Author: Ashley J. (Clever) Earle, Contributing Member, University of Cincinnati Law Review
When thinking about patent protection, most individuals likely picture what patent attorneys describe as a “widget”—a physical, mechanical invention. Patent protection however, covers a much broader spectrum of inventions. It may seem natural to grant patents to protect new innovations such as chemical compounds, technological advances, or ornamental designs, but most people would not automatically include plants in the categories of protectable technologies. Plant patent protection is an unassuming, but integral part of the incentives of creativity protected by intellectual property law; however, obtaining plant protection can be very onerous and unnecessarily technical.
Plant Genetics: Thinking Outside the Punnett Square
The extent of the average person’s knowledge regarding plant genetics likely comes from a high school biology class teaching Gregor Mendel’s crossing of pea plants and the use of Punnett squares. While these techniques appear to be particularly helpful only to avid gardeners seeking to reproduce pink daisies, the dramatic increase of genetically modified crops has brought plant genetics to the forefront of technology. In the United States, in 2014, 96% of the planted area of cotton crops was genetically modified plants, followed by 94% of soybean crops and 93% of corn crops.[1] Crops are engineered to increase herbicide tolerance and insect resistance, to increase protein production, and to produce desired color pigments or other characteristics. Genetically modified plants are being used in the Third World and in developing countries to increase protein production in rice to provide food and nutrients for the more than 120 million children globally that do not receive enough vitamin A in their diet and are at risk of becoming blind.[2] Rice is also genetically engineered to withstand flooding, which allows regions with high rainfall to grow the crop and increase food production.[3] While genetically modified organisms (GMOs) have received very negative media attention, they are much more prevalent (and in many instances, much more helpful) than most consumers realize.[4]
Intellectual Property Plant Protection
The Constitution provides protection for intellectual property rights, enabling Congress “to promote the progress of science and the useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.”[5] While it is widely recognized that plants deserve protection, it can be quite difficult to determine exactly plants fit on the spectrum of intellectual property protection. Utility patents cover new and useful “compositions of matter,” including living things such as plants, but the strict written description and enablement requirements under § 112 of the codified Patent Act set a high bar that can be a difficult standard to meet when describing a newly developed plant species. To address this concern, Congress enacted the Plant Protection Act (PPA) and Plant Variety Protection Act (PVPA) to protect plant species while requiring a less onerous technical disclosure. However, the PPA and PVPA fail to provide the vast scope of protection granted by utility patents, and therefore most inventors will first seek protection through a utility patent—frustrating Congress’s purpose in enacting the PPA and PVPA.
Utility Patents
Under the Patent Act, codified in Title 35 of the U.S. Code, “[w]hoever invents or discovers any new or useful process, machine, manufacture, or composition of matter, or any new and useful improvements thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”[6] However, exactly what falls under the categories of “process, machine, manufacture, or composition of matter has long been debated by the courts.[7] Specifically, the court has struggled to determine whether living organisms and DNA sequences could fall within the scope of a “composition of matter.”[8]
The Supreme Court first held that living things could constitute patent-eligible subject matter in Diamond v. Chakrabarty (1980).[9] In Diamond, the court held that human-made, genetically engineered bacteria that was capable of breaking down crude oil components constituted a “manufacture” or a “composition of matter” within the meaning of 35 U.S.C. § 101, so long as the bacterium produced contained markedly different characteristics from that which exists in nature.[10] Further, in Ex Parte Hibberd, a case regarding the patentability of maize plant technologies including seeds, the USPTO Board of Patent Appeals and Interferences ruled that seeds, plant tissue cultures, and plants constituted patentable subject matter for utility patents.[11] The Supreme Court reiterated the patentability of plants in J.E.M v. Pioneer in 2001, another case regarding patented hybrid corn seed products, holding that newly developed plant breeds are within the scope of coverage of patent eligible subject matter under § 101 and that § 101 is not limited by the Plant Patent Act or Plant Variety Protection Act.[12]
A utility patent covers the functional aspects of an invention, and provides twenty years of protection from others making, using, or selling the device.[13] An application for a utility patent however must meet the stringent requirements of §§ 102, 103, and 112, which provide that the invention be new, useful, non-obvious and that the applicant must provide a written description of the invention, the manner and process of making and using the invention, and the best mode contemplated by the inventor (if known).[14] The inventor must be “in possession” of the invention at the time of filing and must enable one of ordinary skill in the art to both make and use the invention through the written description.[15] Factors in determining the sufficiency of § 112 requirements were established in In re Wands, which include: the level of skill in the art, the breadth of the claims, the nature of the invention, the state of the prior art, the level of predictability, the amount of direction and guidance, the presence or absence of working examples, and the quantity of experimentation.[16]
Obtaining a utility patent for a plant can be very difficult, as it can be hard to fully describe the plant enough to make someone of ordinary skill in the art able to both make and use the plant. To enable someone to “make” a plant, the genetic makeup of the parent plants need to be disclosed, unlike a mechanical invention, which can be described simply by providing drawings and figures of the widget. To be able to adequately use a plant, the possible benefits and uses of the plant, also known as the “agronomically useful phenotypic characteristics” should be disclosed—however, in the beginning stages of research, the usefulness of a plant may be unclear. Crossing two plant parents may also produce vastly different progeny, as the physical characteristics (known as the plant phenotype) can be highly affected by environmental interaction such as heat, drought, and soil conditions. These conditions cause variations in the plants that are produced and create an “unstable genome,” meaning that the same plant species can be cultivated numerous times with varying results of the final plant produced. These inconsistencies make it very difficult to adequately and fully describe a plant species in a patent application which can often lead to rejections of most utility patent applications for plants.
When a patent application is submitted to the United States Patent and Trademark Office (USPTO), a licensed examiner will determine if the invention displays the requisite novelty, utility, and is fully described and enabled. The sufficiency of a specification’s written description is determined on a case-by-case basis and is a factual analysis, “depending on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure.”[17] The written description should include at least a description of a representative number of the plant species by actual reduction to practice (via a deposit of the plant seeds), reduction to drawings, or by disclosure of relevant identifying characteristics.[18] These characteristics include the structure or other physical and/or chemical properties, functional characteristics along with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics sufficient to show the applicant was in possession of the claimed plant.[19] A deposit of the seed and/or cuttings with an approved depository is also required.[20] The deposit is not a substitute for providing as much detail as possible in the specification of a plant utility application; however, a deposit may satisfy or help satisfy the written description and enablement requirements.[21] An applicant must also fully describe the claimed plant variety and its agronomically useful phenotypic characteristics (the usefulness of the plant) such that one skilled in the art can make and use the invention without undue experimentation. Disclosure of the parents of the plant likely is necessary to meet this requirement.[22]
Plant Patent Act
Congress recognized the difficulty in describing plant patents, and attempted to address this concern by enacting the Plant Patent Act. The Plant Patent Act (codified at 35 U.S.C. §§ 161-164) provides protection for asexually reproduced plants including a single variety, sport, mutant, or hybrid plant.[23] Under the PPA, a plant patent application has a relaxed written description requirement, and only must describe the plant “as complete as reasonably possible.[24] A plant patent application must include at least one photograph of the new variety and a detailed botanical description of the plant, reciting the genus, species, varietal name, and method of asexual reproduction of the new variety.[25] If known, a comparison between the new variety and its parents must be given, along with a listing of how the new variety is similar to and different from at least one other variety of the same species.[26] An application should also disclose a description of the plant and its important parts, including the growth characteristics and requirements, plant form, bark, buds, blossoms, foliage, fruit and reproductive organs.[27] If known, additional characteristics may be included, such as fragrance, taste, disease resistance, measurements and color, temperature tolerance, productivity, precocity and vigor.[28]
While a plant patent still grants a term of protection of twenty years from the date of the filing of the application, the PPA only covers asexually reproduced plants.[29] Asexual reproduction produces progeny that are genetically identical to the plant parents.[30] For some inventors, this protection may not be ideal, as the coverage is slightly more narrow than the scope of a utility patent. A utility patent allows an inventor to claim not only the plant as a composition of matter, but also the method of producing the plant species by crossing two parents. If the desired protection centers around breeding two parent plants to produce a new plant species, PPA protection covering only the asexually reproduced plant may not be adequate coverage.
Plant Variety Protection Act
As previously mentioned, the PPA has an explicit exception for tuber-propagated plants (such as potatoes). Instead, the Plant Variety Protection Act (codified at 7 U.S.C. §§ 2321 et. seq.) protects novel variations of sexually reproduced and tuber-propagated plants under the United States Department of Agriculture (USDA). The USDA will issue a Plant Variety Protection (PVP) certificate for plants that are new, distinct, uniform, and stable.[31] A PVPA application must include a statement of distinctiveness of the variety, the breeding history, a description, basis of ownership, and declaration of seed deposit.[32] Notably, a PVP certificate does not include the strict requirement of usefulness or non-obviousness as required by utility patents. To satisfy the distinctiveness requirement under PVPA, an applicant must identify the most similar comparative variety, distinctive traits, and evidence that the differences between the claimed variety and other varieties are clear, stable, and uniform through at least two or three generations of statistical evidence.[33] Traits identified usually include similarity and differences in color, shape, quantitative traits and disease susceptibility, the breeding methodology, stages of selection and multiplication, and genetic variants observed during reproduction.[34] The PVPA grants plant breeders the right to exclude others from selling or reproducing the plant variety, with the term of protection running twenty years from the certificate’s date of issue.[35]
While the PVPA seemingly addresses the inadequacies of the PPA, there are three large loopholes in PVPA protection that render it less than desirable. First, the PVPA contains a provision to safeguard the “public interest in wide usage,” such that the USDA may require compulsory licensing of an otherwise protected species if the plant is necessary to insure adequate supply of food, fiber, or feed for animals. The USDA may also step in if it deems the certificate holder’s demanded licensing price unfair. Under the second exemption, the USDA may declare that the use and reproduction of a protected varied is authorized for bona fide research purposes, which will not constitute infringement. Finally, the PVPA permits farmers to save seed from protected plant varieties to use in the production of crops without constituting infringement. These exceptions can create large, gaping holes in plant protection coverage, and therefore most inventors will enlist the use of the PVPA as a supplemental protection or as a last resort when their utility patent application is rejected.
You Get What You Give: Less Disclosure Equals Less Protection
While the PPA and PVPA require less disclosure, they also offer less protection in return. A plant utility patent covers the plant, the methods of making or using the plant, and methods of breeding the plant, the PPA and PVPA only cover the exact plant and its clones, or in the case of PVPA’s, the plant and its clones or the plant and its homozygous seed.[36] Plant utility patents can cover any kind of plant that can be deposited, whereas the PPA covers only asexually reproduced plants (excluding edible tubers) and the PVPA covers only sexually reproduced plants and edible tubers.[37] Plant utility patents range from $1,300 to $8,000, with PPA protection starting at $1,900 and PVPA starting at $5,150.[38]
Plant protection under the PPA or PVPA is most often used only when an applicant cannot meet the written description or enablement requirement of a utility patent.[39] This directly contradicts Congress’s purpose in enacting the PPA and PVPA. Congress attempted to allow applicants to overcome the high hurdles presented by a utility patent and to still obtain protection for novel plant species. It seems contradictory that Congress would enact two provisions specifically enumerated to protect plants if the best protection was, in fact, neither option. Currently, applicants struggle with meeting the high expectations of a utility plant patent, but are unsatisfied with the protection granted by the PPA and PVPA and are left with no recourse but to choose between not receiving the protection they need and receiving no protection at all.
Plant protection plays an integral but unassuming role in today’s society. Congress needs to step in to expand the protections afforded by the PPA and PVPA to further the intended purpose of properly ensuring the protection of new plant species to help encourage innovation in the basic building blocks of life.
[1] ISAAA, Brief 44-2012: Executive Summary, International Service for the Acquisition of Agri-Biotech Applications, available at http://www.isaaa.org/resources/publications/briefs/44/executivesummary/default.asp (last visited Apr. 21, 2015).
[2] John Foxx, Top 10 Genetically Engineered Crops: Golden Rice, Discovery News (Dec. 12, 2012), http://news.discovery.com/tech/biotechnology/ten-genetically-modified-crops.htm.
[3] Id.
[4] John Dill, The Dangers of GMOs: Know the Hazards, Natural News (Sept. 28, 2010), http://www.naturalnews.com/029869_GMOs_dangers.html.
[5] U.S. Const. art. I § 8, clause 8.
[6] 35 U.S.C. § 101.
[7] Id. See e.g. Diamond v. Chakrabarty, 447 U.S. 303 (1980), Ex parte Hibberd, 227 USPQ 44 (PTO Bd. Pat. App. & Int. 1985) and J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc., 534 U.S. 124 (2001), all later discussed in more detail.
[8] Id.
[9] Diamond v. Chakrabarty, 447 U.S. 303 (1980).
[10] Id.
[11] Ex parte Hibberd, 227 USPQ 443 (PTO Bd. Pat. App. & Int. 1985) (holding that living plants were patentable subject matter in light of Diamond v. Chakrabarty, but rejecting three of the four claims at issue as unpatentable under 35 U.S.C. § 112 for failure to deposit seeds in a recognized public depository).
[12] J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc., 534 U.S. 124, 60 USPQ 2d 1865 (2001). Because Congress specifically enacted the PPA and PVPA to protect plant species, J.E.M. counterclaimed, arguing that Pioneer’s 17 utility patents covering plant species should be invalidated because the PPA and PVPA “set forth exclusive statutory means for protecting plant life.” The Court however, did not find this argument persuasive. Id. at 124
[13] 35 U.S.C. § 271. For protection of ornamental designs, an inventor would apply for a design patent, which provides protection for a more limited fourteen-year term and has different filing requirements than a utility patent. See 35 U.S.C. §§ 171-173.
[14] Id. §§ 102, 103, 112, see also MPEP (8th ed. Rev. 7, Sept. 2008) at 2161. While the Leahy-Smith America Invents Act removed the penalties for failing to disclose the best mode of an invention, the best mode requirement is still considered good law and is a discussion beyond the scope of this article. See 35 U.S.C. §§ 112, 282, MPEP (8th ed. Rev. 7, Sept. 2008) at 2165, and Erik Combs, Uncertainty Surrounds the Best Mode Requirement in the Wake of the America Invents Act, Thompson Coburn LLP, Mondaq (Feb. 19, 2013), http://www.mondaq.com/unitedstates/x/222416/Patent/Uncertainty+Surrounds+The+Best+Mode+Requirement+In+The+Wake+Of+The+America+Invents+Act.
[15] Id.
[16] In re Wands, 858 F.2d 731 (Fed. Cir. 1988) (holding that the applicant’s written description would not require undue experimentation to obtain the antibodies needed to practice the invention as claimed).
[17] In re Wertheim, 541 F.2d 257, 262 (1976)
[18] 66 Fed. Reg. 1099 at 1106.
[19] Id.
[20] Id.
[21] Id.
[22] See Pioneer Hi-Bred Int’l, Inc. v. J.E.M. Ag Supply, Inc., U.S. Dist. LEXIS 21782, 28 (N.D. Iowa, 1998) (holding that a seed deposit did not meet the requirements under 35 USC §112 because the identity of the parents was kept a trade secret, which did not enable one skilled in the art to make or use the invention).
[23] See 35 U.S.C. §§ 161-164, established in 1930, revised in 1952. Asexually reproduced plants produced via stem cuttings, tip cuttings and the like are protected, with the exception of tuber-propagated plants and those found in an uncultivated state, which are not eligible for protection. Protection extends for 20 years (with no annuities or maintenance fees) and excludes others from asexually reproducing, using, selling, or offering to sell the plant variety and any parts of the plant. Id.
[24] Plant patent specifications must include “description as complete as reasonably possible,” relaxing the rigorous requirement of utility patents to enable one of ordinary skill in the art to make and use the invention and to particularly point out and distinctly claim the subject matter which the inventor regards as his invention. See 35 U.S.C. § 112.
[25] Patricia A. Olosky, Protect Your Turf—Intellectual Property Protection for Plants, The Webb Law Firm (Feb. 23, 2015), http://www.webblaw.com/pdf/4-28-14%20Protect%20Your%20Turf.pdf.
[26] Id.
[27] Id.
[28] Id.
[29] 35 U.S.C. § 171.
[30] Meaning that the progeny, or offspring, are all identical clones of the parent plant.
[31] 7 U.S.C. §§ 2321 et. seq.,established in 1970, providing protection for twenty years from the grant date of the PVP certificate to exclude others from sexually reproducing, tuber-propagating, or using the protected plant to form a hybrid, as well as selling, offering to sell, importing or exporting the protected plant; and granting twenty-five years of protection for trees, shrubs and vines. Again, there are no maintenance fees or annuities associated with PVP certificates. Id.
[32] Olosky, supra note 25.
[33] Id.
[34] Id. A PVPA application must also include a deposit of 3,000 untreated, viable (85% germination or better) seeds. Id.
[35] 7 U.S.C. §§ 2321. Tree and vine plants can receive up to twenty-five years of protection. Id.
[36] Anne Marie Grunberg, USPTO Patent Examiner, Intellectual Property Protection for Plants in the United States, AIPLA PowerPoint Presentation, available at http://www.google.com/url?sa=t&rct=j&q=&esrc=s&frm=1&source=web&cd=3&ved=0CCsQFjAC&url=http%3A%2F%2Fwww.aipla.org%2Fcommittees%2Fcommittee_pages%2FBiotechnology%2Fusptobcp%2FBCP%2520Meeting%2520Materials%2FBCP%2520Site%2F030309%2FAMGrunberg_IPPP.ppt&ei=FOYSVYyVLsH3yQTH3oCACQ&usg=AFQjCNFqSYgoRe4c4cAhhFBM45KwE6E5xA&sig2=QnGI5zk7_6t1ywbnYykz7g (last visited Mar. 25, 2015).
[37] Id. A tuber is a plant structure similar to a root used to store nutrients, similar to roots. Tuber crops include potatoes and beet tops. Vegetable Resources, Root and Tuber Crops, http://aggie-horticulture.tamu.edu/vegetable/guides/the-crops-of-texas/root-and-tuber-crops/ (last visited Mar. 25, 2015).
[38] Anne Marie Grunberg, USPTO Patent Examiner, Intellectual Property Protection for Plants in the United States, AIPLA PowerPoint Presentation, available at http://www.google.com/url?sa=t&rct=j&q=&esrc=s&frm=1&source=web&cd=3&ved=0CCsQFjAC&url=http%3A%2F%2Fwww.aipla.org%2Fcommittees%2Fcommittee_pages%2FBiotechnology%2Fusptobcp%2FBCP%2520Meeting%2520Materials%2FBCP%2520Site%2F030309%2FAMGrunberg_IPPP.ppt&ei=FOYSVYyVLsH3yQTH3oCACQ&usg=AFQjCNFqSYgoRe4c4cAhhFBM45KwE6E5xA&sig2=QnGI5zk7_6t1ywbnYykz7g (last visited Mar. 25, 2015).
[39] Id.
