Establishing a new intellectual property rights regime
in the United States Origins, content and problems Benjamin Coriat a, , Fabienne Orsi a,b a CEPN-IIDE, CNRS Research Unit 7115, Paris 13 University, 99 Avenue JB Clement, 94430 Villetaneuse, France b INSERM, Research Unit U379, University of Mditerrane, 232 Bd. Sainte Marguerite, 13009 Marseille, France Received 24 September 2001; received in revised form 16 October 2001; accepted 20 March 2002 Abstract Major changes have been made over the past 20 years in the USintellectual property rights regime. These include the fact that the regime has been opened up to software patents and to business models, on one hand, and to living entities on the otherall within a general environment marked by the relaxation of patentability criteria. They have resulted in major changes in the US system of innovationmore specically in the increasing privatisation of knowledge domains and activities that were previ- ously public. The changes result from the combined effects of a response to US perceptions of increased foreign competition, of the emergence of major new technological opportunities in biotechnology and ICT, and of a series of regulatory changes that have paved the way for the nancial sectors increased involvement, via direct investments in rms whose main activity is comprised of R&D. Contemporary doubts about the viability of these changes reect, the harmful long-term economic effect of the privatisation of basic knowledge (especially in the biopharmaceutical sector) and the difculties that the nancial sector has faced in ensuring the sustainability of the necessary pre-conditions that allow for the development of innovation. 2002 Elsevier Science B.V. All rights reserved. Keywords: Intellectual property rights; Innovation; Biotechnology; Computer program; Financial market 1. Introduction In order to highlight the signicance of the changes that have taken place in the area of intellectual property (as well as its effects on the conditions for producing and diffusing innovation), the present paper has been articulated and organised as follows. Section 2 recaps some of the main ndings from the eld of economics of patent and innovation, in an
Corresponding author. Tel.: +33-1-45-83-36-04;
fax: +33-1-45-83-36-04. E-mail addresses: coriat@club-internet.fr (B. Coriat), f orsi@club-internet.fr (F. Orsi). attempt to clarify how, and to what extent, the new regime deviates from traditional analysis and practices in this area. Some of the legislative changes (initiated by Congress to reinforce the PR regime) are presented and analysed; they have been re-situated in the spe- cic environment of the time, characterised by a sharp drop in American rms competitiveness (Section 3). The analysis then focuses on two specic domains: the continued extension of the area of patentability to computer programs, mathematical algorithms and business models (Section 4); and to living entities (Section 5). These two elds were chosen because they have experienced the most dramatic changes. In Section 6, the paper presents the concomitance of 0048-7333/02/$ see front matter 2002 Elsevier Science B.V. All rights reserved. PII: S0048- 7333( 02) 00078- 1 1492 B. Coriat, F. Orsi / Research Policy 31 (2002) 14911507 change in the IPR systems and nancial sphere and the related changes it has generated as regards the nancing of innovation. The conclusion (Section 7) raises questions about the long-term sustainability of this type of regime in the light of recent developments. 2. Basic principles of the economics of patents, IPR and innovation To highlight the nature and meaning of the changes that have affected the eld of innovation, we think it useful to recall some of the basic principles that have been put forward to explain why certain institutional arrangements (Arrow, 1962)in actual fact differing types of IPRand public incentiveshave been deemed necessary so that R&D activities can maintain a so- cially sufcient level of dynamism (Nelson, 1959). Two series of contributions should be recalled at this juncture, inasmuch as they were once considered to be the theoretical foundations of any type of IPR system. 2.1. Information, knowledge and the trade-off between private and social costs Building on propositions that were rst formulated by Nelson (1959), Arrow introduced in a seminal paper he published in 1962 the idea that knowledge whenever it can be assimilated to informationis a good that will present a number of specic char- acteristics. In particular, the indivisible nature of knowledge means that whatever its production costs, subsequent reproductions cost nothing or next to noth- ing. This attribute is at the origin of market failure as well as free rider problems. Insofar, as market mechanisms are unable to offer those solutions that will induce rms to make a socially optimal level of investment in the production of knowledge, society as a whole runs the risk of always under-investing in knowledge production. To overcome this type of market failure, non-market mechanisms are needed to create the right types of incentives. Two types of fundamental incentives can be de- signed: (1) Patents: These are partial and temporary monop- olies that are awarded to inventors under a given set of conditions. They are the rst institutional arrangements helping to overcome the free rider problem. (2) The allocation of public funds to research (and especially to basic research) is the other direc- tion in which these non-market mechanisms can go. Here, the information and knowledge that has been produced as a result of public subsidies is made available to everyone for zero cost and it is the taxpayer who covers the cost of delivering the public good needed to maintain the type of knowledge ow that makes it possible to ensure societal progress. It is noteworthy that in both cases (patents and/or public subsidies), the main issue is how to limit the innovations social costregardless of whether this cost is to be covered by the consumer or by the tax- payer. 2.2. Open science versus private science Our understanding of the world of basic and/or pub- licly funded research was enhanced by Dasgupta and Davids (1994) seminal paper, devoted to an analysis of the world of open science. 1 In essence, analysis of the world of open science highlights those specic co-ordination mechanisms that are at work in this area of R&D activities. It offers cogent arguments relating to the relative efciency of the whole range of formal and informal rules that govern this world (open publication and communica- tion, priority rules for inventors/discoverers, etc.) and contrasts them with the rules governing the world of private innovation activities, also called the king- dom of technology (based on secrets, patents and rent-seeking). In actual fact, these two worlds are interconnected by many subtle relations, both formal and informal. However, from a theoretical point of view, we should remember that the key principle underlying the ra- tionale for the various types of non-market mecha- nisms that have been designed and implemented in the worlds different national innovation systems (NISs) is the distinction between the granting of patents to reward private innovators, on one hand, and the 1 On the economics of science and the importance of basic research for innovation see also Pavitt (1991). B. Coriat, F. Orsi / Research Policy 31 (2002) 14911507 1493 allocation of public subsidies to fund basic research on the other. One of the present papers main theses is that the traditional borders between these two worlds and logics have partially disappeared, giving birth to a completely new regime of IPR. The following sections constitute an attempt to demonstrate the context within which such changes were introduced and to highlight the qualitative nature of the mutations that have taken place in the intellectual property regime. 3. The new orientations of public innovation policies To understand the context within which these changes took place, the right starting point is clearly the 1980s and the debate that took place amongst in- dustrial strategists and policy makers at the time, one in which many top academic scholars took part. 3.1. The environment of the 1980s: a short word on the origins and scope of these changes Under the title What happened in the 1980s?, Hunt wrote: during the late 1970s and early 1980s, businessmen and policy-makers became increas- ingly concerned about the apparent deterioration of Americas comparative advantage in high technology industries, such as the semiconductor industry. In fact, trends within that industry became a catalyst for dra- matic changes in the way the US protects intellectual property (Hunt, 1999a). As demonstrated by a long list of essays (of which Tysons 1996 book was undoubtedly the most typi- cal expression), received wisdom at the time held that American rms loss of competitiveness could be at least partially explained by two features of the US NIS. 2 On one hand, the system was thought to be both excessively geared towards basic research and also poorly designed for delivering concrete results to rms in a quick and efcient manner. This was especially 2 For an comprehensive analysis of the causes of the US economys loss of the competitiveness, one can refer to the famous essay published by the MIT under the title Made in America (Dertouzos et al., 1989). critical in an age where time-to-market had become a key competitive argument. On the other hand, more and more people felt that it was too easy for corporate rivals to appropriate the research ndings of an R&D program that had been carried out in the US, inasmuch as these ndings were insufciently protected by the patent system. In circumstances such as these, for- eign rivals (notably Japanese rms) could easily take advantage of American discoveries and inventions, at very low cost, and convert them into a series of prod- ucts that would then be competitive in the domestic US market itself. 3 This point of view, which quickly began to dom- inate decision-making circles, gave birth to a series of studies and works that were often sponsored by government authorities and which were intended to modify the general operational framework of the dif- ferent actors involved in innovation activities. Finally, the changes that took place lead to the building of a series of new institutional complementarities (Aoki, 2000) between different types of provisions. Within 20 years, these would totally change the dynamics of the US NIS. Table 1 provides a partial idea of the importance of this legislative activity throughout the 1980s and early 1990s. Section 3.2 concentrates on two of the changes that helped to dramatically modify the operational frame- work in which innovation actors were working. 3.2. The BayhDole Act and the implications thereof The rst major change is the 1980 Patent and Trademark Amendments Act, better known as the BayhDole Act. This Amendment Act paved the way for strategic changes in American State R&D poli- cies by creating a series of incentives and legal tools allowing public research institutions (universities and public labs) to patent their ndings and to exploit the fruits thereof, either directly through the start-up of new businesses (made up of university teams, often in the form of joint ventures with private enterprises) or through the exclusive licenses that were awarded to external for-prot institutions. 3 A book edited by Branscomb et al. (1999) proposes a series of well-documented papers recalling the very peculiar climate prevailing in the 1980s in the US. For a presentation of the US NIS in the early 1990s (Mowery and Rosenberg, 1993). 1494 B. Coriat, F. Orsi / Research Policy 31 (2002) 14911507 Table 1 Selected legislation enabling a competitiveness research and de- velopment policy a Year legislation 1980 Public Law 96-480, StevensonWydler Technology Innovation Act, as amended in 1986 and 1990 1980 Public Law 65-517, Patent and Trademark Amendments Act Patent and Trademark Amendments Act and 1983 Reagans memo on the governments patent policy 1981 Public Law 97-34, Economic Recovery Act 1982 Public Law 97-219, Small Business Innovation Development Act 1983 Public Law 97-414, Orphan Drug Act, as amended in 1984, 1985 and 1990 1984 Public Law 98-462, National Co-operative Research Act 1986 Public Law 99-502, Federal Technology Transfer Act 1986 Public Law 99-660, Drug Export Amendments Act de 1986 1987 Presidential Executive Order 12591 1988 Public Law 100-418, Omnibus Trade and Competitiveness Act b 1993 National Co-operative Research and Production Act 1993 Public Law 103-182, North American Free Trade Agreement 1993 Public Law 230-234, Defence Appropriations Act, Technology Reinvestment Program 1994 Public Law 103-465, General Agreement on Tariffs and Trade Remark: Asides from the Patent and Trademark Amendments Act that was voted in 1980 to which we shall revert below, other elements of note in the new arsenal that Congress set up included: (i) the National Co-operative Research Act (1984) which authorises the relaxation of anti-trust regulations as regards R&D-related co-operation; and (ii) the Trade and Omnibus Act (1988), notably section 301 special dedicated to defending US rms IPR at an international level. Due to a lack of space, the present paper will not examine these two laws (and their effects) in any great detail. a Source: Slaughter and Rhoades (1996, p. 317). b Coriat (2000) offers an analysis of the conditions under which the 1988 Omnibus and Trade Act, including its IPR-specic 301 special section, was originally promoted. Partisans of the BayhDole Act defended its insti- tution of a license-based rent system by saying that if rms have exclusive rights to exploit the new discover- ies that stem from the basic research being carried out in state laboratories, the investment returns on public research will be enhanced and corporate competitive- ness can be restored. Summarising the spirit of these new provisions of the Act, Mowery et al. wrote that the Acts provisions represented a strong expression of support for negotiation of exclusive licenses be- tween universities and industrial rms for the results of federally funded research. In the end, it constituted a Congressional endorsement of the argument that fail- ure to establish patent protection over the results of federally funded university research would limit the commercial exploitation of these results (Mowery et al., 1999, p. 274). It is important to note that these new provisions coincided with the technological breakthroughs being made by academic researchers in IT and biomedicine. This point was emphasised in a recent empirical study by Mowery et al., who compare changes in patenting and licensing activities at Stanford, UC Berkeley and Columbiathese having been the three institutions that for years played a crucial role in biomedical and IT research (today they are still amongst the most active of all American universities involved in the patenting movement (Mowery et al., 1999). 4 Our objective here is not to discuss the impact of the BayhDole Act on university patenting and licensing in any great detail. Extensive literature already exists towards this end. 5 For the purposes of the present pa- per, it sufces that we highlight the nature of the quali- tative changes that the BayhDole Act introduced and that we put them in the context of the other changes that have affected US IPR regime. 3.3. The Court of Appeals for the Federal Circuit (CAFC) and the easing of patentability conditions Congresss 1982 adoption of the Federal Courts Im- provement Act (FCIA), which created a unied judi- cial appellate authority for all cases relating to patent, trademarks, government contracts, tax and interna- tional trade represents another major institutional in- novation that Congress introduced as part of its new policy. 4 More generally, Jaffe (2000) in his very precise and detailed analysis of the changes in the US patent system argues that the number of patents granted to universities rose from 25,00030,000 per annum in 19791984 to 45,00050,000 after 1984, reaching 80,000 in 1998. 5 On this point, see Mowery et al. (1999). B. Coriat, F. Orsi / Research Policy 31 (2002) 14911507 1495 These Courts of Appeal were initially created as a response to demands from rms who were decrying previous Court decisions lack of homogeneity from one American state to the next. In actual fact, the new Courts of Appeal happened to be much more pro-IP and open to patenting than their predeces- sors had been. Amongst the changes they introduced was a new and extended meaning attributed to the Doctrine of equivalents, used to provide patentees with strong protection by broadening their pro- hibitory rights (Jaffe, 2000). Above all, according to most observers the non-obviousness criterion was easedwith one declaring that many patent attorneys believe the obviousness defence to be dead and that the cause of the death lies in the decision of the CAFC (Krastiner, 1991). As a result, the USPTO, which continued initially to make rulings that were based on the more rigorous traditional criteria, modied its doctrine. This was publicised in a series of formal statements that were aimed at putative patent registrants. The change of doctrine ap- pears very clearly in the last Utility Guidelines that the USPTO published on 5 January 2001 (USPTO, 2001a,b). A direct consequence of these changes was the huge surge in the number of patentsan out- come that in our view was indicative of the change in regime. Many other institutional changes, all of which were aimed at increasing rms R&D activity-based com- petitiveness, can be mentioned. Still, the two afore- mentioned series of changes sufce for the purposes of the present paper, given that, in our opinion they are clear enough indicators of the direction and dimension of the changes that were introduced. The two following sections deepen and extend this analysis by focusing on the changes that have taken place in the two key areas of IT and biotechnology. In so doing, they specify the impact that legisla- tive reform has had on the way in which US NIS functions. 4. Between copyright and patent: devising a specic American right for software packages, computer programs and business models A clear illustration of the dissipation of the tradi- tional borders between open and private science is provided by an analysis of changes in software-related IPR. 6 4.1. The progressive shift towards the patentability of mathematical algorithms Analysis here begins in the 1970s, a decade of rapid expansion for the software industry in US, specically as a result of the design and rapid dis- semination of autonomously endowed software packages that could migrate from one machine to an- other (inter-operability). Two related but divergent issues soon cropped up: (i) the battle against piracy (illicit copies prepared for commercial purposes); (ii) rival rms imitation of existing solutions: this lat- ter issue is a particularly complex one, inasmuch as in a world that has chosen to open itself up through an extension of compatibility there is little difference between straightforward imitation (i.e. the imitation of existing software packages being sold in the market under different brand names but without any substantial improvement) and the need to adapt existing products so that they offer improved software solutions which can be com- patible with users practices and with prevailing standards. We should remember that the CONTU Commis- sion, whose recommendations became the benchmark in this eld, was originally organised within this en- vironment. After intensive consultation, the CONTU came out in favour of extending and deepening the copyright principle so that software could be covered under its provisions. These recommendations were in- corporated into the Computer Software Act of 1980. In practice, however, the design of this legal framework (which suggests that software be covered by Copy- right Law), proved unable to offer a denitive solution to this problem. A 1982 Courts of Appeal ruling found that the Computer Software Act provided a framework which was too narrow and restrictive. Often overruled by (or subordinated to) a major Supreme Court rul- ing, the Courts of Appeal ended up by introducing a 6 For a recent review of the main changes in jurisprudence, especially regarding business models (Merges, 1999; Liotard, in press). 1496 B. Coriat, F. Orsi / Research Policy 31 (2002) 14911507 common practice of software patenting through their own jurisprudence. As such, there has been a pro- gressive shift from a copyright to a patent-based regime. Other shifts would result from a jurisprudence that, from one ruling to the next, extended the principle of software patentability to new areas. At this point, it should be remembered that from the 1950s to the 1970s, the USPTO had taken an overtly hostile posi- tion to the patenting of computer programs. It had done so because of the very nature of such products, which it analysed as a sequence of abstract stages and/or math- ematical algorithmscharacteristics that are explic- itly excluded from patenting by the US Patents code. Besen and Raskind (1991), in their exhaustive survey of changes in the IPR system, wrote, when Visicalc was developed in 1979, the Patent Ofce, relying on Supreme Court case law, took the position that the mathematical algorithms in computer programs were not a protectable subject matter. In this view, soft- ware that is assimilated to a procedure for solving a given type of mathematical problem 7 could not be covered by Patent Law. It remains that this situation would change quickly after the Supreme Court Diamond versus Diehr (1981) ruling which introduced a radical change of doctrine. According to Besen and Raskind, this ruling negated previous Supreme Court decisions by nding . . . patentable subject matter in a process utilising a computer algorithm. Since that case the Patent Ofce has begun to grant patents to computer programs (Besen and Raskind, 1991). Diamond versus Diehr is an important case insofar as it supports the idea that if software could not be patented per se, when it was introduced in a process, it could be patented as long as this process satised the conditions that were stipu- lated under the Law, namely the utility requirement. Nevertheless, this was only the rst step of the change process. In actual fact, jurisprudence would 7 See the famous case of Benson S. Ct 175 USPQ 673 in which after a long judicial process the Supreme Court ended up by rejecting a patent application. This was a key ruling that would have ultimately have long term jurisprudential value. The Supreme Courts main argument was that it is justiable to refuse to patent a computer program that is based on algorithms that cannot be patented. For a detailed presentation of previous and of subsequent jurisprudence on software package patentability, see Samuelson (1998). gradually shift from a situation in which the existence of an algorithm in a computer program could not con- stitute a motive for refusing the award of a patent to a situation in which: (i) the patent could be granted to programs (including algorithms) if they offer some kind of industrial utility (as long as a precise and care- ful technical description of the invention justifying the award of a patent was also patented); (ii) the patent is granted to pure business models or intellectual meth- ods without any need whatsoever to demonstrate its utility through detailed technical descriptionswith the method itself now being protected. This development was nally concretised in the famous case of Street Bank and Trust versus Sig- nature Financial Group (based on a 1998 CAFC ruling) marking jurisprudential recognition that sim- ple methods can be patentedas long as they are automated (Merges, 1999; Liotard, in press; and the USPTO White Paper on Business Models, 2001). Other precisions are needed to complete this anal- ysis of the specicity of the new American software patent regime. This is a highly complex and unstable eld, and the present paper does not aspire to deal with it in an exhaustive manner. However, there is at least one dimension of this new legal framework that has to be claried. It concerns recompilation rights. 4.2. The recompilation issue Recompilation means the right that an individual is either granted, or else refused, to freely access a given programs source code, to modify it and im- prove it. This is a crucial factor, since by giving new- comers access to source codes it creates the necessary pre-conditions for the products inter-operability and therefore, their improvement. Remember that the soft- ware packages that you can buy in the market con- tain defects and bugs. This limits the uses to which consumers can put these products. Moreover, editors sometimes deliberately introduce some of these short- comings into their programs. For these reasons, source code access is a highly sensitive and strategic issue, with varying approaches having been followed in dif- ferent parts of the world. 8 8 A 14 May 1994 European Union directive authorizes recompi- lation that enhances the programs inter-operability, thus ensuring that users benet from a modicum of adaptability so that they B. Coriat, F. Orsi / Research Policy 31 (2002) 14911507 1497 After a period of hesitation, the recompilation issue was claried in the US, once again via jurisprudence, with the Supreme Courts Sega versus Accolade ruling (which has since become a benchmark in this eld). This ruling, which protects source code access, is a fundamental one. It has created a situation in which certain large incumbent rms can force some of their products on the rest of the market, imposing them as de facto market standard. Moreover, they can use the benets of network externalities to establish virtually unassailable monopoly positions. Recent anti-trust ac- tions against Microsoft showhowBill Gates company has been able to use some of the Laws stipulations in a strategic manner so as to prevent any real com- petition from taking place in a wide range of products and services. 9 In short, and even if these new provisions may open up some market niches for a few small but highly spe- cialised editors, the cumulative effects of the newtypes of property rights awarded on computer software, cou- pled with the existence of network externalities, cre- ate conditions that help the big software editors to strengthen their long-term situation. This is because monopoly advantages are being twinned with the ben- ets of network externalities (Arthur, 1989)a situ- ation that, in the words of two successive presidents of the FTC, has created a whole new set of difcult problems for anti-trust policies in this area (Pitofski, 2001; Muris, 2001). Such were these problems that the regulatory authorities had to launch a new series of hearings on this subject in 2002. 5. From the Chakrabarty ruling to the patenting of human genes: a new IPR regime for living entities The developments that the present section discusses are certainly amongst the most spectacular and illus- are not restricted to the programs being sold by just one editor. As such, this right favors the development of open solutions for software packages (Smets-Solanes, 2000). This right for re- compilation is in fact . . . an incentive for developers to publish interface-related information; to move towards inter-operable stan- dards; and to give positive and appropriate answers to demands from individual users (idem). 9 See DOJ versus Microsoft: nding of facts. Available at http://ftc.gov. trative of all of the changes we analyse. 10 A real (or at least a partial) privatisation of academic research in molecular biology has been triggered. From the rst steps (patenting of genetic engineering methods) to the latest ones (EST patenting), these changes have been carried out with a view towards transferring (via exclusive licensing) many decisive elements in cur- rent basic molecular biology research programs into the hands of private rms, often through joint ventures with academic teams under the specic provisions in- troduced by the BayhDole Act. 5.1. Some of the conditions that have lead to a change in regime To fully understand the nature of the changes that have taken place in this area, we must refer to the Common Law tradition that prevails in the Amer- ican legal system. Applied to Patent Law and more specically to the eld of living entities that we are ex- amining here, the American version of Common Law presents two distinguishing features. (i) In the absence of any texts with explicit refer- ences to the limits of patentability as applied to living entities, American jurisprudence has made a tacit distinction between products of nature and non-naturally occurring manufactures or compo- sitions of matter (a distinction that is nowhere to be found in Civil Patent Law). The US Congress has, therefore, been able to declare that anything under the sun made by man can be patented (Congress, second session, 5, 1952). (ii) Crucial to all American doctrine is the concept of utility, which can be applied to any type of invention or discovery. Patents are explicitly granted because they are deemed to be useful (Utility Patent) for societal progress. This is because, as pointed out by Eisenberg (1995), US Law states the term invention means invention or discovery (c.f. Article 100a). This type of equivalency is nowhere to be found in the Conti- nental European tradition, where the basic prin- ciple underlying the entire doctrine of patenting is the distinction between discovery (as applied to the production of knowledge) and inventions (i.e. technical devices enabling an exploitation of 10 This section is indebted to Orsi (2001). 1498 B. Coriat, F. Orsi / Research Policy 31 (2002) 14911507 knowledge) (see on this point the Article 52a of the Convention on European). Having claried the peculiarities that typify the doc- trinal foundations of current jurisprudence, we can reconstitute the history of the regime change, and show how this brought about the patentability of liv- ing organismsand ultimately of human genes. This shift involved the three following phases: 5.2. 19711980: The US Supreme Courts Chakrabarty ruling and the inclusion of single cell living organisms into the domain of patentability Following a long drawn-out judicial procedure, (that began in 1971) the Supreme Court, in 1980, nally granted General Electric a patent for a genetically modied micro-organism that was able to absorb ma- rine pollution. By so doing, the Supreme Court was overturning the USPTOs initial decision. Its ruling was that gene- tically engineered micro-organisms are statutorily covered by 35 USC 101 as a non naturally occurring manufacture or composition of matter (Jaenischen, 1995). Another signicant event occurred in the wake of this ruling. In 1980, Stanford University requested and was awarded a patent for a DNA recombination technique involving the use of genetic engineering to transplant a gene from one living entity into another. This meant that a process for producing biologically functional molecular chimeras (Stanford Universitys claim in its patent application) had now entered the domain of patentability. Such a process, the epitome of a scientic knowledge production vehicle, was based on a new knowledge in genetic engineeringone that could not have been patented before the Chakrabarty ruling. For all of these reasons, the domain of patentabil- ity opened up to new biotechnological processes that allowed for the production of transgenic animals (or plants) which can be dened as pure research tools and used for scientic experimentation. 5.3. The patentability of multicellular organisms and the USPTOs new doctrine In 1987, another threshold was crossed when the USPTO ofcially recognised the changes that rul- ings by the Supreme Court and by various Courts of Appeal had provoked. In a famous public statement (which some observers consider to be historic), the agency let it be known that the USPTO now considers non-naturally non-human multicellular liv- ing organisms, including animals, to be patentable (USPTO, 1987). The statement had immediate and explicit consequences: as early as 1988, a patent was awarded for the invention of a genetically modied mammal, the so-called oncomouse/Harvard. This was a precursor for many patents that have been granted since then, covering a whole range of trans- genic animals created by different laboratories. The signicance of all of these changes is that the eld of patents was now open to any biologi- cal material that required human interventions. Ac- cording to the Supreme Court and the USPTO, the non-natural aspect of such inventions stems from their man-made attributes, even where the proper- ties they reveal are natural ones. This conrms the idea of equivalency, in the US doctrine between discovery and invention. 5.4. 1991: The NIHs registration of a patent on partial DNA sequences (ESTs); conict with the HGP; and renewed discussions on the patentability of human genes The sum-up of this trend was the NIHs 1991 ap- plication for a patent protection to cover partial gene sequences (so-called ESTs). This application took the trends logic to an ex- treme, inasmuch as it covered sequences that were only partial. The NIHs could not have been unaware that it would be impossible to satisfy the normal statu- tory pre-conditions for patenting, i.e. to demonstrate the utility of such sequences. This is undoubtedly why the application would allege that such sequences do indeed contain a modicum of patent-related utility, in that despite their lack of identiable functions they can help to develop knowledge of the genetic foundations of health, disease and biological functions(quoted in Schrecker et al. (1996)). In other words, the NIHs ar- gument was that these partial sequences had a utility dimension since they could conceivably contribute to a future progress of knowledge by helping to identify those genes that are implicated in certain diseases (and by discovering new therapeutic targets). B. Coriat, F. Orsi / Research Policy 31 (2002) 14911507 1499 Here it is interesting to note that the USPTO re- jected the NIHs claim, but only because in its view further work (was) needed to establish the utility of the claimed object. The NIHs patent application provoked a real crisis in the international open science community. The idea that knowledge becomes a market commodity once State authorities are prepared to award a patent for it, completely contradicts the mindset that had presided over the implementation and the functioning of the Human Genome Program (HGP). Remember that the HGP is an international academic program which is built on an open science model. Launched in 1988 at the behest of the NIHs and the DoE to enhance the sequencing of human genes, the HGPs basic rule is the free circulation of knowledge (NRC, 1988; OTA, 1988). Designed to avoid duplications and to pro- mote collaboration within the scientic community, its core activity involves the constitution of databases containing the partial DNA sequences that the HGP teams have identied and which are made available to researchers for free (OCDE, 1995). A 1998 USPTO decision to grant Incyte Pharmaceuticals a patent for partial sequences (involving the identication and coding of some of the proteins expressed in various cells and human tissues) will lead to even further controversy inasmuch as it conrms a new dimension in this extension of the area of patentability (Patent 5,817,479). As a result of these new circumstances, many nd- ings from the basic research that is being carried out in this eld now come under the proviso of bilateral monopolies. Thus, the famous Harvard Mouse, in principle nothing more than a cancer research tool and once covered by a patent, was handed over to Dupont Corporation as part of an exclusive licensing arrange- ment. The best-known example in this area is the breast and ovarian cancer gene (BRCA1 gene) that was jointly granted to the University of Utah, to NIH and to a rm called Myriad Genetics, which enjoys exclu- sive rights to the exploitation of all of the benets that can be derived from diagnosing this gene (and from re- lated therapy). This is a prime example of knowledge being turned into a commodity. It has brought imme- diate economic prots to those actors who hold these new property rights. Along the same lines, the patent that Stanford University was awarded for its DNA re- combination technique (which has been licensed to a large number of institutions) turned out be one of the most protable patents of the entire 1980s (Mowery et al., 1999). This patent is at the origin of one of Stan- ford Universitys two largest licensing programs (for more on this topic, see Burns and Sandelin (1997)). However, important the immediate gains have been for the rms and other for-prot institutions that enjoy the benets of this new IPR, this is only one aspect of the economic effects that have been produced by the changes in the IPR system. To carry out a more exhaustive evaluation of such effects, we should con- sider another eld of analysis, namely those changes that have taken place in the nancial sphere. 6. A distinctive feature of the new regime: the new key role played by nancial markets 6.1. Institutional complementarities: the connection between the new IPR provisions and changes in nancial regulations Alongside the changes that the BayhDole Act in- troduced, another batch of new regulations were in- troduced. Their purpose was to encourage the entry of venture capital into the new hi-tech rms that were coming out of the research sector. At least two of the nancial regulatory changes are worthy of mention: (i) those that allow pension funds to invest in venture capital rms and to take stakes in risky companies listed on the Nasdaq; (ii) those that brought about the Nasdaqs transformation from a market (which had been created in 1971 as an automated over-the-counter price quotation system), to a stock market that is spe- cialised in innovative rms. Here, it is paramount to note that it would have been impossible to set up a market dedicated to the launching of new innovative but loss-making rms, had a whole series of statutory changes not taken place. The main steps of this statutory change process can be presented as follows. 11 The rst phase revolves around the equity markets regulatory barriers to entry for innovative but risky rms. As pointed out by Gompers and Lerner (1998), these restrictions were replaced by the new ERISA pension fund regulations. Introduced in 1974 and 11 This paragraph is largely based on Orsi (2001). 1500 B. Coriat, F. Orsi / Research Policy 31 (2002) 14911507 amended in 1979, the new regulations modied the prudential rule, enabling pension funds to make major investments in new and innovative (but unprotable) and risky companies. Pension funds were allowed . . . to invest substantial proportions of their portfo- lios in corporate equities and other risky securities. . . rather than just in high-grade corporate and govern- ment securities (Lazonick and OSullivan, in press). This changed both the supply of capital to these mar- kets as well as their level of liquiditymaking it possible to nance (through venture capital compa- nies that have come to be widely dominated by the pension funds) a whole range of new rms that would otherwise have never found enough funding. This caused a crisis throughout the venture capital industry in the mid-1980s, partly due to the excess liq- uidity the pension funds were injecting into the system (Janhson, 1984). So many start-up IPOs were being funded by venture capitalists that the markets OTC section was unable to absorb them. Nor could they be directly sold to the more established rms. Ultimately, this meant that the venture capitalists were being cut off from their traditional exit options (Gompers, 1996). At the same time, the SEC (in a joint effort with the NASD 12 ) initiated a change in the Nasdaqs status. The new regulations authorised an initial and contin- uous listing on the Nasdaq of rms that had recorded losses for several years in a row. One consequence was that the Nasdaq, unlike traditional stock exchanges such as the AMEX and the NYSE, was alone able to apply the so-called Alternative 2 system (NASD, 1984), wherein non-protable rms can be listed (and oated via IPOs) as long as they respect a number of specic criteria. Moreover, these unprotable rms were allowed to include a whole range of intangible assets in their nancial statements, the most important ones being their portfolio of patents and other IPR. 13 In this way, a new exit option was opened for ven- ture capital rms, inasmuch as a much higher num- ber of new start-ups could now be launched on the Nasdaq. 12 National Association of Security Dealers: the entity in charge of Nasdaq regulations (under the supervision of the SEC). 13 As stated by the new regulations underlying Alternative 2: net tangible assets shall mean total asset including the value of patents copyrights and trademarks but excluding the value of goodwill less total liabilities (Series Rules 4200 denition 28). Such modications of the nancial regulatory framework served to complement the changes that had been affecting the IPR regime. By so doing, they created a series of institutional complementarities (Aoki, 2000). Conditions were, therefore, set up dur- ing the 1980s enabling the otation of companies that were to be initially funded by venture capitalists (and often founded as joint ventures with universities and public labs) before being promoted via Nasdaq IPOs. In many cases, such rms main assets were IPR-based. This model, which was very success- ful for Genentech, would later serve as a benchmark for promoting the launch of a number of biotech companies. 14 Another very successful model at that time was the one that was applied to the Internet rms, based as it was on virtual clients, with the companies value being determined by the number of web pages visited. 6.2. From IPR to the nancial markets: towards a nance-driven model of innovation If we look at the example of biotech rms, it is noteworthy that most of them (those that come on the scene in the late 1980s and early 1990s) were made up of research teams coming out of public sec- tor laboratories (universities, NIH, etc.), usually under the scientic supervision of star scientists (Zucker et al., 1998). Table 2 below, which covers the whole of the biotech sector, highlights the relative weakness of such rms income growth rates (earnings having risen from US$ 11.5 to 18.8 billion) when compared with the rise in their market capitalisation (which jumped from US$ 52 to $97 billion). Above all, this table shows that the sector as a whole has been making losses for a long time, with net losses having risen from US$ 2 billion (over 19961999) to US$ 3.1 billion in 1999. 14 We should remember that Genentech, the rst US biotech rm to be listed, was launched on the OTC market in 1980, just 3 months after the Chakrabarty ruling. This IPO is considered to be one of the most spectacular in recent history, even though at the time the rm did not have a single product to sell. Founded by Pr Boyer (co-owner of the rDNA patent technique) and a venture capitalist (Mr. Swanson), the rm specialized exclusively in basic research. The success of its IPO convinced the investor community of the potential value of rms that are based on this type of model (more on this in Orsi (2001)). B. Coriat, F. Orsi / Research Policy 31 (2002) 14911507 1501 Table 2 Biotech highlights 19961999 (US$ billion) 1999 1998 1997 1996 Product sales 13.6 12 10.6 8.9 Revenues 18.8 16.6 14 11.5 R&D expenses 6.9 6.7 5.6 4.6 Net loss 3.1 1.9 1.8 2.2 Market capitalisation 97 93 83 52 Number of companies 327 317 294 260 Employees 114000 106000 94000 73000 Source: Ernst and Young (1998, 1999). Given the sectors lack of protability and the rel- atively slow growth in its product sales and revenues, development would appear to be highly dependent on the way in which it is evaluated by the investor community and on intangible resources, such as IPR. As stated by the Biotechnology Industry Or- ganisation (one of the sectors more inuential trade associations), there is a critical synergy between the biotechnology industry and intellectual property protection. . . . Patents give investors condence and inuence their willingness to put their capital at risk. Based on this argument, the organisation has con- cluded, let there be no mistake, patents are very important to securing capitalvery important to our very viability! (BIO, 1994). 15 This relationship between IPR and market cap- italisation, which lies at the heart of the sectors dynamics, has been analysed by a number of ob- servers, notably by Austin (1992, 1993) who tested this relationship in two econometric studies where he focused on correlations between the date a patent registration is announced in the press (Wall Street Journal) and changes in a rms stock price. The author concluded that the strongest result. . . is that the patents announced in the press are indeed highly valued when they issue (Austin, 1993, p. 256) and came up with two specications relating to this point: recorded values are higher when the announcement relates to the patent having actually been granted (as opposed to a mere attempt to register an invention) and when it is a broad rather than a narrow patent (Austin, 1992, 1993). In addition, Austin shows that 15 These quotes come from a contribution made by the BIO the 17 October 1994 hearing of the USPTO (held in San Diego, CA). when an important patent is granted, the net value of the entire industry appears to rise. 16 This overall situation in the biotech sector (particu- larly for its subgroup of genomic rms) has lead to a highly strategic game in which institutional investors try to ensure the patents commercial promotion, thus underpinning and enhancing their securities market value. Market valuation becomes increasingly impor- tant inasmuch as these rms, which do not pay out any dividends, can only reward shareholders through cap- ital gains. This explains the stock markets extraordi- nary volatility, a situation that over the past few years has caused a asset bubble to formand to burst. By leav- ing genomics to one side (their extraordinary volatil- ity is illustrated in Fig. 1) and comparing changes in biotech company valuations, on one hand, and in the Nasdaq index, on the other, a number of observations arise. From October 1998 (when the Nasdaq hit its low for the period under consideration) to early March 2000 (when it hit its high), the Nasdaq Index rose from 1419 (on 8 October 1998) to 4897 (on 7 March 2000), a jump of 345%. The biotechnology index experienced on the other hand a relatively greater increase than the composite index did. Over the period under study, the Nasdaq biotechnology index (NBI) jumped 527% (ris- ing from 285 on 8 October 1998 to 1505 on 7 March 2000). In both cases the indexes skyrocketed starting in late 1999, when the bubble began. If we compare the two indices trend reversals be- tween January and March 2001, we can see that the Nasdaq composite dropped by 25% and the NBI by 35%. Even though the Biotech index subsequently re- covered (without returning to its 1Q 2000 high), the major and sudden leaps upwards (+527%) and then downwards (35% off the high) during the period un- der study clearly attest to the way in which the biotech sector, as a whole, moved hand in hand with the 16 Campart and Pster (in press) provide other indications of how sensitive the nancial markets are to patent announcements. Based on a panel of 158 patent-related litigation announcements (REUTERS new services) in the biopharmaceutical sector, the au- thor establishes a series of correlations between such announce- ments (the litigation itself) and changes in the market capital- isation of the rms involved. The latter (apprehended over the 5 days following the announcement) moves clearly downwards when a patent dispute is announced and rises in case the ruling is favourable to the rm whose patent had come under attack. 1502 B. Coriat, F. Orsi / Research Policy 31 (2002) 14911507 Fig. 1. Comparing changes in the Nasdaq composite, in the Nasdaq Biotech Index and in two of the main genomic rms. NBI: Nasdaq Biotechnology Index; INCY: Incyte Pharmaceuticals; HGSI: Human Genome Sciences. INCY and HGSI are given here as illustrations. The same exercise for the other main genomic rms gives analogous results. Source: Orsi (2001), compiled by the author on the basis of Nasdaq data. Nasdaq bubble. In fact, both going up and coming down, it moved even more than the Nasdaq did as a whole. The situation with ICT is more complicated, due to the greater diversity of factors involved. Moreover, it is not an IPR trade that prevails as such (as is the case for numerous biotech rms). Instead it is companies strategic utilisation of extended and reinforced prop- erty rights. We can, however, make two observations about the two basic situations in this domain. (i) Together with the benets of market externali- ties, the awarding of strong patents for computer Table 3 Estimates of patents on computer software by companies in 1998 (based on sample of 3336 patents) Companies No. of patents Companies No. of patents IBM 1200 Hewlett-Packard 260 Motorola 360 Sony 250 Fujitsu 330 Hitachi 250 Canon 330 Xerox/Fuji Xerox 240 Microsoft 310 Mitsubishi 240 Lucent/BellCore 300 Intel 230 NEC 280 Toshiba 220 Sun Microsystem 260 Source: Aharonian, http://Ipf.ai.mit.edu/Patent/inps-19981018.text. B. Coriat, F. Orsi / Research Policy 31 (2002) 14911507 1503 Table 4 Estimates of patents on business models Ranking 19771989 (13-year span) 19901994 (5-year span) 19951999 (5-year span) 1 PitneyBowes 134 PitneyBowes 47 PitneyBowes 77 2 Sharp Corporation 39 IBM 32 Fujitsu LTD 64 3 Omron Electronics 31 Hitachi 23 IBM 58 4 IBM 26 Sharp 11 NCR 30 5 Casio 21 Omron 9 Hitachi 27 6 Tokyo Electric 21 Alcatel Business System a 9 Citibank 22 7 Hitachi 10 NCR 6 EDS a 21 8 NCR 7 AT&T a 6 Microsoft a 20 9 Toshiba 6 Unisys a 6 Neopost a 16 10 Merrill Lynch 5 Casio 5 Matsushita Electric Industrial a 16 Attalla Technovations 5 Frama A.G. a 5 Source: USPTO (2001a,b). a Indicates a new assignee from previous period. programs has often strengthened the position of large incumbent rms. The aforementioned ex- ample of Microsoft provides an illustration of these processes. More generally, it should be noted that large incumbent rms usually engage in cross-licensing activities within patent pools (Merges, 1999) that are designed to protect them from the risk of exposure to hold-ups (Shapiro, 2001). This allows them to prosper by developing their own products. (ii) At the other extreme of the spectrum, the new patents that have been granted to computer pro- grams and/or business models (whose number soared from about 4000 in 19921993 to nearly 40,000 patents in 1998) 17 have often facilitated the launching of small specialised rms that oper- ate in specic market niches. Venture capitalists will be especially prepared to work with such rms when the greater the chance that they will be taken over at a later date by large rms and if the innovations that these start-ups have origi- nated are protected by patents or by copyright. Different situations obviously co-exist. Note, how- ever, the traditional software developers dominance, as well as the impressive speed with which the big new entrants have been able to become market lead- ers. For instance, Microsoft, ranked 24th in 1995 with only 39 software patents applications, occupied three years later rank 5, with 310 applications during 1998 alone (Tables 3 and 4). 17 See http://Ipf.ai.mit.edu/patent/inps-19981018.text. In this eld as well, the situation has lead to a number of highly strategic games having been played. As pointed out in recent studies, it seems that most of the patents that the bigger rms have been reg- istering are not meant to protect inventions. Instead they are supposed to hinder virtual rivals, or create strong bargaining positionssee Cohen et al. (2002), who conclude their very detailed statistical analysis by saying that . . . the most prominent motives for patenting include the prevention of rivals from patent- ing related inventions (i.e. patent blocking), the use of patents in negotiations and the prevention of suits (Cohen et al., 2002, p. 1). In the same vein, Hall and Ham conclude in a survey dedicated to patenting in the semiconductor industry that our preliminary evidence suggests that the pro-patent shift in the 1980s has altered the patent strategy of semiconductor rms. . . . On the one hand, stronger patent rights may have well facilitated specialisation in the industry. . . . On the other hand, such positive effects are countered by a socially inefcient process whereby rms amass vast patent portfolios simply as bargaining chips. In essence, a patent portfolio race may ensue (Hall and Ham, 1999, p. 24). 7. Conclusion: an initial assessment and evaluation of the new IPR regime The many changes that the present article has dis- cussed are a topic of widespread analysis and debate nowadays. 1504 B. Coriat, F. Orsi / Research Policy 31 (2002) 14911507 At rst glance, the new policies the American authorities and Courts have been deploying in or- der to enforce the new IPR regime would appear to have been successful. In some areas (semiconduc- tors and computer software in particular) American rms who had been overtaken by their Asian ri- vals during the 1980s were market leaders again. More signicant is the fact that many new rms have entered the market. The areas we have studied (biotech, genetics, semiconductors, computer soft- ware, etc.) were characterised throughout the 1990s by the proliferation of companies of all different sizes. However, despite such ostensible successes, the new regime does not appear to have stabilised. There has been a great deal of tension in certain areas and this has raised questions about the future. Two points are particularly salient at this juncture and we would like to nish this article by focusing on those issues that remain unanswered. 7.1. Tensions arising from the extension of patentability to previously excluded areas and from the relaxation of the traditional criteria First of all, remember that the patenting of hu- man genes has raised serious ethical problems in the eld of life sciences (c.f. the 1996 debate that raged throughout the European Academies of Sci- ences). The international community remains strongly divided on this point. Opponents to the new doc- trine are particularly incensed because it does not seem to offer the sorts of guarantees that knowl- edge production requires, in terms of the long-term innovation process and the social costs that this infers. As such, and even without taking any ethical con- siderations into account, some pharmaceutical rms who have been actively advocating the patentability of ESTs and genes (and who have helped to fund numer- ous companies in this eld) have often at the same time openly expressed doubts about the processs long-term sustainability. Given the delays and risks associated with research activities in this area, they are afraid that they will no longer be able to undertake such long and risky ventures if they have to pay royalties in order to access basic upstream knowledge. According to Heller and Eisenberg, this is a typical anti-commons tragedy. 18 The authors observe that the privatisa- tion of biomedical research must be more carefully deployed to sustain both upstream research and down- stream product development. Otherwise more intellec- tual property rights paradoxically may lead to fewer useful products for improving human health (Heller and Eisenberg, 1998). What is at stake here is the principle of granting patents to basic or upstream research (along these lines, apart from Eisenbergs arguments, see also Rais view on the dangers of patenting upstream research in biopharmaceuticals (Rai, 2001)). Regarding computer programs and business mod- els, even though the ethical dimension is absent (or certainly less visible), some of the economic prob- lems involved in the patentability of algorithms are akin to those that are involved in gene patentabil- ity. Remember that a simple computer program uses dozens of algorithms. As such, if property conicts arise between the rms who use these algorithms, many of the actors (beginning with those who work on the Internet) would come under threat and the whole process of innovation could be impeded. Typ- ically this might generate a situation such as the one that Shapiro (2001) analysed, with the creation of a patent thicket. At a theoretical level, no truly novel argument has been made to supplement Kitchs old plea in favour of large prospects being handed to rms by means of extremely broad-based patents (Kitch, 1977). Nor has any new empirical study contradicted Merges and Nelsons (1990) response to Kitchs views. Quite the contrary, recent theorisation in this eld has es- tablished that wherever sequential innovation takes place, an overly generous granting of patents can strongly hinder the innovation process (Hunt, 1999b; Bessen and Maskin, 2000). This argument has also been endorsed by some of the most innovative soft- ware developers around, i.e. Oracle or Adobe man- agers during the public hearings that the USPTO 18 According to the authors, the argument is as follows: the tragedy of commons metaphor helps to explain why people overuse shared resources. However, the recent proliferation of in- tellectual property rights in biomedical research suggests a dif- ferent tragedy, an anticommons one in which people under-use scarce resources because too many owners can block each other? (Heller and Eisenberg, 1998). B. Coriat, F. Orsi / Research Policy 31 (2002) 14911507 1505 held at the San Jose Convention Centre in 1994 (c.f. http://lpf.ai.mit.edu/patents/). Finally, most observers have concluded that the ex- tension of patents into new elds poses a number of future threats and uncertainties, yet does not provide any unassailably persuasive argument in favour of di- luting the rules of open science. 7.2. Is a nance-driven innovation model a sustainable one? The recent bursting of the Nasdaqs speculative bubbleand the meaning thereof We have shown that one of the key changes that took place during the 1980s was the new institutional com- plementarities that gave rise to an alliance between the nancial markets and the new innovative rms that were granted new types of patents. 19 To a large extent the so-called new economy is grounded and rooted in this new alliance. From this point of view, no one can deny that the new comple- mentarities that have taken root in the US NIS have had remarkable effects. In particular, the Nasdaq has turned out to be a powerful catalyst, amplify- ing the changes that were introduced in the US NIS during the 1980s and encouraging the rise of many new rmsspecically in the new R&D intensive sectors. It remains that the year 2000 marked a turning point. The bursting of the stock markets nancial bubble lead to a succession of bankruptcies, rings and dramatic readjustments. Many of the new stars of the 1990s (particularly some of the Internet rms) sawtheir accumulated share value drop dramatically. 20 The same applied to a number of ICT rms. Lastly, if one looks at the gures, it is clear that the entire biotech went through a major upheaval (without men- tioning the genomic rms, who experienced an even rockier ride (Fig. 1). Even if a number of factors can be used to explain the creation and subsequent bursting of the Nasdaq bubble (given that the new relationships between IPRs and venture capital only constitute one of 19 Firms constantly recycle this argument when talking about venture capital (i.e. software editors explaining why they defend the idea of software patentability). On this subject read Herings (op. cit.), which the USPTO organised in San Jose in 1994. 20 This question is now well documented. 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