Law Commons^™

Is The Chemical Genus Claim Really “Dead” At The Federal Circuit?: Part Ii, Christopher M. Holman

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A 2020 law review article entitled The Death of the Genus Claim (“Death”) purports to document a dramatic shift in the Federal Circuit’s interpretation of 35 U.S.C. 112(a)’s enablement and written description requirements, particularly as applied to chemical genus claims. According to the authors of Death, it has become nearly impossible to obtain a chemical genus claim that will be upheld as valid in the face of a challenge for overbreadth under Section 112(a). Death was cited extensively in Amgens’s successful petition for certiorari in Amgen v. Sanofi, a case asking the Supreme Court to overturn the Federal Circuit’s decision …

Is The Chemical Genus Claim Really “Dead” At The Federal Circuit?: Part I, Christopher M. Holman

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A 2020 law review article entitled The Death of the Genus Claim (“Death”) purports to document a dramatic shift in the Federal Circuit’s interpretation of 35 U.S.C. 112(a)’s enablement and written description requirements, particularly as applied to chemical genus claims. According to the authors of Death, it has become nearly impossible to obtain a chemical genus claim that will be upheld as valid in the face of a challenge for overbreadth under Section 112(a). Death was cited extensively in Amgens’s successful petition for certiorari in Amgen v. Sanofi, a case asking the Supreme Court to overturn the Federal Circuit’s decision …

Corporate Governance Gaming: The Collective Power Of Retail Investors, Sergio Alberto Gramitto Ricci, Christina M. Sautter

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The GameStop saga and meme stock frenzy have shown the pathway to the most disruptive revolution in corporate governance of the millennium. New generations of retail investors use technologies, online forums, and gaming dynamics to coordinate their actions and obtain unprecedented results. Signals indicate that these investors, whom we can dub wireless investors, are currently expanding their actions to corporate governance. Wireless investors’ generational characteristics suggest that they will use corporate governance to pursue social and environmental causes. In fact, wireless investors can set in motion a social movement able to bring business corporations to serve their original partly-private-partly-public purpose. …

In Juno V. Kite The Federal Circuit Strikes Down Patent Directed Towards Pioneering Innovation In Car T-Cell Therapy, Christopher M. Holman

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Chimeric antigen receptor T-cells (also known as CAR T-cells) are T-cells that have been genetically engineered to produce an artificial T-cell receptor for use in immunotherapy. In recent years CAR-T cell therapy has emerged as an important new modality of cancer treatment, particularly for blood-borne cancers like leukemia. As would be expected, important advances in the development of CAR T-cell therapy have been the subject of extensive patenting and licensing activity. Juno v. Kite, a recent decision of the Court of Appeals of the Federal Circuit striking down a foundational CAR T-cell therapy patent, has raised serious questions as to …

Perma.Cc And Web Archival Dissonance With Copyright, Paul D. Callister

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Harvard’s Perma.cc offers the solution to linkrot—the phenomenon that citations in academic journals to web materials disappears with the passage of time, resulting in “broken links” and disappearance of material from the Web.

This article will describe Perma.cc and outline the kinds of copyright issues that may arise, including heavy use of copyright statutes and caselaw. It will examine the kind of preservation use of copyrighted materials, with reference to fair use, and the library prerogatives as exceptions to the exclusive rights of authors of materials found on the Web. This analysis includes detailed analysis of “transformative use” and the …

Why Illinois Should Reevaluate Its Video Tolling (V-Toll) Subsidy, Randall K. Johnson

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Tolls are levies with a limited base. This base is made up of drivers that pay user fees, in cash or via electronic transponder, in exchange for access to state-administered roads. In Illinois, every single toll is a function of three factors: vehicle characteristics, tollway entry point, and how far a driver goes on state-administered roads.

It is commonly assumed that any toll violation, i.e., any failure to pay, results in a traffic ticket, administrative fees and state-imposed sanctions. Such an assumption, however, is only partly true due to overly forgiving Illinois state policies. Examples include the Traffic Ticket Exemption, …

Visual Appropriation Art, Transformativeness, And Fungibility, Jasmine C. Abdel-Khalik

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As an intentionally flexible doctrine, fair use in copyright has a long history of ambiguity and criticism. While courts have developed various standards and considerations to give fair use some shape, key decisions have generally done so in the context of textual material. Likewise, the examples in Judge Leval’s seminal work on fair use involve textual material. His argument to assess the first fair use factor based on transformativeness has won the day. But in contrast to the textual examples, interpreting the meaning and transformation of visual works is rife with danger.

Recent appropriation art cases exemplify this danger and …

Determining The Composition, Joe Bennett, Sean M. O'Connor

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This chapter explores the interpretation of a musical work in the context of changes to songwriters’ creative behaviors, driven by changes in composing technologies. It argues that in the 21st century, a musical work (MW) is fully embodied in a phonorecording, and that single, artificially isolated elements (such as melodic fragments) should be considered de minimis for the purposes of copyright infringement litigation. This view is evidenced by the self-reported creative activities of more than 200 songwriting teams, taken from the popular podcast Song Exploder. Three detailed case studies are provided from this collection, all based on songwriting teams using …

Scènes À Faire As Identity Trait Stereotyping, Jasmine C. Abdel-Khalik

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Judge Learned Hand's decision in Nichols v. Universal Pictures is unquestionably seminal in the development of copyright law. For the first time, a court articulated that stock characters, a form of scènes à faire, are so fundamental that all should have access. Therefore, a stock character, like one defined simply as a butcher with a cleaver and in a white coat, is not copyright protectable material.

However, the specific stock characters identified by Judge Hand raise some previously unexplored questions. The decision identifies two stock characters: "the low comedy Jew and Irishman." What exactly is “the low comedy Jew and …

Congress Considering Legislation Intended To Reverse The Recent Trend Toward Devaluation Of The Us Patent Right, Christopher M. Holman

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Decisions of the United States Supreme Court spanning the last quarter of a century that have, in the aggregate, substantially devalued the patent right. The Court’s four decisions reinvigorating and substantially raising the patent eligibility bar have probably resulted in the most critical commentary, but a host of other decisions have also served to erode the patent right in multiple dimensions, including the scope of potentially patent-able subject matter as well as the strength and enforce-ability of issued patents. In 2011 Congress joined in when it enacted the America Invents Act (AIA), which includes multiple provisions tending to devalue patents, …

The Supreme Court’S Devaluation Of U.S. Patents, Christopher M. Holman

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In a span of three weeks during the spring of 2017, the U.S. Supreme Court issued three patent decisions, bringing the total number of patent decisions for the 2016-2017 term to six. This means that the October 2016 term ties the previous record of six patent decisions in the October 2014 term. This represents a tremendous increase in the number of patent decisions compared to earlier times, and particularly the early days of the Federal Circuit. For reference, during the first quarter of a century the Federal Circuit was in existence, the Supreme Court heard on average less than one …

Eli Lilly V. Teva: Generic Companies Infringe Under Akamai Iv In Case Of Divided Infringement, Christopher M. Holman

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The U.S. Supreme Court’s 2014 decision in Limelight Networks v. Akamai Technologies decision (Akamai III), in conjunction with the Federal Circuit’s stance on divided infringement claims, effectively undermined the value of method claims, particularly in the realm of pharmaceuticals, diagnostics, and other biotechnology related innovation, by limiting the ability of patentees to establish liability in cases where steps of the claimed method are performed by multiple parties. On remand, the en banc Federal Circuit in Akamai Technologies v. Limelight Networks (Akamai IV) sought to address the problem by expanding the definition of direct infringement under 271(a) to encompass more scenarios …

In Defense Of Secondary Pharmaceutical Patents: Response To The Un's Guidelines For Pharmaceutical Patent Examination, Christopher M. Holman

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In 2015 the United Nations Development Programme issued a document entitled Guidelines for Pharmaceutical Patent Examination: Examining Pharmaceutical Patents from a Public Health Perspective (the “Guidelines”). The heart of the Guidelines is a category-by-category examination of eight types of “secondary” pharmaceutical patent claims: Markush claims; selection patents; polymorphs; enantiomers; salts; ethers and esters; compositions; doses; combinations; prodrugs; metabolites; and new medical uses. The Guidelines advise patent offices to apply heightened patentability requirements to these claims in a manner that would effectively deny patent protection to important pharmaceutical innovations currently afforded patent protection. In particular, the Guidelines postulate that many forms …

Charting The Contours Of Copyright Regime Optimized For Engineered Genetic Code, Christopher M. Holman

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There is a growing disconnect between the traditional patent-centric approach to protecting biotechnological innovation and the emerging intellectual property imperatives of “synthetic biology,” a promising new manifestation of biotechnology that enables the design and construction of artificial biological pathways, organisms or devices, as well as the redesign of existing natural biological systems. As explained in previous articles, one way to deal with this disconnect would be to expand the scope of copyrightable subject matter to encompass engineered genetic sequences, much in the way that copyright was expanded in the 1970s and 1980s to include computer programs. The present article expands …

The Mayo Framework Is Bad For Your Health, Christopher M. Holman

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This Article begins by providing a brief historical retrospective of the development of the patent eligibility doctrine, and then delves into the related questions of: (1) what are the Supreme Court’s policy objectives for the recent reinvigoration of the patent eligibility doctrine; and (2) has it achieved those objectives? The article then discusses three important out-standing questions regarding the application of the new test for patent eligibility: (1) what constitutes a natural phenomenon; (2) what constitutes an inventive step; and (3) what, if any, role does preemption play in the analysis? The article then provides four examples of recent lower …

Are Engineered Genetic Sequences Copyrightable?: The U.S. Copyright Office Addresses A Matter Of First Impression, Christopher M. Holman, Claes Gustafsson, Andrew W. Torrance

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In spite of the compelling logic that would support extending copyright to engineered DNA sequences, copyright protection for genetic code has not been legally recognized in the US, or as far as we know anywhere. The Copyright Act is silent on the point, the courts do not appear to have ever addressed the question, and the Copyright Office has taken the position that an engineered genetic sequence is not copyrightable subject matter. In an attempt to advance the conversation, we submitted an engineered DNA sequence to the Copyright Office for registration, and then appealed the Office’s decision refusing to register …

The Critical Role Of Patents In The Development, Commercialization And Utilization Of Innovative Genetic Diagnostic Test And Personalized Medicine, Christopher M. Holman

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Arguments in favor of reining in the availability of effective patent protection in the area of genetic diagnostic testing are based largely on two fundamental misconceptions regarding the role of patents in this important area of technological innovation. The first is the mistaken assumption that patents negatively impact patient access to genetic diagnostic testing by preventing research that might lead to new or improved versions of a genetic test and by increasing the cost of testing services. The second is the failure to appreciate the substantial positive role patents play in in the development and utilization of genetic diagnostic tests. …

Do Biotech Patent Lawsuits Really “Overwhelmingly Lose?”: A Response To Our Divided Patent System, Christopher M. Holman

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On October 14, 2014, Stanford’s Professor Mark Lemley tweeted “My new study with Allison & Schwartz shows that software and biotech patent lawsuits overwhelmingly lose.” He was referring to an article entitled Our Divided Patent System, co-authored by Lemley and two other prominent law professors. Taken at face value, the assertion that “biotech patent lawsuits overwhelmingly lose” would seem to hold troubling implications for biotechnology. In order to better understand the basis for Lemley’s assertion, I reanalyzed the underlying data and found that the situation is not nearly as bleak as his tweet might suggest. My significantly different interpretation of …

Developments In Synthetic Biology Are Altering The Ip Imperatives Of Biotechnology, Christopher M. Holman

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While the accomplishments of the biotechnology industry have been substantial, recent technological advances promise to dramatically increase the power and utility of the discipline over the coming years. The term “synthetic biology” has been coined to describe the application of these powerful new tools to the engineering of synthetic genetic sequences and organisms. In essence, synthetic biology represents the next iteration in the ongoing evolution of biotechnology, and hopes run high that in time, the fruits of synthetic biology will dwarf the past successes of conventional biotechnology. There is, however, some concern that the current patent-centric approach to Intellectual Property …

Supreme Court Asked To Consider Role Of Post-Filing Evidence In Assessing Obviousness Of Pharmaceutical Inventions, Christopher M. Holman

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On January 20, 2015, Bristol-Myers Squibb petitioned for certiorari in Bristol-Myers Squibb v. Teva Pharmaceutical, asking whether an assessment of obviousness should "consider post-filing evidence showing the actual differences between a patented invention and the prior art." The district court had found patent claims directed towards Entacavir (an anti-hepatitis drug) obvious in view of structural similarity between the drug and a prior art compound, in spite of the fact that the prior art compound was highly toxic and therefore not a viable candidate for use as a human drug. A Federal Circuit panel affirmed the district court's decision to disregard …

Patent Eligibility Post-Myriad: Reinvigorated Judicial Wildcard Of Uncertain Effect, Christopher M. Holman

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In the 1970s and early 1980s the US Supreme Court issued several landmark decisions establishing the contours of patent eligibility, a judicially created doctrine that serves as a gatekeeper to prevent the patenting of subject matter deemed so fundamental as to be better left unpatented. Over the course of the next 25 years the Court of Appeals of the Federal Circuit oversaw a progressive expansion in the scope subject matter deemed patent eligible, highlighted by the adoption in the 1990’s of a “useful, concrete and tangible” test for patent eligibility that for all practical purposes seemed to subsume the patent …

How Real Is The Concern That Seed Patents Will Turn Farmers Into Inadvertent Infringers?, Christopher M. Holman

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The fear that farmers could be found liable for patent infringement based on the inadvertent presence of patented genetically modified plants on the farmer’s fields has led to calls for limitations on the scope and enforceability of patents. These “reforms” would be especially problematic for agricultural biotechnology companies like Monsanto, but the repercussions could be more widespread, impacting a host of important cutting-edge technologies like synthetic biology and nanotechnology. Although stories of farmers being sued by Monsanto after their fields where inadvertently contaminated by genetic drift are widely circulated, inadvertent infringement based upon genetic drift or the presence of trace …

Mayo, Myriad, And The Future Of Innovation In Molecular Diagnostics And Personalized Medicine, Christopher M. Holman

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Contrary to popular perception, the Supreme Court’s recent decision in Association for Molecular Pathology v. Myriad Genetics, Inc., finding certain patent claims reciting isolated genomic DNA molecules patent ineligible is likely to have a relatively minor impact on the patenting of diagnostics and personalized medicine. Method claims generally play a much more important role than isolated DNA claims in the patenting of innovations in this important technological sector, and the Court’s earlier decision in Mayo v. Prometheus Labs that held claims directed towards non-genetic methods of personalized medicine to be patent ineligible will likely prove significantly more problematic in this …

Do Police Learn From Lawsuit Data?, Randall K. Johnson

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A compelling new theory argues that lawsuit data collection has a deterrent effect on police misconduct. If this theory is correct, why has the number of police misconduct cases still increased over time? Does the trend continue if police departments consistently gather lawsuit data? A § 1983 dataset, which is introduced in this paper, provides an answer. This dataset shows that lawsuit data collection does not correlate with better deterrence of § 1983 cases. The dataset therefore indicates that police departments may not learn from lawsuit data.

Unpredictability In Patent Law And Its Effect On Pharmaceutical Innovation, Christopher M. Holman

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In recent years, the major innovator pharmaceutical companies have experienced two pronounced and significant trends: a decreasing output of innovative new drugs and cutbacks in research and development (R&D) investment. The two phenomena probably are not unrelated and raise significant concerns for a society intent upon providing affordable health care for an aging population. While the root causes of these trends are complex and diverse, we should not overlook the critical role patents play in creating the necessary incentives for the substantial investment required to develop pharmaceutically-interesting chemical compounds into actual drugs and to take them through the clinical trials …

Misplaced Fears In The Legislative Battle Over Affordable Biotech Drugs, David E. Adelman, Christopher M. Holman

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Much like tort reform, the debate over recently enacted legislation on biotech drugs — and particularly regulatory supplements to patent protection — has taken on a significance that dwarfs its impact on prescription drug expenditures. Under the Health Care Reform legislation, Congress enacted two major reforms: First, creation of an abbreviated Food and Drug Administration (FDA) approval process for follow-on biologics (FOBs), which are the analogues of generics for biotech drugs. Second, establishment of a twelve-year “data exclusivity” period in which clinical testing data collected by brand-name innovators cannot be used by producers of FOBs to satisfy FDA testing requirements. …

The Role Of Patent Eligibility In Policing Claim Scope, Christopher M. Holman

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Bilski v. Kappos (Bilski II) empowered the lower courts to deploy patent eligibility as a doctrinal tool for policing claim scope. Because Bilski II leaves the test for patent eligibility largely undefined, the lower courts and PTO, in particular the Federal Circuit, could actively invoke the doctrine as a “wildcard” to invalidate patent claims deemed unduly broad, or otherwise “unworthy” by the court. Judge Rader made a similar observation recently with respect to the Lilly written description requirement, another doctrine of patentability for which the criteria for compliance remains largely undefined. However, early indications suggest that the Federal Circuit and …

Introduction: Symposium On Law, Entrepreneurship, And Economic Recovery, Anthony J. Luppino

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No abstract provided.

Fixing A Hole: Eliminating Ownership Uncertainties To Facilitate University-Generated Innovation, Anthony J. Luppino

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No abstract provided.

To Live In In-‘Fame’-Y: Reconceiving Scandalous Marks As Analogous To Famous Marks, Jasmine C. Abdel-Khalik

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In 1905, Congress enacted a revised trademark registration act, which included a prohibition on registering marks containing or consisting of scandalous or immoral material. Because Congress failed to provide any further guidance either in legislative history or in the statutory language, administrative bodies and the courts have struggled to define this standard. Over the past century, decisions applying this prohibition have been inconsistent. The general public and potential trademark owners are unable to predict accurately if a mark will be accepted or refused for federal registration, which has some significant benefits. Perhaps because of this uncertainty, some estimate that hundreds …