Defensive Publishing and the Public Domain Sara Boettiger, Senior Advisor, PIPRA and Chief Economist, M-Cam, Inc., U.S.A

CHAPTER 10.1

Defensive Publishing and the Public Domain Sara Boettiger, Senior Advisor, PIPRA and Chief Economist, M-Cam, Inc., U.S.A. Cecilia Chi-Ham, Director, Biotechnology Resources, PIPRA, U.S.A.

ABSTRACT negative effects. For instance, when research tools IP (intellectual property) rights can reward innovators and or enabling technologies are patented and not encourage investment in developing new products and available for licensing, the creative and collabora- services. However, the exclusionary power of IP rights can sometimes have negative effects, making technologies less tive process of innovation can potentially be im- accessible and, thereby, potentially impeding innovation. peded. To ensure the balance between access and To make informed decisions about how to balance ac- protection requires an understanding of both the cess and protection requires an understanding of both the traditional IP rights system (patents, copyrights, traditional IP rights system (patents, copyrights, trademarks, and trade secrets) and alternative mechanisms for trademarks, and trade secrets) and alternative preserving access to technologies. This chapter provides concepts, such as defensive publishing, public a brief introduction to the public domain and defensive domain, and open source. publishing and examines issues concerning the choice be- Debates about IP policy and the need to seek hind the choice of whether to publicly disclose or to pat- a socially optimal balance between IP rights and ent an innovation. Discussing the strategic use of defensive publishing in IP management, the chapter considers the public domain are important for the pursuit both the utility of defensive publishing and its limitations of vibrant national and international innovation for supporting broad innovation. After an examination of systems. This chapter’s focus, however, is narrow- the public domain and how it relates to other open-ac- er. Rather than examining how policies regard- cess concepts, such as open source and the commons, the chapter focuses on the practical considerations involved ing the public domain might support innovation, when using public-domain technologies and defensive we look instead at how, given current IP laws, IP publishing to manage intellectual property. management practitioners can best use the public domain to support particular goals. The term public domain describes a body of work that is freely available, legally unprotected, 1. Introduction and not subject to individual ownership. Public A well-functioning innovation system strikes a domain implies the absence of individual IP rights. balance between protecting technologies and pre- This definition exemplifies the language associat- serving access to them. IP (intellectual property) ed with the public domain and what remains after rights can provide incentives that reward innova- all the boundaries of IP rights have been staked. tors and encourage investment in the develop- Likewise, we commonly refer to a technology ment of new products and services. However, falling into the public domain, as if there were the exclusionary power of IP rights can also have never a conscious decision to place something in

Boettiger S and C Chi-Ham. 2007. Defensive Publishing and the Public Domain. In Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices (eds. A Krattiger, RT Mahoney, L Nelsen, et al.). MIHR: Ox- ford, U.K., and PIPRA: Davis, U.S.A. Available online at www.ipHandbook.org. © 2007. S Boettiger and C Chi-Ham. Sharing the Art of IP Management: Photocopying and distribution through the Inter- net for noncommercial purposes is permitted and encouraged.

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the public domain; instead, the public domain In recent decades, many authors have exam- encompasses the residuals of the processes of the ined how innovation systems have been changing IP rights system. This chapter, however, does not in response to the expanding system of IP rights. view the public domain as simply a default for As IP rights have become stronger, broader, and technologies that are not claimed via IP rights. more far-reaching, many technologies that might Instead, the chapter aims to promote a broader previously have been freely accessible in the pub- appreciation of the public domain as a valu- lic domain are now proprietarily owned. This able resource. The authors seek to facilitate the phenomenon has been particularly noticeable in discerning use of the public domain as a tool the fields of health and agriculture. (among a set of tools that include traditional IP In 1980, a landmark U.S. Supreme Court rights and related licensing mechanisms) of pru- decision (Diamond v. Chakrabarty)2 set the stage dent IP management. for a burgeoning biotechnology industry and an Section 2 provides background that illus- exponential rise in the number of life-science pat- trates the importance of the public domain and ents. Allowing for the patenting of human-made how it has changed in recent decades. Section microorganisms, the decision clarified the Court’s 3 briefly introduces two other open-access con- position that patentability did not depend on the cepts—the commons and open source—in order distinction between living and inanimate things, to distinguish three alternatives from one other but instead between inventions made by “man” and defines their relation to the IP rights system. and those that exist naturally. Among other influ- Section 4 uses a narrower, legalistic definition of ences to increased patenting during this period, the public domain to discuss the practical impli- the Bayh-Dole Act of 1980 has played a role. It cations surrounding public domain technologies. set up new rules for the interface between aca- That section reviews the patent-law concepts nec- demia, in which publications are the currency of essary for understanding both the construction the trade, and the commercialization of universi- of a successful defensive publication, how to as- ty research through patenting and licensing.3 The certain whether a technology is, in a legal sense, rise in the patenting of life-science technologies part of the public domain. Section 5 introduces and the corresponding reduction in the number the practice of defensive publishing, examining of technologies remaining in the public domain how best to place innovations into the public do- has been most remarkable in developed countries. main. Section 6 considers potential strategies for Still, in many developing countries, patenting re- the IP manager choosing between patenting and mains sparse.4 Indeed, despite the strengthening defensive publishing. Section 7 outlines practi- of IP rights policies worldwide through TRIPS cal issues confronted by users of public domain (the Agreement on Trade-Related Aspects of technologies. Intellectual Property Rights) and TRIPS-plus, international disparities in patenting behavior are likely to persist. Understanding these differences 2. Innovation and the public domain can be important for understanding how best to “There is no area in which public concern about in- use the public domain. tellectual property and the public domain has been Substantial differences in patenting behavior greater than in scientific and technical research. can also be found between the public and private Whether it is the controversy over the patenting of, sectors within a country. Public sector patenting and access to, the humane genome or pluripotent behavior and the use of the public domain may stem cell lines, the appropriate role of intellectual be influenced by culture (for example, the land- property in university research, or the use of ethno- grant universities in the United States, the cen- botany and traditional herbal knowledge in phar- ters of the Consultative Group on International maceutical patenting, the coexistence of science and Agricultural Research, (CGIAR), and many other property rights has been a fairly constant concern public sector agricultural research institutions over the last 15 years.” –James Boyle1 worldwide have a strong history of contributions

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to the public domain), a lack of resources relative domain if one can make, use, offer for sale, sell, or to the private sector, and institutional structures import the invention without infringing an active that often are designed to accommodate differ- patent and if there are no other types of IP rights ent goals. Although there clearly are exceptions, that lay claim to the invention. Technologies in public sector institutions and individual research- the public domain can be used with impunity be- ers are generally at a disadvantage when it comes cause, by definition, there is an absence of owner- to strategically employing the patent system to ship and therefore free access. This description of achieve their research and development goals. In the public domain as a distinct set of technologies these instances, the public domain can be a cru- with a defined boundary, though, is misleading. cial resource. In fact, the boundary between the two sets can This chapter does not consider whether the be difficult to discern, can vary from country to shift in the relative strength of the public domain country, and is continually shifting. It is no sim- in the life sciences is disadvantageous, and, if so, ple task to ascertain whether or not a technology to whom. Such complex issues have been consid- is in the public domain. ered widely in the literature on IP policy. Instead, the chapter focuses on how to use the public do- 3.2 Open source main to achieve individual IP management goals. Like the public domain, open source is character- Whether research and development goals in- ized by free accessibility. However, with regard to volve decisions about how to access technologies, open-source technology, free access derives from how to preserve widespread access to newly de- a different source. Free access in the public do- veloped technologies, or how to ensure that inno- main is defined by an absence of ownership, but vations continue along the research and develop- free access in open source is dependent upon the ment path toward commercialization unimpeded presence of IP rights that enable the use of open- by IP issues, a solid understanding of the public source licenses. domain is paramount. It is essential to know how The concept of open source has its origins the public domain interfaces with the IP rights in computer software. Once computer code has system in order to know when and how to use it. been fixed in a tangible means of expression, it is automatically the subject of copyright protection. This copyright protection allows the owner 3. Defining open-access concepts to license the code. A typical (non-open source) In this section we compare the concept of pub- license might, for example, contain terms that lic domain with two other concepts: open source restrict the use of the licensed product or stipu- and the commons. These three terms all relate to late fees to be paid. But the terms of an open open-access alternatives to the traditional IP source license are seen as an unusual reversal of rights system, but they are very different from one typical licensing terms (so unusual the license is another. sometimes called copyleft). By signing an open- source license, the licensee agrees to ensure that 3.1 Public domain the software will remain available for public use, In its usage to date, the term public domain is elas- modification, and redistribution; the licensee tic and inexact. A definition can be but one of many is then in breach if he or she privately appro- definitions, each surely a function of perspective and priates the technology and restricts its public agenda ... 5 availability. Defining the term public domain as the ab- Such legal protection from private appropri- sence of individual property rights creates two ation has been used to generate a self-defending mutually exclusive sets of technology: one that is commons of software code that is collaboratively protected by some form (any form) of IP rights added to and improved upon. A technology li- and another that has no IP rights. Thus, in patent censed under an open-source license, therefore, law, a technology is considered to be in the public cannot be in the public domain; otherwise there

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would be no license and no way of enforcing the The collective-management concept translates, commons. albeit loosely, into the term’s use in reference to Several versions of open-source licenses are intellectual property. commonly used, and they vary in the restrictive- In addition to describing the management of ness of their terms. For instance, there may be a a body of intellectual property, the term commons provision that any code that is combined with has also been used in reference to characteristics the licensed code will fall under the ambit of the of ownership and access.7 Whether a commons is open-source license. Therefore the entire body of defined by lack of private ownership, open access, code can only be licensed under the same open- or collective management seems to vary according source license terms—it cannot be privately ap- to the context in which it appears and to the au- propriated. Thisviral quality limits the utility of thor’s own interpretation of the word. Depending the open-source license in certain commercial on the choice of definition, commons can apply contexts but increases the potential for growth to the public domain and to open source. of the protected commons of code. Other versions of open-source licenses are less viral and have been tailored to different business needs. 4. Review of related legal concepts In the fields of health and agriculture, open Before discussing the use of the public domain source has been most easily adopted in areas with in greater detail, this section briefly reviews the similar technology characteristics (for example, relevant sections of patent law. The legal back- genomics). Attempts to apply the open-source ground presented here is important for defen- model to nondigital technology sectors6 encoun- sive publishing, that is, intentionally placing a ter a range of difficulties. Patent law, not copy- technology in the public domain through pub- right law, protects technologies in these sectors of lication and thereby preventing future patenting. the life sciences. Applying open-source licensing In addition, understanding these legal concepts mechanisms in patent law has its own set of le- will make clearer the discussion in Section 7 on gal challenges. Also, there are differences related how to ascertain whether technologies are truly to the innovation processes of non-digital tech- in the public domain. Much of this material will nologies. The amounts of time, capital, and risk be familiar to the reader who has read in this involved in, for instance, the production process Handbook the chapters on freedom to operate of pharmaceuticals, are vastly different from the (FTO)8 and on various aspects of patenting and production process in software production. In patenting strategies.9 addition, some technologies simply lend themselves less easily to the type of collaborative in- 4.1 Patentability requirements and their novation structures that successful open-source importance in defensive publishing models are based upon. Still, the tenets of open Defensive publishing seeks to preclude future source resonate among communities of innova- patenting in a technology area by making it tors in a wide range of technology sectors. The impossible for a potential patentee to satisfy one search for new applications of the open-source or more of the statutory patentability require- model is surely a worthwhile pursuit. ments.10 A solid understanding of patentability requirements allows for greater success in de- 3.3 The Commons fensive publishing. In particular, the patent-law The term commons has been used widely in vari- concepts of novelty, nonobviousness, and enable- ety of contexts; its meaning, as applied to IP, is ment are key. less clear cut than those of either public domain or open source. Outside the field of intellectual 4.1.1 Prior art and the patent property, the commons frequently refers to a com- application process monly managed resource (for example, an ejido In order to meet patentability standards, the in Mexico describing commonly managed lands). claimed invention must satisfy the statutory

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requirements of utility,11 novelty,12 and nonobvi- publication must be matched with attention to its ousness,13 the latter two of which involve an eval- prominence in search engines that patent exam- uation of prior art. In addition, the patent must iners may be more likely to use. Perhaps more im- be ��sufficiently described and enabled in the patent portantly, diligent attention should also be paid application.14 If�� the patent examiner assesses the to newly published patent applications in the prior art and deems that the claimed invention is field of interest. As these applications are issued, either not new, or is obvious, the patent may be evidence suggests that the author of a defensive denied, or the claims may need to be narrowed in publication may need to make the publication order to account for the documented prior art. It known to the patent examiner in order to be con- should be noted that the term prior art encom- sidered as prior art and, therefore, limit the claims passes both nonpatented and patented prior art. of the proposed patent. If defensive publications (This chapter does not consider the latter.) are brought to light after a patent issues, recourse Citations of prior art can be added by either through patent invalidation is possible but may the applicant or the examiner.15 U.S. patent law be prohibitively expensive. There are provisions does not require the patent applicant to search for within U.S. patent law for the submission of pri- prior art (that duty falls to the patent examiner). or art during a patent’s application process, and However, if the applicant or inventor is aware of this window of opportunity should be strategi- prior art, it must be included. The duty to dis- cally utilized.18 close exists under the requirement that appli- cants act in “candor and good faith” when deal- 4.1.2 Novelty and nonobviousness ing with the U.S. Patent and Trademark Office An invention is ineligible for patent protection (PTO) during the patent-prosecution process. if it is either not new or obvious in light of ex- A breach of this duty can be considered inequi- isting prior art. The novelty and nonobviousness table conduct and may result in the patent be- requirements for patentability define the param- ing unenforceable, but there is nothing to pre- eters within which defensive publishing can be vent intentional ignorance of prior art on behalf implemented. The parameters define how public- of the applicant. In fact, since 2001, when the ly disclosed inventions, as prior art, can be used PTO began to record which citations were added to support future patentability rejections. by the examiner, 40% of U.S.�� patents have re- Disclosure of an invention, and the accom- sulted from applications in which the applicant panying bar from future patentability due to lack has listed no prior art at all.16 of novelty, is not limited to publications in print- It is unclear how thoroughly examiners ed form. An invention can become ineligible for search for prior art. Patents, both domestic and patenting through any public knowledge of the international, are a kind of prior art that allows invention, or though its being used or offered for for relatively easy and expeditious searching. sale. However, it is important to note that U.S. Defensive publishing, however, depends on the law limits the use of nonprinted evidence in sup- ability of patent examiners to find publications port of a lack of novelty rejection to that which in nonpatent prior art searches. Sampat17 discusses originates within the United States. If the inten- the difficulties patent examiners face in searching tion is to use evidence from other countries to for nonpatent prior art and notes the growing con- support a rejection on lack of novelty grounds, cern that these various constraints on effective prior the evidence must be either a patent or a printed art searching are increasingly binding, and that the publication.19 The section of U.S. patent law rel- PTO is issuing more and more “low quality” pat- evant to novelty and defensive publishing says ents, [that is,] patents that would not have been is- that a patent application can be rejected on the sued had the examiner considered the entire universe basis of lack of novelty if “the invention was … of relevant prior art. patented or described in a printed publication in So for those seeking to practice defensive this or a foreign country, before the invention thereof publishing, the skills of crafting a good defensive by the applicant for patent, or … more than one

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year prior to the date of the application for patent the two patentability requirements described in the United States.”20 In most other countries, above (novelty and nonobviousness). In order to the one-year grace period does not exist; public support rejections under the novelty requirement, disclosure of an invention immediately bars pat- the publication, or nonpatent prior art, must be entability in those countries. enabled. If the reference is supporting a rejection In addition to understanding the timing on grounds of nonobviousness, enablement may of disclosures, a successful defensive publishing not be as critical a factor; a nonenabling publica- strategy should consider the meaning of the words tion can still be used to support a rejection on printed and publication. For example, is a docu- grounds of nonobviousness.22 This section -con ment posted on the Internet considered printed, siders enablement for an author constructing a such that the document constitutes prior art and defensive publication. works to reduce future patenting? Sections 5.1– Although the legal definitions vary somewhat 5.4 discuss best practices in regard to the content depending on the country in question, in general of defensively published documents, as well as the enablement requirement is meant to ensure their date and mode of publication. that the document contains enough detail for a The nonobvious requirement in U.S. law person skilled in the art to be able to make and states that if the existing prior art is such that a use the invention after reading the document. A person who is skilled in the art would not have key question is whether it is clear that the public difficulty coming up with the invention, the -in possessed the invention prior to the date the pat- vention is not patentable: “… if the differences ent applicant claims to have invented it. While between the subject matter sought to be patented the burden of proof of enablement for prior art and the prior art are such that the subject matter falls to the patent applicant, who must provide as a whole would have been obvious at the time the facts supporting a purported lack of enablement invention was made to a person having ordinary (this presumption of enablement in prior art is no skill in the art to which said subject matter pertains. different for a nonpatent publication than for a Patentability shall not be negatived by the manner patent), it is still worthwhile considering enable- in which the invention was made.”21 ment in a defensive publication. In comparison to the novelty requirement, When plants are the claimed inventions that the patentability requirement of nonobviousness a defensive publication is seeking to protect from gives a broader range of possibilities for defensive patentability, enablement may require that some- publishing to prevent future patenting. The key one of ordinary skill be able to reproduce the difference is that in order to support a rejection plant. Descriptions of the plant variety, however under the novelty requirement, the printed pub- detailed, may be insufficient. In one case, a ref- lication must include each and every limitation erence describing a rose was found not enabled, of the claimed invention, either explicitly or im- despite explicit detail and evidence that the au- plicitly. A rejection under the nonobvious require- thor was in possession of the rose.23 In this case ment, however, only requires that the content of the court ruled that, without information on the the prior art publication can be modified in an grafting process, reproduction of the rose was im- obvious way to arrive at the claimed invention. possible. In other cases, supporting documenta- In addition, the patent examiner can use combi- tion may be necessary to indicate that seeds were nations of prior art to support a nonobviousness publicly available within the time frame necessary rejection, so even disclosures in defensive publish- to bar patenting. ing that are partially complete may still create difficulties for those wishing to patent in the field. 4.2 Overlapping claims and dominant patents What are the legal concepts used to ascertain 4.1.3 Enablement whether a technology is in the public domain Careful defensive publishing anticipates how best and therefore freely available? This question is to support a patent examiner’s rejections under relevant to both scientists and IP managers who

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are considering what technologies to choose for of the chapter by Fenton et al. 25) An initial search a project. These pesrons must proceed with cau- delivers the documents detailed in this figure: sev- tion, because the use of a technology in a publi- eral scientific papers and a group of patents. Once cation, or the decision to in-license a technology the documents are arranged chronologically, we under an active patent, may go only part way to can see that the E8 promoter’s DNA sequence providing the right to practice the technology or was disclosed early in our chronology in two pursue a certain research project. scientific publications. But ascertaining whether A common misunderstanding in this area the E8 promoter is still in the public domain and stems from a belief that patent claims define therefore available freely involves further investi- mutually exclusive areas of technology. In reality, gation. Years after the initial publications, several the patent claims overlap each other: the use of patents were issued that claimed variations on the one technology can infringe claims in more than sequence and the right to use of the original E8 one patent. While the issuance of a patent gives promoter sequence when combined with partic- the patentee the right to exclude others from ular genes. Therefore, while the original sequence practicing the invention, it does not imply that itself remains in the public domain, when using the patentee can practice the invention without, the sequence care must be taken to avoid infring- perhaps, infringing existing patents. When the ing subsequent patent claims. rights to existing patents are needed to practice Published scientific literature, trade journals, a technology, those patents are considered domi- conference proceedings, abandoned patents,26 nant patents. and expired patents are all good sources for find- The existance of broad, pioneering patents ing public domain technologies. In the case of illustrate how dominant patents can affect the expired and abandoned patents, the boundaries rights to use downstream innovations. For ex- of the forfeited IP rights have been clearly de- ample, Monsanto’s claim to the plant transforma- fined by the claims of the patent: the previous tion method using Agrobacterium means that all owner of the patent no longer has the legal right patents in which the claims specifically depend to exclude someone from using what is set out on this transformation method are blocked by a in the claims of the patent. But these two areas previous patent. U.S. Patent No. 6,369,298 is a are especially prone to overlapping claims from patent assigned to Pioneer Hi-Bred International, other patents that may still be active and affect Inc. (now a subsidiary of DuPont) for transfor- the freedom to use the technology. Companies mation of sorghum. In this case, the claimed often file multiple patents in a technology space, technology depends on the Agrobacterium trans- or there may be multiple patents in one family formation method. A third party intending to that arose from an initial application. Just be- practice this technology would likely not only cause a patent has expired and entered the public need a license for U.S. 6,369,298 but also for domain does not mean the technology is avail- Monsanto’s Agrobacterium transformation domi- able for use. nant patent(s).24 When seeking to identify whether a technol- Pioneering patents like the one described ogy is in the public domain, one must be cau- above are relatively uncommon, but overlapping tious because of overlapping claims. Armed with claims and dominant patents exist in all areas of this knowledge, research into a potential public patented technology. Understanding the overlap- domain technology begins with publicly available ping nature of patent claims is crucial for those patent databases.27 These databases provide a great who intend to utilize the public domain, because deal of information about the boundaries of the using a technology that appears to be in the pub- public domain. Nonetheless, it can be difficult to lic domain may involve infringing one or more understand the interplay between the published patents. scientific literature and patents, as illustrated in The case study of the E8 fruit promoter pro- the E8 case study. PIPRA offers technical assis- vides another example (see the timeline in Figure 1 tance in this regard, analyzing technologies used

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in public sector agricultural research to ascertain the goals of promoting access, primarily by pro- with greater accuracy the boundaries of the pub- viding important leverage. lic domain.28 5.1.1 Will the technology need private-sector resources for further development and 5. When to use defensive publishing: distribution? the choice between patenting IP rights provide private economic incentives that and publishing can sometimes be critical to research, develop- Deciding whether to patent or publish is a stra- ment, and distribution processes. As an example, tegic decision that must take into account a consider the investment needed to bring a drug host of variables: the mission of the institution from discovery through to delivery. Although (and/or the funding agency) involved, the goals an accurate estimate of the true cost of drug de- of the individual project, the financial resources velopment is the subject of a lively debate, it is available to spend on IP protection, the nature inarguably hundreds of millions of dollars.30 In of the technology, the functionality of the court most cases it is unreasonable to expect the public system in the countries where the technology will sector to take on the levels of investment and risk be used, and the strategies being employed by involved in drug development. A parallel example other institutions producing similar technologies. can be seen in agriculture, where regulatory clear- Moreover, defensive publishing and patenting ance may be needed for a new product, or seed inventions each has its limitations and benefits. distribution networks may need to be engaged. Other strategies, such as trade secrecy, trademark It is important, therefore, to assess early whether protection, and bailment29 need to be considered private capital is likely to be necessary, at some as options when formulating an IP management point, for research, development, regulatory clear- strategy. ance, manufacturing, and distribution. IP rights Defensive publishing is often associated with can facilitate the private sector’s engagement by promoting access, but there are instances where, providing critical assets for bargaining (for exam- perhaps counter-intuitively, defensive publish- ple, in product development partnerships). ing may not be the most appropriate choice for getting widespread access to either an end-prod- 5.1.2 Are there benefits to be gained uct or a newly developed technology. There are from segmenting the market? instances, however, where patenting has limita- One benefit of choosing to patent, rather than tions and defensive publishing may be the better publish, is that patenting provides an opportu- choice. nity to segment the market of technology users or licensees. An IP manager may require differ- 5.1 Can defensive publishing promote access? ent licensing terms, for instance, depending on Many institutions and/or sponsors, particularly whether the technology will be used commer- in the fields of health and agriculture, place a cially or for humanitarian purposes. Alternatively, high priority on promoting widespread access the license might contain terms to segment the to developed technologies. Indeed, publishing market geographically or by fields of use. An continues to play a critical role in universities exclusive license may be implemented, for ex- and at other public sector research institutions. ample, to limit the technology’s use to one major Recent changes in the worldwide use of patent- crop, reserving all other uses of the technology ing discussed above, however, are forcing these for widely accessible and nonexclusive licens- institutions to reassess whether this IP manage- ing. Using such an approach, income generation ment strategy is the best way to support their and access may be complementary goals for the goals. This section focuses on promoting access IP provider. Or the rights to a technology in, for and highlights some instances where the choice instance, developed country markets may be ex- to patent a technology may be key to achieving changed for contractual obligations to deliver the

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product to developing countries for a reasonable nature of the technology may place the owner in price. Choosing to protect the technology with a position to demand a wide range of contractual IP rights instead of defensive publishing may pro- obligations in exchange for the use of the selec- vide bargaining leverage that ultimately achieves tion system. BiOS, for example, operates on this the institution’s goals. principle by providing patented enabling technologies under licensing terms that support the 5.1.3 Is the technology a research tool organizations open-access goals.32 (enabling technology)? A second scenario concerns improvement A body of evidence indicates that the patenting patents. Here, as in the previous example, suppose and access restrictions (through exclusive licens- the IP manager chooses not to patent the novel se- ing, for example) of enabling technologies can lection system. Improvements to the technology limit the progress of innovation in health and are subsequently invented and patented, restrict- agriculture.31 Indeed, the existence and effects of ing the uses of the original technology. Had the patent thicket– or anticommons-dynamics are IP manager patented the technology, the value of now fairly well accepted. The task of this section, the subsequent improvement patents would de- however, is not to consider the policy question of pend on access to the underlying dominant pat- whether research tools should be patentable, but ent (see Section 4.2 on dominant patents). The to examine the choice between patenting (nota- E8 case study provides a concrete example where, bly in the examples given here with widespread had the original sequence been patented instead nonexclusive licensing) and defensive publishing of published, the use of some of the downstream for the IP manager whose goal is to promote ac- patents would depend on Agritope, Inc. or cess in a context where research tools, and im- Epitope, Inc. licensing the original patent. For provements to them, are widely patented. In technologies that do not lend themselves to sub- other words, how can IP management preserve sequent restrictions from improvement patents, the right to use an enabling technology? this is not a concern. Mouse models are an ex- As a first example, consider plant transfor- ample of this type of technology. The majority of mation that confers a new trait. Access to several mouse models used in research, for instance, are complementary enabling technologies is required licensed and not patented. to produce a product. A vector that includes a promoter, selectable marker, a backbone, and a 5.2 Using defensive publishing as a tool gene of interest must be used, as well as a trans- in an IP management strategy formation method and germplasm. Lack of access Clearly, the common perception that publishing to any one technology may delay research and de- inherently promotes access may require recon- velopment or, in some cases, altogether prevent sideration. Still, what are the merits of defen- the progress of the project. sive publishing for supporting a wide variety of In such a case, the complementary nature IP management goals? And how does it high- of the technologies implies that the decision to light the limitations of using patents to protect patent may confer bargaining leverage. If an IP innovations? manager chooses not to patent an enabling technology, for example, a novel selection system with 5.2.1 The costs of maintaining wide applicability in plant transformation, the a patent portfolio ability to control the technology’s applications is Patent portfolios are costly to develop and main- lost. Research projects where the selection system tain. Moreover, they sometimes require a lengthy would otherwise have been the limiting factor maturation period before reaching a point (where all other technologies are owned or acces- where they return income. Unless a licensee is sible) could progress, without impediment, if the found who will underwrite the cost before the technology were to be published. Alternatively, if prosecution process starts, the initial investment the IP manager chooses to patent, the essential in the cost of prosecuting patents can be large,

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particularly where protection is sought in mul- costs for patent litigation in the United States tiple countries. Even where licensees are already in exceed $2 million dollars per case. Any decision place, it can be many years before a license gener- to patent must include an assessment of whether ates a positive cash flow. In examining U.S. uni- the patentee can afford to enforce the patent. In versity technology transfer offices (TTOs), Heher addition to the expense, the maturity or efficacy notes that 40%–50% operate at a net loss and of the patent law system in the countries likely to that profitability often depends on income aris- be involved should be considered. If the technol- ing from one or more blockbuster patents.33 In a ogy lends itself to bailment, for example, more cross-country comparison of TTOs, he finds that control over the use of technologies may be “the first and foremost requirement for success from found through contract law, particularly in technology transfer is a well-funded high quality re- countries where the patent system is not well search system as the benefits from commercialisation developed. of research are directly proportional to the magnitude of the investment in research.”34 While direct and 5.2.4 Defensive publishing as an indirect economic impacts provide broad benefits active strategy from building an institutional patent portfolio Defensive publishing is most effective as an active and TTO, the investment is long term and high strategy. This is a different use of publishing than risk. If resources are particularly constrained, the that found in many research institutions today. decision to expend money on patenting deserves The use of defensive publishing requires carefully careful consideration. Less expensive alternatives constructed disclosures with the greatest possible to patenting may support IP management goals public exposure and diligent worldwide monitor- and allow more resources to be directed toward ing of new patent applications as they arise in a research. particular technology field. When a patent application appears for which the defensive publication 5.2.2 Transaction costs of licensing has the potential to force a narrowing of the claims The transaction costs of negotiating licenses are or a total rejection, the appropriate channels must substantial and may need to be accounted for be used to alert the patent office of the published in the decision to patent. For instance, if the prior art. IP management goal is to promote access to a technology, and the choice is either defensive 5.2.5 Using defensive publishing in publishing or nonexclusive licensing, the costs of combination with patenting negotiating multiple nonexclusive licenses, or de- One of the strongest roles defensive publishing vising licensing language to segment the market can play is when it is used, not as a substitute for of technology users suitably, may outweigh the patenting, but in conjunction with it. As an ex- benefits. Transaction costs can be somewhat re- ample, consider a strategy where an IP manager duced in take-it-or-leave-it nonexclusive licenses, patents a core technology and then defensively but these tend to be rare. publishes the surrounding, related innovations, thereby reducing the likelihood that others will 5.2.3 Enforcement considerations: be able to obtain dominant patents. Obtaining costs and legal Infrastructure patents on improvements to a core technology as The costs (and feasibility) of enforcing the patent they are discovered may be a poor use of limited may also need to be considered. Because a pat- resources. In addition to improvements, new uses ent confers exclusionary rights, it may be worth- of the core technology may be discovered as re- less without the ability to enforce those rights. search and development progress. But defensive- Enforcement may require litigation against infring- ly publishing these improvements and alternative ers or using the patent to invalidate subsequent uses will inexpensively and effectively contribute blocking patents. In either case, patent litigation to preserving the right to a wide field of applica- is a game for players with deep pockets. Average tions for the core technology.

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5.3 Preserving access: ten questions to consider at the outset of a research project, using better- For the IP manager deciding on a strategy for pre- known tools (which are often proprietary) may be serving public access, considering the following important in the initial proof of concept stages of questions should be helpful: research. In this case, it is worthwhile to identify • What are the IP management goals of the whether public domain technologies are available institution or inventor? for substitution at a later stage. • Will the technology need the engagement The identification and promotion of substi- of private-sector resources for further devel- tute technologies from the public domain is one opment and distribution? of PIPRA’s important contributions to the field • Are there benefits to be gained from seg- of agriculture. PIPRA’s mandate is to assist pub- menting the market? lic sector researchers worldwide in overcoming IP • Is the technology a research tool (enabling impediments to the research, development, and technology)? distribution of staple crops for developing coun- • Do the benefits of patenting and licensing tries and minor crops in developed countries. outweigh the costs? Because the commercial market for these crops • How and where might the patent be is too small to attract private-sector investment, enforced? the public sector primarily pursues research and • Are there other viable options for protec- development with respect to such crops—often tion—trade secrecy, bailment, trademarks, without the resources to successfully address IP and so forth? issues. Public domain technologies are therefore • In which territories/countries is the tech- a critical resource for developing these orphan nology likely to be used? crops. • Can the technology be licensed without As PIPRA’s library of technical and legal in- patenting? formation on public domain and patented, but • Can defensive publishing be used in con- accessible-enabling technologies (including free- junction with traditional forms of IP dom-to-operate opinions from attorneys) in agri- protection? culture grows, so does the demand for knowledge of what technologies are in the public domain and how they might be employed in place of currently 6. Using public domain technologies used patented technologies. Some practical con- Public domain technologies are valuable inputs siderations for researchers and IP managers with to research. Indeed, they are a crucial but com- regard to identifying public-domain technologies monly underutilized resource for researchers. are laid out below. Using research tools or enabling technologies in the public domain reduces transaction costs and 6.1 Patent databases provide mitigates future potential IP impediments in the only part of the picture research and development process. As the E8 case study illustrates, an investigation In developed countries, many of the standard must begin with a search through both the pub- inputs of science in the fields of health and agri- lished scientific literature and patent databases. It culture have been patented. Scientists, however, is both the comparison of the content and the continue to use these tools because they have a timing of the publication of each contributing well-known history, including known levels of document that will determine whether the tech- efficiency and documented use in specific crops. nology in question is in the public domain and The use of patented research tools, on the other its limitations for use. A simple patent search hand, can open the institution to infringement may mislead by returning a bewildering number liability and/or create problems in later stages of related patents. But a comparison of these pat- of commercialization. While the maximum use ents with the published literature can reveal that, of public domain technologies may be desirable for instance, the core technology is in the public

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domain and that the patent thicket is made up public domain are more expansive in some of improvements, and other patents, limiting countries than in others, opportunities may ex- the utility of the original technology. If this is ist to design research strategies that take advan- the case, knowledge of these limitations may be tage of these differences. critical in designing a research plan that invents For example, the territorial limits of patents around existing patents and maximizes the use of have led to suggestions that developing-country the public domain technology. research institutions should use technologies that Sequence comparisons may provide another are not patented domestically but are patented in critical piece of information for the researcher more-developed countries. Legally, a researcher seeking to use a public domain technology. As an using a technology in a country where no pat- example, PIPRA’s analysis of the Soybean Heat ent has been filed is not infringing. However, an Shock Promoter found that changing the se- obvious constraint surfaces when the product of quence by one nucleotide allowed researchers to the research is destined for export into a country avoid infringing the issued patents.35 It should be where there is patent protection. In this case, de- noted, however, that this case is somewhat anom- spite the lack of patent protection domestically, it alous. The determination by PIPRA’s attorneys may be necessary to investigate the patent land- that altering a single nucleotide avoided existing scapes of export markets. patents was reached by carefully considering both There are still further considerations. In or- prior art and patents. Generalizations cannot der to use a technology that resides in the public be made, because it is only through examining domain domestically, but is patented elsewhere, how both sets of specific documents interact that a researcher may require the transfer of materials FTO can be evaluated. However, the example il- or know-how from the patentee. These often in- lustrates how critical the use of sequence analy- volve material transfer agreements (MTAs) with sis tools such as BLAST can be when analyzing restrictive terms and reach-through obligations patents. In general, careful attention to the prior that may hinder research and interfere with broad art and the use of homology measures in patent access for researchers in developed and develop- claims may be necessary to identify the specific ing countries alike. Even where no patent rights public domain sequence. are found, this situation may involve negotiating agreements (such as nonasserts) with the technol- 6.2 The landscape is continually changing ogy owner. In addition, even when large compa- The boundary of the public domain changes nies as patentees are not concerned with infringe- as new patents are issued. Periodic updates of ment issues or losing market share, the companies the analysis are necessary to check for recent- may be concerned about liability and stewardship ly issued patents that may restrict the use of issues. Finally, developing country research insti- the original technology. Searches can be hindered tutions, or the organizations that sponsor their because patent applications remain unpub- research, may attach considerable value to the lished—and therefore invisible in patent search building of relationships with the company that engines—for many months after their initial fil- has patented the technology. Therefore, despite ing dates. the lack of patent protection and the legal freedom to use a technology, there may still be im- 6.3 Geographical considerations portant reasons to negotiate a license. Finding out what is in the public domain is made even more complex by the territorial nature of patents. The analysis for the E8 case 7. The mechanics of study considered only the situation in the defensive publishing United States; any other country would re- This last section focuses on the mechanics of de- quire collecting a different set of documents. fensive publishing: how to best ensure that a dis- Nonetheless, because the boundaries of the closure precludes downstream patenting by others.

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Elements to consider in drafting a successful de- plant transformation vector, as well as its use in fensive publication include: content, language of particular crops. choice, publication venue, and publication date. Whether the inclusion of certain language The following sections elaborate on best practices in a publication will prevent future patenting in in defensive publishing. this case is uncertain, and it should be noted that the combination of prior art references in support 7.1 Content of a rejection on nonobviousness grounds comes The goal of defensive publishing is to prevent pat- with several caveats. A successful rejection of a enting in a particular technology area. Therefore, claimed invention due to obviousness must show, constructing a disclosure specifically designed to not only that someone skilled in the art would create evidence to prevent patentability will in- have been able to combine the prior art refer- crease the likelihood that fewer patents will issue ences, but that they would have been motivated to in this technology space. The disclosure should do so. Second, there must be a reasonable expec- be as complete and detailed as possible. Where tation of success for the purported combination. relevant, a publication should include descrip- Third, the references taken together must teach or tions of all parts of the experiment, experimental suggest all the elements of the claimed invention. conditions, diagrams, formulas, procedures, se- When drafting the content of a defensive publica- quences, materials, and methodologies. We indi- tion, it is impossible to anticipate all the possible cated earlier that enablement of the publication combinations of the author’s technology with may be important; a defensive publication should that belonging to others, but by using language include evidence illustrating possession of the in- that acknowledges the caveats above, the author vention and enable a person skilled in the art to can broaden the subject matter of the disclosure make and/or use the invention. as much as possible.

7.1.1 Consider disclosing the potential 7.1.2 Consider disclosing potential for combining technologies alternative applications In addition to a thorough description, defensive As with potential combinations, it may be worth- publishing should include potential combinations while to include alternative applications of the of the target technology with other technologies. technology, even if they are not documented in This is true even for combinations for which the detail. If the technology is a product, the author author may not have detailed documentation. may want to consider including the current prod- As the case study of E8 revealed, the inclusion uct, potential uses of the product, and derivative of additional combinations can expand the use products. While defensive publication can place of the document to support future nonobvious- a product technology in the public domain, pro- ness rejections. Publishing the sequence of the E8 cesses developed later using that product can still plant promoter did not prevent the issuance of be patented. By anticipating potential applica- future patents claiming the use of the promoter tions, the author of the defensive publication combined with particular genes. If the authors of may contribute to an obviousness-type rejection the original publication had ended their paper in the future. If the technology disclosed is a pro- by articulating the likely success of the sequence cess, the author might consider including details for promoting the expression of broad classes of products derived from the process. These con- of genes, there may have been stronger grounds siderations anticipate the patentability of product for rejecting subsequent patents. To extend this and process patents. As an example of product point, a defensive publication may be even stron- and process patents, consider the famous Cohen- ger if it anticipates not only the promoter-gene Boyer technology. This was not one patent, but combination, but also its potential use in entire three: (1) a process patent for the construction of systems, such as the transformation method, se- molecular chimeras, (2) a product patent for pro- lectable marker systems, and other elements of a teins made using recombinant eukaryote DNA,

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and (3) a product patent for proteins made using The publication language may need to be, for recombinant prokaryote DNA.36 example, one spoken in the countries in which the patent will be barred. It may be important, 7.1.3 Consider disclosing related alternatives however, to write at least the abstract and title in One way to design around a defensive publica- English to maximize the chances that this partic- tion (or a patent) is to alter, even minimally, the ular disclosure will be brought to the attention of structure of the technology. TGo anticipate this, the patent offices in the United States and Europe defensive publication can indicate how the tech- during prior art searches. Still, given the limita- nology may be altered while still maintaining tions of nonpatent prior art searching in patent the original disclosed functions and characteris- offices, the best post-publication strategy isto tics. This follows common practice in drafting monitor the published application in the technol- patent claims. For instance, a sequence may be ogy field and alert the relevant patent office to the published that includes a percentage homology defense publication. within which the function of the technology remains the same. In addition, it may be useful to 7.3 Where to publish include homologies across different species. As noted previously, U.S. law uses the words “printed publication” in its novelty require- 7.1.4 Consider depositing biological materials ment. U.S. courts have adopted a broad defini- For some inventions involving biological mate- tion of the word printed, to include documents rial, we have established that a written description stored on electronic media, and on microfilm.40 is insufficient to convey the technology in such a Documents posted on the Internet may therefore way that a person skilled in the art can practice it. be used to satisfy the printed aspect of the novelty For such inventions, the patent system has come requirement. to depend on the deposit of biological materials in The word publication has also been fairly recognized, publicly accessible culture collections broadly interpreted to mean any printed docu- worldwide. As a rule of thumb, if the biological ment that is freely available to the public. Peer- material can be made, or isolated, without undue reviewed publications are only one option for experimentation, or if the material is otherwise defensive publication, and their constraints on known and readily available, it is not necessary content may leave the author with a less than to deposit material. In many cases, however, a complete defense. Printed materials presented at defensive publication will be stronger if biologi- trade shows, conferences, seminars, or on Web cal materials are deposited (the deposit accession sites are all considered to satisfy the definition of number should be referenced, where relevant, in publication. Indeed, major corporations have used the publication and sequence information given). this kind of defensive publishing as part of their Patent deposits worldwide have been regu- IP management strategy for many decades. IBM lated since 1980 when the Budapest Treaty on provides perhaps the best-known example of the the International Recognition of the Deposit use of a technical journal for defensive publish- of Microorganisms for the Purposes of Patent ing. The success of that strategy is illustrated by Procedure came into force.37 The World a 2002 search of the U.S. patent database by Bill Intellectual Property Organization38 provides Barrett that found almost 10,000 patent citings an updated list of the countries that have rati- of IBM’s Technical Disclosure Bulletin.41 By pub- fied the Treaty and the collections that are rec- lishing technical disclosures without the content ognized as international depositary authorities restrictions of peer-reviewed publications, IBM (IDAs).39 wields an inexpensive, flexible tool that comple- ments its overall patenting strategy. 7.2 Choice of language A number of companies specialize in pub- The choice of language (that is, English, or other) lishing nonpatent prior art. The Web site IP.com, in a defensive publication can also be important. for example, provides expertise in defensive

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publishing and offers a search engine to make it management plan begins by identifying the in- easy for a patent examiner to navigate through puts and enabling technologies used in research. the site’s library of disclosures.42 Disclosing an A strategic IP plan also clearly articulates the in- invention through such a company will increase tended use of the technologies that are produced. the likelihood that a patent examiner will see it. Once this framework is established, IP manage- The companies, however, may charge hundreds ment tools can be used effectively to support the of dollars for such a disclosure. Another method project’s goals. of disclosure is the use of the statutory invention The public domain is a valuable resource registration procedure, whereby the PTO allows for early-stage thinking about a project’s re- for the registration of an invention that is unex- search tools. The above practical considerations amined. This method, too, can be expensive. The will hopefully assist in effectively incorporating most cost-effective way to defensively publish is to public-domain technologies into an IP manage- publish for free on the Internet (but dating mate- ment plan, thus reducing the need to in-license rial published on the Internet can be problematic; technologies and freeing up resources for more see next section). If the Internet is used to publish research. Moreover, when managing the prod- defensively, there may be a greater need to moni- ucts of a research project, one tool to consider tor recently published patent applications in the alongside more traditional IP rights is defensive field of interest. publishing, or placing a technology in the public domain. When considering defensive publishing, 7.4 Timing and date stamping however, IP managers should keep in mind both The date of a defensive publication is a critical its utility and its limitations. n piece of information that must be documented and discernible by the patent office. It helps the patent examiner to determine whether the publi- Acknowledgements cation brings into doubt the patentability of the Thanks to Fredh Fredrik, of the Center for Intellectual Property Studies at Chalmers University of Technology, subject matter. The dating of material published for his research assistance and to Michael Lang of Harness, on a Web site can be a difficult matter: many Dickey & Pierce, P.L.C. for reviewing and discussing an documents on the Web are date stamped on the earlier version of this chapter. date of access, not the date of posting. Obviously, this practice can cause problems for a party those SARA BOETTIGER, Senior Advisor, One Shields Avenue, PRB attempting to preclude future patenting in a - Mail Stop 5, University of California, Davis, Davis, CA, 95616-8631, U.S.A. [email protected] technology area by using the Internet for defensive publishing. Fortunately, there are solutions. CECiLIA CHI-HAM, Director, Biotechnology Resources, PIPRA Many companies now offer digital time stamping University of California, Department of Plant Sciences, (DTS) or digital notary services. This technology Plant Reproductive Biology Building, Extension Center Circle, Davis, CA, 95616, U.S.A. [email protected] has become accepted legal proof that the con- tents of a publication existed at a particular point 43 in time and has not changed since that time. 1 Boyle J. 2003. Foreword: The Opposite of Property? Law Another readily accessible method of establishing and Contemporary Problems 66(1-2):25. www.law.duke. the date of an Internet publication is to scan a edu/shell/cite.pl?66+Law+&+Contemp.+Probs.+1+(Wi nterSpring+2003). document that includes a date and a signature, and post the pdf on the Web. 2 447 US 303 (1980). 3 The Bayh-Dole Act (1980) altered incentive structures surrounding the development of publicly funded research by mandating institutional ownership and 8. Conclusion the ability to exclusively license these inventions. See, This chapter has examined how IP managers and also in this Handbook, chapter 3.3 by Gregory Graff and researchers can use the public domain and defen- chapter 3.2 by Rachel�� A Nugent and Gerald�� T Keusch. sive publishing to their advantage. A strategic IP 4 Because patents are territorial grants of exclusionary

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rights, the patent landscape can vary considerably formal interference proceeding. Outside the scope of among countries. an interference proceeding, proof of lack of novelty is 5 Lange D. 2003. Re-imagining the Public Domain. limited to printed documents and patents. Law and Contemporary Problems 66(1-2): 463. www. 20 The one-year period is based on the priority date, which culturaleconomics.atfreeWeb.com/Anno/Lange%20Re is usually the date on which the patent application is imaging%20the%20Public%20Domain%20LCP%2020 filed.It�� is possible, however, for a patent to have a priority 03.htm date that is earlier than the date on which it was filed. 6 For example, the Biological Innovation for Open Society Continuation and divisional applications, for instance, (BiOS, www.bios.net). may retain the priority date of the “parent” application from which they are derived (in these instances it is 7 The discussion of the commons here derives from the even possible for one patent to have more than one excellent compilation of collected papers from the priority date, as different content in the claims may Duke Conference on the Public Domain (www.law. have entered the patent application process at different duke.edu/pd/papers.html), in Law and Contemporary times). In addition, the establishment of a priority date Problems, 66, Winter and Spring 2003, where readers must encompass international applications. If a patent will find an in-depth discussion of many facets of the is filed on an invention in Japan, and then later a U.S. public domain. application is filed, the U.S. application will retain the 8 See, also in this Handbook, chapter 14.2 by SP Kowalski; priority date of the earlier Japanese application. Patent chapter 14.4 by GM Fenton, C Chi-Ham, and S Boettiger; applications can also have earlier priority dates if a and chapter 14.1 by A Krattiger. provisional application was filed first. 9 See, also in this Handbook, chapter 10.5 by O Livne, 21 35 U.S.C. 103 Conditions for patentability; nonobvious chapter 10.6 by AS Viksnins and AM McCrackin, and subject matter. chapter 11.8 by S Shotwell. 22 “Even if a reference discloses an inoperative device, it is 10 This section refers in particular to U.S. patent law. prior art for all that it teaches.” Beckman Instruments v. However, internationally the requirements for LKB Produkter AB, 13 USPQ2d 1301, 1304 (Fed. Cir. 1989). patentability tend to be similar. “A non-enabling reference may qualify as prior art for the purpose of determining obviousness under 35 U.S.C. 11 ��35 U.S.C. § 101. 103.” Symbol Technologies Inc. v. Opticon Inc., 19 USPQ2d 12 ��35 U.S.C. § 102. 1241, 1247 (Fed. Cir. 1991). 13 ��35 U.S.C. § 103. 23 In re LeGrice, 133 USPQ 365 (CCPA 1962). 14 ��35 U.S.C. § 112. 24 Monsanto’s patent application(s) for Agrobacterium 15 A member of the public can also add citations. See mediated transformation have not yet issued as footnote 14. patents in the U.S. Until this happens, it is impossible to say with certainty which patents will be blocked by the 16 ��Alcácer ��J and M Gittelman. 2004. How Do I Know What issued claims. In addition, Monsanto’s Agrobacterium- You Know? Patent Examiners and the Generation of mediated transformation patents in other parts of the Patent Citations. Working Paper. www.olin.wustl.edu/ world have already expired; dominance changes by cres/research/calendar/files/alcacer_gittelman.pdf#s territory. earch=%22Alc%C3%A1cer%20and%20Gittelman%20( 2004)%22. 25 See supra note 8. 17 Sampat BN. Examining Patent Examination: an Analysis 26 In addition to patents that have been abandoned due of Examiner and Applicant Generated Prior Art. to non-payment of maintenance fees, some abandoned Working Paper. faculty.haas.berkeley.edu/wakeman/ patent applications may also be in the public domain. ba297tspring05/Sampat.pdf. Under a revised law, U.S. patent applications filed on or after 29 November 2000 are to be published 18 35 U.S.C. §301.�� Citation of prior art: “Any person at any within 18 months. Prior to this change in law, patent time may cite to the Office in writing prior art consisting applications were not publicly available. The new law of patents or printed publications which that person still contains an option for secrecy up until the point believes to have a bearing on the patentability of any that the patent issues. If the patentee elects to forego claim of a particular patent. If the person explains foreign patenting, s/he has the right to request that in writing the pertinency and manner of applying the application remain unpublished. such prior art to at least one claim of the patent, the citation of such prior art and the explanation thereof 27 See, for instance, www.uspto.gov. will become a part of the official file of the patent. At 28 www.pipra.org. the written request of the person citing the prior art, his 29 If the technology has an element of tangible property, or her identity will be excluded from the patent file and bailment may be used (for example, material transfer kept confidential.” agreements) to protect the technology under contract 19 §102(g) allows for proof of prior invention in any law instead of patent law—a choice that may be country that is a member of the WTO, but this is warranted in countries where patents are more difficult limited to cases where inventorship is disputed in a or prohibitively expensive to enforce in comparison

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with contracts. 35 Contact PIPRA for more information on the written 30 A report by the Global Alliance on Tuberculosis Drug FTO opinion for this technology. Development on the economics of tuberculosis drug 36 Intellectual Property Rights and Research Tools in development estimated the cost of drug development Molecular Biology: Summary of a Workshop Held at for a tuberculosis indication was US$115-240 million. the National Academy of Sciences, February 15-16, See The Economics of TB Drug Development (October, 1996 (1997), p. 40; www.nap.edu/readingroom/books/ 2001) at www.tballiance.org. These figures are property/5.html. well below many other cited estimates for drug 37 The term “microorganism” was appropriate at the development cost, such as the well publicized study by time the Treaty was named because the primary uses DiMasi et al (DiMasi AA, RW Hansen and HG Grabowski. of biological materials in industry involved bacteria 2003. The price of innovation: new estimates of drug and lower fungi. Today the term is interpreted broadly development costs. Journal of Health Economics 22: within the context of the Budapest Treaty to include 151–185). a wide range of biological materials (for example, 31 See, for example, BD Wright and PG Pardey. 2006. The bacteria, viruses, isolated DNA, and cell lines, etc. (see Evolving Rights to Intellectual Property Protection in Fritz D and V Weihs. 2001. Deposition of Biological the Agricultural Biosciences. Int. J Tech and Globalisation Material for Patent Protection in Bio-Technology. Appl 2(1/2):12-29. While they articulate the complexity of the Microbiol Biotechnol 57:443–450.) issues and admit that “definitive evidence on the effects 38 www.wipo.int. of IPR on agricultural research will not be available soon, if ever,” their paper also includes a catalog of 39 See www.wipo.int/treaties/en/registration/budapest/ examples where the path of research has been altered pdf/ida.pdf for a current list. Also of relevance is because of IP rights. Tomatoes with improved shelf- chapter 10.10 by Dennis Harney and Timothy McBride life characteristics, fungus-resistant strawberries, in this Handbook. hypoallergenic wheat, as well as herbicide tolerant 40 In re Wyer, 655 F.2d 221, 226-27 (C.C.P.A. 1981). barley, turf grass, and lupin are all examples where 41 Barrett B. 2002. Defensive Use of Publications in an research and development were suspended due to IP Intellectual Property Strategy. Nature Biotechnology roadblocks. 20:191-193. 32 www.bios.net. 42 www.ip.com. 33 ��Heher AD. 2004. Economic Modelling of Institutional Research and Innovation. Unpublished�� Report for 43 For instance, www.digistamp.com offers non-profit SARIMA. SARIMA Project 3. University of Cape Town: organizations performing medical or environmental Cape Town. public research use of their service at 30 cents per time stamp. 34 See supra note 33, page 3.

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