Laws. Utility patents 35 U.S.C. § 101-112 Eligible subject matter, novel, Table 1. Intellectual property protection mechanisms for plants. See text for examples of each type of protection. z y x Plant patents 35 U.S.C. § 161-164 Asexually reproduced plants PVP certificate 7 U.S.C. § 2321-2582‘form,’ and ‘strain’ Sexually reproduced plants or their equivalents in some vegetatively propagated cultivars

764 HORTSCIENCE VOL. 54(4) APRIL 2019 Literature Cited Batur, F. and T. Dedeurwaerdere. 2014. The use of agrobiodiversity for plant improvement and the intellectual property paradigm: Institutional fit and legal tools for mass selection, conventional and molecular plant breeding. Life Sci. Soc. Policy 10(14):1–29. Chen, J. 2005. The parable of the seeds: Interpret- ing the Plant Variety Protection Act in further- ance of policy. Notre Dame Law Rev. 81:106–166. Clark, J.R. 2011. Intellectual property and horti- cultural science: The path from idea, technol- ogy development, commercialization, and impact. HortScience 46:4–5. Finn, C.E., B.C. Strik, B.M. Yorgey, and R.R. Martin. 2011. ‘Onyx’ trailing blackberry. Hort- Science 46:657–659. Fowler, C. 2000. The Plant Patent Act of 1930: A sociological history of its creation. J. Pat. Trade- mark Off. Soc. 82(9):621–644. Hale, C., D. Hunter, W. Roberts, R. Ikin, and S. McMaugh (eds.). 2014. XXIX International Horticultural Congress on : Sus- taining lives, livelihoods and landscapes (IHC2014): International symposia on innova- tive plant protection in horticulture, biosecur- ity, quarantine pests, and market access. Acta Horticulturea Proceeding 1105. International Association for Plant Taxonomists. 2012. International code of nomenclature for algae, fungi, and plants. 19 July 2018. . International Society for Horticultural Science. 2009. International code of nomenclature for cultivated plants. 19 July 2018. . International Society for Horticultural Science. Fig. 1. To protect or not to protect: A decision tool for publicly releasing or protecting a new plant cultivar. 2018. International cultivar registration au- thority. 19 July 2018. .  Luby, J.J. and D.S. Bedford. 2015. Cultivars as can be very susceptible to disease and re- What is the point of view of key consumer brands: Trends in protecting and quire a certified disease-free propaga- stakeholders—such as commodity groups, commercializing apple cultivars via intellec- tion environment. A patent-license allows growers, university partners, seed compa- tual property rights. Crop Sci. 55(6):2504– a commercial grower to recover these nies, and nurseries—regarding protection? 2510. added costs.  Is there current commercial interest in Nirwan, P. 2017. Trade secrets: The hidden IP  IP protection can be used to maintain ge- marketing and producing the cultivar for right. WIPO Magazine 6:31–34. netic identity and purity. For example, sale or a high probability of commercial- Pardey, P.G., B. Koo, J. Drew, J. Horwich, and C. genetic drift may cause a seed-propagated ization in the future? Nottenburg. 2013. The evolving landscape of cultivar to lose a desired trait, such as an  Is the potential market for the cultivar of plant varietal rights in the United States, 1930– 2008. Nat. Biotechnol. 31(1):25–29. onion shape: global vs. high globe. A sufficient size to warrant protection?  Plowman, R.D. 1993. Intellectual property pro- license with the restriction to use certified Is foreign protection needed? tection of plants: The Agricultural Research seed will guarantee that the desired trait  If co-owned, what is the co-owner’s Service perspective, p. 33–40. In: Intellectual will be expressed in a population at a de- opinion? property rights: Protection of plant materials. sired level. CSSA Special Publ. no. 31. If it is decided that a cultivar should be Shelton, A.C. and W.F. Tracy. 2017. Cultivar When determining the best mechanism protected, the next steps vary depending on development in the U.S. public sector. Crop for dissemination of a germplasm or cultivar, whether the variety is clonally propagated, Sci. 57(4):1823–1835. the following factors are considered by ARS: seed propagated, or tuber propagated. For Stommel, J. and R.J. Griesbach. 2005. Capsicum annuum L. ‘Black Pearl’. HortScience 40:1571– clonally propagated cultivars, a plant patent  1573. How is the cultivar different from and/or application is filed at the USPTO. For seed- U.S. Department of Agriculture. 2013. Plant Vari- better than the closest currently available or tuber-propagated cultivars, a PVPC appli- ety Protection Act and regulations and rules of cultivar? cation is submitted to the PVPO. It is advis- practice. 19 July 2018. . growers and consumers beyond what and strive to have all required data collected U.S. Department of Agriculture. 2018. U.S. na- could be achieved through public release? before presenting a cultivar to the committee tional plant germplasm system. 19 July 2018.  Is protection needed to maintain genetic for consideration of protection. Because . U.S. Patent and Trademark Office. 2000. 19 July identify or to ensure the appropriate ARS’s policy is the free use of its cultivars 2018. . oleic acid soybeans? For seed-propagated utility patent protection for plants. Figure 1 U.S. Patent and Trademark Office. 2018. 19 July crops, what class of certified seed is presents a decision tool for whether the plant 2018. .

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