Law Commons^™

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 …

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 …

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 …

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 …

Intellectual Property Resources In And For Space: The Practitioner's Experience, Gary Myers

Faculty Publications

Today, our inquiry is timely because, increasingly, intellectual property law is becoming more important in space activities. The increasing sophistication of international cooperation and the growth of commercial and private space activities have brought intellectual property issues to greater prominence.

2004 Update - 180-Day Exclusivity Under The Hatch-Waxman Amendments To The Federal Food, Drug, And Cosmetic Act, Erika Lietzan

Faculty Publications

This article updates the author's previously published article on the topic, provides some insight into recent events in this area of the law, and specifies a few minor items that were noted incorrectly in the earlier work.

Cybercoverage For Cyber-Risks: An Overview Of Insurers' Responses To The Perils Of E-Commerce, Robert H. Jerry Ii, Michele L. Mekel

Faculty Publications

With nearly seven percent of the world's population currently online and e-commerce forecast to hit $6.8 trillion by 2004, one need not be Nostradamus to predict that the Internet means great change for all industries - including the insurance industry. Presently, however, the proverbial cart is leading the horse as the insurance industry struggles to develop strategies to quantify, cover, and contain "cyber-risks." Policyholders also face new challenges as they confront the possibility that their traditional insurance coverages are woefully inadequate either to secure their electronic and intellectual property assets or to guard against their potential e-commerce liabilities to third …

Statutory Interpretation, Property Rights, And Boundaries: The Nature And Limits Of Protection In Trademark Dilution, Trade Dress, And Product Configuration Cases, Gary Myers

Faculty Publications

This article, however, takes the view that the basic landscape in trademark law is unlikely to change in the near future. Congress has only recently enacted the Trademark Dilution Act, and there seems to be little movement to amend it dramatically, let alone repeal it. There have been several recently enacted amendments to the Lanham Act addressing functionality that make great sense and are consistent with the principles suggested here, as will be discussed below. Moreover, the Supreme Court in Two Pesos, Qualitex, Park ‘n’ Fly, and Samara has recently set forth rules that will allow trade dress claims to …

The Restatement's Rejection Of The Misappropriation Tort, Gary Myers

Faculty Publications

Some legal theories, like the proverbial vampire, refuse to die. The common law tort of misappropriation is one such legal theory, and the recent Restatement (Third) of Unfair Competition (Restatement) may finally lead to the demise of this outdated cause of action. Misappropriation began advisedly enough as a means of protecting certain intellectual property rights from unjust usurpation, often by direct competitors employing improper means. Arising before comprehensive copyright, patent, and trademark laws were fully developed, the tort may have played an important role in protecting intangible proprietary interests.The tort's high water mark was the 1918 Supreme Court decision in …

Re-Tailoring Jury Trial Rights, Richard C. Reuben

Faculty Publications

The debate over improving the civil justice system has gone through many permutations over the years. Discovery, punitive damages and alternative dispute resolution are but a few of the paths that have been pursued. A case argued to the U.S. Supreme Court in January addresses the question from yet another-and potentially a more fundamental direction: the reach of the Seventh Amendment's guarantee of a jury trial in civil cases in federal court.

Trademark Parody: Lessons From The Copyright Decision In Campbell V. Acuff-Rose Music, Gary Myers

Faculty Publications

Parodies have long provided many of us with amusement, entertainment,and sometimes even information. An effective parody can convey one or more messages with powerful effect. The message may be a political statement, social commentary, commercial speech, a bawdy joke, ridicule of a brand name, criticism of commercialism, or just plain humor for its own sake. Often someone's ox is being gored, or someone feels that a property right has been infringed. The party so injured often contemplates a lawsuit, and an array of legal theories are available to further that impulse. Perhaps copyright infringement is the claim, if some protectable …