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Module III: Managing Intellectual Property
Forms of Protection for Biological Inventions
There are three basic forms of protection available to innovators: statutory (legal forms, including patents and plant breeders’ rights); "mixed" (a combination of legal and court-provided protection, including trade secrets and "unfair competition" laws); and property-based protection. Faculty focused mainly on patents, plant breeders’ rights, and trade secrets.
The presentation on patents was based mostly on US law, with reference to some key differences between US and European standards (e.g., animals are patentable in the United States but not in Europe). Patents cover machines, manufactures, compositions of matter, and processes; they prohibit making, using, selling, and importing without permission of the patent-holder, for a 20-year period (there is a narrow exemption for research). To be patentable, an innovation must be new, useful, and non-obvious. In addition, the inventor must make an "enabling disclosure," i.e., a disclosure of sufficient information about the invention that a person skilled in the relevant art can duplicate it. Patentability does not ensure commercial success: of a total of some six million patents granted in the United States, only a few thousand have resulted in products available in the market.
In terms of the requirements, "newness" is determined by comparison to the state of the art, regardless of whether existing comparable products or processes are patented; "utility" is a fairly low standard, in that it is not difficult to demonstrate some use for a given innovation, yet the stated use must be quite specific; "non-obviousness" is the most difficult determination, and takes into account the failure of others to solve the same problem, any commercial success achieved, synergistic effects (getting more from the whole than the sum of the parts), or the very recognition of the problem (i.e., an obvious solution to a non-obvious problem). The patent-seeker must identify the difference between the prior art and the invention, and the patent examiner must make the determination whether these differences would have been obvious "to the worker of ordinary skill."
The "enabling disclosure" is a sort of bargain between the patent owner and the public. The patent-seeker must disclose the secrets of the patent so it can be used by others at the end of the protected period, so the useful innovation is not lost to the world, e.g., in the event of the inventor’s death. The requirements are that the disclosure must permit the invention to be practiced fully according to the best method known at the time of filing (but not necessarily improvements made subsequent to filing, which can be significant). For biological materials, deposits of samples may be used in fulfillment of this requirement. (In fact many valuable germplasm samples are available to anyone through the US patent office for a $300 fee. If the patent is held only in the United States, it is quite possible for a Nigerian, for example, to obtain and utilize valuable biological innovations in this way.)
The benefits of patents, from the seeker’s point of view, include the affirmative protection against copying ("innocent" infringement not allowed, and extra penalties for willful infringement); the narrowness of the research exemption; the lack of a "saved seed" exemption, preventing competition from customers; the known term of protection; and the substantial jurisprudential experience in patent law. The disadvantages of patents, again from the seeker’s point of view, are that the high standards make them difficult to obtain; enabling deposits create a potential "leak" of protected information; the term is finite (although known, and considerable at 20 years); and every standard of protection is a potential source of defense against infringement.
Plant Breeders’ Rights
For the most part, plant breeding innovations have not been covered adequately under patent law; therefore, Plant Breeders’ Rights (PBRs) were developed as an alternative, to deal more specifically with the special circumstances that plant breeders face. PBRs are similar to patents, having a 20-year term of protection (25 years for trees and vines), but have their own requirements and standards. The standards are that the breed in question must be new, distinct, uniform, and stable. The latter three standards are often collectively referred to as DUS standards. "Distinct" is a kind of substitute for a patent’s "non-obvious" requirement, and is a fairly low standard in that any new feature of the plant, even strictly visual features, can render it distinct; "uniform" means that all the plants in the breed are the same; and "stable" means that the plant is true-breeding generation after generation.
Obtaining breeders’ rights is far less daunting than applying for a patent—the process is almost as simple as filling out a form, the cost is less (no attorney’s fees required, but there is still a $2500 filing fee), and the decision time is shorter. Therefore these rights can offer valuable protection for small farmers, researchers, or biotechnology companies wishing to commercialize a new discovery. Mike Roth noted that the large firms will always be able to out-spend small ones on research and legal matters, but they cannot necessarily out-think the smaller firms’ scientists. Plant Breeders’ Rights represent a legal tool the "small fish" can use to protect themselves in "shark-infested waters."
The benefits of PBR from the seeker’s point of view include the lower standards for obtaining rights; the easier, shorter application process; the specificity to plant varieties; widespread acceptance in many countries (they are required under TRIPS); the known term; and the ease of policing compared to patents. The disadvantages from the seeker’s point of view include the breeder’s exemption permitting research use; the farmer’s saved seed exemption, meaning customers can become competitors; the limited term; the fact that compliance is not universal; and the limited jurisprudential experience in the area to date. As noted in group discussion, several of these "disadvantages" are also advantages from other points of view, e.g., those of researchers and farmers.
A trade secret, as the name implies, is valuable commercial information protected by virtue of its being known only to the firm using it, i.e., by being secret. Although keeping a secret is essentially a private matter entailing private risk, some legal support is offered for trade secrets (including under TRIPS), with infringement based on misappropriation or a breach of a confidential relationship; still, once the secret is out, it is no longer a trade secret. In order to be protected under the law, a trade secret must be protected by reasonable measures. Keeping an innovation as a trade secret rather than applying for a patent or breeders’ rights may be a desirable option, depending on the type of innovation and whether it can reasonably be expected to remain secret.
The benefits of a trade secret include an unlimited term (as long as the secret remains secret); its applicability to a wide variety of technologies; the lack of standards to meet; and criminal penalties for infringement, with substantial jurisprudential experience. The disadvantages include complete loss of protection if the secret is disclosed; the existence of well-established defenses against infringement (including claim to independent discovery, inadvertent disclosure by owner, and reverse engineering); the requirement of a "separate, actionable wrong-doing" for infringement; and the lack of protection compliance in many countries.
Utility models can be considered as "small patents" for "small inventions," and are available as an alternative to patents in several countries. They were used in Japan very successfully as that country attempted to catch up technologically with the West. Utility models are more easily accessible, with lower requirements for the inventive step in the innovation. They also have lower fees and a shorter term than patents, and are sometimes limited to specific types of innovation, such as products only. There are no international standards for utility models.
Forms of Protection for Biological Inventions