Law Commons^™

Intellectual Property As A Determinant Of Health, Ana Santos Rutschman

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Public health literature has long recognized the existence of determinants of health, a set of socio-economic conditions that affect health risks and health outcomes across the world. The World Health Organization defines these determinants as “forces and systems” consisting of “factors combin[ing] together to affect the health of individuals and communities.” Frameworks relying on determinants of health have been widely adopted by countries in the global South and North alike, as well as international institutional players, several of which are direct or indirect players in transnational intellectual property (IP) policymaking. Issues raised by the implementation of IP policies, however, are …

Google V. Oracle Amicus Merits Stage Brief: Vindicating Ip’S Channeling Principle And Restoring Jurisdictional Balance To Software Copyright Protection, Peter Menell, David Nimmer, Shyamkrishna Balganesh

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The Federal Circuit’s decisions in Oracle v. Google conflict with this Court’s seminal decision in Baker v. Selden, 101 U.S. 99 (1879), misinterpret Congress’s codification of this Court’s fundamental channeling principle and related limiting doctrines, and upend nearly three decades of sound, well-settled, and critically important decisions of multiple regional circuits on the scope of copyright protection for computer software. Based on the fundamental channeling principle enunciated in Baker v. Selden, as reflected in § 102(b) of the Copyright Act, the functional requirements of APIs for computer systems and devices, like the internal workings of other machines, are …

Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman

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Patent protection for several of the world’s best-selling and most promising drugs — biologics — has begun waning. Over the next few years, many other drugs in this category will lose critical patent protection. In principle, this should open the United States market to competition, as more manufacturers are now able to produce relatively cheaper versions of these expensive drugs, known as biosimilars. That, however, has not been the case. This Article examines this problem in the context of the articulation between anticompetitive behaviors and regulatory interventions in the biopharmaceutical arena, and argues for a novel solution: a timelier response …

The Mosaic Of Coronavirus Vaccine Development: Systemic Failures In Vaccine Innovation, Ana Santos Rutschman

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Scientists are racing to develop vaccines against the novel coronavirus. While some vaccine candidates may enter the market in record time, the current vaccine innovation ecosystem exposes governance lacunas at both the international and domestic levels.

In The Shadow Of The Law: The Role Of Custom In Intellectual Property, Jennifer E. Rothman

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Custom, including industry practices and social norms, has a tremendous influence on intellectual property (“IP”) law, from affecting what happens outside of the courts in the trenches of the creative, technology, and science-based industries, to influencing how courts analyze infringement and defenses in IP cases. For decades, many scholars overlooked or dismissed the impact of custom on IP law in large part because of a belief that the dominant statutory frameworks that govern IP left little room for custom to play a role. In the last ten years, however, the landscape has shifted and more attention has been given to …

Amending Patent Claims, Gregory Reilly

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Patent claims traditionally have been freely amendable to overcome a finding of unpatentability. For that reason, the Patent Office’s restrictive approach to amendments in new post-issuance review proceedings created by the America Invents Act provoked strident criticism; generated administrative, statutory, and constitutional challenges; and fractured the Federal Circuit. This Article supplies the comprehensive evaluation of the costs and benefits of patent claimamendments, both in examination and post-issuance, surprisingly missing in the literature.The results are mixed. Amendments in initial examination are less clearly warranted than commonly thought, with the costs – primarily problematic drafting incentives – often overlooked and the benefits …

Brief Of Intellectual Property Law Scholars As Amici Curiae In Support Of Neither Party, Westerngeco Llc V. Ion Geophysical Corp., No. 16-1011, Us Supreme Court, Timothy R. Holbrook, Ann Bartow, Dan L. Burk, Donald P. Harris, David C. Hricik, Amy L. Landers, Yvette Joy Liebesman, Lee Ann W. Lockridge, Jason Rantanen

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This amici curiae brief was filed on behalf of Intellectual Property Law Scholars in WesternGeco LLC v. Ion Geophysical Corp. in the U.S. Supreme Court. The question presented is:

"Whether the U.S. Court of Appeals for the Federal Circuit erred in holding that lost profits arising from prohibited combinations occurring outside of the United States are categorically unavailable in cases in which patent infringement is proven under 35 U.S.C. § 271(f)."

In RJR Nabisco, Inc. v. European Community, 136 S. Ct. 2090 (2016), the Supreme Court articulated a two-step method for assessing the extraterritorial reach of a US statute:

1. …

Innovation And Tradition: A Survey Of Intellectual Property And Technology Legal Clinics, Cynthia L. Dahl, Victoria F. Phillips

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For artists, nonprofits, community organizations and small-business clients of limited means, securing intellectual property rights and getting counseling involving patent, copyright and trademark law are critical to their success and growth. These clients need expert IP and technology legal assistance, but very often cannot afford services in the legal marketplace. In addition, legal services and state bar pro bono programs have generally been ill-equipped to assist in these more specialized areas. An expanding community of IP and Technology clinics has emerged across the country to meet these needs. But while law review articles have described and examined other sectors of …

Ip Preparedness For Outbreak Diseases, Ana Santos Rutschman

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Outbreaks of infectious diseases will worsen, as illustrated by the recent back-to-back Ebola and Zika epidemics. The development of innovative drugs, especially in the form of vaccines, is key to minimizing future outbreaks, yet current intellectual property (IP) regimes are ineffective in supporting this goal.

IP scholarship has not adequately addressed the role of IP in the development of vaccines for outbreak diseases. This Article fills that void. Through case studies on the recent Ebola and Zika outbreaks, it provides the first descriptive analysis of the role of IP from the pre- to the post-outbreak stages, specifically identifying IP inefficiencies. …

Brief Amici Curiae Of Intellectual Property Professors In Support Of Petitioner, No. 18-600, Texas Advanced Optoelectronic Solutions, Inc. V. Renesas Electronics America, Inc., Timothy R. Holbrook, Ann Bartow, Andrew Chin, David C. Hricik, Yvette Joy Liebesman, Lucas Osborn

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To comply with the obligations of the Uruguay Round Agreements, particularly the Agreement on the Trade Related Aspects of Intellectual Property (TRIPS), Congress amended 35 U.S.C. § 271(a) to make it an act of infringement to “offer to sell” a patented invention within the United States. See Uruguay Round Agreements Act, Pub. L. No. 103-465, §§ 531-533, 108 Stat. 4809 (1994).

The Federal Circuit has interpreted this provision in a manner contrary to the presumption against the extraterritorial reach of United States laws. The Federal Circuit has held that location of the ultimate sale contemplated in the offer controls the …

The Actavis Inference: Theory And Practice, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro

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In FTC v. Actavis, Inc., the Supreme Court considered "reverse payment" settlements of patent infringement litigation. In such a settlement, a patentee pays the alleged infringer to settle, and the alleged infringer agrees not to enter the market for a period of time. The Court held that a reverse payment settlement violates antitrust law if the patentee is paying to avoid competition. The core insight of Actavis is the Actavis Inference: a large and otherwise unexplained payment, combined with delayed entry, supports a reasonable inference of harm to consumers from lessened competition.

This paper is an effort to assist courts …

The Costs Of Patent Reform: Early Data And Abuses In The Uneven Playing Field Of Post-Issuance Review, Gregory Dolin

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No abstract provided.

Dubious Patent Reform, Gregory Dolin

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The 2011 America Invents Act sought to drastically improve the American patent system by creating new review processes for already issued patents. These processes were meant to reduce patent litigation costs and clear the field of "dubious patents," all the while increasing certainty in the existence and scope of patent rights. Though this was not the first attempt to achieve these goals, Congress failed to heed the lessons of past reforms or fully take into account the costs associated with these new post-issuance review mechanisms. The result was a set of dubious reforms. This Article marshals empirical data and case-study …

Non-Price Competition In “Substitute" Drugs: The Ftc's Blind Spot, Gregory Dolin

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As the recent case of United States v. Lundbeck illustrates, the Federal Trade Commission’s lack of knowledge in medical and pharmacological sciences affects its evaluation of transactions between medical and pharmaceutical companies that involve transfers of rights to manufacture or sell drugs, causing the agency to object to such transactions without solid basis for doing so. This article argues that in order to properly define a pharmaceutical market, one must not just consider the condition that competing drugs are meant to treat, but also take into account whether there are “off-label” drugs that are used to treat a relevant condition, …

Actavis And Error Costs: A Reply To Critics, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro

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The Supreme Court’s opinion in Federal Trade Commission v. Actavis, Inc. provided fundamental guidance about how courts should handle antitrust challenges to reverse payment patent settlements. In our previous article, Activating Actavis, we identified and operationalized the essential features of the Court’s analysis. Our analysis has been challenged by four economists, who argue that our approach might condemn procompetitive settlements.

As we explain in this reply, such settlements are feasible, however, only under special circumstances. Moreover, even where feasible, the parties would not actually choose such a settlement in equilibrium. These considerations, and others discussed in the reply, serve to …

The Debilitating Effect Of Exclusive Rights: Patents And Productive Inefficiency, William Hubbard

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Are we underestimating the costs of patent protection? Scholars have long recognized that patent law is a double-edged sword. While patents promote innovation, they also limit the number of people who can benefit from new inventions. In the past, policy makers striving to balance the costs and benefits of patents have analyzed patent law through the lens of traditional, neoclassical economics. This Article argues that this approach is fundamentally flawed because traditional economics rely on an inaccurate oversimplification: that individuals and firms always maximize profits. In actuality, so-called "productive inefficiencies" often prevent profit maximization. For example, cognitive biases, bounded rationality, …

Reinventing Copyright And Patent, Abraham Bell, Gideon Parchomovsky

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Intellectual property systems all over the world are modeled on the one-size-fits-all principle. However important or unimportant, inventions and original works of authorship receive the same scope of protection, for the same period, backed by the same variety of legal remedies. Metaphorically speaking, all intellectual property is equal under the law. This equality comes at a heavy price. The equality principle gives all creators access to the same remedies, even when those remedies create perverse incentives. Moreover, society overpays for innovation by inflicting on society more monopoly losses than are strictly necessary to incentivize production.

In this Article, we propose …

Activating Actavis, Aaron Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro

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In Federal Trade Commission v. Actavis, Inc., the Supreme Court provided fundamental guidance about how courts should handle antitrust challenges to reverse payment patent settlements. The Court came down strongly in favor of an antitrust solution to the problem, concluding that “an antitrust action is likely to prove more feasible administratively than the Eleventh Circuit believed.” At the same time, Justice Breyer’s majority opinion acknowledged that the Court did not answer every relevant question. The opinion closed by “leav[ing] to the lower courts the structuring of the present rule-of-reason antitrust litigation.”

This article is an effort to help courts and …

Competitive Patent Law, William Hubbard

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Can U.S. patent law help American businesses compete in global markets? In early 2011, President Barack Obama argued that, to obtain economic prosperity, the United States must "out-innovate . .. the rest of the world,"¹ and that patent reform is a "critical dimension[]" ² of this innovation agenda. Soon thereafter, Congress enacted the most sweeping reforms to U.S. patent law in more than half a century, contending that the changes will "give American inventors and innovators the 21st century patent system they need to compete."³ Surprisingly, no legal scholar has assessed whether patent reform is capable of making …

The Competitive Advantage Of Weak Patents, William Hubbard

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Does U.S. patent law increase the competitiveness of U.S. firms in global markets? This Article argues that, contrary to the beliefs of many U.S. lawmakers, U.S. patent law currently undermines the ability of U.S. firms to compete in global markets because strong U.S. patent rights actually weaken an overlooked but critical determinant of U.S. competitiveness: rivalry among U.S. firms. Intense domestic rivalry drives firms to improve relentlessly, spawns related and supporting domestic industries, and encourages the domestic development of advanced factors of production—like specialized labor forces. U.S. patents restrict rivalry among foreign firms less because U.S. patents have little extraterritorial …

What's A Name Worth?: Experimental Tests Of The Value Of Attribution In Intellectual Property, Christopher J. Buccafusco, Christopher Jon Sprigman, Zachary C. Burns

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Despite considerable research suggesting that creators value attribution – i.e., being named as the creator of a work – U.S. intellectual property (IP) law does not provide a right to attribution to the vast majority of creators. On the other side of the Atlantic, however, many European countries give creators, at least in their copyright laws, much stronger rights to attribution. At first blush it may seem that the U.S. has gotten it wrong, and the Europeans have made a better policy choice in providing to creators a right that they value. But for reasons we will explain in this …

Inventing Norms, William Hubbard

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Patent law strives to promote the progress of technology by encouraging invention. Traditionally, scholars contend that patent law achieves this goal by creating financial incentives to invent in the form of exclusive rights to new technology. This traditional view of invention, however, fails to recognize that inventors are motivated by more than money. Like most people, inventors are also motivated by social norms, that is, shared normative beliefs favoring certain actions while disfavoring others. This Article argues that many Americans embrace social norms that favor and encourage successful invention. Because of these "inventing norms" inventors enjoy enhanced personal satisfaction and …

Reverse Settlements As Patent Invalidity Signals, Gregory Dolin

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Over the last decade a new type of settlements, commonly referred to as “reversed payment settlements” or simply “reverse settlements,” emerged in litigation over patents covering pharmaceutical products. What differentiates these new settlements from their traditional counterparts is that whereas traditionally, the alleged trespasser on someone else's rights pays the rights-holder to settle the litigation, in these new settlements it is the rights holder that pays the alleged trespasser. These settlements are a direct consequence of the various incentives provided by the Hatch-Waxman Act - an Act designed to increase competition between brand name and generic manufactures of pharmaceutical products. …

The Creativity Effect (With C. Sprigman), Christopher J. Buccafusco

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No abstract provided.

Resale Price Maintenance: Consignment Agreements, Copyrighted Or Patented Products And The First Sale Doctrine, Herbert J. Hovenkamp

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The rule of reason adopted for resale price maintenance in the Supreme Court’s Leegin decision, which upset the century old Dr. Miles rule of per se illegality, requires some reconsideration of a number of issues about antitrust treatment of RPM. Under the old per se rule, bona fide “consignment” agreements were not covered by Section 1 of the Sherman Act at all because there was said to be no qualifying “agreement” between the supplier and the dealer. Rather the dealer was simply said to be acting as an agent of the seller. However, insofar as RPM produces competitive dangers, such …

Explaining The Demise Of The Doctrine Of Equivalents, David L. Schwartz

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This article provides a novel theoretical model and extensive empirical evidence to explain the decline of a historically important patent law doctrine known as the “doctrine of equivalents.” In recent years, distinguished academics have studied the doctrine of equivalents. While these scholars noted that the doctrine of equivalents had decreased in its successful use and provided some grounds for the decline, none clearly explained why. As such, the cause and precise mechanism behind the so-called “demise” of the doctrine of equivalents have largely remained a mystery.

This article explains that the demise occurred because of two complementary forces discussed for …

Courting Specialization: An Empirical Study Of Claim Construction Comparing Patent Litigation Before Federal District Courts And The International Trade Commission, David L. Schwartz

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The United States International Trade Commission (ITC) has recently become an important adjudicator of patent infringement disputes, and the administrative law judges (ALJs) on the ITC are widely viewed as experts on patent law. This Article empirically examines the performance of the ITC in patent claim construction cases. The Article also compares the performance of the ITC on claim construction with that of federal district courts of general jurisdiction. This study does not find any evidence that the patent-experienced ALJs of the ITC are more accurate at claim construction than district court judges or that the ALJs learn from the …

Efficient Definition And Communication Of Patent Rights: The Importance Of Ex Post Delineation, William Hubbard

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As with any area of law, rights and duties relating to patents should be clearly communicated in an efficient manner. Unfortunately, uncertainty concerning the scope of the rights granted by patents frequently results in expensive litigation. Most proposals for reducing this uncertainty do not examine its root causes and focus only on measures to provide additional clarification in patent applications. Such ex ante proposals are often inefficient because considerable uncertainty is inherent, given the limits of language and of our ability to foresee future developments. In addition, ex ante clarification often would be wasteful because so few patents are valuable …

Patents, Taxes And The Nuclear Option: Do We Need A “Tax Strategy Patent” Ban?, Max Oppenheimer

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No abstract provided.

The "Reasonable Plant" Test: When Progress Outruns The Constitution, Max Oppenheimer

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No abstract provided.