Source: https://cookingupastory.com/patent-law-how-patents-grew-over-time-to-include-living-organisms
Timestamp: 2019-04-20 10:33:12+00:00

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Part 1: Monsanto sells a glyphosate-based herbicide called “Roundup.” Monsanto also sells seeds for crops – such as soy, corn, sugar beet, cotton, and others – that are genetically engineered to resist Roundup. Monsanto calls these seeds “Roundup Ready.” Patent law was critical to Monsanto’s business strategy, on both the herbicide and crop seed sides of the picture. Patenting a chemical, like glyphosate, doesn’t sound surprising. But patenting seeds, the germs of life, may sound surprising. How did it come to be the case that one can get a patent on a living thing? In a series of three posts – including this one – I try to share the highlights of this legal and technological story. The story itself has unfolded over many decades.
As a preliminary item, I should clear up a point about terminology. There are actually three different kinds of patents under U.S. law. When most of us hear the word “patent,” we think of a patent on a drug compound, or on a computer chip – in short, a new and inventive useful object. In law, this is known as a “utility patent,” a patent on something useful. U.S. law also provides for patents on new and inventive ornamental designs for articles of manufacture; this type is known as a “design patent.” Finally, there is the “plant patent,” for new and inventive plant varieties, which I will describe in more detail below.
Before discussing patent protection for plants in detail, it’s probably best to tackle a big picture question – namely, why have a patent system at all, for any kind of invention? The answer turns on facts about information. Specifically, it can take an enormous amount of time and money to develop a new piece of information (like the chemical identity of an effective new drug, or the steps in a new process for hardening metal), but very little to use the new information once someone else has found it for us. This disparity between the cost of developing and the ease of using new information may deter people from making the big up-front investment in developing new information in the first place. To encourage such investments, we give people who come up with new useful inventions the right to exclude others from exploiting the invention, at least for a period of time; the right to exclude others helps an inventor recoup the costs of inventing, and perhaps earn a larger return (which fund more inventions).
This right to exclude others, which is what a utility patent gives its owner, has important limitations built into it. The limitations, like the protection itself, follow from the nature of information. First, patent rights expire. There is no need to give someone an eternal right in order to encourage investments in invention, and we don’t do so. Second, patents aren’t available on the most basic building blocks of innovation, for, if they were available, they might stifle the very innovation we are trying to encourage. The courts have long held that patents are not available for laws of nature, natural phenomena, or abstract ideas. These basic building blocks of innovation are our common heritage, and everyone has access to them.
This last point is a bridge to my main topic in these posts: How did it come to pass that one can patent a living thing, such as a genetically modified plant or animal?
What is patentable? What is not? These are questions that every patent system must answer, and different systems have given different answers – both historically, and today.
For example, in 1474, the Republic of Venice created what patent law scholars recognize as the first modern patent statute. This patent law allowed an inventor to patent “any new and ingenious device” built in Venice, assuming all the law’s requirements were met. The term “device” covered things like a machine to raise water, a saw mill, or an excavation device. It did not, however, cover processes (such as tanning leather or curing meat). By making a basic system-design choice like this, a legislature decides which inventive activities it wants to encourage by holding out the reward of a patent right – a right to exclude others from making, using, or selling the invention for a term of years.
What about the U.S. utility patent system? What can one patent in the U.S.? Congress passed our first national patent statute in 1790, 316 years after the Venice statute. (That means that, when Congress created our first patent law, the idea of patent protection was already very old. Our country itself, dated from 1776, is only 233 years old!) Congress revised the Patent Act in 1793, and the definition of patentable subject matter that Congress set forth at that time has the very same words today (with the exception of a one-word substitution that Congress made in 1952). Section 101 of the Patent Act (in Title 35 of the U.S. Code) states as follows: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” (Congress substituted the word “process” for the word “art” in 1952.) Of course, although these statutory words have been the same for more than 200 years, the technology to which we have applied the words has changed dramatically.
We can think of Section 101 as a list of four categories: processes, machines, manufactures, and compositions of matter. Most of the time, it is easy to see, and all agree, that a given item falls within one of these categories. From fluoxetine hydrochloride, the active ingredient in Prozac (U.S. Patent No. 4,314,081) to bubble wrap (U.S. Patent No. 3,142,599) to the airplane (U.S. Patent No. 821,393), practical solutions to concrete problems fall comfortably within the scope of Section 101. Processes, like tanning leather, smelting ore, and curing rubber, are patent-eligible too. Some technologies, however, present tough line-drawing problems. Biotechnology (including living, genetically-modified organisms) and computer programs have generated some of the most interesting questions about whether something is patentable. As we learn about these controversies, we see the important roles played by every actor in the patent system – the inventor community, Congress, the Patent Office, and the federal courts. (State legislatures and courts don’t play a material role in our patent system, which is exclusively federal.) The general public has a role to play too, of course, in making its views known to these other patent system actors.
When it comes to contemporary patent protection for new plants and other living things, it helps to know the context that two important statutory changes provide. One took place in 1930, and the other in 1970. In both instances, Congress responded to what industry players said was an inability to get utility patent protection for their inventions on an equal footing with other industries. Congress expanded the scope of patentable subject matter on both occasions.
Congress first considered expanding patent protection to include plants in 1892, but it did not enact the PPA until May 1930. Supported by celebrated plant breeders like Luther Burbank and inventors like Thomas Edison, the PPA relies on an analogy between new breeder-produced varieties and new mechanical, electrical, or chemical inventions. According to the committee reports Congress prepared in support of the PPA, “a plant discovery resulting from cultivation is unique, isolated, and is not repeated by nature, nor can it be reproduced by nature unaided by man, and such discoveries can only be made available to the public by encouraging those who own the single specimen to reproduce it asexually and thus create an adequate supply.” Of course, it’s fair to ask – given the appeal of the analogy between a newly bred plant variety and a newy invented plough or mill – why hadn’t plant breeders simply applied for regular utility patents (before Congress passed the PPA)?
Congress solved both of these problems with the PPA, by creating a new kind of patent called a “plant patent,” different from a utility patent. Congress expressly made new plant varieties patentable, in language now codified at 35 U.S.C. § 161: “Whoever invents or discovers and asexually reproduces any distinct and new variety of plant, including cultivated sports, mutants, hybrids, and newly found seedlings, other than a tuber propagated plant or a plant found in an uncultivated state, may obtain a patent therefor, subject to the conditions and requirements of this title.” (The courts have construed the word “plant” in the PPA to have its common meaning, rather than a strict scientific meaning. Thus, for example, the courts decided that bacteria are not eligible for plant patent protection under § 161. In re Arzberger, 112 F.2d 834 (CCPA 1940).) Congress also ensured that the disclosure requirement for a plant patent would not be so demanding as to prevent protection, in language now codified at 35 U.S.C. § 162: “No plant patent shall be declared invalid for noncompliance with [the disclosure requirement for utility patents] if the description is as complete as is reasonably possible.” A plant patent gives its owner the “the right to exclude others from asexually reproducing the plant, and from using, offering for sale, or selling the plant so reproduced, or any of its parts, throughout the United States, or from importing the plant so reproduced, or any parts thereof, into the United States.” 35 U.S.C. § 163. In short, a plant patent covers a single new plant and its asexually reproduced offspring.
The PPA “was the first legislation anywhere in the world to grant patent rights to plant breeders.” Imazio Nursery, Inc. v. Dania Greenhouses, 69 F.3d 1560, 1563 (Fed. Cir. 1995). It’s important to recognize, however, that the PPA’s limit to asexually reproduced copies of the original parent plant is a serious one. PPA protection does not give the patentee the right to prevent someone from cultivating a similar variety on his or her own. Nor does it pertain to plants reproduced by seeds, or seeds themselves. Indeed, according to the congressional reports supporting the PPA, the patented plants “must be asexually reproduced in order to have their identity preserved”; “seedlings … would not preserve the character of the individual.” Requiring asexual reproduction also helps to prove that the claimaint has actually developed a new variety “by separating variations resulting from fluctuations in environmental conditions from true plant variations.” Imazio Nursery, 69 F.3d at 1566.
A crop seed company, even after the PPA’s enactment, could not stop others from saving crop seed and planting in the next season. As Professor Keith Aoki (UC Davis) noted in a recent article, “[t]he seed industry wanted explicit patent rights in sexually reproduced varieties without any inquiry into seed ‘quality,’” i.e., any assessment whether the new seed variety would produce better plants than existing varieties. Weeds, Seeds & Deeds: Recent Skirmishes in the Seed Wars, 11 Cardozo J. Int’l & Comp. L. 247, 284 (2003).
Congress created a patent-like system for seed-reproduced plants in 1970, with the enactment of the PVPA. This statute is not part of the Patent Act. Instead, it creates a Plant Variety Protection Office within the Department of Agriculture. (The Patent Office is in the Department of Commerce.) A successful applicant receives a plant variety protection certificate, not a patent. Specifically, “[t]he breeder of any sexually reproduced or tuber propagated plant variety (other than fungi or bacteria) who has so reproduced the variety … shall be entitled to plant variety protection for the variety, subject to the conditions and requirements of this chapter, if the variety is” new, distinct, uniform, and stable. 7 U.S.C. § 2402(a). The certificate gives its owner the right “to exclude others from selling the variety, or offering it for sale, or reproducing it, or importing it, or exporting it, or using it in producing (as distinguished from developing) a hybrid or different variety therefrom.” 7 U.S.C. § 2483(a)(1). But this right to exclude has significant exceptions – exceptions that a crop seed company would find especially annoying. The PVPA-based power to exclude another from “reproducing” the covered seed does not bar a farmer from saving seed from one crop and planting it at a later time. 7 U.S.C. § 2543. And competing seed companies can conduct research on a PVPA-protected variety: “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 chapter.” 7 U.S.C. § 2544. Neither seed-saving, nor research use, would be permitted as a matter of course under the Patent Act, with a regular utility patent. As a result, utility patent protection remained desirable to the seed companies, even after Congress enacted the PVPA.
When Congress passed the PPA, it made it clear that one could throw the cloak of patent protection around a new plant variety and its asexually reproduced progeny. And when it passed the PVPA, Congress made it clear that one could get patent-like protection for seed crops, subject to some important limitations (like saving seed for replanting). But unanswered questions remained. (1) Could one obtain a utility patent on a living organism, such as a genetically modified bacterium, or even a multicellular organism? (2) Could one obtain a utility patent on a plant, even if the plant could also be covered by a PVPA certificate or a PPA plant patent?
Isolated examples suggested that the answer to each question might be “yes,” although there was no widely shared general understanding on these points. For example, Louis Pasteur successfully obtained U.S. Patent No. 141,072 in 1873, Claim 2 of which gave him the right to exclude others from making, using, or selling his new “[y]east, free from organic germs of disease, as an article of manufacture.” Little is known about why, in 1873, the Patent Office was willing, in Pasteur’s case, to view a living thing as an article of manufacture. In 1975, University of Illinois researcher Earl Patterson obtained U.S. Patent No. 3,861,079 – a regular utility patent – on a new corn hybrid seed. Would such grants ultimately stand up in court, if asserted in patent infringement actions?
In Part 2, on Friday July 31, I’ll explore two Supreme Court cases that help answer these questions, one called Diamond v. Chakrabarty and one called JEM Ag Supply v. Pioneer Hi-Bred.

References: § 161
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 § 2402
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