Trumping TRIPS: Indian patent proficiency and the evolution of an evergreening enigma
TL;DR: In this paper, the authors discuss the long and tortuous history of the provision and discuss India's efforts to tailor its patent regime to promote the national interest whilst remaining compliant with TRIPS, in contrast to a number of other countries that have simply toed the line of the developed world's maximalist intellectual property (IP) agenda.
Abstract: Section 3(d) of India’s Patents Act forbids patents on pharmaceutical substances that do not demonstrate a significantly enhanced efficacy over and above prior known substances. This article discusses the long and tortuous history of the provision. Only after an extended period of difficulty did India get to grips with World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and interpret it strategically to benefit the nation and its industry. This sophistication reached a near crescendo with the emergence of section 3(d), its crude drafting notwithstanding. India’s efforts to tailor its patent regime to promote the national interest whilst remaining compliant with TRIPS stands in stark contrast to a number of other countries that have simply toed the line of the developed world’s maximalist intellectual property (IP) agenda. As such, it represents a significant milestone and a valuable lesson in the IP and development debates.
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TL;DR: In this article, the authors explore the relative roles of an invention's conception and reduction to practice in patent law by exploring it through the lens of obviousness, and show that it can be just as important as conception in the context of patent application.
Abstract: Patent law has been missing the obvious. Tasked with advancing innovation by awarding an exclusive right to make or use certain inventions in exchange for their creation and disclosure to the public, patent law has installed certain threshold conditions as gatekeepers to ensure that the valuable patent right is granted only to worthy inventions. The Supreme Court's recent decision in KSR International Co. v. Teleflex Inc. shone a spotlight on nonobviousness and on articulating the criterion flexibly enough to guarantee that patents issue only to inventions constituting a sufficient advance in the state of the art, thereby encouraging, not stifling, innovation. Despite this overarching salutary and important purpose highlighted in KSR, neither courts nor scholars have analyzed or clearly settled on the object of the obviousness inquiry, a critical component of a nonobviousness determination. That is, what is it that must be nonobvious? Some courts have implied that the object that must be nonobvious is the concept of the invention (the complete idea as articulated in the patent's claims). Other courts have hinted that it might be some combination of the concept and the reduction to practice of a working model. As troubling as these irreconcilable judicial intimations are, they have been made by courts without any reflective analysis. This Essay suggests that the correct object to be analyzed for obviousness is actually the union of two different aspects of invention that the courts have varyingly identified: the concept and the reduction to practice of a working model. Requiring an assessment of obviousness at each of these layers is more faithful to the nonobviousness doctrine and patent law's underlying policies than the current doctrinal state of confusion. Application of this layered inquiry indicates that obviousness is currently being assessed improperly, particularly with regard to technologies of relatively recent vintage, principally software and biotechnology, where the reduction to practice of a working model is inherently complex even once the inventive concept is fixed in the inventor's mind. A layered inquiry would advance the goals set out in KSR by properly and flexibly readjusting nonobviousness doctrine to exclude from patentability those inventions that are not significant leaps forward in the state of the art. This exploration of the layers of invention in the context of the doctrine of obviousness has wide-reaching implications in patent law well beyond obviousness. This Essay is a first step in questioning the relative roles of an invention's conception and reduction to practice in patent law generally, by exploring it through the lens of obviousness. Until now, many areas of patent law seem to have elevated the inventive role of conception over that of actual reductions to practice, be it with regard to what must be accomplished to secure a patent, what must be contributed to an invention to be recognized as a joint inventor, or with regard to patent law's on-sale bar. But in other contexts in patent law, such as the availability of injunctive relief for patent infringement, the relative importance of reduction to practice is acknowledged. This Essay suggests that it is due time to question whether reduction to practice deserves an elevated role in patent law generally by demonstrating that it can be just as important as conception in the context of obviousness.
7 citations
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TL;DR: In this paper, the authors posits four main causes of patent jurisprudence unpredictability, including the generality of terms in the U.S. patent statute, the presence of numerous mental states affecting patentability, affirmative defenses, and remedies, and the difficulty encountered by the court in attempting to formulate easy rules of general applicability for determining patent claim scope.
Abstract: This paper posits four main causes of unpredictability in the Federal Circuit's patent jurisprudence. First among these is the generality of terms in the U.S. patent statute, leaving most of the fleshing out to be done by judges on a case-by-case basis. Another is the presence in the statute of numerous mental states affecting patentability, affirmative defenses, and remedies. These presence or absence of these mental states is inherently difficult to determine long after the fact in many cases. Another injector of unpredictability revolves around the numerous difficulties encountered by the court in attempting (fruitlessly) to formulate easy rules of general applicability for determining patent claim scope. Basically an exercise in characterizing a technological family in words, the effort is never going to be easy at the margins.
3 citations
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TL;DR: In this paper, the authors look at the validity of the obviousness inquiry in light of these uncertainties and conclude that invention duplication evidence from the Australian Aktiebolaget case would be the most beneficial type of expert evidence for the current obviousness standard as it stands.
Abstract: The granting of patents is qualified by the assessment of whether the said invention is obvious or involved an inventive step, and has some utility The obviousness inquiry, based on the Windsurfer test, is a factual and objective inquiry, but its evaluative nature inherently requires some degree of subjective opinion or intuition from patent examiners and courts The resultant uncertainty is demonstrated by the different outcomes of the Aktiebolaget cases heard around the world, where dependence on the notional person and derived expert witnesses is such that different results developed from the same facts and expert witnesses This paper looks at the validity of the obviousness inquiry in light of these uncertainties It concludes that invention duplication exercise evidence from the Australian Aktiebolaget case would be the most beneficial type of expert evidence for the current obviousness standard as it stands However, it also find that obviousness may not be needed at all and that removing the inquiry may not be as detrimental as it first appears, but economic studies would be required to see its true effect
2 citations
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TL;DR: In this paper, the authors argue that at a formal level TRIPS leaves developing countries far more policy space than is commonly recognized and identify compensating strategies that may facilitate the effective use of TRIPS flexibilities, responding to the transnationalized pressures that TRIPS implementation sets up.
Abstract: In 2005, India amended its patent law to provide product patents on medicines, to comply with the WTO’s TRIPS Agreement. In order to mitigate the impact on access to medicines, India at the same time adopted an expansive menu of flexibilities in its patent law. Reviewing these important flexibilities, some of which are entirely novel, this article argues that at a formal level TRIPS leaves developing countries far more policy space than is commonly recognized. But while TRIPS as a formal matter cannot produce deep harmonization, it nonetheless channels a strong harmonizing force, because it inserts countries into a transnational circuit that fills in the gaps in the Agreement and that works against the use of TRIPS flexibilities. Limits on administrative resources, the influence of transnational legal networks, and the threat of unilateral retaliation from high-protection jurisdictions all make it difficult for countries like India to implement an autonomous vision of patent law. The paper also identifies compensating strategies that may facilitate the effective use of TRIPS flexibilities, responding to the transnationalized pressures that TRIPS implementation sets up. I call these strategies fragmentation, mimicry, and counter-harmonization. As I demonstrate, counter-harmonization shows the most promise for developing countries, because it offers countries safety in numbers, can lower the administrative costs of implementing an alternative patent law, and can generate a transnational legal counterculture. Lastly, the paper engages with the literature about the implications of the legalization of the global trading regime. The case study offered here suggests that legalization cannot simply be identified, as some prominent trade law scholars have argued, with the substitution of politics for principle, and with the leveling of power differences between states. It also suggests a new perspective on the debate over whether the WTO has a “constitutional” form, and if so, what this means. To date, those who claim a constitutional nature for the WTO have identified that nature with a move beyond politics. The analysis offered here suggests that if the WTO has a constitutional nature, it lies in its capacity to mobilize and channel, rather than to suppress or transcend, political disagreement.
90 citations
TL;DR: In this article, the authors pointed out that patent law is not technology-neutral in theory, but it is technology-specific in application, and that the application of the same general legal standards can lead to such different results in diverse industries.
Abstract: Patent law has a general set of legal rules to govern the validity and infringement of patents in a wide variety of technologies. With a very few exceptions, the statute does not distinguish between different technologies in setting and applying legal standards. In theory, then, we have a unified patent system that provides technology-neutral protection to all kinds of technologies.Of late, however, we have noticed an increasing divergence between the rules themselves and the application of the rules to different industries. The best examples are biotechnology and computer software. In biotechnology cases, the Federal Circuit has bent over backwards to find biotechnological inventions nonobvious, even if the prior art demonstrates a clear plan for producing the invention. On the other hand, the court has imposed stringent enablement and written description requirements on biotechnology patents that do not show up in other disciplines. In computer software cases, the situation is reversed. The Federal Circuit has essentially excused software inventions from compliance with the enablement and best mode requirements, but has done so in a way that raises serious questions about how stringently it will read the nonobviousness requirements. As a practical matter, it appears that while patent law is technology-neutral in theory, it is technology-specific in application.The paper explains how the application of the same general legal standards can lead to such different results in diverse industries. Much of the variance in patent standards is attributable to the use of a legal construct, the "person having ordinary skill in the art" (PHOSITA), to determine obviousness and enablement. The more skill those in the art have, the less information an applicant has to disclose in order to meet the enablement requirement - but the harder it is to meet the nonobviousness requirement. The level of skill in the art affects not just patent validity, but also patent scope. We do not challenge the idea that the standards in each industry should vary with the level of skill in that industry. We think the use of the PHOSITA provides needed flexibility for patent law, permitting it to adapt to new technologies without losing its essential character. We fear, however, that the Federal Circuit has not applied that standard properly in either the biotechnology or computer software fields. The court has a perception of both fields that was set in earlier cases but which does not reflect the modern realities of either industry. The changes in an industry over time present significant structural problems for patent law, both because law is necessarily backward-looking and precedent-bound and because applying different standards to similar inventions raises concerns about horizontal equity. Nonetheless, we believe the courts must take more care than they currently do to ensure that their assessments of patent validity are rooted in understandings of the technology that were accurate at the time the invention was made.
29 citations
Posted Content•
TL;DR: In this article, the authors introduce a mathematical model of innovation and patenting to analyze the effects of nonobviousness indeterminacy, and they conclude that the patent system is not too low, but both too high and too low.
Abstract: The dominant current perception in patent law is that the core requirement of nonobviousness is applied too leniently, resulting in a proliferation of patents on trivial inventions that actually retard technological innovation in the long run. This Article reveals that the common wisdom is only half correct. The nonobviousness standard is not too low, but both too high and too low. It is indeterminate. Three principal factors produce nonobviousness indeterminacy: a failure to identify the quantum of innovation necessary to satisfy the standard, a failure to define the baseline level of ordinary skill against which to measure an innovation, and the epistemic infeasibility of requiring a technologically lay decision maker to judge from the perspective of a more highly trained and educated person of ordinary skill in the art.This Article introduces a mathematical model of innovation and patenting to analyze the effects of nonobviousness indeterminacy. Based on the model, indeterminacy in nonobviousness decisions has several unexpected consequences. First, indeterminacy results in an excessive total number of patent grants, and in many patent grants on obvious inventions. Second, indeterminacy leads to too many patent applications on obvious inventions and too few applications on non-obvious inventions. Third, uncertainty causes more patent litigation than is optimal and leads to incorrect litigation outcomes. Fourth, indeterminacy leads to inefficiently low incentives to research and develop great advances, and excessively high incentives to invest in mundane innovation. All of these effects occur even assuming that decision makers apply the nonobviousness standard correctly on average.That many of the current patent system ills may result from indeterminacy rather than from too low a nonobviousness standard has significant consequences for the patent system and for current recommendations for reform. Perhaps most critically, arguments for raising (or lowering) the nonobviousness threshold, a mainstay of recent legal and economic analysis, may be somewhat inapposite, unless and until we can establish greater specificity in the standard. This Article concludes with several recommendations for improving determinacy in nonobviousness decisions, including differentiating nonobviousness analysis and developing a substantive nonobviousness standard.
8 citations
Posted Content•
TL;DR: In this article, the authors explore the relative roles of an invention's conception and reduction to practice in patent law by exploring it through the lens of obviousness, and show that it can be just as important as conception in the context of patent application.
Abstract: Patent law has been missing the obvious. Tasked with advancing innovation by awarding an exclusive right to make or use certain inventions in exchange for their creation and disclosure to the public, patent law has installed certain threshold conditions as gatekeepers to ensure that the valuable patent right is granted only to worthy inventions. The Supreme Court's recent decision in KSR International Co. v. Teleflex Inc. shone a spotlight on nonobviousness and on articulating the criterion flexibly enough to guarantee that patents issue only to inventions constituting a sufficient advance in the state of the art, thereby encouraging, not stifling, innovation. Despite this overarching salutary and important purpose highlighted in KSR, neither courts nor scholars have analyzed or clearly settled on the object of the obviousness inquiry, a critical component of a nonobviousness determination. That is, what is it that must be nonobvious? Some courts have implied that the object that must be nonobvious is the concept of the invention (the complete idea as articulated in the patent's claims). Other courts have hinted that it might be some combination of the concept and the reduction to practice of a working model. As troubling as these irreconcilable judicial intimations are, they have been made by courts without any reflective analysis. This Essay suggests that the correct object to be analyzed for obviousness is actually the union of two different aspects of invention that the courts have varyingly identified: the concept and the reduction to practice of a working model. Requiring an assessment of obviousness at each of these layers is more faithful to the nonobviousness doctrine and patent law's underlying policies than the current doctrinal state of confusion. Application of this layered inquiry indicates that obviousness is currently being assessed improperly, particularly with regard to technologies of relatively recent vintage, principally software and biotechnology, where the reduction to practice of a working model is inherently complex even once the inventive concept is fixed in the inventor's mind. A layered inquiry would advance the goals set out in KSR by properly and flexibly readjusting nonobviousness doctrine to exclude from patentability those inventions that are not significant leaps forward in the state of the art. This exploration of the layers of invention in the context of the doctrine of obviousness has wide-reaching implications in patent law well beyond obviousness. This Essay is a first step in questioning the relative roles of an invention's conception and reduction to practice in patent law generally, by exploring it through the lens of obviousness. Until now, many areas of patent law seem to have elevated the inventive role of conception over that of actual reductions to practice, be it with regard to what must be accomplished to secure a patent, what must be contributed to an invention to be recognized as a joint inventor, or with regard to patent law's on-sale bar. But in other contexts in patent law, such as the availability of injunctive relief for patent infringement, the relative importance of reduction to practice is acknowledged. This Essay suggests that it is due time to question whether reduction to practice deserves an elevated role in patent law generally by demonstrating that it can be just as important as conception in the context of obviousness.
7 citations
01 Jan 2006
TL;DR: In this paper, the authors examine some of the ways that heuristics might be used (and should not be used) in the creation and application of laws and regulations, and examine the social and institutional factors that support or inhibit the effectiveness of heuristic.
Abstract: In making and applying law, many agents and institutions aim for some optimal solution, yet end up mired in complexity and inefficiency. Their decision-making processes may therefore be improved by the judicious use of simplifying heuristics. In this report we examine some of the ways that heuristics might be used (and should not be used) in the creation and application of laws and regulations. We begin by distinguishing m-heuristics (mental heuristics used by a person) from l-heuristics (legal heuristics as simplified procedures encoded into law). The human mind appears to be prepared by evolution to use certain m-heuristics when making moral judgments. To the extent that l-heuristics map onto m-heuristics, they are likely to be cognitively easy and to seem legitimate to many participants. We next examine the lawmaking process and the steps at which mand l-heuristics might be used by specific agents. In the third section we take Roman law as a case study in which l-heuristics were widely and effectively employed. We consider the lessons of ancient Rome for modern law. In the fourth section we consider legal and moral objections to the use of heuristics, such as constitutional prohibitions on using factors such as age, sex, and race in decision making, or the need for explicit listings of reasons to allow for judicial review. In the fifth section, we examine the social and institutional factors that support or inhibit the effectiveness of heuristics. We conclude with suggestions for further research, including the question of how to explain and justify l-heuristics in ways that people will understand
6 citations