Digital Commons Network^™

The Case Of The Missing Device Patents, Or: Why Device Patents Matter, Erika Lietzan, Kristina M. L. Acri, Evan Weidner

Faculty Publications

A company that earns premarket approval of its medical device is entitled to an extension of one patent claiming the device, to make up for some of the time it spent doing premarket research. Yet, surprisingly, a mere thirteen percent of those eligible for this extension (also known as patent term "restoration") ask for one. In contrast, most drug companies entitled to this same patent extension ask for one.

In this Article, we attribute the imbalance largely to differences between the two regulatory frameworks. In brief, because the FDA classifies and regulates devices based on what they do and how …

Muddy Waters: Fair Use Implications Of Google V. Oracle America, Inc., Gary Myers

Faculty Publications

The United States Supreme Court ruling in Google LLC v. Oracle America, Inc. ended a long-running dispute between two giant technology companies. The case, which first began in 2010, has received considerable attention and commentary with regard to the scope of copyright protection for software and then about the contours of the fair use defense. The Court ultimately left the software copyright questions for another day, but it did render an important decision on fair use, the first major precedent on this important topic since 1994.

The Court’s fair use ruling provides important guidance on the scope of fair use …

Resorbing Patent Law's Kessler Cat Into The General Law Of Preclusion, Dennis D. Crouch, Homayoon Rafatijo

Faculty Publications

It has become exceedingly common in our legal system that courts, in the guise of respect for precedent, compound upon errors. Legal precedents are written documents, but "[t]he reality we can put into words is never reality itself." As such, we seldom find a court decision that embodies the entire legal reality regarding the questions presented. In this respect, the legal system inherently suffers from a lack of what mathematicians call completeness. Each decision gives rise to countless inferences because what lower courts observe by reading the precedent is not the entire legal reality but an incomplete reality exposed to …

Copyright Law: An Open Source Casebook, Gary Myers

Open Educational Resources

Copyright Law is an open access casebook available for free to students. This edition was published in Spring 2019.

Digital Sampling V. Appropriation Art: Why Is One Stealing And The Other Fair Use? A Proposal For A Code Of Best Practices In Fair Use For Digital Music Sampling, Melissa Eckhause

Missouri Law Review

This Article examines the disparate treatment of music and visual arts sampling under copyright law. Not only does this Article argue that the more liberal fair use principles adopted in recent visual arts cases should be applied to digital music sampling, but it also sets forth a preliminary Code of Best Practices in Fair Use for Digital Music Sampling (“Digital Music Sampling Code”).

Does Trips Stop International Ip Free-Riders, Sam F. Halabi

Faculty Publications

Innovation policy-a relatively new phrase for an old set of top-down competitiveness approaches (e.g. "industrial policy," "science policy," "research policy," and "technology policy")-is necessarily a combination of centralized investment, structure of private-sector incentives, and public policy priorities.This combination has always been unwieldy, multivariate, and politically charged. As a result, constituencies favoring one or other approaches (e.g. longer patent protection, more funding of public universities and research infrastructure, tariff or non-tariff import measures) have lacked a unifying framework through which to analyze shared problems. In Innovation Policy Pluralism, Daniel J. Hemel and Lisa Larrimore Ouellette provide that framework. With a focus …

The "Evergreening" Metaphor In Intellectual Property Scholarship, Erika Lietzan

Faculty Publications

This article is a plea for changes in the scholarly dialogue about "evergreening" by drug companies. Allegations that drug companies engage in "evergreening" are pervasive in legal scholarship, economic scholarship, medical and health policy scholarship, and policy writing, and they have prompted significant policymaking proposals. This Article was motivated by concern that the metaphor has not been fully explained and that policymaking in response might therefore be premature. It canvasses and assesses the scholarly literature-more than 300 articles discussing or mentioning "evergreening." It catalogues the definitions, the examples, and the empirical studies. Scholars use the term when describing certain actions …

Viral Sovereignty, Intellectual Property, And The Changing Global System For Sharing Pathogens For Infectious Disease Research, Sam F. Halabi

Faculty Publications

This article analyzes the substantial changes under way in the global system for infectious disease research demonstrated by the changing practices in negotiating MTAs. Instead of the open system of sharing bacterial and viral human pathogens that characterized the research system for much of the 20th Century, notions of "viral sovereignty," access contingent upon provisions like sharing research benefits, and acrimonious negotiations, are far more common. The increasing barriers to the flow of research material and related data like genetic sequencing information are posing threats to public health responses and the potential use of such resources in diagnostic, therapeutic, and …

The Drug Repurposing Ecosystem: Intellectual Property Incentives, Market Exclusivity, And The Future Of "New" Medicines, Sam F. Halabi

Faculty Publications

The pharmaceutical industry is in a state of fundamental transition. New drug approvals have slowed, patents on blockbuster drugs are expiring, and costs associated with developing new drugs are escalating and yielding fewer viable drug candidates. As a result, pharmaceutical firms have turned to a number of alternative strategies for growth. One of these strategies is "drug repurposing"-finding new ways to deploy approved drugs or abandoned clinical candidates in new disease areas. Despite the efficiency advantages of repurposing drugs, there is broad agreement that there is insufficient repurposing activity because of numerous intellectual property protection and market failures. This Article …

Ex Parte Seizures Under The Dtsa And The Shift Of Ip Rights Enforcement, Yvette Joy Liebesman

The Business, Entrepreneurship & Tax Law Review

The ex parte seizure provision of the Defend Trade Secrets Act is another step in a long line of legislation that shifts the costs of private enforcement to the public, which already has a toehold in copyright and trademark law. The ex parte provision—which is not incorporated into any state trade secret law—relieves rights owners of two “burdens.” First, it relieves the trade secret owner of the burden of actually having to compete in the marketplace. Second, it relieves the trade secret owner of the burden of the costs associated with the discovery process of a lawsuit. The effect of …

Symposium Keynote: The Dtsa And The New Secrecy Ecology, Orly Lobel

The Business, Entrepreneurship & Tax Law Review

The Defend Trade Secrets Act (“DTSA”), which passed in May 2016, amends the Economic Espionage Act (“EEA”), a 1996 federal statute that criminalizes trade secret misappropriation. The EEA has been amended several times in the past five years to increase penalties for violations and expand the available causes of action, the definition of a trade secret, and the types behaviors that are deemed illegal. The creation of a federal civil cause of action is a further expansion of the secrecy ecology, and the DTSA includes several provisions that broaden the reach of trade secrets and their protection. This article raises …

The Defend Trade Secrets Act Whistleblower Immunity Provision: A Legislative History, Peter Menell

The Business, Entrepreneurship & Tax Law Review

The Defend Trade Secrets Act of 2016 ("DTSA") was the product of a multi-year effort to federalize trade secret protection. In the final stages of drafting the DTSA, Senators Grassley and Leahy introduced an important new element: immunity "for whistleblowers who share confidential information in the course of reporting suspected illegal activity to law enforecement or when filing a lawsuit, provided they do so under seal." The meaning and scope of this provision are of vital importance to enforcing health, safety, civil rights, financial market, consumer, and environmental protections and deterring fraud against the government, shareholders, and the public. This …

Print Your Own Pandora's Box: 3d Printing, Intellectual Property Law, And The Internet For Lay-Lawyers, Adam Lewental

The Business, Entrepreneurship & Tax Law Review

This comment’s main purpose is to explore intellectual property law meant to protect against manufacturing infringement after manufacturing becomes decentralized. Part II glimpses into the applicable 3D printing technology, with a focus on its current capabilities and future application. Part III explores the rift between utility and design intellectual property protection within the framework of intellectual property protection. Part IV analyzes the overlap of the technology and the law. Part V projects the potential impact of inaction by drawing comparisons to parallel issues, as well as the potential impact of the technology itself.

Developing A Matrix For Intellectual Property As Subject Of International Law, Sam F. Halabi

Faculty Publications

Intellectual property disputes implicating diverse and seemingly unrelated international legal regimes have become more frequent, acrimonious, and high-stakes. This trend has spawned an enormous academic literature endeavoring to rationalize the approach various interpretive authorities take to intellectual property disputes. Graeme Austin and Larry Helfer's Human Rights and Intellectual Property offered a framework by which to resolve claims for or against intellectual property protection based on human rights arguments; Susy Frankel has extensively assessed the application of customary international rules of interpretation in furtherance of a rationalizing approach to complex IP conflicts; and Jerry Reichman. Paul Uhlir. and Tom Dedeurwaerdere have …

Wrongly Affirmed Without Opinion, Dennis D. Crouch

Faculty Publications

In his 1909 treatise on appellate jurisdiction, the future Justice Benjamin Cardozo explained the role of appellate courts - not simply "declaring justice between man and man, but . .. settling the law." In Justice Cardozo's view, the appellate courts exist "not for the individual litigant, but for the indefinite body of litigants, whose causes are potentially involved in the specific cause at issue." Justice Cardozo's vision more than a century ago still resonates, and precedential opinions form a mainstay of appellate court activity nationwide. However, one court of appeals is quite different from the rest. The Court of Appeals …

Dispute Resolution Tools In Patent Infringement Cases: Aoki V. Gilbert, No. 2:11-Cv02787-Tln-Cnd, 2015 Wl 5734626 (E.D. Cal. 2015), Brandon Craig

Journal of Dispute Resolution

While arbitration has become a widely accepted alternative to litigation, the role it should play in patent disputes has been widely debated. Issued by the federal government, patents confer a temporary monopoly on the production, use, and sale of new innovations. The government may have an interest in keeping such disputes out of the private realm of arbitration, at least when the dispute is over the validity of the patent. For other patent issues such as licensing, which is essentially a private contract, arbitration may serve as a useful and cost-effective alternative. Even when arbitration is not warranted, other useful …

International Intellectual Property Shelters, Sam F. Halabi

Faculty Publications

The battle over the reach and strength of international protections for intellectual property rights is one of the critical flashpoints between wealthy and low-income countries: those protections are perceived to obstruct access to essential medicines, thwart regulatory efforts to promote individual and population health, and undermine traditional forms of agriculture and food production. While scholars have thoroughly tracked the bilateral and multilateral trade and investment treaties responsible for the expansion of international intellectual property rights worldwide, they have paid significantly less attention to the strength and form that opposition to international intellectual property expansion has taken. This Article examines the …

The Myths Of Data Exclusivity, Erika Lietzan

Faculty Publications

This article contributes to an ongoing academic and public policy dialogue over whether and on what terms U.S. law should provide “data exclusivity” for new medicines. Five years after a new drug has been approved on the basis of an extensive application that may have cost more than one billion dollars to generate, federal law permits submission of a much smaller application to market a duplicate version of the drug. This second application is a different type of application, and it may cost no more than a few million dollars to prepare. A similar sequence is true for biological medicines: …

The History And Future Of E-Commerce Patents, Dennis D. Crouch, Mitchell L. Terry

Faculty Publications

The past two decades have seen a great rise in the patenting of e-commerce inventions. Now, those same patents are taking an equally great fall. In a series of four recent cases, the U.S. Supreme Court has shifted the doctrine of patent eligibility and, in the process, raised the bar for e-commerce and software patents - making it more difficult to obtain and enforce those types of patents.

Multipolarity, Intellectual Property And The Internationalization Of Public Health Law, Sam F. Halabi

Faculty Publications

This Article critically examines the proliferation of international legal agreements addressing global health threats like the outbreak of infectious diseases, tobacco use and lack of access to affordable medicines. The conventional wisdom behind this trend is that a global normative shift has occurred which has caused states to regard health as “special” and less subject to the normal rules of international law making because health threats endanger all of humanity. This Article challenges that thesis, arguing that at the same time the number and scope of international health law treaties has grown, developed states have subordinated health law to intellectual …

The Standard For Awarding Attorney Fees Under 35 U.S.C. Section 285 To Prevailing Parties In Patent Litigation - Octane Fitness, Llc V. Icon Health & Fitness, Inc. And Highmark, Inc. V. Allcare Health Management Systems, Dennis D. Crouch, Jafon Fearson

Faculty Publications

The Supreme Court granted certiorari in two patent infringement cases that both concern shifting of attorney fees under the “exceptional case” standard of 35 U.S.C. § 285. The Federal Circuit has traditionally been resistant to fee shifting awards—especially in cases where an accused infringer is the prevailing party. In Octane Fitness, petitioner asks the Court to lower the standard for proving an exceptional case. In Highmark, petitioner asks for deference to lower court exceptional case findings.

A New Framework For Assessing Clinical Data Transparency Initiatives, Erika Lietzan

Faculty Publications

Biopharmaceutical companies submit vast amounts of clinical data and analysis to support approval of their medicines, expecting the information to be kept confidential, as has been the practice of regulators around the world for decades. Over the last ten years, however, pressure has been mounting for regulators or industry to release this information. Legal scholars have generally taken the view that no relevant doctrines or bodies of law preclude the release of this material and that public policy considerations compel its release. This article argues that the scholarship to date has overlooked key considerations: the special issues presented by operation …

Seed Patents, Patent Exhaustion, And Third Parties - Bowman V. Monsanto Co., Dennis D. Crouch

Faculty Publications

Monsanto patents cover genetically modified glyphosate-resistant soybeans. A farmer purchased soybeans from a commodity market and argues that the “first sale doctrine” exhausts the patent rights as to those soybeans and their progeny. If successful, the farmer can save and replant the soybeans without paying licensing fees. Monsanto argues that exhaustion does not apply to new soybeans grown through replanting; even rights in the parent seeds are exhausted. In addition, Monsanto argues that the purchased soybeans are bound by a use-restriction servitude that bars farmers from planting seeds purchased from the commodity market.

A Trademark Justification For Design Patent Rights, Dennis D. Crouch

Faculty Publications

This article presents a new set of empirical results to support the theoretical construct that design patents fill a gap in trade dress law protection. Based on the data, I tentatively reject the oft-stated conventional wisdom that design patents are worthless for many because procurement is too slow, expensive, and difficult. Rather, based on a first-of-its-kind analysis of the prosecution history files of a large sample of recently issued design patents, I conclude that the current design patent examination system operates as a de facto registration system. Notably, more than ninety-eight percent (98%) of the patents in my study were …

International Trademark Protection And Global Public Health: A Just-Compensation Regime For Expropriations And Regulatory Takings, Sam F. Halabi

Faculty Publications

Lawmakers in developed and developing countries are expanding legal protections for trademarks – words, combinations of colors, signs, letters, numerals, figurative elements and designs meant to convey the origin and quality of firms’ goods or services. The purported rationales underlying trademark protection are promotion of competition and reduction of consumers’ information costs. Trademark law promotes competition by giving trademark holders an incentive to invest in the quality of goods or services and then associate that quality with a relatively easy-to-identify brand, mark or logo. The law punishes private actors who attempt to free-ride on the goodwill built by the trademark …

Copyright Versus The Public Domain: Does The Constitution Allow Congress To Take Works From The Public Domain And Replace Those With Private Exclusive Rights?, Dennis D. Crouch, Ted Wright

Faculty Publications

This case arose out of U.S. treaty obligations to restore copyright to foreign authors who had failed to comply with the pre-1989 formalities in the law. Section 514 of the Uruguay Round Agreement Act (URAA) restores those copyrights and, in doing so, allowed thousands of widely disseminated works to be removed from the public domain. Petitioners challenge the law—arguing that the law overreaches constitutional authority and violates speech rights protected by the First Amendment.

Operating Efficiently Post-Bilski By Ordering Patent Doctrine Decision-Making, Dennis D. Crouch, Robert P. Merges

Faculty Publications

Now that the Supreme Court has decided Bilski v. Kappos, there is an enormous amount of speculation about the case’s impact on patent applicants, litigants, and other participants in the patent system. Most of the commentary is concerned with the holding in Bilski, how this holding will be applied by courts and the Patent Office, and ultimately, the effect of the holding on inventors, and those who hold and seek patents.

Book Review: Reviewing Part Iii Of Innovation For The 21st Century: Harnessing The Power Of Intellectual Property And Antitrust Law, Dennis D. Crouch

Faculty Publications

I have very much enjoyed reading Professor Michael Carrier's important new book on the intersection of law and innovation, and greatly appreciate his contributions to the field. In this short essay, I will focus my discussion on my sole area of expertise—patent law. Carrier takes-on the subject of patents in Part III of his book. I agree with most of what Carrier writes. To make this essay more interesting, I focus on some of our areas of apparent disagreement.

An Empirical Study Of The Role Of The Written Description Requirement In Patent Prosecution, Dennis D. Crouch

Faculty Publications

An en banc Federal Circuit is now considering whether Section 112 of the Patent Act as properly interpreted includes a written description requirement that is separate and distinct from the enablement requirement. Although the USPTO has no direct role in the infringement dispute, the government submitted an amicus curie brief arguing that a separate written description requirement is “necessary to permit the USPTO to perform its basic examination function.” However, when pressed during oral arguments the government could not point to any direct evidence supporting its contention.

This essay presents the results of a retrospective empirical study of the role …

Unofficial Legislative History Of The Biologics Price Competition And Innovation Act 2009, An, Erika Lietzan, Krista Hessler Carver, Jeffrey Elikan

Faculty Publications

On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act of 2009 (BPCIA) which created a regulatory pathway for, and scheme for litigation of patent issues relating to, “biosimilar” biological products. This article discusses the history of the BPCIA and explains its provisions. Section I provides background and a history of the regulation of drugs and biological products in the United States. Section II describes the growing interest in biosimilar approval from the early 2000s through September 2006, when the legislative debate began in earnest. Section III describes the legislative and stakeholder process from …