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August 2009 externality and seek to determine the optimal

IP & LAW balance of the direct costs of applying for a

From the Editor patent with the indirect cost caused by
The Intellectual Property regulatory delay. Our proposed theoretical
Literature Watch contains a and empirical framework enable explicit
selection of the most recent Courts and the Patent System measurement of the cost of delay and the
working papers, published Dan Burk and Mark Lemley implications of changing patent application
reports, and books that are Regulation, Vol. 32, No. 2, pp. 18-23, fees. The results have implications for a
variety of policy questions involving optimal
relevant to the understanding Summer 2009 fees, patent quality, and competition policy.
of intellectual property rights ( We include in this submission a basic
(IPR) issues. Innovation and patent law work differently in theoretical model that can be extended to
different industries. To some degree, the examine a number of policy implications,
Alina Marinova, Editor courts’ interpretations of patent and including the relationship between trademark law accommodate those examination time and patent quality. We also
differences. It is not much of an exaggeration describe an empirical approach that enables
to say that the patent system must bend or quantification of the cost of delay. Both the
break: a patent system that is not flexible model and the empirical work enable us to
enough to account for these industry discuss additional policy questions such as
differences is unlikely to survive, let along the importance of application versus renewal
accomplish its stated goals. We believe the fees, the consequence of the self-funding
system has the flexibility to do both, but this constraint on patent offices, and the impact
will require the courts to better recognize and of higher quality patents on rent-seeking
use the policy levers they have been given. activities. Preliminary results show that the
patent office revenue maximizing fee
Congestion Pricing for Patent exceeds the optimal fee for patent holders,
Applications but that the optimal fee for patent holders is
Alan Marco and James Prieger positive.
Working Paper
Patents as Administrative Acts:
In this paper we study the main factors
Patent Decisions for Administrative
determining the optimal level of intellectual Review
property (IP) protection. We are especially Chris Dent
interested in how optimal protection should Sydney Law Review, Vol. 30, No. 4,
change as the size of the economy grows. 2008
There is a large literature that explores the
qualitative aspects of optimal IP policy, (
and a significant empirical literature that Currently, challenges to decisions in the
attempts to measure such things as the Australian patent system may be heard in
Contact LECG either the Patent Office, if the challenge
For more information on the value of In recent years a great deal of
attention has been paid to patent reform. comes before the grant of the patent, or in
issues discussed in this the Federal Court, if a granted patent is
This debate is exemplified by recent popular
newsletter, please contact: publications (Jaffe and Lerner, 2004; Bessen challenged. This is the case despite the
and Meurer, 2008), as well as publicized grant decision being an administrative
Anne Layne-Farrar patent litigation such as the NTP v. decision. This Paper considers the decisions
Chicago Research-in-Motion patent litigation (the made as part of the patent system - including Blackberry patents). At the same time, the decision by a patent examiner to grant a
scholars point to the over-burdened patent patent and the adjudicatory decisions of
offices, the growth in patent applications, opposition and revocation - and explores the
and the proliferation of low-quality or potential for the challenges to the grant
overlapping patents. In this paper, we take a decision to be subject to administrative
novel approach to dealing with the flood of review. In particular, the Paper raises the
applications at the patenting authorities in possibility of examiners’ decisions being
the US and Europe and the resulting delay subject to merits review in the Administrative
and issuance of low quality patents. We Appeals Tribunal and judicial review before
explore the magnitude of the congestion the Federal Court.

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A Stone's Throw Away from a The Court of Appeals for the Federal Circuit
European Patent Court: The is found to defer to the decisions of the lower
court. We also see an increased likelihood of
European Patent Litigation a pro-patent decision by the appeals court
Agreement with an increase in the proportion of
Stefan Luginbuehl republican judges on the bench.
Working Paper
( Rational Competition Policy and
The EPO Working Party on Litigation and its Reverse Payment Settlements in
sub-group have in the past three and a half Hatch-Waxman Patent Litigation
years elaborated a treaty text of an David Opderbeck
agreement for a European Patent Litigation
System. The heart of this system includes a
Working Paper
European Patent Court. The agreement on (
the cornerstones for a Community Patent This paper examines the problem of 'reverse
Court, and on the other points in regard to payment' settlements in patent litigation
the Community patent in the common under the Hatch-Waxman Act. A reverse
political approach of March 3, 2003, payment settlement involves a payment from
questions the further necessity for a a branded pharmaceutical company to a
European Patent Court. The author shows generic manufacturer, usually in return for
why in any case a European Patent Court the generic manufacturer’s agreement to
would be needed. delay market entry. Federal appellate courts,
regulatory agencies and commentators are
divided about the legality of such
An Empirical Analysis of the agreements. This paper argues that the
Adjudication of Patent Cases by the importance of product market definition has
Court of Appeals for the Federal been overlooked in existing treatments of the
Circuit issue. The paper develops an empirically-
based 'Settlement Competition Index' that
Manasseh Zechariah could be used by courts and regulatory
Working Paper agencies to evaluate reverse payment
( settlements. A formula to calculate the
The enforcement of patent rights affects the Settlement Competition Index is provided
scope of the monopoly rights provided by and tested with hypothetical and real-world
them and hence the incentives they provide. examples.
Greater likelihood of a pro-patent decision by
the enforcement mechanism provides a The Levels of Abstraction Problem in
larger scope of monopoly rights. I investigate Patent Law
the likelihood of a pro-patent decision by the
Court of Appeals for the Federal Circuit in Tun-Jen Chiang
patent cases to see how it varies with Working Paper
characteristics of the patent, the litigants and (
the litigation itself. This model corrects for The concept of “invention” is fundamental to
the fact that not all patent cases get patent law. What the patentee creates as the
appealed after trial by incorporating a invention, he receives as his monopoly
selection model for the appeal of cases. I reward. This quid pro quo suggests that
also incorporate the litigants' uncertainty patent scope is self-defining: the patentee
about appealing a case using a receives whatever invention he created, and
heteroscedastic selection model. I estimate nothing else.
the model using simulated maximum The quid pro quo framework breaks down,
likelihood and use the GHK simulation however, because “invention” means
method. Results show that overall the Court different things on the two sides of the
of Appeals for the Federal Circuit is an anti- equation. The invention that the patentee
patent court. However, significant differences creates is an embodiment. The invention that
exist between different classes of patents defines monopoly scope, however, is an
with drug patents being more likely to be idea. Moreover, every patented embodiment
decided pro-patent than software patents. contains many ideas, at different levels of
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abstraction. Courts must choose one idea to Circuit have persisted and the number of
give legal protection, with important Federal Circuit judges who are on record as
consequences. The higher the level of indicating that the standard should be
abstraction chosen, the more scope the revisited has steadily grown.
patentee receives, with attendant incentive Part I of this Article examines whether the
benefits and monopoly costs. Cybor rule of de novo appellate review of
Courts that have treated idea and patent claim construction is consistent with
embodiment as a unitary invention have Supreme Court precedent, focusing primarily
ignored the necessity of this choice, on Seventh Amendment decisions. Part II
effectively exercising their discretion discusses whether or not it is appropriate for
arbitrarily and silently. This Article argues the Federal Circuit to set the boundary
instead for a legal realist approach that between issues of fact and issues of law in
acknowledges discretion in determining patent cases. Finally, Part III addresses the
patent scope, discards the conflicting yet extent to which various proposed standards
absolutist rules governing this area, and of appellate review of claim construction are
determines scope based on balancing principled, with particular emphasis on their
incentives and monopoly costs, with compatibility with the Seventh Amendment.
transparent analysis allowing better
information to be collected and greater Indeterminism and the Property-
predictability in outcomes. Patent Equation
Alan James Devlin
Appellate Review of Patent Claim
Yale Law & Policy Review,
Construction: Should the Federal
Circuit Be its Own Lexicographer In
Matters Related to The Seventh Fierce debate has raged over the relative
Amendment? primacy of liability and property rules in
Eileen Herlihy informing patent jurisprudence. Those who
Michigan Telecommunications and favor the latter path often see prescriptive
Technology Law Review, Vol. 15, parallels in the rules properly brought to bear
on owners of physical and intellectual
p. 469, 2009 property. Others view the intellectual domain
( as sufficiently distinct as to render the law of
This article addresses the need for a tangible property incongruous and
principled standard of appellate review of inapplicable.
patent claim construction, emphasizing the This Article seeks to promote a novel
necessity for such a standard to be perspective on this dialectic, by focusing on
compatible with Seventh Amendment law. the import of a heretofore unappreciated
In Cybor Corp. v. FAS Technologies, Inc., tenet of the analogy between intellectual and
the Federal Circuit resolved internal conflict real property. Those who seek to inform the
regarding the appropriate standard of optimal construction of patent rules through
appellate review by establishing a de novo long-established norms of property law face
standard and overruling its past inconsistent a challenge in the form of the asymmetric
precedent. The appropriateness of this de legal certainty that characterizes these
novo standard of appellate review has respective property rights. More specifically,
generated extensive debate and the validity of ownership rights in patented
disagreement within the judiciary, the patent technology is heavily stochastic, whereas
bar and academia. It has been over ten rights in physical property are largely
years since a majority of the Federal Circuit definite. The issue of certainty implicates
endorsed this standard of review, taking the both the epistemological and consequential
position that it was in line with the Supreme qualities of ownership, and should inform the
Court's seminal Seventh Amendment optimal construction of property rights
Markman case, which holds that judges, accordingly. This holds especially true with
rather than juries, should construe patent intellectual property, where exclusivity
claims. Over the years since the Federal comes at the cost of the Lockean 'enough
Circuit endorsed the de novo standard of and as good' condition, given the public good
review, the dissenting voices on the Federal benefits foregone by private ownership.
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This insight begs two major conclusions. apparatus or involve a transformation to a
First, there may be good normative ground different state or thing, ultimately rejecting
for tempering the exclusive rights properly the patent application as unpatentable
associated with highly probabilistic property subject matter. The patent applicants have
rights. Second, in an environment of free asked the U.S. Supreme Court to determine
contract, one should be concerned that a two issues: first, the meaning of “process” in
patentee may be able to transform the 35 U.S.C. § 101 and whether the lower court
aoristic right granted it by Congress into a properly relied on a “machine-or-
certain one, thus deriving a greater transformation” test, and second, the test’s
pecuniary return than was inherent in the potential conflict with 35 U.S.C. § 273, which
'patent bargain.' The legitimacy and scope of provides protection for “method[s] of doing or
the power to exclude lies at the heart of this conducting business.” The Court’s decision
transformative process, creating a spectrum could change the way that research and
that charts a direct association between business are done, and patent protection for
patent certainty and freedom of contract. such investments. Parts 1 and 2 of this
Indeterminism thus bears significant article address Bilski directly and what is and
repercussions for the property-patent is not in dispute. Part 3 addresses the
equation. This Article charts the positive “machine-or-transformation” test, while Parts
source of the divergence in determinism 4 and 5 address reasons not to adopt such a
between intellectual and tangible property, test.
and explores the normative repercussions of
that departure for the formulation of both Why Weak Patents? Rational
substantive patent law and ideal restraints
on freedom of contract. Interestingly, the Ignorance or Pro-'Customer' Tilt?
capricious nature of intellectual property Zhen Lei and Brian Wright
need not strip the property-patent equation Working Paper
of all legitimacy. Nevertheless, the (
temptation to borrow wholesale from the law The United States Patent and Trademark
governing real property must be met with Office (USPTO) grants many weak patents
sensitivity for the distinctions between the that would be ruled invalid if subjected to
property characteristics at issue. The Article more thorough scrutiny. Some observers see
concludes by suggesting that improvements weak patents as evidence of the need for
in the prosecution and re-examination allocation of more resources to increase the
processes would greatly strengthen the accuracy of patent examinations. Others
property-patent equation. Until that time, argue that the costs of such reform would
though, qualified limitations on the right to outweigh the benefits; weak patents reveal
exclude, and rights derived therefrom, may the “rational ignorance” of the Patent Office;
be normatively justified. it is optimal to leave examiners unequipped
to identify more weak applications, deferring
The 'Process' of Patenting: Why the large costs of more definitive
Should We Care About a Potential determination of validity until patents are
U.S. Supreme Court Decision in Bilski litigated. Here we address the assumption
underlying both positions: that examiners
V. Doll? cannot distinguish weak patents from strong.
Johanna Dennis We find that US examiners’ prior art
Computer Law & Security Review, Vol. searches reveal that they can and do identify
25, No. 6, 2009 many patents that are of dubious validity.
( They conduct a more intensive search for
prior art for applications they accurately
In Bilski v. Doll, the U.S. Supreme Court is
identify as weak, because they bear the
called to define one of the categories of
burden of proof of non-patentability, but not
patent eligible subject matter, “process”
of patentability. Our study suggests that the
patents. In 2008, the Court of Appeals for the
rules and procedures of the USPTO have
Federal Circuit held that the category has a
forced examiners to grant many of these
narrow meaning, and that to be eligible for a
weak applications. Given the resources at
process patent under 35 U.S.C. § 101, the
hand, examiners possess information about
invention must involve a machine or
the validity of their patents that society
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does not use. We do not find the balance of positively associated with price markup, a
the marginal costs and benefits of market power and market performance
information about patent validity that would measure, and then move to explore the
characterize rational ignorance at the relationship between royalty rates and
USPTO. market structure. Two complementary sets
of market structure factors are discussed.
Intellectual Property Right Regimes, The first one is technology intensiveness or
Firms and the Commodification of technology opportunity, on which we
demonstrate that technology intensive
Knowledge sectors tend to have higher royalty rates
Benjamin Coriat and Oliver Weinstein than other sectors. The second set covers
Working Paper the traditional measures of barriers of entry.
( Regression analysis reveal that royalty rates
The aim of this paper is to analyze the exhibit a negative linear relationship with two
evolution of the intellectual property regime, measures of barriers to entry, the ratio of
and more precisely the patent regime, in the sales to capital invested and the ratio of
USA, since the 19th century. To do so, we sales to operating costs. Finally, cluster
shall consider intellectual property within the analysis is conducted to reveal group pattern
context of general transformations in among the industries studied, using royalty
capitalism, focusing on two main historical rate, markup, and the ratio of sales to capital
phases. Firstly, the period covering the invested as variables. The analysis yields
formation and development of “corporate four distinguishable groups of industries, and
capitalism” dominated by large corporations. the characteristics of each group are
And then the new phase, which opened up in discussed. Cluster analysis also
the 1980s, marked by the rise to power of corroborates our conclusion that while both
finance. From a perspective of institutional traditional barriers of entry and technology
complementarities, we seek to show how the intensiveness contribute to determining
characteristics and implications of IPR market power, one set of factors can exert
regimes can only be understood in relation to more dominant and pronounced impact than
transformations in the main institutional the other one in a specific industry, as
forms of capitalism: forms of the firm, the evidenced by media and internet/software
status of labour (the 'wage-labour nexus'), sectors, in which market power is mainly
and market forms. created by their technology and know-how
embedded in legally-protected IP.

Jostling for Advantage: Licensing and

IP & LICENSING Entry into Patent Portfolio Races
Ralph Siebert and G/ Von Graevenitz
Working Paper
Royalty Rate and Industry Structure: (
Some Cross-Industry Evidence Complex high technology industries are
increasingly affected by patent thickets in
Stephen Becker and Jiaging Lu which firms’ patents mutually block the use
Working Paper of important technologies. Firms facing
( patent thickets patent intensively to acquire
This paper continues where Kemmerer and bargaining chips and use licensing to ensure
Lu (2008) left off, and explores the freedom to operate. Such licensing allows
relationship between royalty rates and rivals to either avoid or resolve hold-up from
market structure among industries. blocking patents. R&D incentives depend on
Economists have studied innovation, R&D, whether licensing takes place ex ante or ex
and market structure for decades, and also post. We model the choice between ex ante
have investigated patent licensing methods licensing and entry into patent portfolio races
across industries. However, there is very leading to ex post licensing. It is shown that
little research on the relationships between higher degrees of blocking lead firms to
market structure and royalty rates. In this license ex post while stronger product
paper, we first show that royalty rates are market competition leads firms to license

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ex ante. Empirical results support these licensing income is key to funding research
theoretical predictions. and technology transfer operations. Yet,
there is virtually nothing in the opinion that
The Individual Inventor Motif in the rationalizes the result in terms of innovation
Age of the Patent Troll policy.
This article suggests that this dire view of
Christopher Anthony Cotropia MedImmune is wrong: that the decision
Working Paper leaves patentees free to share the risks of
( invalidation with their licensees, so long as
The individual inventor motif has been part of they do so expressly, thereby giving potential
American patent law since its inception. The licensees strong incentives to vet validity at
question is whether the recent patent troll the start of a relationship - and early in the
hunt has damaged the individual inventor's life of the patent. After setting out the
image and, in turn, caused Congress, the arguments for reading MedImmune as
United States Patent and Trademark Office promoting private ordering, the article
(USPTO), and the courts to not be as discusses five general approaches to
concerned with patent law's impact on the contracting in its light. It concludes with a
small inventor. This Article explores whether look at the limits of party autonomy,
there has been an attitude change by looking suggesting that MedImmune also casts
at various sources such as congressional doubt on a line of cases upholding
statements and testimony in discussions of agreements between branded
the recent proposed patent reform pharmaceutical companies and generic
legislation, the USPTO's response to manufacturers that eliminate competition in
comments on two recently proposed sets of the name of reducing litigation costs.
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 IP & INNOVATION
essentially nil. This investigation also
provides a broader insight into the various
governmental institutions' roles in patent law.
Demythologizing PHOSITA
Dethroning Lear? Incentives to Matthew Herder
Innovate After MedImmune Working Paper
Rochelle Dreyfuss and Lawrence Pope (
Berkley Technology Law Journal, Vol. The Supreme Court of Canada recently took
occasion in the context of a pharmaceutical
24, 2009. “selection patent” case, Apotex. v. Sanofi-
( Synhtelabo, to revise the doctrine of non-
The Supreme Court’s 2007 decision in obviousness. Although cognizant of changes
MedImmune v. Genentech reversed prior made to the same doctrine in the United
case law and allowed a licensee in good States and United Kingdom, a critical flaw in
standing to challenge the validity of the how the doctrine is being applied that
licensed patent. In some ways, the decision appears peculiar to the Canadian context
was unsurprising. It made patent law more escaped the Supreme Court’s attention.
consistent with general rules on justiciability Using content analysis methodology, this
and with the Court’s recent concerns about paper shows that lower Canadian courts
the strength and prevalence of patents. Still, frequently fail to adequately characterize the
the decision is, in significant ways, “person having ordinary skill in the art”
astonishing. By apparently shifting all of the (PHOSITA) for the purpose of the
risk of invalidation to patentees and putting obviousness inquiry. The paper argues,
them into inferior bargaining positions moreover, that this surprisingly common
relative to licensees, it arguably undermines analytical mistake betrays a deep
patent value, reduces incentives to invest, misunderstanding of innovation, one which
and endangers the public interest in scientific assumes that actors consult patents to learn
progress. It is especially detrimental to about scientific developments, misconceives
patent holders in emerging sectors, where the boundary between proprietary
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knowledge and non-proprietary knowledge creators of new types of securities have
as static instead of dynamic, and ignores the shown less interest in the patent system.
industry-specific nature of innovation. The Nevertheless, the rate of innovation in this
paper also offers a historical account of the field has remained constant. At this time, the
evolution of the non-obviousness test, available data are not sufficient to reach an
identifies several factors that undermine entirely conclusive determination with
PHOSITA’s characterization, and develops a respect to whether the patent system has
multi-layered prescription to remedy the affected the design of new types of
problem. In sum, unless the judiciary begins securities. However, the results are still of
to demythologize PHOSITA by making great significance and cast doubts on the
findings of fact in each case where soundness of the State Street decision, at
obviousness is at issue, the current chasm least to the extent that it involves the
between patent law doctrine and the goal of financial industry. By deciding In re Bilski,
facilitating innovation will only widen. the Federal Circuit now has the opportunity
to readdress the issue of the patentability of
Is the Use of Patents Promoting the this subject matter in a way that more closely
Creation of New Types of Securities? reflects the goal of the patent system as it is
described in the Constitution.
Stefania Fusco
Santa Clara Computer and High Did Trips Spur Innovation? An
Technology Law Journal, Vol. 25, No. 2, Empirical Analysis of Patent
2009 Duration and Incentives to Innovate
( David Abrams
Has there been a change in the level of
innovation of financial methods subsequent
Working Paper
to the State Street decision that allowed the (
award of patents to protect such methods? How to structure IP laws in order to
Ten years following the issuance of State maximize social welfare by striking the right
Street, the patentability of business methods balance between incentives to innovate and
is still so controversial that the Federal access to innovation is an empirical
Circuit has recently considered overruling its question. It is a challenging one to answer,
own precedent by rehearing In re Bilski en both because innovation is difficult to value
banc. The goal of the patent system is to and changes in IP protection are rare. The
promote innovation. If an increase in the 1995 TRIPS agreement provides a unique
level of innovation of financial methods is not opportunity to learn about this question for
present, the adoption of this form of two reasons. First, the adoption of the
intellectual property to protect creativity in agreement was uncertain until shortly before
the industry is unjustified and, potentially, adoption, making it a plausibly exogenous
even harmful. Indeed, it is important to change to patent duration. Second, the
ascertain the correct balance between nature of the law change meant that the
encouraging innovation on the one hand, patent duration change was heterogeneous
and leaving enough “raw material” upon across patent classes. Using both patent
which individuals can build new ideas on the counts and citation-weighted counts, I am
other. A first step in accomplishing this able to take advantage of the TRIPS-induced
objective is to understand whether the patent law change to empirically estimate the
system is “doing its job” or, in other words, impact of patent duration on innovation. I find
whether the provided protection is actually evidence for an increase in innovation due to
inducing innovation in a specific industry. patent term extension following TRIPS. Both
In this article, the author presents an patent counts and citation-weighted counts
empirical study of innovative types of increased more following TRIPS in those
securities that have emerged over the past classes that received greater expected term
25 years. The author also investigates the extensions relative to classes receiving
patent practice of the financial industry and shorter extensions. While the precise
identifies the patent applications submitted calibration of innovation valuation is difficult,
and the patents issued on different types of this paper provides the first attempt to
securities. Finally, the author discusses her empirically estimate its response to a major
findings and concludes that, recently,
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change to patent duration, from the TRIPS ISPs may lead to ISPs’ over-zealous
agreement. censorship and thereby decrease or limit
free access to copyright materials.
Patent Policy, Patent Pools, and the Meanwhile, the ISPs also argued that it is
Accumulation of Claims in Sequential unfair for them to bear the full social costs
generated by their users’ unlawful activities,
Innovation merely because they are providing facilities
Gaston Llanes and Stefano Trento and services. So far, dozens of studies have
Working Paper been produced to criticise those arguments
( and justify ISPs’ indirect copyright liability
We present a dynamic model where the from legal point of view; however, less
accumulation of patents generates an attention has been paid to the economic
increasing number of claims on sequential implication of ISPs’ indirect copyright liability
innovation. We study the equilibrium and the significance it achieves at the
innovation activity under three regimes: confluence of law and economics.
patents, no-patents and patent pools. Patent Utilizing an evaluation criterion: economic
pools increase the probability of innovation efficiency-Hicks-Kaldor criterion and a simple
with respect to patents, but we also find that: economic model: cost-benefit analysis, both
(1) their outcome can be replicated by a are drawn from the theory of economics, this
licensing scheme in which innovators sell paper examines economic strength of
complete patent rights, and (2) they are indirect liability regime in the context of ISPs’
dynamically unstable. We find that none of liability for online copyright infringement. It
the above regimes can reach the first or employs a string of relevant cases against
second best. Finally, we consider patents of those who allegedly facilitate copyright
finite duration and determine the optimal infringements to compare the costs and
patent length. benefits of ISPs’ indirect copyright liability
and also three applications of it including
vicarious liability, contributory liability and
inducement liability. The paper finally
IP & COPYRIGHT 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
ISP Indirect Copyright Liability extensive online copyright infringements and
Regime: An Economic Efficient bring long term social welfare to the society.
Liability Regime for Online
The Ethical Visions of Copyright Law
Copyright Protection Shaped by
James Grimmelmann
Internet Technology
77 Fordham Law Review 2005 (2009)
Weixiao Wei
23rd BILETA Annual Conference, This symposium essay explores the
March 2008 imagined ethics of copyright: the ethical
( stories that people tell to justify, make sense
ISPs’ indirect copyright liability permits of, and challenge copyright law. Such ethical
regulation where traditional legislation fails to visions are everywhere in intellectual
meet requirements of copyright protection in property discourse, and legal scholarship
a new digital environment, and makes a third ought to pay more attention to them. The
party possibly to prevent or decrease the risk essay focuses on a deontic vision of
of copyright infringement at low cost. reciprocity in the author-audience
However, though it has been hailed as a relationship, a set of linked claims that
forceful tool for governing ISPs’ liability for authors and audiences ought to respect
fierce copyright infringement committed by each other and express this respect through
their users over the Internet in most of the voluntary transactions.
jurisdictions, the strength of this liability Versions of this default ethical vision animate
regime is still being challenged. Some groups as seemingly antagonistic as the
argued that imposing indirect liability on the music industry, file sharers, free software

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advocates, and Creative Commons. remains fairly agnostic in this debate.
"Respect copyrights," "Don't sue your Despite the varying interests and incentives
customers," "Software should be free," and "I that motivate authors to create, copyright law
love to share" are all ethical claims about gives all authors exactly the same bundle of
copyright that share some common rights. Although the term of those rights
intuitions, even as they draw very different differs depending on whether the author is
conclusions. The essay provides a corporate or individual, and although an
framework for thinking about these ethical employer can acquire rights in a work
visions of intellectual property and then puts without having actually created the work
these various visions into conversation with (through the work-for-hire doctrine), both the
each other. individual and the corporate author hold the
same rights to prevent certain unauthorized
A Tale of (at Least) Two Authors: uses of the work. Copyright law makes no
Focusing Copyright Law on Process attempt to match the rights it grants to the
needs of the party to whom it grants those
Over Product rights, resulting in too much protection in
Laura Heymann some instances and not enough in others. It
Journal of Corporation Law, seems particularly unbalanced to engage in
Forthcoming 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
U.S. copyright law accords its bundle of
rights to the author of the work. But despite
Copyright law might, therefore, better
the centrality of this figure in the Copyright
accomplish its goals if it took better account
Act, the statute doesn’t define the term, and
of the activities and interests of authors
commentators have yet to agree on precisely
rather than focusing on the products of their
what characteristics this creature should
creativity. Different types of authors engage
have. As history and scholarship show, an
in different modes of creation and therefore
author can take on many different personas,
have different interests in controlling the
she can be individual or corporate; she can
results of their work. The goal of this Article
be someone who creates deliberately or
is to consider whether copyright law would
accidentally; and she can work separately or
be improved by recognizing this perspective.
in collaboration with others. Far more
attention has been paid to this individual’s
creative output: works of authorship. Works Copyright Law as Mediational
of authorship are the creations to which Means: Report on a Mixed Methods
rights attach, and so discovering the Study of U.S. Professional Writers
substance and boundaries of such works is Martine Courant Rife
often the first step in any copyright analysis.
As a result, in U.S. copyright law, the author
Working Paper
is defined more by what she creates, a (
copyrightable work, than by why she creates. This article reports on an empirical study
This result seems odd, because U.S. conducted among US professional writers
copyright law is typically explained as composing in digital writing environments.
affording authors economic incentives to The study explored US copyright law’s
create so that the public benefits from the mediational influence on digital composing
development of new works. An author will be using a sequential transformative mixed
reluctant to create and commercialize her methods research design. A digital survey
work if a second-comer can simply copy that (N=334) was administered to a randomly
work and sell it so as to recoup her cost of selected population of students and teachers
copying, far more cheaply than the author in US technical and professional writing
herself, who must also recoup the cost of programs and interviews were conducted
production. This explanation assumes, with select writers as well. The study
however, that authors create in response to examined three main areas of inquiry: 1) the
economic incentives. While this may be true status of knowledge and understanding of
for some authors and for some forms of copyright law in the field of technical and
expression, it is unquestionably not true for professional writing; 2) the creative thinking
others. Copyright law itself, however, processes, or rhetorical invention, of writers
Page 9 of 17
in these programs composing webtexts in distribution, digital transmissions and
light of copyright law; and 3) what happens technical protections - while maintaining the
to mediational means as writers leverage maximum opportunity for the quality and
them in digital contexts. In this article the quantity of content to grow in the new, digital
study’s six major findings and seven granular environment. A successful negotiation of the
findings as well as implications are briefly Protocol will indeed help to make new laws
summarized and discussed. The study in the digital copyright era.
hopes to provide a baseline that might be
used for further research in cross-cultural or Inadvertent File Sharing Over Peer-
international contexts.
to-Peer Networks: How it Endangers
Copyright Law of the European Citizens and Jeopardizes National
Union Security, Testimony Before the U.S.
Arun Krishnan House Committee on Oversight and
Working Paper Government Reform
( Thomas Sydnor
Neither the Current EC Directives nor TRIPS The Progress & Freedom Foundation
make significant legal adjustments to cater U.S. Congressional Testimony, 2009
for digitised information systems serving (
world networks, for information Certain distributors of popular file-sharing
superhighways are too novel and shifting a programs have repeatedly failed to prevent,
phenomenon. The implications for Copyright, and may have knowingly caused and
as the most likely tool for shoring up their perpetuated, inadvertent file-sharing,
economic value, are of course, under urgent Inadvertent sharing cannot be remediated by
scrutiny. Whatever else, the provision of on- self-regulation by distributors of file-sharing
line services for education, information, programs because certain distributors have
entertainment, business and Government repeatedly violated every set of self-
promises very considerable realignments in regulations proposed - including a Code of
what may be loosely labeled the information Conduct and a set of Volutary Best Practices
industry. In conditions of such insecurity, it that they drafted.
seems highly important at least to ensure, if Three critical defects are present in every
possible, that creators and other providers released version of the LimeWire 5 file-
can secure returns on the users of their sharing program: (1) every version is
material which correspond to the sale of dangerously unpredictable and can share all
copies and the showing of material in of a user's personal document, image, video,
cinemas and on television in the world to and audio files just by being installed, (2)
date. There are considerable hopes and every version violates critical provisions of
considerable dangers in a digitised world. the LimeWire's own Voluntary Best
Authors, and the creative works that they Practices, (3) every version contains a
develop, will ultimately determine whether feature that LimeWire itself knew to be a
new digital networks and the global needlessly dangerous of means of ensuring
information society succeed or fail. People that one reasonable mistake by a child could
simply will not take part in the new digital inadvertently share thousands of a family's
networks if the content available is not most sensitive personal files.
sufficiently interesting, creative or useful. In short, the problem of inadvertent sharing
Maintaining strong copyright protections for has persisted for nine years because
authors of every kind of creative work is distributors of file-sharing programs like
necessary to ensure that these authors have LimeWire LLC have repeatedly responded to
adequate, market-driven incentives and even the most serious and well-documented
rewards to create such content and to make concerns about inadvertent sharing with half-
it available to the public in these new ways. measures, misrepresentations, whitewash,
The Berne Protocol offers thoughtful and and other conduct that, considered in its
sensitive solutions to the challenges entirety, could strongly suggest bad faith - an
presented by the global Information society - intent to cause and perpetuate inadvertent
particularly as to the issues of computer sharing. Consequently, the widespread, well-
programs, temporary copying and use, documented breaches of national, military,
Page 10 of 17
corporate, and family security caused by further establishes that the above
inadvertent sharing may be nothing more - or amendments exert a greater influence on the
less - than the acceptable 'collateral damage' magnitude of monthly musical copyright
of schemes intended to trick users into registrations by the Big Four record labels
sharing popular music and movies. than other musical copyright owners.
Congress should pursue a two-pronged
remedial strategy. First, this issue should be The Tangled Web of UGC: Making
formally referred to law-enforcement
agencies possessing relevant civil and Copyright Sense of User-Generated
criminal enforcement authority. And Content
Congress should support efforts to amend Daniel J. Gervais
H.R. 1319, The Informed P2P User Act, in Vanderbilt Journal of Entertainment
order to grant the Federal Trade
Commission additional targeted enforcement
and Technology Law, Vol. 11, No. 4, pp.
powers. 841-870, 2009
Copyright as an Incentive for Musical Even as a mere conceptual cloud, the term
Creation: An Examination of the “user-generated content” is useful to discuss
the societal shifts in content creation brought
Effects of Copyright Law Changes On about by the participative Web and perhaps
Registrations, 1978-2006 best epitomized by the remix phenomenon.
Katherine Hill This Essay considers the copyright aspects
Working Paper of UGC. On the one hand, the production of
UGC may involve both the right of
( reproduction and the right of adaptation - the
This paper examines the effect of changes in
right to prepare derivative works. On the
United States copyright legislation on the
other hand, defenses against claims of
quantity of musical copyright registrations
infringement of these rights typically rely on
between the years 1978-2006. The
(transformative) fair use or the fact that an
legislative amendments examined herein
insubstantial amount (such as a quote) of the
are: (1) the Bern Convention Implementation
preexisting work was used. One might also
Act of 1988, (2) the Uruguay Round
rely on another type of fair use defense - for
Agreements Act of 1994, (3) the Sonny Bono
example, that the second work was used in
Copyright Term Extension Act of 1998, (4)
news reporting, or, although the case law on
the Digital Millennium Copyright Act also of
this point is still controversial, that the
1998, and (5) the Family Entertainment and
reproduction was fair use because it made
Copyright Act of 2005. The author
the work more accessible. While it is clear
manipulated Library of Congress data in
that creating original content by reusing
order to carry out said analysis, since no
preexisting content is nothing new, the focus
prior data set of musical copyright
here is on amateur creation and reuse and
registrations had been previously compiled.
the Essay discusses whether the amateur
Although federal copyright legislation
nature of the content constitutes a new
regulates all cultural industries, the
normative vector. The Essay suggests that
properties of musical compositions are
the first step to find adequate answers is a
sharply distinct from those of the literary
proper taxonomy of UGC.
works upon which copyright legislation was
crafted. Additionally, music has undergone a
drastic evolution with respect to its primary Law and Innovation in Copyright
methods of consumption since the Industries
establishment of U.S. copyright legislation in Matthew J. Baker and Brendan
1790. These facts warrant analysis of the
efficacy of copyright legislation specifically
as an incentive for musical creation. This Review of Economic Research on
paper finds significant evidence that the Copyright Issues, Vol. 6, No. 1, pp. 61-
Sonny Bono and Digital Millennium Acts, and 82, 2009
the Family and Entertainment Act all provide (
statistically significant positive incentive for
the creation of musical works. This paper
Page 11 of 17
The impact of copyright law on innovation is affects our lives. The converging
a topic of much debate. We use quarterly technologies raise several core issues such
data on aggregate copyright applications in as telecom sector is concerned with
both the U.S. and Canada to estimate an infrastructure regulation and access issues;
empirical model of copyright applications. broadcasting industry is more worried with
We measure changes in the breadth of access and content issues; information
copyright protection by tabulating outcomes technology is trying to deal with contribute
of important court cases and new statutes with new regulatory issues of framing, hyper
pertaining to copyright protection. We find linking, deep-linking, inlining, fixation,
that the flow of applications exhibits a small communication, publication, parallel imports,
but significant positive response to court rights management information, allocation of
decisions broadening copyright protection. frequency spectrum, fair dealing, implied
We also find that applications: 1) respond license, liability of Internet Service Providers
negatively to increases in registration fees 2) (ISP), and jurisdiction etc.
move counter-cyclically 3) have a strong This paper in particular questions the
seasonal component and 4) may increase as regulatory framework for the
computing technology becomes more widely telecommunications, broadcasting and
available. information technology sectors in a
convergence environment, and taking in to
Copyright Implications of the account relevance and need to safeguard
the public interest.
Convergence of Telecommunication,
Broadcasting & Information The Google Book Settlement and the
Technology - Lesson for India Fair Use Counterfactual
Tabrez Ahmad Matthew Sag
Proceedings of the SPCI 08 Working Paper
International Conference of Cyberlaw, (
2008 This Article compares the Google Book
( Search Settlement to the most likely
The paper identifies copyright implications of outcome of the litigation the settlement
convergence in India, examining especially resolves. It argues that Google was never
how Indian law is approaching convergence likely to receive the courts unqualified
of telecommunication, broadcasting and approval for its massive digitization effort
information technology issues. The delicate and that the most likely outcome of the
balance of rights and obligations of litigation was that book digitization would
intermediaries of Internet such as copyright qualify as a fair use subject to an opt-out.
owners, domain name holders, consumers, Accordingly, the aspects of the proposed
netizens and internet service providers can settlement which allow Google to continue to
be upset when trying to keep the legal operate its book search engine in its current
developments abreast with the technological form should not be controversial; they
advances. As more and more digital essentially mirror the court’s most likely fair
products in network environment are use ruling if the case had gone to trial. In
emerging efficient management and effect, the opt-out that fair use would likely
controlled distribution of such products have have required has been replaced by the
become one of the important considerations, ability of copyright owners to opt out of the
in an unprecedented way. The copyright class-action settlement.
owners are under a constant threat of In the wake of the proposed Settlement, the
loosing control over their products on the Google Book debate has shifted away from
information superhighway and are the merits of book digitization, and refocused
experimenting various technological adjuncts on questions of commoditization and control.
to retain control. Differences in rules are This Article highlights four critical areas in
beginning to be questioned. Now legal which the Settlement differs sharply from the
regulation is a great challenge before the predicted fair use ruling. First, the Settlement
world because the way legal and regulatory permits Google to engage in a significant
reforms are carried out will eventually range of uses including the complete
determine the manner in which convergence electronic distribution of books that go well

Page 12 of 17
beyond fair use. Second, the Settlement just the opposite asymmetries. Because
provides for initial cash payments by Google there are numerous works that generate high
to the copyright owners and a fairly generous social value but low private value, the impact
revenue sharing agreement, neither of which of costly screens would be to preclude the
would have been required under a fair use production of many of the publicly beneficial
ruling. Third, the agreement creates a new works that copyright is designed to create. In
set of institutional arrangements that will addition to providing a positivist explanation
govern the relationship between Google and for why the patent and copyright systems
the copyright owners covered by the differ, this application of costly screen theory
Settlement. The foundations of this new also points in the direction of what we call a
institutional framework are the Settlement unified theory of IP process. This theory
agreement itself, the creation of a collective illuminates the essential connection between
rights management organization called the the statutory construction of exclusive rights
“Book Rights Registry” and the “Author in information and the particular processes
Publisher Procedures”. The fourth area in by which those rights vest.
which the Settlement differs from the likely
fair use outcome relates to the accessibility, Should Different Information
commoditization and control of orphan Economies Have the Same Duration
of Copyright?
Costly Screens, Value Asymmetries, Michael Yuan
and the Creation of Intellectual Review of Economic Research on
Property Copyright Issues, Vol. 6, No. 1, pp. 61-
Jonathan S. Masur and David Fagundes 82, 2009
Working Paper (
Copyright has been increasingly
( internationalized and, recently, more and
Copyrights arise the moment an author fixes
more harmonized. However, there has been
a work in a tangible medium of expression,
little theoretical study of international
costlessly and immediately. Patents, by
copyright. This paper develops and analyzes
contrast, arise only after an applicant
a non-cooperative two-country model of
successfully navigates a cumbersome
copyright, where two countries trade in
examination process. Numerous writers
information goods and each with an open
have critiqued the resulting proliferation of
and competitive information goods industry
copyrights as excessive, in some cases
sets copyright policy to pursue self-national
arguing for more formalities in order to
interest. The model suggests that an
restrict the ease of copyright vesting. The
increase in demand for information goods in
patent examination process has drawn
a country calls for longer copyright protection
criticism as costly and ineffective — in
in this country and shorter protection in its
contrast to copyright, too laden with
trading partner; decreases in fixed or per-
formalities. In this paper, we focus on
product creative costs in a country with lower
process costs (or lack thereof) to show that
such costs call for marginally shorter
these very different means for acquiring
protection; and an improvement in the
intellectual property rights may be more
economies of creative scale in a country with
optimal than is generally believed. The high
better economies of creative scale calls for
costs of navigating the examination process
marginally longer protection. Understanding
deter would-be patentees who expect their
these rational responses of nations to
property rights to generate only low private
changes in creative technologies and
value. Moreover, due to an important
markets should be helpful for international
asymmetry among the social and private
copyright-policy making.
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
Page 13 of 17
to public health. These risks were addressed
through negotiation of the Doha Declaration
IP & DEVELOPMENT 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.
Innovation and Technology Transfer The “Doha Declaration process” broadly
to Address Climate Change: Lessons speaking has resulted in some positive
from the Global Debate on movement.
Intellectual Property and Public
Climate Change, Technology
Transfer and Intellectual Property
Frederick Abbott
ICTSD Programme on IPRs and
Krishna Ravi Srinivas
Sustainable Development, Issue Paper
Working Paper
No. 24, 2009
( Technology development and transfer has
This paper examines issues surrounding the
been identified as a key element in the Bali
development and transfer of technologies for
Action Plan. In the negotiations on a global
addressing the problem of climate change
climate treaty the developing nations have
based on the experience of developing
put forth ideas and plans to ensure that
countries in addressing problems of
intellectual property rights (IPRs) do not
innovation and access in the field of
become a barrier to transfer of climate
friendly technology. In this discussion paper,
It looks at alternative energy resources
this question of technology transfer,
(AERs) and climate change mitigation
intellectual property rights is addressed in
technologies (MTs), at the forms of
the context of climate change. Patent
intellectual property rights (IPRs) used to
statistics shows the dominance of developed
promote and protect innovation, and at the
countries in specific technologies. The
ways these IPRs may have different effects
analysis on specific technologies indicates
and implications for AERs/MTs as compared
that IPRs is an important issue in
with pharmaceutical technologies. It is
development and transfer of technology and
generally assumed that the originator
it is a barrier. Data indicates that although
pharmaceutical sector is highly dependent
developing countries have made some
on strong patent protection, mainly because
progress, the dominance of developed
of the high cost involved in developing novel
countries in terms of patents, royalty and
drug therapies and the low cost of reverse
licensing income and expenditure on
engineering these new drugs. Preliminary
Research and Development remains as
research suggests that most AERs/MTs
before. The historical experience is that
industries may be less dependent on strong
stronger IPRs do not always result in more
patent protection, and/or that patents are
technology transfer and technology
less likely to cause signifi cant bottlenecks in
absorption. Hence the argument that
the development and transfer of AERs/MTs.
developing countries should provide stronger
While it is premature to come to a defi nitive
protection of IPRs to encourage technology
conclusion because researchers are only
transfer has to be challenged. The
now focusing on the evidence, there is some
technology transfer under UNFCCC and
basis for anticipating that IPRs will present
Kyoto Protocol has been minimal and
fewer risks for developing countries in the
insufficient to meet the needs of developing
context of climate change than for public
countries. The harmonization of IPRs
through TRIPS has limited the options of
Developing country negotiators understood
countries to use compulsory licensing and
that the GATT Uruguay Round negotiations
competition policy. TRIPS has not facilitated
on trade related aspects of intellectual
technology transfer, particularly to Least
property rights would affect access to
Developed Countries (LDCs) and the North-
medicines. The resulting WTO TRIPS
South divide on this issue has resulted in a
Agreement did, in fact, present serious risks
stalemate. Under these circumstances it is
Page 14 of 17
futile to expect that TRIPS alone will result in crisis in 2008 reignited more wide-ranging
more transfer of climate-friendly interest in the role of the WTO in global
technologies. Using Common But economic management, prompting calls for
Differentiated Responsibility principle in the WTO to do more to sustain a global open
technology development and transfer is trading system, and in particular to take
desirable. Many proposals and suggestions greater leadership on issues of trade
have been made to stimulate technology finance, aid for trade, and surveillance of
development and transfer. Montreal Protocol protectionist measures. Amidst a growing
is a successful example that is relevant in body of scholarly literature and policy
the context of climate change. The proposals commentary on the governance and
including the proposals made by developing institutional reform of the WTO, this chapter
countries deserve a serious consideration proposes a distinctive approach.
and innovative solutions have to be found.
Humanity does not have the luxury of finding The Regulation of Creativity Under
solutions over a century to solve problems
created by global climate change. the WIPO Internet Treaties
Developing countries need both Ruth Okediji
development and access to technologies Working Paper
that will facilitate the transition to less carbon (
intensive economy within the next two or The WIPO Copyright Treaty and the WIPO
three decades. So it is essential that IP Performances and Phonograms Treaty
issues do not become a barrier in this (WIPO Internet Treaties) recite a need for a
transition. The challenge of climate change digital copyright framework to facilitate
calls for out of the box thinking to find 'adequate solutions to questions raised by
solutions that can make a difference. The new economic, social, cultural and
IPR issues in technology transfer need to be technological developments.' It can hardly be
tackled by a combination of policy measures, contested that the social and cultural
incentives and bringing in changes at the developments to which the Treaties refer do
global IP regime under TRIPS. not derive from the cultural or economic
conditions (much less technological
Making WTO Reform Work for developments) of the developing and least-
Developing Countries: Improving developed countries. Consistent with their
predecessors, the WIPO Internet Treaties
How the WTO’s Functions are marginalize collaborative forms of creative
Governed engagement with which citizens in the global
Carolyn L Deere South have long identified and continue in
REDESIGNING THE WORLD the tradition of assuming that copyright’s
TRADE ORGANIZATION FOR THE most enduring cannons are culturally neutral.
Recently, however, the rise of Web 2.0 and
TWENTY-FIRST CENTURY, D. the salience of new forms of creativity
Steger, ed., Wilfred Laurier University mediated by digital technologies and social
Press, 2009 networking sites have exposed structural
( tensions in copyright laws of OECD
The debate on the institutional reform and countries similar to those which developing
governance of the WTO has now been countries have historically raised in
underway for over fifteen years. In the opposition to the Berne Convention. This
context of a Doha Round of multilateral trade Essay reviews the evolution of the WIPO
negotiations stumbling forward in fits and Internet Treaties and argues that the
starts, the most prominent focus of framework established just over a decade
discussions of WTO reform has been options ago is increasingly less relevant in
for improving the process of the WTO addressing the challenges of creativity in the
negotiation process. Throughout the past ten digital age. The Treaties do not provide a
years, however, there have also been a meaningful basis for a harmonized approach
number of broader debates about the to encourage new creative forms in much the
governance of the multilateral trading system same way the Berne Convention fell short of
and calls for institutional reform at the WTO. embracing diversity in patterns and modes of
Most recently, the onset of global financial authorial expression. The growing social
Page 15 of 17
and legal recognition of new forms of attempt to reconcile intellectual property with
creativity enabled through digital access to medicines, our research shows
technologies offers an important opportunity otherwise. We draw on qualitative analyses
to challenge anew claims that globally of 54 interviews and a lexicometric analysis
mandated copyright norms can effect of press releases to show that their
incentives to create that are relevant across enthusiastic public statements contrast
geographical, cultural and technological deeply with their internal, cynical beliefs.
boundaries. Most of these actors not only consider the
WTO decision to be fundamentally flawed
TRIPS and Essential Medicines: Must but claim to have known this prior to its
adoption. We argue that a procedural norm
One Size Fit All? Making the WTO of consensus-seeking impeded traditional
Responsive to the Global Health bargaining over this sensitive issue and that
Crisis distrust among participants hindered truth-
Rochelle Dreyfuss seeking deliberation. Caught between
strategic and communicative actions, state
INCENTIVES FOR GLOBAL HEALTH: and non-state actors found themselves
PATENT LAW AND ACCESS TO trapped in their own rhetoric of reconciling
ESSENTIAL MEDICINES, Thomas intellectual property with access to
Pogge, Matthew Rimmer, Kim medicines. They realized that the
Rubenstein, eds. Cambridge University appearance of a solution, rather than a
functional solution, provided the only realistic
Press, 2010 solution to a fruitless and publicly damaging
( continuation of debate. From a theoretical
This paper was written as the introductory perspective, this case study sheds a new
chapter to Incentives for Global Health: light on the gray zone between rational
Patent Law and Access to Essential choice and constructivism, where both
Medicines, edited by Thomas Pogge, discourse and strategies matter. From an
Matthew Rimmer, and Kim Rubenstein empirical perspective, it illustrates the risk of
(Cambridge University Press). It challenges seeking consensus within international
the critique of the TRIPS Agreement as a regimes when the procedural norm of
one-size-fits-all regime. To be sure, there are consensus coexists with a high level of
WTO members who prefer to think of the distrust.
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 IP & BIOTECHNOLOGY
health needs. TRIPS accommodations are
not perfect: the second part of the paper
considers the roles that other international Patent Amendment Act 2005: Its
organizations, such as WHO, and other
international obligations, such as human
Effect on Indian Pharmaceutical
rights agreements, can be used to influence Company
the development and interpretation of Prantik Garai
international intellectual property law. Working Paper
Consensus-Seeking, Distrust, and India has a history of the patent acts starting
Rhetorical Entrapment: The WTO form 1911. All happened was pre
Decision on Access to Medicines independence. The Patent Act, 1970 was the
first patent act to the independent India. It
Jean-Frédéric Morin and E. Richard had provision for only process patent but did
Gold not have any provision for product patent.
Working Paper Therefore the process could have been
( patented but not the end product which gave
While the WTO secretariat, key delegations, rise to the concept of reverse mechanism.
several NGOs, and industry publicly present Absence of product patent helped the Indian
the August 30th 2003 WTO decision as an pharmaceutical industries to use this at
Page 16 of 17
their advantage and find out a drug of same 'biomarkers' research have systematically
specification by a different method. This failed to validate newly discovered molecular
helped the Indian Pharmaceutical industries variations, be they genomic, proteomic,
to flourish. After India signed the TRIPS it metabolomic, or dynamic interactions
was obliged to amend the patent act and amongst them all, with clinical outcomes as
introduce the product patent. The researcher they amass and unfold over time. This is, in
in the article discusses how the signing of part, attributable to deficiencies in the
the TRIPS was detrimental to the interest of present regulatory framework. Ambiguous
the Indian Pharmaceutical Industries and its standards for evaluating study design and
effect on the Indian Economy. The product risk, as well as seemingly redundant
researcher in his paper would also deal in requirements from different regulatory
details the amendment of the patent act and authorities have led some, if not driven
its pros and corns. others, to escape oversight. However, it also
reflects a marked failure of coordination, a
University Patent Licensing for the failure not only to put into place large-scale
Research and Development of collections of biological specimens
accompanied by longitudinal patient health
Pharmaceuticals in Developing information, but a failure to ensure
Countries continuous data exchange amongst the
Gail Evans researchers, clinicians, healthcare providers,
Intellectual Property Quarterly, No.3, and private firms already attempting to
commercialize biomarker-related
pp. 311-344, 2009 technologies. The argument advanced in this
( paper is that intellectual property rights
More than 80 per cent of the world's (especially patents), and the set of practices
population lives in developing countries that those rights tend to engender, contribute
where communicable diseases account for significantly to the paucity of data sharing
50 per cent of the disease burden. The that currently pervades biomarkers research.
opening Recital of World Health Further, these patent-related issues cannot
Organization's Global Strategy and Plan of be easily disentangled from other barriers
Action on Public Health, Innovation and facing personalized medicine, particularly the
Intellectual Property affirms the need to deficiencies of the present regulatory
construct a sustainable basis for research framework. And the way in which the
and development relevant to diseases that discourse around the impact of patent rights
disproportionately affect developing upon early stage scientific research has
countries. The author discusses how been framed helps account for why this
universities in developing countries should dimension of the problem has received
negotiate for favourable patent licensing minimal attention to date.
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
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

Page 17 of 17