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IP & LAW Courts and the Patent System Dan Burk and Mark Lemley Regulation, Vol. 32, No. 2, pp. 18-23, Summer 2009 (http://ssrn.com/abstract=1432452) Innovation and patent law work differently in different industries. To some degree, the courts’ interpretations of patent and trademark law accommodate those differences. It is not much of an exaggeration to say that the patent system must bend or break: a patent system that is not flexible enough to account for these industry differences is unlikely to survive, let along accomplish its stated goals. We believe the system has the flexibility to do both, but this will require the courts to better recognize and use the policy levers they have been given. Congestion Pricing for Patent Applications Alan Marco and James Prieger Working Paper (http://ssrn.com/abstract=1443470) In this paper we study the main factors determining the optimal level of intellectual property (IP) protection. We are especially interested in how optimal protection should change as the size of the economy grows. There is a large literature that explores the qualitative aspects of optimal IP policy, and a significant empirical literature that attempts to measure such things as the value of In recent years a great deal of attention has been paid to patent reform. This debate is exemplified by recent popular publications (Jaffe and Lerner, 2004; Bessen and Meurer, 2008), as well as publicized patent litigation such as the NTP v. Research-in-Motion patent litigation (the Blackberry patents). At the same time, scholars point to the over-burdened patent offices, the growth in patent applications, and the proliferation of low-quality or overlapping patents. In this paper, we take a novel approach to dealing with the flood of applications at the patenting authorities in the US and Europe and the resulting delay and issuance of low quality patents. We explore the magnitude of the congestion

externality and seek to determine the optimal balance of the direct costs of applying for a patent with the indirect cost caused by regulatory delay. Our proposed theoretical and empirical framework enable explicit measurement of the cost of delay and the implications of changing patent application fees. The results have implications for a variety of policy questions involving optimal fees, patent quality, and competition policy. We include in this submission a basic theoretical model that can be extended to examine a number of policy implications, including the relationship between examination time and patent quality. We also describe an empirical approach that enables quantification of the cost of delay. Both the model and the empirical work enable us to discuss additional policy questions such as the importance of application versus renewal fees, the consequence of the self-funding constraint on patent offices, and the impact of higher quality patents on rent-seeking activities. Preliminary results show that the patent office revenue maximizing fee exceeds the optimal fee for patent holders, but that the optimal fee for patent holders is positive. Patents as Administrative Acts: Patent Decisions for Administrative Review Chris Dent Sydney Law Review, Vol. 30, No. 4, 2008 (http://ssrn.com/abstract=1443566) Currently, challenges to decisions in the Australian patent system may be heard in either the Patent Office, if the challenge comes before the grant of the patent, or in the Federal Court, if a granted patent is challenged. This is the case despite the grant decision being an administrative decision. This Paper considers the decisions made as part of the patent system - including the decision by a patent examiner to grant a patent and the adjudicatory decisions of opposition and revocation - and explores the potential for the challenges to the grant decision to be subject to administrative review. In particular, the Paper raises the possibility of examiners’ decisions being subject to merits review in the Administrative Appeals Tribunal and judicial review before the Federal Court.

August 2009 From the Editor The Intellectual Property Literature Watch contains a selection of the most recent working papers, published reports, and books that are relevant to the understanding of intellectual property rights (IPR) issues.

Alina Marinova, Editor amarinova@lecg.com

Contact LECG For more information on the

issues discussed in this newsletter, please contact:

Anne Layne-Farrar

Chicago ALayne@lecg.com

312.267.8243

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A Stone's Throw Away from a European Patent Court: The European Patent Litigation Agreement Stefan Luginbuehl Working Paper (http://ssrn.com/abstract=1403098) The EPO Working Party on Litigation and its sub-group have in the past three and a half years elaborated a treaty text of an agreement for a European Patent Litigation System. The heart of this system includes a European Patent Court. The agreement on the cornerstones for a Community Patent Court, and on the other points in regard to the Community patent in the common political approach of March 3, 2003, questions the further necessity for a European Patent Court. The author shows why in any case a European Patent Court would be needed. An Empirical Analysis of the Adjudication of Patent Cases by the Court of Appeals for the Federal Circuit Manasseh Zechariah Working Paper (http://ssrn.com/abstract=1443575) The enforcement of patent rights affects the scope of the monopoly rights provided by them and hence the incentives they provide. Greater likelihood of a pro-patent decision by the enforcement mechanism provides a larger scope of monopoly rights. I investigate the likelihood of a pro-patent decision by the Court of Appeals for the Federal Circuit in patent cases to see how it varies with characteristics of the patent, the litigants and the litigation itself. This model corrects for the fact that not all patent cases get appealed after trial by incorporating a selection model for the appeal of cases. I also incorporate the litigants' uncertainty about appealing a case using a heteroscedastic selection model. I estimate the model using simulated maximum likelihood and use the GHK simulation method. Results show that overall the Court of Appeals for the Federal Circuit is an anti-patent court. However, significant differences exist between different classes of patents with drug patents being more likely to be decided pro-patent than software patents.

The Court of Appeals for the Federal Circuit is found to defer to the decisions of the lower court. We also see an increased likelihood of a pro-patent decision by the appeals court with an increase in the proportion of republican judges on the bench. Rational Competition Policy and Reverse Payment Settlements in Hatch-Waxman Patent Litigation David Opderbeck Working Paper (http://ssrn.com/abstract=1440780) This paper examines the problem of 'reverse payment' settlements in patent litigation under the Hatch-Waxman Act. A reverse payment settlement involves a payment from a branded pharmaceutical company to a generic manufacturer, usually in return for the generic manufacturer’s agreement to delay market entry. Federal appellate courts, regulatory agencies and commentators are divided about the legality of such agreements. This paper argues that the importance of product market definition has been overlooked in existing treatments of the issue. The paper develops an empirically-based 'Settlement Competition Index' that could be used by courts and regulatory agencies to evaluate reverse payment settlements. A formula to calculate the Settlement Competition Index is provided and tested with hypothetical and real-world examples. The Levels of Abstraction Problem in Patent Law Tun-Jen Chiang Working Paper (http://ssrn.com/abstract=1434465) The concept of “invention” is fundamental to patent law. What the patentee creates as the invention, he receives as his monopoly reward. This quid pro quo suggests that patent scope is self-defining: the patentee receives whatever invention he created, and nothing else. The quid pro quo framework breaks down, however, because “invention” means different things on the two sides of the equation. The invention that the patentee creates is an embodiment. The invention that defines monopoly scope, however, is an idea. Moreover, every patented embodiment contains many ideas, at different levels of

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abstraction. Courts must choose one idea to give legal protection, with important consequences. The higher the level of abstraction chosen, the more scope the patentee receives, with attendant incentive benefits and monopoly costs. Courts that have treated idea and embodiment as a unitary invention have ignored the necessity of this choice, effectively exercising their discretion arbitrarily and silently. This Article argues instead for a legal realist approach that acknowledges discretion in determining patent scope, discards the conflicting yet absolutist rules governing this area, and determines scope based on balancing incentives and monopoly costs, with transparent analysis allowing better information to be collected and greater predictability in outcomes. Appellate Review of Patent Claim Construction: Should the Federal Circuit Be its Own Lexicographer In Matters Related to The Seventh Amendment? Eileen Herlihy Michigan Telecommunications and Technology Law Review, Vol. 15, p. 469, 2009 (http://ssrn.com/abstract=1437242) This article addresses the need for a principled standard of appellate review of patent claim construction, emphasizing the necessity for such a standard to be compatible with Seventh Amendment law. In Cybor Corp. v. FAS Technologies, Inc., the Federal Circuit resolved internal conflict regarding the appropriate standard of appellate review by establishing a de novo standard and overruling its past inconsistent precedent. The appropriateness of this de novo standard of appellate review has generated extensive debate and disagreement within the judiciary, the patent bar and academia. It has been over ten years since a majority of the Federal Circuit endorsed this standard of review, taking the position that it was in line with the Supreme Court's seminal Seventh Amendment Markman case, which holds that judges, rather than juries, should construe patent claims. Over the years since the Federal Circuit endorsed the de novo standard of review, the dissenting voices on the Federal

Circuit have persisted and the number of Federal Circuit judges who are on record as indicating that the standard should be revisited has steadily grown. Part I of this Article examines whether the Cybor rule of de novo appellate review of patent claim construction is consistent with Supreme Court precedent, focusing primarily on Seventh Amendment decisions. Part II discusses whether or not it is appropriate for the Federal Circuit to set the boundary between issues of fact and issues of law in patent cases. Finally, Part III addresses the extent to which various proposed standards of appellate review of claim construction are principled, with particular emphasis on their compatibility with the Seventh Amendment. Indeterminism and the Property-Patent Equation Alan James Devlin Yale Law & Policy Review, Forthcoming (http://ssrn.com/abstract=1435902) Fierce debate has raged over the relative primacy of liability and property rules in informing patent jurisprudence. Those who favor the latter path often see prescriptive parallels in the rules properly brought to bear on owners of physical and intellectual property. Others view the intellectual domain as sufficiently distinct as to render the law of tangible property incongruous and inapplicable. This Article seeks to promote a novel perspective on this dialectic, by focusing on the import of a heretofore unappreciated tenet of the analogy between intellectual and real property. Those who seek to inform the optimal construction of patent rules through long-established norms of property law face a challenge in the form of the asymmetric legal certainty that characterizes these respective property rights. More specifically, the validity of ownership rights in patented technology is heavily stochastic, whereas rights in physical property are largely definite. The issue of certainty implicates both the epistemological and consequential qualities of ownership, and should inform the optimal construction of property rights accordingly. This holds especially true with intellectual property, where exclusivity comes at the cost of the Lockean 'enough and as good' condition, given the public good benefits foregone by private ownership.

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This insight begs two major conclusions. First, there may be good normative ground for tempering the exclusive rights properly associated with highly probabilistic property rights. Second, in an environment of free contract, one should be concerned that a patentee may be able to transform the aoristic right granted it by Congress into a certain one, thus deriving a greater pecuniary return than was inherent in the 'patent bargain.' The legitimacy and scope of the power to exclude lies at the heart of this transformative process, creating a spectrum that charts a direct association between patent certainty and freedom of contract. Indeterminism thus bears significant repercussions for the property-patent equation. This Article charts the positive source of the divergence in determinism between intellectual and tangible property, and explores the normative repercussions of that departure for the formulation of both substantive patent law and ideal restraints on freedom of contract. Interestingly, the capricious nature of intellectual property need not strip the property-patent equation of all legitimacy. Nevertheless, the temptation to borrow wholesale from the law governing real property must be met with sensitivity for the distinctions between the property characteristics at issue. The Article concludes by suggesting that improvements in the prosecution and re-examination processes would greatly strengthen the property-patent equation. Until that time, though, qualified limitations on the right to exclude, and rights derived therefrom, may be normatively justified. The 'Process' of Patenting: Why Should We Care About a Potential U.S. Supreme Court Decision in Bilski V. Doll? Johanna Dennis Computer Law & Security Review, Vol. 25, No. 6, 2009 (http://ssrn.com/abstract=1433847) In Bilski v. Doll, the U.S. Supreme Court is called to define one of the categories of patent eligible subject matter, “process” patents. In 2008, the Court of Appeals for the Federal Circuit held that the category has a narrow meaning, and that to be eligible for a process patent under 35 U.S.C. § 101, the invention must involve a machine or

apparatus or involve a transformation to a different state or thing, ultimately rejecting the patent application as unpatentable subject matter. The patent applicants have asked the U.S. Supreme Court to determine two issues: first, the meaning of “process” in 35 U.S.C. § 101 and whether the lower court properly relied on a “machine-or-transformation” test, and second, the test’s potential conflict with 35 U.S.C. § 273, which provides protection for “method[s] of doing or conducting business.” The Court’s decision could change the way that research and business are done, and patent protection for such investments. Parts 1 and 2 of this article address Bilski directly and what is and is not in dispute. Part 3 addresses the “machine-or-transformation” test, while Parts 4 and 5 address reasons not to adopt such a test. Why Weak Patents? Rational Ignorance or Pro-'Customer' Tilt? Zhen Lei and Brian Wright Working Paper (http://ssrn.com/abstract=1434275) The United States Patent and Trademark Office (USPTO) grants many weak patents that would be ruled invalid if subjected to more thorough scrutiny. Some observers see weak patents as evidence of the need for allocation of more resources to increase the accuracy of patent examinations. Others argue that the costs of such reform would outweigh the benefits; weak patents reveal the “rational ignorance” of the Patent Office; it is optimal to leave examiners unequipped to identify more weak applications, deferring the large costs of more definitive determination of validity until patents are litigated. Here we address the assumption underlying both positions: that examiners cannot distinguish weak patents from strong. We find that US examiners’ prior art searches reveal that they can and do identify many patents that are of dubious validity. They conduct a more intensive search for prior art for applications they accurately identify as weak, because they bear the burden of proof of non-patentability, but not of patentability. Our study suggests that the rules and procedures of the USPTO have forced examiners to grant many of these weak applications. Given the resources at hand, examiners possess information about the validity of their patents that society

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does not use. We do not find the balance of the marginal costs and benefits of information about patent validity that would characterize rational ignorance at the USPTO. Intellectual Property Right Regimes, Firms and the Commodification of Knowledge Benjamin Coriat and Oliver Weinstein Working Paper (http://ssrn.com/abstract=1440866) The aim of this paper is to analyze the evolution of the intellectual property regime, and more precisely the patent regime, in the USA, since the 19th century. To do so, we shall consider intellectual property within the context of general transformations in capitalism, focusing on two main historical phases. Firstly, the period covering the formation and development of “corporate capitalism” dominated by large corporations. And then the new phase, which opened up in the 1980s, marked by the rise to power of finance. From a perspective of institutional complementarities, we seek to show how the characteristics and implications of IPR regimes can only be understood in relation to transformations in the main institutional forms of capitalism: forms of the firm, the status of labour (the 'wage-labour nexus'), and market forms.

IP & LICENSING Royalty Rate and Industry Structure: Some Cross-Industry Evidence Stephen Becker and Jiaging Lu Working Paper (http://ssrn.com/abstract=1447997) This paper continues where Kemmerer and Lu (2008) left off, and explores the relationship between royalty rates and market structure among industries. Economists have studied innovation, R&D, and market structure for decades, and also have investigated patent licensing methods across industries. However, there is very little research on the relationships between market structure and royalty rates. In this paper, we first show that royalty rates are

positively associated with price markup, a market power and market performance measure, and then move to explore the relationship between royalty rates and market structure. Two complementary sets of market structure factors are discussed. The first one is technology intensiveness or technology opportunity, on which we demonstrate that technology intensive sectors tend to have higher royalty rates than other sectors. The second set covers the traditional measures of barriers of entry. Regression analysis reveal that royalty rates exhibit a negative linear relationship with two measures of barriers to entry, the ratio of sales to capital invested and the ratio of sales to operating costs. Finally, cluster analysis is conducted to reveal group pattern among the industries studied, using royalty rate, markup, and the ratio of sales to capital invested as variables. The analysis yields four distinguishable groups of industries, and the characteristics of each group are discussed. Cluster analysis also corroborates our conclusion that while both traditional barriers of entry and technology intensiveness contribute to determining market power, one set of factors can exert more dominant and pronounced impact than the other one in a specific industry, as evidenced by media and internet/software sectors, in which market power is mainly created by their technology and know-how embedded in legally-protected IP. Jostling for Advantage: Licensing and Entry into Patent Portfolio Races Ralph Siebert and G/ Von Graevenitz Working Paper (http://ssrn.com/abstract=1445304) Complex high technology industries are increasingly affected by patent thickets in which firms’ patents mutually block the use of important technologies. Firms facing patent thickets patent intensively to acquire bargaining chips and use licensing to ensure freedom to operate. Such licensing allows rivals to either avoid or resolve hold-up from blocking patents. R&D incentives depend on whether licensing takes place ex ante or ex post. We model the choice between ex ante licensing and entry into patent portfolio races leading to ex post licensing. It is shown that higher degrees of blocking lead firms to license ex post while stronger product market competition leads firms to license

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ex ante. Empirical results support these theoretical predictions. The Individual Inventor Motif in the Age of the Patent Troll Christopher Anthony Cotropia Working Paper (http://ssrn.com/abstract=1434921) The individual inventor motif has been part of American patent law since its inception. The question is whether the recent patent troll hunt has damaged the individual inventor's image and, in turn, caused Congress, the United States Patent and Trademark Office (USPTO), and the courts to not be as concerned with patent law's impact on the small inventor. This Article explores whether there has been an attitude change by looking at various sources such as congressional statements and testimony in discussions of the recent proposed patent reform legislation, the USPTO's response to comments on two recently proposed sets of patent rules, and recent Supreme Court patent decisions. These sources indicate that the rhetoric of the motif has remained unchanged, but its substantive impact is essentially nil. This investigation also provides a broader insight into the various governmental institutions' roles in patent law. Dethroning Lear? Incentives to Innovate After MedImmune Rochelle Dreyfuss and Lawrence Pope Berkley Technology Law Journal, Vol. 24, 2009. (http://ssrn.com/abstract=1439884) The Supreme Court’s 2007 decision in MedImmune v. Genentech reversed prior case law and allowed a licensee in good standing to challenge the validity of the licensed patent. In some ways, the decision was unsurprising. It made patent law more consistent with general rules on justiciability and with the Court’s recent concerns about the strength and prevalence of patents. Still, the decision is, in significant ways, astonishing. By apparently shifting all of the risk of invalidation to patentees and putting them into inferior bargaining positions relative to licensees, it arguably undermines patent value, reduces incentives to invest, and endangers the public interest in scientific progress. It is especially detrimental to patent holders in emerging sectors, where

licensing income is key to funding research and technology transfer operations. Yet, there is virtually nothing in the opinion that rationalizes the result in terms of innovation policy. This article suggests that this dire view of MedImmune is wrong: that the decision leaves patentees free to share the risks of invalidation with their licensees, so long as they do so expressly, thereby giving potential licensees strong incentives to vet validity at the start of a relationship - and early in the life of the patent. After setting out the arguments for reading MedImmune as promoting private ordering, the article discusses five general approaches to contracting in its light. It concludes with a look at the limits of party autonomy, suggesting that MedImmune also casts doubt on a line of cases upholding agreements between branded pharmaceutical companies and generic manufacturers that eliminate competition in the name of reducing litigation costs.

IP & INNOVATION Demythologizing PHOSITA Matthew Herder Working Paper (http://ssrn.com/abstract=1448087) The Supreme Court of Canada recently took occasion in the context of a pharmaceutical “selection patent” case, Apotex. v. Sanofi-Synhtelabo, to revise the doctrine of non-obviousness. Although cognizant of changes made to the same doctrine in the United States and United Kingdom, a critical flaw in how the doctrine is being applied that appears peculiar to the Canadian context escaped the Supreme Court’s attention. Using content analysis methodology, this paper shows that lower Canadian courts frequently fail to adequately characterize the “person having ordinary skill in the art” (PHOSITA) for the purpose of the obviousness inquiry. The paper argues, moreover, that this surprisingly common analytical mistake betrays a deep misunderstanding of innovation, one which assumes that actors consult patents to learn about scientific developments, misconceives the boundary between proprietary

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knowledge and non-proprietary knowledge as static instead of dynamic, and ignores the industry-specific nature of innovation. The paper also offers a historical account of the evolution of the non-obviousness test, identifies several factors that undermine PHOSITA’s characterization, and develops a multi-layered prescription to remedy the problem. In sum, unless the judiciary begins to demythologize PHOSITA by making findings of fact in each case where obviousness is at issue, the current chasm between patent law doctrine and the goal of facilitating innovation will only widen. Is the Use of Patents Promoting the Creation of New Types of Securities? Stefania Fusco Santa Clara Computer and High Technology Law Journal, Vol. 25, No. 2, 2009 (http://ssrn.com/abstract=1446806) Has there been a change in the level of innovation of financial methods subsequent to the State Street decision that allowed the award of patents to protect such methods? Ten years following the issuance of State Street, the patentability of business methods is still so controversial that the Federal Circuit has recently considered overruling its own precedent by rehearing In re Bilski en banc. The goal of the patent system is to promote innovation. If an increase in the level of innovation of financial methods is not present, the adoption of this form of intellectual property to protect creativity in the industry is unjustified and, potentially, even harmful. Indeed, it is important to ascertain the correct balance between encouraging innovation on the one hand, and leaving enough “raw material” upon which individuals can build new ideas on the other. A first step in accomplishing this objective is to understand whether the patent system is “doing its job” or, in other words, whether the provided protection is actually inducing innovation in a specific industry. In this article, the author presents an empirical study of innovative types of securities that have emerged over the past 25 years. The author also investigates the patent practice of the financial industry and identifies the patent applications submitted and the patents issued on different types of securities. Finally, the author discusses her findings and concludes that, recently,

creators of new types of securities have shown less interest in the patent system. Nevertheless, the rate of innovation in this field has remained constant. At this time, the available data are not sufficient to reach an entirely conclusive determination with respect to whether the patent system has affected the design of new types of securities. However, the results are still of great significance and cast doubts on the soundness of the State Street decision, at least to the extent that it involves the financial industry. By deciding In re Bilski, the Federal Circuit now has the opportunity to readdress the issue of the patentability of this subject matter in a way that more closely reflects the goal of the patent system as it is described in the Constitution. Did Trips Spur Innovation? An Empirical Analysis of Patent Duration and Incentives to Innovate David Abrams Working Paper (http://ssrn.com/abstract=1443412) How to structure IP laws in order to maximize social welfare by striking the right balance between incentives to innovate and access to innovation is an empirical question. It is a challenging one to answer, both because innovation is difficult to value and changes in IP protection are rare. The 1995 TRIPS agreement provides a unique opportunity to learn about this question for two reasons. First, the adoption of the agreement was uncertain until shortly before adoption, making it a plausibly exogenous change to patent duration. Second, the nature of the law change meant that the patent duration change was heterogeneous across patent classes. Using both patent counts and citation-weighted counts, I am able to take advantage of the TRIPS-induced law change to empirically estimate the impact of patent duration on innovation. I find evidence for an increase in innovation due to patent term extension following TRIPS. Both patent counts and citation-weighted counts increased more following TRIPS in those classes that received greater expected term extensions relative to classes receiving shorter extensions. While the precise calibration of innovation valuation is difficult, this paper provides the first attempt to empirically estimate its response to a major

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change to patent duration, from the TRIPS agreement. Patent Policy, Patent Pools, and the Accumulation of Claims in Sequential Innovation Gaston Llanes and Stefano Trento Working Paper (http://ssrn.com/abstract=1439752) We present a dynamic model where the accumulation of patents generates an increasing number of claims on sequential innovation. We study the equilibrium innovation activity under three regimes: patents, no-patents and patent pools. Patent pools increase the probability of innovation with respect to patents, but we also find that: (1) their outcome can be replicated by a licensing scheme in which innovators sell complete patent rights, and (2) they are dynamically unstable. We find that none of the above regimes can reach the first or second best. Finally, we consider patents of finite duration and determine the optimal patent length.

IP & COPYRIGHT ISP Indirect Copyright Liability Regime: An Economic Efficient Liability Regime for Online Copyright Protection Shaped by Internet Technology Weixiao Wei 23rd BILETA Annual Conference, March 2008 (http://ssrn.com/abstract=1398323) ISPs’ indirect copyright liability permits regulation where traditional legislation fails to meet requirements of copyright protection in a new digital environment, and makes a third party possibly to prevent or decrease the risk of copyright infringement at low cost. However, though it has been hailed as a forceful tool for governing ISPs’ liability for fierce copyright infringement committed by their users over the Internet in most of the jurisdictions, the strength of this liability regime is still being challenged. Some argued that imposing indirect liability on the

ISPs may lead to ISPs’ over-zealous censorship and thereby decrease or limit free access to copyright materials. Meanwhile, the ISPs also argued that it is unfair for them to bear the full social costs generated by their users’ unlawful activities, merely because they are providing facilities and services. So far, dozens of studies have been produced to criticise those arguments and justify ISPs’ indirect copyright liability from legal point of view; however, less attention has been paid to the economic implication of ISPs’ indirect copyright liability and the significance it achieves at the confluence of law and economics. Utilizing an evaluation criterion: economic efficiency-Hicks-Kaldor criterion and a simple economic model: cost-benefit analysis, both are drawn from the theory of economics, this paper examines economic strength of indirect liability regime in the context of ISPs’ liability for online copyright infringement. It employs a string of relevant cases against those who allegedly facilitate copyright infringements to compare the costs and benefits of ISPs’ indirect copyright liability and also three applications of it including vicarious liability, contributory liability and inducement liability. The paper finally concludes that only ISPs’ indirect copyright liability regime shaped by the technology through the development of the Internet is the most efficient liability regime to tackle extensive online copyright infringements and bring long term social welfare to the society. The Ethical Visions of Copyright Law James Grimmelmann 77 Fordham Law Review 2005 (2009) (http://ssrn.com/abstract=1388844) This symposium essay explores the imagined ethics of copyright: the ethical stories that people tell to justify, make sense of, and challenge copyright law. Such ethical visions are everywhere in intellectual property discourse, and legal scholarship ought to pay more attention to them. The essay focuses on a deontic vision of reciprocity in the author-audience relationship, a set of linked claims that authors and audiences ought to respect each other and express this respect through voluntary transactions. Versions of this default ethical vision animate groups as seemingly antagonistic as the music industry, file sharers, free software

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advocates, and Creative Commons. "Respect copyrights," "Don't sue your customers," "Software should be free," and "I love to share" are all ethical claims about copyright that share some common intuitions, even as they draw very different conclusions. The essay provides a framework for thinking about these ethical visions of intellectual property and then puts these various visions into conversation with each other. A Tale of (at Least) Two Authors: Focusing Copyright Law on Process Over Product Laura Heymann Journal of Corporation Law, Forthcoming (http://ssrn.com/abstract=1442074) U.S. copyright law accords its bundle of rights to the author of the work. But despite the centrality of this figure in the Copyright Act, the statute doesn’t define the term, and commentators have yet to agree on precisely what characteristics this creature should have. As history and scholarship show, an author can take on many different personas, she can be individual or corporate; she can be someone who creates deliberately or accidentally; and she can work separately or in collaboration with others. Far more attention has been paid to this individual’s creative output: works of authorship. Works of authorship are the creations to which rights attach, and so discovering the substance and boundaries of such works is often the first step in any copyright analysis. As a result, in U.S. copyright law, the author is defined more by what she creates, a copyrightable work, than by why she creates. This result seems odd, because U.S. copyright law is typically explained as affording authors economic incentives to create so that the public benefits from the development of new works. An author will be reluctant to create and commercialize her work if a second-comer can simply copy that work and sell it so as to recoup her cost of copying, far more cheaply than the author herself, who must also recoup the cost of production. This explanation assumes, however, that authors create in response to economic incentives. While this may be true for some authors and for some forms of expression, it is unquestionably not true for others. Copyright law itself, however,

remains fairly agnostic in this debate. Despite the varying interests and incentives that motivate authors to create, copyright law gives all authors exactly the same bundle of rights. Although the term of those rights differs depending on whether the author is corporate or individual, and although an employer can acquire rights in a work without having actually created the work (through the work-for-hire doctrine), both the individual and the corporate author hold the same rights to prevent certain unauthorized uses of the work. Copyright law makes no attempt to match the rights it grants to the needs of the party to whom it grants those rights, resulting in too much protection in some instances and not enough in others. It seems particularly unbalanced to engage in a multifactor, nuanced analysis of the defendant’s use and then to compare it to a monolithic right on the plaintiff’s side of the equation. Copyright law might, therefore, better accomplish its goals if it took better account of the activities and interests of authors rather than focusing on the products of their creativity. Different types of authors engage in different modes of creation and therefore have different interests in controlling the results of their work. The goal of this Article is to consider whether copyright law would be improved by recognizing this perspective. Copyright Law as Mediational Means: Report on a Mixed Methods Study of U.S. Professional Writers Martine Courant Rife Working Paper (http://ssrn.com/abstract=1434247) This article reports on an empirical study conducted among US professional writers composing in digital writing environments. The study explored US copyright law’s mediational influence on digital composing using a sequential transformative mixed methods research design. A digital survey (N=334) was administered to a randomly selected population of students and teachers in US technical and professional writing programs and interviews were conducted with select writers as well. The study examined three main areas of inquiry: 1) the status of knowledge and understanding of copyright law in the field of technical and professional writing; 2) the creative thinking processes, or rhetorical invention, of writers

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in these programs composing webtexts in light of copyright law; and 3) what happens to mediational means as writers leverage them in digital contexts. In this article the study’s six major findings and seven granular findings as well as implications are briefly summarized and discussed. The study hopes to provide a baseline that might be used for further research in cross-cultural or international contexts. Copyright Law of the European Union Arun Krishnan Working Paper (http://ssrn.com/abstract=1442484) Neither the Current EC Directives nor TRIPS make significant legal adjustments to cater for digitised information systems serving world networks, for information superhighways are too novel and shifting a phenomenon. The implications for Copyright, as the most likely tool for shoring up their economic value, are of course, under urgent scrutiny. Whatever else, the provision of on-line services for education, information, entertainment, business and Government promises very considerable realignments in what may be loosely labeled the information industry. In conditions of such insecurity, it seems highly important at least to ensure, if possible, that creators and other providers can secure returns on the users of their material which correspond to the sale of copies and the showing of material in cinemas and on television in the world to date. There are considerable hopes and considerable dangers in a digitised world. Authors, and the creative works that they develop, will ultimately determine whether new digital networks and the global information society succeed or fail. People simply will not take part in the new digital networks if the content available is not sufficiently interesting, creative or useful. Maintaining strong copyright protections for authors of every kind of creative work is necessary to ensure that these authors have adequate, market-driven incentives and rewards to create such content and to make it available to the public in these new ways. The Berne Protocol offers thoughtful and sensitive solutions to the challenges presented by the global Information society - particularly as to the issues of computer programs, temporary copying and use,

distribution, digital transmissions and technical protections - while maintaining the maximum opportunity for the quality and quantity of content to grow in the new, digital environment. A successful negotiation of the Protocol will indeed help to make new laws in the digital copyright era. Inadvertent File Sharing Over Peer-to-Peer Networks: How it Endangers Citizens and Jeopardizes National Security, Testimony Before the U.S. House Committee on Oversight and Government Reform Thomas Sydnor The Progress & Freedom Foundation U.S. Congressional Testimony, 2009 (http://ssrn.com/abstract=1443289) Certain distributors of popular file-sharing programs have repeatedly failed to prevent, and may have knowingly caused and perpetuated, inadvertent file-sharing, Inadvertent sharing cannot be remediated by self-regulation by distributors of file-sharing programs because certain distributors have repeatedly violated every set of self-regulations proposed - including a Code of Conduct and a set of Volutary Best Practices that they drafted. Three critical defects are present in every released version of the LimeWire 5 file-sharing program: (1) every version is dangerously unpredictable and can share all of a user's personal document, image, video, and audio files just by being installed, (2) every version violates critical provisions of the LimeWire's own Voluntary Best Practices, (3) every version contains a feature that LimeWire itself knew to be a needlessly dangerous of means of ensuring that one reasonable mistake by a child could inadvertently share thousands of a family's most sensitive personal files. In short, the problem of inadvertent sharing has persisted for nine years because distributors of file-sharing programs like LimeWire LLC have repeatedly responded to even the most serious and well-documented concerns about inadvertent sharing with half-measures, misrepresentations, whitewash, and other conduct that, considered in its entirety, could strongly suggest bad faith - an intent to cause and perpetuate inadvertent sharing. Consequently, the widespread, well-documented breaches of national, military,

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corporate, and family security caused by inadvertent sharing may be nothing more - or less - than the acceptable 'collateral damage' of schemes intended to trick users into sharing popular music and movies. Congress should pursue a two-pronged remedial strategy. First, this issue should be formally referred to law-enforcement agencies possessing relevant civil and criminal enforcement authority. And Congress should support efforts to amend H.R. 1319, The Informed P2P User Act, in order to grant the Federal Trade Commission additional targeted enforcement powers. Copyright as an Incentive for Musical Creation: An Examination of the Effects of Copyright Law Changes On Registrations, 1978-2006 Katherine Hill Working Paper (http://ssrn.com/abstract=1444452) This paper examines the effect of changes in United States copyright legislation on the quantity of musical copyright registrations between the years 1978-2006. The legislative amendments examined herein are: (1) the Bern Convention Implementation Act of 1988, (2) the Uruguay Round Agreements Act of 1994, (3) the Sonny Bono Copyright Term Extension Act of 1998, (4) the Digital Millennium Copyright Act also of 1998, and (5) the Family Entertainment and Copyright Act of 2005. The author manipulated Library of Congress data in order to carry out said analysis, since no prior data set of musical copyright registrations had been previously compiled. Although federal copyright legislation regulates all cultural industries, the properties of musical compositions are sharply distinct from those of the literary works upon which copyright legislation was crafted. Additionally, music has undergone a drastic evolution with respect to its primary methods of consumption since the establishment of U.S. copyright legislation in 1790. These facts warrant analysis of the efficacy of copyright legislation specifically as an incentive for musical creation. This paper finds significant evidence that the Sonny Bono and Digital Millennium Acts, and the Family and Entertainment Act all provide statistically significant positive incentive for the creation of musical works. This paper

further establishes that the above amendments exert a greater influence on the magnitude of monthly musical copyright registrations by the Big Four record labels than other musical copyright owners. The Tangled Web of UGC: Making Copyright Sense of User-Generated Content Daniel J. Gervais Vanderbilt Journal of Entertainment and Technology Law, Vol. 11, No. 4, pp. 841-870, 2009 (http://ssrn.com/abstract=1444513) Even as a mere conceptual cloud, the term “user-generated content” is useful to discuss the societal shifts in content creation brought about by the participative Web and perhaps best epitomized by the remix phenomenon. This Essay considers the copyright aspects of UGC. On the one hand, the production of UGC may involve both the right of reproduction and the right of adaptation - the right to prepare derivative works. On the other hand, defenses against claims of infringement of these rights typically rely on (transformative) fair use or the fact that an insubstantial amount (such as a quote) of the preexisting work was used. One might also rely on another type of fair use defense - for example, that the second work was used in news reporting, or, although the case law on this point is still controversial, that the reproduction was fair use because it made the work more accessible. While it is clear that creating original content by reusing preexisting content is nothing new, the focus here is on amateur creation and reuse and the Essay discusses whether the amateur nature of the content constitutes a new normative vector. The Essay suggests that the first step to find adequate answers is a proper taxonomy of UGC. Law and Innovation in Copyright Industries Matthew J. Baker and Brendan Cunningham Review of Economic Research on Copyright Issues, Vol. 6, No. 1, pp. 61-82, 2009 (http://ssrn.com/abstract=1436160)

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The impact of copyright law on innovation is a topic of much debate. We use quarterly data on aggregate copyright applications in both the U.S. and Canada to estimate an empirical model of copyright applications. We measure changes in the breadth of copyright protection by tabulating outcomes of important court cases and new statutes pertaining to copyright protection. We find that the flow of applications exhibits a small but significant positive response to court decisions broadening copyright protection. We also find that applications: 1) respond negatively to increases in registration fees 2) move counter-cyclically 3) have a strong seasonal component and 4) may increase as computing technology becomes more widely available. Copyright Implications of the Convergence of Telecommunication, Broadcasting & Information Technology - Lesson for India Tabrez Ahmad Proceedings of the SPCI 08 International Conference of Cyberlaw, 2008 (http://ssrn.com/abstract=1440644) The paper identifies copyright implications of convergence in India, examining especially how Indian law is approaching convergence of telecommunication, broadcasting and information technology issues. The delicate balance of rights and obligations of intermediaries of Internet such as copyright owners, domain name holders, consumers, netizens and internet service providers can be upset when trying to keep the legal developments abreast with the technological advances. As more and more digital products in network environment are emerging efficient management and controlled distribution of such products have become one of the important considerations, in an unprecedented way. The copyright owners are under a constant threat of loosing control over their products on the information superhighway and are experimenting various technological adjuncts to retain control. Differences in rules are beginning to be questioned. Now legal regulation is a great challenge before the world because the way legal and regulatory reforms are carried out will eventually determine the manner in which convergence

affects our lives. The converging technologies raise several core issues such as telecom sector is concerned with infrastructure regulation and access issues; broadcasting industry is more worried with access and content issues; information technology is trying to deal with contribute with new regulatory issues of framing, hyper linking, deep-linking, inlining, fixation, communication, publication, parallel imports, rights management information, allocation of frequency spectrum, fair dealing, implied license, liability of Internet Service Providers (ISP), and jurisdiction etc. This paper in particular questions the regulatory framework for the telecommunications, broadcasting and information technology sectors in a convergence environment, and taking in to account relevance and need to safeguard the public interest. The Google Book Settlement and the Fair Use Counterfactual Matthew Sag Working Paper (http://ssrn.com/abstract=1437812) This Article compares the Google Book Search Settlement to the most likely outcome of the litigation the settlement resolves. It argues that Google was never likely to receive the courts unqualified approval for its massive digitization effort and that the most likely outcome of the litigation was that book digitization would qualify as a fair use subject to an opt-out. Accordingly, the aspects of the proposed settlement which allow Google to continue to operate its book search engine in its current form should not be controversial; they essentially mirror the court’s most likely fair use ruling if the case had gone to trial. In effect, the opt-out that fair use would likely have required has been replaced by the ability of copyright owners to opt out of the class-action settlement. In the wake of the proposed Settlement, the Google Book debate has shifted away from the merits of book digitization, and refocused on questions of commoditization and control. This Article highlights four critical areas in which the Settlement differs sharply from the predicted fair use ruling. First, the Settlement permits Google to engage in a significant range of uses including the complete electronic distribution of books that go well

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beyond fair use. Second, the Settlement provides for initial cash payments by Google to the copyright owners and a fairly generous revenue sharing agreement, neither of which would have been required under a fair use ruling. Third, the agreement creates a new set of institutional arrangements that will govern the relationship between Google and the copyright owners covered by the Settlement. The foundations of this new institutional framework are the Settlement agreement itself, the creation of a collective rights management organization called the “Book Rights Registry” and the “Author Publisher Procedures”. The fourth area in which the Settlement differs from the likely fair use outcome relates to the accessibility, commoditization and control of orphan works. Costly Screens, Value Asymmetries, and the Creation of Intellectual Property Jonathan S. Masur and David Fagundes Working Paper (http://ssrn.com/abstract=1441987) Copyrights arise the moment an author fixes a work in a tangible medium of expression, costlessly and immediately. Patents, by contrast, arise only after an applicant successfully navigates a cumbersome examination process. Numerous writers have critiqued the resulting proliferation of copyrights as excessive, in some cases arguing for more formalities in order to restrict the ease of copyright vesting. The patent examination process has drawn criticism as costly and ineffective — in contrast to copyright, too laden with formalities. In this paper, we focus on process costs (or lack thereof) to show that these very different means for acquiring intellectual property rights may be more optimal than is generally believed. The high costs of navigating the examination process deter would-be patentees who expect their property rights to generate only low private value. Moreover, due to an important asymmetry among the social and private value of patents, the costly screen is likely to select against socially harmful patents in disproportionately high numbers. The examination system thus eliminates patents that create low social value while creating no risk of eliminating patents that generate high social value. Copyright is characterized by

just the opposite asymmetries. Because there are numerous works that generate high social value but low private value, the impact of costly screens would be to preclude the production of many of the publicly beneficial works that copyright is designed to create. In addition to providing a positivist explanation for why the patent and copyright systems differ, this application of costly screen theory also points in the direction of what we call a unified theory of IP process. This theory illuminates the essential connection between the statutory construction of exclusive rights in information and the particular processes by which those rights vest. Should Different Information Economies Have the Same Duration of Copyright? Michael Yuan Review of Economic Research on Copyright Issues, Vol. 6, No. 1, pp. 61-82, 2009 (http://ssrn.com/abstract=1436157) Copyright has been increasingly internationalized and, recently, more and more harmonized. However, there has been little theoretical study of international copyright. This paper develops and analyzes a non-cooperative two-country model of copyright, where two countries trade in information goods and each with an open and competitive information goods industry sets copyright policy to pursue self-national interest. The model suggests that an increase in demand for information goods in a country calls for longer copyright protection in this country and shorter protection in its trading partner; decreases in fixed or per-product creative costs in a country with lower such costs call for marginally shorter protection; and an improvement in the economies of creative scale in a country with better economies of creative scale calls for marginally longer protection. Understanding these rational responses of nations to changes in creative technologies and markets should be helpful for international copyright-policy making.

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IP & DEVELOPMENT Innovation and Technology Transfer to Address Climate Change: Lessons from the Global Debate on Intellectual Property and Public Health Frederick Abbott ICTSD Programme on IPRs and Sustainable Development, Issue Paper No. 24, 2009 (http://ssrn.com/abstract=1433579) This paper examines issues surrounding the development and transfer of technologies for addressing the problem of climate change based on the experience of developing countries in addressing problems of innovation and access in the field of medicines. It looks at alternative energy resources (AERs) and climate change mitigation technologies (MTs), at the forms of intellectual property rights (IPRs) used to promote and protect innovation, and at the ways these IPRs may have different effects and implications for AERs/MTs as compared with pharmaceutical technologies. It is generally assumed that the originator pharmaceutical sector is highly dependent on strong patent protection, mainly because of the high cost involved in developing novel drug therapies and the low cost of reverse engineering these new drugs. Preliminary research suggests that most AERs/MTs industries may be less dependent on strong patent protection, and/or that patents are less likely to cause signifi cant bottlenecks in the development and transfer of AERs/MTs. While it is premature to come to a defi nitive conclusion because researchers are only now focusing on the evidence, there is some basis for anticipating that IPRs will present fewer risks for developing countries in the context of climate change than for public health. Developing country negotiators understood that the GATT Uruguay Round negotiations on trade related aspects of intellectual property rights would affect access to medicines. The resulting WTO TRIPS Agreement did, in fact, present serious risks

to public health. These risks were addressed through negotiation of the Doha Declaration on the TRIPS Agreement and Public Health, the Article 31bis amendment and the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property. The “Doha Declaration process” broadly speaking has resulted in some positive movement. Climate Change, Technology Transfer and Intellectual Property Rights Krishna Ravi Srinivas Working Paper (http://ssrn.com/abstract=1440742) Technology development and transfer has been identified as a key element in the Bali Action Plan. In the negotiations on a global climate treaty the developing nations have put forth ideas and plans to ensure that intellectual property rights (IPRs) do not become a barrier to transfer of climate friendly technology. In this discussion paper, this question of technology transfer, intellectual property rights is addressed in the context of climate change. Patent statistics shows the dominance of developed countries in specific technologies. The analysis on specific technologies indicates that IPRs is an important issue in development and transfer of technology and it is a barrier. Data indicates that although developing countries have made some progress, the dominance of developed countries in terms of patents, royalty and licensing income and expenditure on Research and Development remains as before. The historical experience is that stronger IPRs do not always result in more technology transfer and technology absorption. Hence the argument that developing countries should provide stronger protection of IPRs to encourage technology transfer has to be challenged. The technology transfer under UNFCCC and Kyoto Protocol has been minimal and insufficient to meet the needs of developing countries. The harmonization of IPRs through TRIPS has limited the options of countries to use compulsory licensing and competition policy. TRIPS has not facilitated technology transfer, particularly to Least Developed Countries (LDCs) and the North-South divide on this issue has resulted in a stalemate. Under these circumstances it is

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futile to expect that TRIPS alone will result in more transfer of climate-friendly technologies. Using Common But Differentiated Responsibility principle in technology development and transfer is desirable. Many proposals and suggestions have been made to stimulate technology development and transfer. Montreal Protocol is a successful example that is relevant in the context of climate change. The proposals including the proposals made by developing countries deserve a serious consideration and innovative solutions have to be found. Humanity does not have the luxury of finding solutions over a century to solve problems created by global climate change. Developing countries need both development and access to technologies that will facilitate the transition to less carbon intensive economy within the next two or three decades. So it is essential that IP issues do not become a barrier in this transition. The challenge of climate change calls for out of the box thinking to find solutions that can make a difference. The IPR issues in technology transfer need to be tackled by a combination of policy measures, incentives and bringing in changes at the global IP regime under TRIPS. Making WTO Reform Work for Developing Countries: Improving How the WTO’s Functions are Governed Carolyn L Deere REDESIGNING THE WORLD TRADE ORGANIZATION FOR THE TWENTY-FIRST CENTURY, D. Steger, ed., Wilfred Laurier University Press, 2009 (http://ssrn.com/abstract=1436593) The debate on the institutional reform and governance of the WTO has now been underway for over fifteen years. In the context of a Doha Round of multilateral trade negotiations stumbling forward in fits and starts, the most prominent focus of discussions of WTO reform has been options for improving the process of the WTO negotiation process. Throughout the past ten years, however, there have also been a number of broader debates about the governance of the multilateral trading system and calls for institutional reform at the WTO. Most recently, the onset of global financial

crisis in 2008 reignited more wide-ranging interest in the role of the WTO in global economic management, prompting calls for the WTO to do more to sustain a global open trading system, and in particular to take greater leadership on issues of trade finance, aid for trade, and surveillance of protectionist measures. Amidst a growing body of scholarly literature and policy commentary on the governance and institutional reform of the WTO, this chapter proposes a distinctive approach. The Regulation of Creativity Under the WIPO Internet Treaties Ruth Okediji Working Paper (http://ssrn.com/abstract=1433848) The WIPO Copyright Treaty and the WIPO Performances and Phonograms Treaty (WIPO Internet Treaties) recite a need for a digital copyright framework to facilitate 'adequate solutions to questions raised by new economic, social, cultural and technological developments.' It can hardly be contested that the social and cultural developments to which the Treaties refer do not derive from the cultural or economic conditions (much less technological developments) of the developing and least-developed countries. Consistent with their predecessors, the WIPO Internet Treaties marginalize collaborative forms of creative engagement with which citizens in the global South have long identified and continue in the tradition of assuming that copyright’s most enduring cannons are culturally neutral. Recently, however, the rise of Web 2.0 and the salience of new forms of creativity mediated by digital technologies and social networking sites have exposed structural tensions in copyright laws of OECD countries similar to those which developing countries have historically raised in opposition to the Berne Convention. This Essay reviews the evolution of the WIPO Internet Treaties and argues that the framework established just over a decade ago is increasingly less relevant in addressing the challenges of creativity in the digital age. The Treaties do not provide a meaningful basis for a harmonized approach to encourage new creative forms in much the same way the Berne Convention fell short of embracing diversity in patterns and modes of authorial expression. The growing social

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and legal recognition of new forms of creativity enabled through digital technologies offers an important opportunity to challenge anew claims that globally mandated copyright norms can effect incentives to create that are relevant across geographical, cultural and technological boundaries. TRIPS and Essential Medicines: Must One Size Fit All? Making the WTO Responsive to the Global Health Crisis Rochelle Dreyfuss INCENTIVES FOR GLOBAL HEALTH: PATENT LAW AND ACCESS TO ESSENTIAL MEDICINES, Thomas Pogge, Matthew Rimmer, Kim Rubenstein, eds. Cambridge University Press, 2010 (http://ssrn.com/abstract=1443248) This paper was written as the introductory chapter to Incentives for Global Health: Patent Law and Access to Essential Medicines, edited by Thomas Pogge, Matthew Rimmer, and Kim Rubenstein (Cambridge University Press). It challenges the critique of the TRIPS Agreement as a one-size-fits-all regime. To be sure, there are WTO members who prefer to think of the Agreement that way. However, the paper demonstrates how the flexibilities built into the TRIPS Agreement allow a state to fashion local law to deal with its population’s health needs. TRIPS accommodations are not perfect: the second part of the paper considers the roles that other international organizations, such as WHO, and other international obligations, such as human rights agreements, can be used to influence the development and interpretation of international intellectual property law. Consensus-Seeking, Distrust, and Rhetorical Entrapment: The WTO Decision on Access to Medicines Jean-Frédéric Morin and E. Richard Gold Working Paper (http://ssrn.com/abstract=1435747) While the WTO secretariat, key delegations, several NGOs, and industry publicly present the August 30th 2003 WTO decision as an

attempt to reconcile intellectual property with access to medicines, our research shows otherwise. We draw on qualitative analyses of 54 interviews and a lexicometric analysis of press releases to show that their enthusiastic public statements contrast deeply with their internal, cynical beliefs. Most of these actors not only consider the WTO decision to be fundamentally flawed but claim to have known this prior to its adoption. We argue that a procedural norm of consensus-seeking impeded traditional bargaining over this sensitive issue and that distrust among participants hindered truth-seeking deliberation. Caught between strategic and communicative actions, state and non-state actors found themselves trapped in their own rhetoric of reconciling intellectual property with access to medicines. They realized that the appearance of a solution, rather than a functional solution, provided the only realistic solution to a fruitless and publicly damaging continuation of debate. From a theoretical perspective, this case study sheds a new light on the gray zone between rational choice and constructivism, where both discourse and strategies matter. From an empirical perspective, it illustrates the risk of seeking consensus within international regimes when the procedural norm of consensus coexists with a high level of distrust.

IP & BIOTECHNOLOGY Patent Amendment Act 2005: Its Effect on Indian Pharmaceutical Company Prantik Garai Working Paper (http://ssrn.com/abstract=1435186) India has a history of the patent acts starting form 1911. All happened was pre independence. The Patent Act, 1970 was the first patent act to the independent India. It had provision for only process patent but did not have any provision for product patent. Therefore the process could have been patented but not the end product which gave rise to the concept of reverse mechanism. Absence of product patent helped the Indian pharmaceutical industries to use this at

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their advantage and find out a drug of same specification by a different method. This helped the Indian Pharmaceutical industries to flourish. After India signed the TRIPS it was obliged to amend the patent act and introduce the product patent. The researcher in the article discusses how the signing of the TRIPS was detrimental to the interest of the Indian Pharmaceutical Industries and its effect on the Indian Economy. The researcher in his paper would also deal in details the amendment of the patent act and its pros and corns. University Patent Licensing for the Research and Development of Pharmaceuticals in Developing Countries Gail Evans Intellectual Property Quarterly, No.3, pp. 311-344, 2009 (http://ssrn.com/abstract=1447234) More than 80 per cent of the world's population lives in developing countries where communicable diseases account for 50 per cent of the disease burden. The opening Recital of World Health Organization's Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property affirms the need to construct a sustainable basis for research and development relevant to diseases that disproportionately affect developing countries. The author discusses how universities in developing countries should negotiate for favourable patent licensing agreements which would allow them to research and develop drugs for neglected diseases, to give other researchers access to the patented technologies to develop them further, and to ensure that public health needs for the medicines are met. Patents & the Progress of Personalized Medicine: Biomarkers Research as Lens Matthew Herder Annals of Health Law, Forthcoming (http://ssrn.com/abstract=1435468) Progress toward 'personalized medicine' remains stymied by several factors. Most glaring is the questionable quality of the data expected to drive this new treatment paradigm. Institutions and firms engaged in

'biomarkers' research have systematically failed to validate newly discovered molecular variations, be they genomic, proteomic, metabolomic, or dynamic interactions amongst them all, with clinical outcomes as they amass and unfold over time. This is, in part, attributable to deficiencies in the present regulatory framework. Ambiguous standards for evaluating study design and product risk, as well as seemingly redundant requirements from different regulatory authorities have led some, if not driven others, to escape oversight. However, it also reflects a marked failure of coordination, a failure not only to put into place large-scale collections of biological specimens accompanied by longitudinal patient health information, but a failure to ensure continuous data exchange amongst the researchers, clinicians, healthcare providers, and private firms already attempting to commercialize biomarker-related technologies. The argument advanced in this paper is that intellectual property rights (especially patents), and the set of practices that those rights tend to engender, contribute significantly to the paucity of data sharing that currently pervades biomarkers research. Further, these patent-related issues cannot be easily disentangled from other barriers facing personalized medicine, particularly the deficiencies of the present regulatory framework. And the way in which the discourse around the impact of patent rights upon early stage scientific research has been framed helps account for why this dimension of the problem has received minimal attention to date.