Protecting Intellectual Property in Plants and Seeds Editor’S Note: This Is the Final Part of a Six-Part Series on Patent Law

column intellectual property Protecting Intellectual Property in Plants and Seeds Editor’s note: This is the final part of a six-part series on patent law. odern biotechnology makes possible living organisms, such as plants, created a need for a new type of Mthe selective transfer of genetic ma- intellectual property protection. terial between organisms, and has allowed for the development of seeds and plants The Plant Patent Act of 1930 that tolerate herbicides, resist pests, have improved nutritional profiles, grow in ad- Eventually, the nursery and seed industries fought for and obtained verse conditions, and have better handling statutory provisions to protect their intellectual property, separate and processing characteristics (1, 2). The from the existing but unused utility patent provisions. First, Congress research and development behind such enacted the Plant Patent Act (PPA) in 1930. The PPA protected the products can be costly. Presently, such invention or discovery of, and the asexual reproduction of, distinct products, and the innovations underlying and new varieties of plants, including ornamentals, fruit trees, and berry plants. In 1952, the provisions of the PPA were incorporated KEITH A. ZULLOW them, can be protected by utility patents, into the patent statute as 35 U.S.C. Sections 161–164 (3). Goodwin Procter plant patents, certification under the Plant New York, NY Variety Protection Act, and trade secrets. This column introduces these forms of The Plant Variety Protection Act of 1970 protection and their historical context. In 1970, Congress enacted the Plant Variety Protection Act (PVPA). Unlike the asexually produced plants described above cov- Historical Review ered by the PPA, the PVPA protects such agriculturally important The Seed Industry crops as cereal grains, grasses, and vegetables that are grown from In the 1800s, the federal government seed (i.e., via sexual reproduction). The PVPA is a certification pro- collected seeds from around the world to gram run by the Plant Variety Protection Office (PVPO) of the distribute to U.S. farmers (3, 4, 5). This USDA. The PVPO issues Certificates of Protection for new varieties government program brought new germ- of plants that are seed reproduced (or tuber propagated), upon ex- plasm into the U.S. gene pool (6). The pro- amination to determine that a plant is a new, distinct variety, and gram ended in 1924 and at that point the genetically uniform and stable (7). The remedies for infringement U.S. government was distributing millions include damages and injunctions (8). Thus, PVPA certification helps of packets of seeds annually (3, 4, 5). The protect innovators who have invested large amounts of time and money into developing seed technologies and innovations in sexu- RA IVO A. Kar M A S elimination of the government program ally reproduced plants. Goodwin Procter gave the emerging seed industry an incen- New York, NY tive to invest in research and development. The elimination of the government seed The U.S. Supreme Court program also coincided with a rediscovery Finally, in 1980, the U.S. Supreme Court began to clarify and of Gregor Mendel’s groundbreaking pea- expand the coverage of utility patents to include plants. In a seminal breeding experiments of the mid-1860s, accelerating progress in decision, Diamond v. Chakrabarty, 447 U.S. 303 (1980), the Su- plant and seed science. Consequently, there was an increased need preme Court addressed the patentability of a genetically-modified to protect the “fruits” of such research and development. Unfortu- bacterium capable of breaking down crude oil. The patent examiner nately, the courts had not yet recognized utility patents as a viable had allowed claims to a method of producing the bacterium and to means of protecting seeds. an innoculum containing the bacterium. However, the examiner de- nied the claims to the bacterium itself, in part because micro-organ- The Nursery Industry isms are “products of nature,” and living things were not deemed In this same time frame, the nursery industry successfully com- patentable under U.S. patent law, which identifies patentable subject mercialized asexually reproduced plants. Asexual reproduction matter as “any new and useful process, machine, manufacture, or (e.g., grafting, budding, rooting) allowed for mass production of ge- composition of matter.” The Supreme Court ruled that the bacterium netically identical plants, which was important for plants such as was a “manufacture” or “composition of matter,” and was therefore fruit trees and ornamentals. Unfortunately, once a company intro- patentable subject matter (9). duced a new plant variety into the market, a competitor nursery In 2001, in J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Intern., Inc., could buy the plant and start to mass produce it, taking profits from 534 U.S. 124 (2001), the Supreme Court re-emphasized what it had those who discovered or bred the new variety (5). This, combined said in Chakrabarty, that the utility patent statute is “forward-look- with the fact that the courts did not think utility patents could protect ing” and that “Congress employed broad general language in draft- ing § 101 precisely because [new types of] inventions are often un- doi:10.1094 / CFW-53-6-0319 foreseeable” (3). As such, the Supreme Court found that utility pat- CEREAL FOODS WORLD / 319 ents could be issued for plants, such as the new varieties of hybrid and inbred corn involved in the case. IP Protection for Plants These Supreme Court cases make it clear that utility patents are available for innovations in plants and seeds, provided the statutory • Innovations in plant and seed technologies may requirements of patentability are met (i.e., utility, novelty, nonobvi- be protected by utility patent, plant patent, PVPA ousness, definiteness, written description, enablement, and best certification, and trade secret. mode (35 U.S.C. Sections 101, 102, 103, 112)). • Utility patents are available for plants that reproduce sexually and asexually, and are not confined to the Comparison of IP Protection for Plants plant itself. The PPA, PVPA, and utility patents are three potential means of • Plant patents protect asexually reproduced plants. protecting intellectual property relating to plants. Trade secret • PVPA certification is a program run by the USDA protection may also be available. These protections are compared for sexually reproduced plants. and contrasted below. PPA Plant Patents Plant patents cover only asexually reproduced plants (e.g., grafting, budding, rooting) excluding tuber-propagated plants or plants is kept secret and misappropriation can be proven, trade secret pro- found in an uncultivated state. Plant patents have only one claim tection can be effective, although enforcement can be expensive. For written in a formal format, directed to the plant itself, and a less example, the owner of a trade secret in the genetic make-up of certain stringent written description requirement than utility patents. Com- seed corn recovered $46 million in damages for trade secret misap- mercially important plants eligible for plant patent protection in- propriation by a competitor upon proving that: the genetic make-up/ clude ornamentals, fruit trees, berry plants, and other plants typically messages had been kept secret; the competitor possessed the pro- associated with the nursery industry. Plant patent requirements are tected genetic messages; and the competitor obtained the protected recited in 35 U.S.C. Sections 161 and 162. “Distinctness” is the pri- genetic messages by improper means. The trial, which was followed mary hurdle to patentability (8). Additional information on plant by an appeal, lasted 37 days, involved over 1,100 exhibits, and re- patents is available at the USPTO website and in treatises (8, 10). sulted in over 9,000 pages of transcript (11). As the above comparisons show, utility patents provide the great- PVPA Certification est range of protection to innovations across the plant and seed PVPA certification is overseen by the PVPO of the USDA. Certi- world. However, utility patents are usually harder to obtain than fication protects innovation in sexually reproduced plants. Sexually plant patents or PVPA certifications. reproduced plants were omitted from the PPA because when the PPA was enacted new varieties could not be reproduced true to type (3, Continuing Exploration of Patents and Patent Law 8). By 1970, the state of the technology had changed and the need to protect innovation in sexually reproduced plants was recognized (8). This article series provided an introduction to patent law for sci- A PVPA certificate has no claims, and is directed to a single plant entists, engineers, and other food industry professionals. Readers variety (8). Obtaining a PVPA certification entails filling out a form, interested in continuing to learn about patents can explore the USP- paying the appropriate fee, and providing information such as breed- TO website (12). One can also search for and read patents in an area ing history, a statement of distinctness, and an objective description of interest. For example, searching the USPTO database for patents of the variety. PVPA applications are examined for distinctness, uni- with “corn” in the title retrieves over 1,300 patents dating back to formity, and stability to assess whether a plant meets the statutory 1976. Included are patents on plants, seeds, methods of breeding, “novel variety” standard (8). Presently, the certification process costs devices,

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