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The Oversimplification Of Deregulation: A Case Study On Clinical Decision Support Software, Deeva V. Shah
The Oversimplification Of Deregulation: A Case Study On Clinical Decision Support Software, Deeva V. Shah
Michigan Telecommunications & Technology Law Review
Until the December 2016 passage of the Cures Act, the FDA had regulatory power over clinical decision support (CDS) software; however, the Act removed a large group of CDS software from the FDA’s statutory authority. Congressional intent was to increase innovation by removing regulatory blockades—such as device testing and certification—from the FDA’s purview. This note argues that the enactment of this specific provision of the Act will instead stymie innovation and overlook the unfortunate safety consequences inherent in its deregulation. CDS software is a burgeoning field ripe for innovation; however, rapid innovation can often lead to a slew of mistakes—mistakes …
After Myriad: Reconsidering The Incentives For Innovation In The Biotech Industry, Daniel K. Yarbrough
After Myriad: Reconsidering The Incentives For Innovation In The Biotech Industry, Daniel K. Yarbrough
Michigan Telecommunications & Technology Law Review
35 U.S.C. § 101 allows a patent for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Recently, the Supreme Court issued several key decisions affecting the doctrine of patentable subject matter under § 101. Starting with Bilski v. Kappos (2011), and continuing with Mayo Collaborative Services, Inc. v. Prometheus Laboratories (2012), Association for Molecular Pathology v. Myriad Genetics (2013) and, most recently, Alice Corporation Pty. Ltd. v. CLS Bank International (2014), every year has brought another major change to the way in which the Court assesses patentability. In Myriad, the …
Creating A Plug-In Electric Vehicle Industry Cluster In Michigan: Prospects And Policy Options, Thomas P. Lyon, Russell A. Baruffi Jr.
Creating A Plug-In Electric Vehicle Industry Cluster In Michigan: Prospects And Policy Options, Thomas P. Lyon, Russell A. Baruffi Jr.
Michigan Telecommunications & Technology Law Review
This Article seeks to examine how policy can be used strategically to foster the development of a plug-in electric vehicle ("PEV") industry cluster in Michigan. The tendency for certain industries to localize in particular regions has captured the interest of much economic research and policy discussion in recent years. The trend toward the clustering of new industries has stayed strong despite the acceleration of globalization. Attention to clusters has proven to be an enduring theme in economic development circles for nearly thirty years. Clusters generate synergies that make industrial activity greater than the sum of contributions by individual players. In …
Pioneers Versus Improvers: Enabling Optimal Patent Claim Scope, Timothy Chen Saulsbury
Pioneers Versus Improvers: Enabling Optimal Patent Claim Scope, Timothy Chen Saulsbury
Michigan Telecommunications & Technology Law Review
Arising most commonly as a defense to an infringement claim, enablement requires a patent to describe the claimed invention in sufficient detail to permit a person having ordinary skill in the relevant field to replicate and use the invention without needing to engage in "undue experimentation." If a patent claim is not "enabled"--i.e., if a person having ordinary skill in the art (PHOSITA) who studied the patent cannot make or use the invention without undue experimentation--the claim is invalid and can no longer be asserted. This penalty deters patent applicants from claiming more than they invented and allows others to …
Why Fdca Section 505(U) Should Not Concern Us Greatly, Kyle Faget
Why Fdca Section 505(U) Should Not Concern Us Greatly, Kyle Faget
Michigan Telecommunications & Technology Law Review
Among the many amendments found in the Food and Drug Administration Amendment Act of 2007 (FDAAA) is a provision at the end of the act, Section 505(u), which grants chiral switches five years of market exclusivity under certain circumstances. Prior to Congressional enactment of the FDAAA, the Food and Drug Administration (FDA) refused to award new chemical entity (NCE) status to enantiomers of previously approved racemic mixtures. The FDA defines a new chemical entity ("NCE") as a drug that contains no active moiety that has been approved by the FDA in any other application submitted under Section 505(b) of the …
Research Tool Patents After Integra V. Merck - Have They Reached A Safe Harbor, Wolrad Prinz
Research Tool Patents After Integra V. Merck - Have They Reached A Safe Harbor, Wolrad Prinz
Michigan Telecommunications & Technology Law Review
The saga surrounding the Integra v. Merck cases has rekindled a heated debate about the proper scope of both common law exemption and the safe harbor provision, causing significant concern for owners of research tool patents. This Article will argue that the next judicial decision addressing the question of research tool patents should clarify that they are in a safe harbor because none of the two exemptions from infringement referenced above extends to the use of research tools in experiments in order to preserve the necessary incentives for their creation in the first place. Allowing access to research tools under …
Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz
Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz
Michigan Telecommunications & Technology Law Review
Before a new drug can be marketed, the Food and Drug Administration must be satisfied that it is safe and effective. According to conventional wisdom, the cost and delay involved in this process diminish the incentives to invest in the development of new drugs. Accordingly, several reforms aimed at restoring such incentives have been implemented or advocated. This Article challenges the central argument that drug regulation and drug innovation are necessarily at odds with one another. Although intuitively appealing, the argument that drug regulation negatively affects the incentives to innovate does not fully capture the role that regulation plays in …
Economics And The Design Of Patent Systems, Robert M. Hunt
Economics And The Design Of Patent Systems, Robert M. Hunt
Michigan Telecommunications & Technology Law Review
I use intuition derived from several of my research papers to make three points. First, in the absence of a common law balancing test, application of uniform patentability criteria favors some industries over others. Policymakers must decide the optimal tradeoff across industries. Second, if patent rights are not closely related to the underlying inventions, more patenting may reduce R&D in industries that are both R&D and patent intensive. Third, the U.S. private innovation system has become far more decentralized than it was a generation ago. It is reasonable to inquire whether a patent system that worked well in an era …
Patents And Diversity In Innovation, Brian Kahin
Patents And Diversity In Innovation, Brian Kahin
Michigan Telecommunications & Technology Law Review
Over the past quarter-century, the patent system has expanded in scope and significance, claiming a central position in a U.S. economy increasingly based on knowledge and intangible assets. This historic expansion has come at the cost of controversy and, within the past five years, growing public scrutiny from outside the system--from the press, business, Congress, and finally the Supreme Court. However, proposed reforms are marked by deepening divisions between sectors of the economy. The information technology (IT) and services industries favor strong reforms while pharmaceutical and biotech industries, as well as the patent bar, favor modest, incremental reforms. This yawning …
Knowledge, Competition And The Innovation: Is Stronger Ipr Protection Really Needed For More And Better Innovations, Giovanni Dosi, Luigi Marengo, Corrado Pasquali
Knowledge, Competition And The Innovation: Is Stronger Ipr Protection Really Needed For More And Better Innovations, Giovanni Dosi, Luigi Marengo, Corrado Pasquali
Michigan Telecommunications & Technology Law Review
The main questions addressed in this Article are thus: given that growth is a highly desirable phenomenon and that it is primarily spurred by technological innovation, how should society solve the problem of favoring a sufficient level of investments in R&D? In particular, is it necessarily true and always desirable that, independent of any other consideration, society should protect innovators from competition and shelter them in a legally protected and enforced monopoly? Is it true that the real source of economic value of new recipes is only found in the blueprints of ideas that those recipes implement? Is it necessarily …
The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg
The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg
Michigan Telecommunications & Technology Law Review
This Article reexamines the role of FDA regulation in motivating investment in biopharmaceutical innovation. I begin by challenging the standard story that it is the patent system that makes drug development profitable, and drug regulation that makes it costly, by showing how patents add to costs and how drug regulation works in tandem with patents to protect profits. I then compare FDA-administered exclusive rights to patents as a means of fortifying drug development incentives, suggesting ways that FDA-administered rights might be preferable both from the perspective of policy makers and from the perspective of firms. In the remainder of the …
Why Pharmaceutical Firms Support Patent Trolls: The Disparate Impact Of Ebay V. Mercexchange On Innovation, Jeremiah S. Helm
Why Pharmaceutical Firms Support Patent Trolls: The Disparate Impact Of Ebay V. Mercexchange On Innovation, Jeremiah S. Helm
Michigan Telecommunications & Technology Law Review
Before the unanimous decision in eBay v. MercExchange, patent holders were almost always granted an injunction against an infringer. In fact, the Federal Circuit, in deciding eBay, noted that, upon a finding of infringement, an injunction would issue unless there were extraordinary circumstances. The Court, in a brief opinion, disagreed with the Federal Circuit and explained that the injunction issue in a patent case must be analyzed under the traditional four-factor test.[...] Is the four-factor test fairer or better than the Federal Circuit's near-automatic injunction rule? It is certainly more difficult to administer a factor test as compared to a …
Supporting Innovation In Targeted Treatments: Licenses Of Right To Nih-Funded Research Tools, Tanuja V. Garde
Supporting Innovation In Targeted Treatments: Licenses Of Right To Nih-Funded Research Tools, Tanuja V. Garde
Michigan Telecommunications & Technology Law Review
Support for new drug development has taken some interesting turns in current patent law jurisprudence. Beginning with the severe curtailment of scope of the common law experimental use doctrine in Madey v. Duke University, and culminating with the recent Supreme Court decision in Merck KGaA v. Integra Lifesciences I, Ltd., broadening the scope of the statutory research exemption, the freedom to conduct experimental research using another's patented inventions becomes dependent in part on the purpose of the research. That the patent at issue in Merck was characterized by the Federal Circuit as being directed to a research tool raised the …
Better, Faster, Cheaper - Later: What Happens When Technologies Are Suppressed, Kurt M. Saunders, Linda Levine
Better, Faster, Cheaper - Later: What Happens When Technologies Are Suppressed, Kurt M. Saunders, Linda Levine
Michigan Telecommunications & Technology Law Review
Some inventions never see the light of day. Others enter the spotlight after long delays and the factors that slowed the arrival of that innovation are ignored. Technology suppression is a real occurrence involving well known and widely used products. In this Article, we examine the topic of technology suppression, seeking to reveal the tactics of suppression and the patterns and conditions under which it occurs. Current examples of US technologies are used to highlight the significance of this phenomenon. We consider related factors, including market and innovation forces, and we identify suppressive tactics, using illustrative cases where patent nonuse …
Festo: A Case Contravening The Convergence Of Doctrine Of Equivalents Jurisprudence In Germany, The United Kingdom, And The United States, Katherine E. White
Festo: A Case Contravening The Convergence Of Doctrine Of Equivalents Jurisprudence In Germany, The United Kingdom, And The United States, Katherine E. White
Michigan Telecommunications & Technology Law Review
Despite differences in patent law jurisprudence in Germany, the United Kingdom and the United States, the fundamental principles underlying each system serve the same basic purpose: to encourage technological innovation and dissemination of knowledge. In granting exclusive patent rights, it is important that the scope of patent protection not be so broad as to remove existing knowledge from the public domain. The scope of protection should strike a balance between granting adequate patent rights while preserving the public's ownership in the public domain or the prior art. To encourage innovation patentees must attain significant exclusive rights, while potential infringers receive …
To Innovate Or Not To Innovate, That Is The Question: The Functions, Failures, And Foibles Of The Reward Function Theory Of Patent Law In Relation To Computer Software Platforms , Seth A. Cohen
Michigan Telecommunications & Technology Law Review
The patent system has traditionally been viewed as having two primary functions: the reward function and the prospect function. Although these theories do explain some behavior which results from the practical applications of the patent system, they also overlook some behavior of the patent system which indicates a failure of these functions. In order to properly prevent such failure, this paper proposes that the patent system adopt an orientation that will lead to increased innovative rivalry and competition. In Part I, using the computer operating system software market as an example, I propose a framework for reconceptualizing patent protection as …