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 …

Pleasure Patents, Andrew Gilden, Sarah R. Wasserman Rajec

Faculty Publications

The United States Patent and Trademark Office has granted thousands of patents for inventions whose purpose is to facilitate the sexual pleasure of their users. These "pleasure patents" raise a range of novel questions about both patent theory and the relationship between law and sexuality more broadly. Given that "immoral" inventions were long excluded from the patent system, and that sexual devices were widely criminalized for much of the past 150 years, how have patentees successfully framed the contributions of their sexual inventions? If a patentable invention must be both new and useful, how have patentees described the utility of …

Third-Party Interests And The Property Law Misfit In Patent Law, Sarah Rajec

Faculty Publications

Courts and scholars have long parsed the characteristics of patent grants and likened them, alternately, to real or personal property law, monopolies, public franchises and other regulatory grants, or a hybrid of these. The characterizations matter, because they can determine how patents are treated for the purposes of administrative review, limitations, and remedies, inter alia. And these varied treatments in turn affect incentives to innovate. Patents are often likened to real property in an effort to maximize rights and allow inventors to internalize all of the benefits from their activities. And courts often turn first to real property analogies when …

Right On Time: A Reply To Professors Allen, Claeys, Epstein, Gordon, Holbrook, Mossoff, Rose, And Van Houweling, Dotan Oliar, James Y. Stern

Faculty Publications

A simple observation started us off in writing Right on Time. Studying and teaching intellectual property law, we noticed striking parallels between traditional first possession rules in property law and analagous rules governing the acquisition of patent, copyright, and trademark rights. We thought that established first possession principles could illuminate the workings of IP law. As we dug in, however, it became increasingly clear that our premise wasn’t quite right. While many penetrating commentators had said many penetrating things about first possession, the leading treatments tended to focus on significant individual aspects of the overall issue. What we could …

The Harmonization Myth In International Intellectual Property Law, Sarah R. Wasserman Rajec

Faculty Publications

There is a dominant narrative in international intellectual property ("IP") law of ever-increasing harmonization. This narrative has been deployed in ways descriptive, prescriptive, and instrumental: approximating the historical trend, providing justification, and establishing the path forward. Appeals to harmonization are attractive. They evoke a worldwide partnership and shared sacrifice to meet the goals of innovation and access to technology through certainty, efficiency, and increased competition through lowered trade barriers. Countries with strong IP protections consistently and successfully tout the importance of certainty and lower trade barriers when seeking new and stronger protections from countries with lower levels of protection. Yet …

Right On Time: First Possession In Property And Intellectual Property, Dotan Oliar, James Y. Stern

Faculty Publications

How should we allocate property rights in unowned tangible and intangible resources? This Article develops a model of original acquisition that draws together common law doctrines of first possession with original acquisition doctrines in patent, copyright, and trademark law. The common denominator is time: in each context, doctrine involves a trade-off between assigning entitlements to resources earlier or later in the process of their development and use. Early awards risk granting exclusivity to parties who may not be capable of putting resources to their best use. Late awards prolong contests for ownership, which may generate waste or discourage acquisition efforts …

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 …

Design Patent Infringement Needs A Free Expression Defense (La Infracción De Patentes De Diseño Necesita Una Defensa De Libre Expresión), Richard J. Peltz-Steele, Ralph D. Clifford

Faculty Publications

English Abstract: As elsewhere in the world, design patents are propagating copiously in U.S. intellectual property law. Notwithstanding their fertility, design patents face potentially prohibitive and as yet unexplored legal challenges. One possibility is that the U.S. Congress might lack the very power to authorize design patents. Another possibility – our subject here, with implications for design patents in Europe and around the world – is that design patents violate fundamental rights if there is not a defense to infringement founded in the freedom of expression.

Spanish Abstract: Las patentes de diseño se propagan en abundancia en el derecho de …

The Market For Software Innovation Through The Lens Of Patent Licenses And Sales, Colleen V. Chien

Faculty Publications

Software innovation is transforming the US economy. Yet our understanding of how patents and patent transactions support this innovation is limited, in part because of a lack of public information about patent licenses and sales. Claims about the patent marketplace, for example, extolling the virtues of intermediaries like non-practicing entities, or questioning the social utility of ex post patent licenses, tend not to be grounded in empirical evidence. This article brings much-needed data to the policy debate by analyzing transactional data from several proprietary databases of patent licenses and transfers, and reporting several novel findings. First I find that, despite …

Comparative Patent Quality, Colleen Chien

Faculty Publications

One of the most urgent problems with the US patent system is that there are too many patents of poor quality. Most blame the US Patent and Trademark Office (USPTO) – its mistakes, overly generous grant rate, and lack of consistency. But, the quality and quantity of patents in force is the product of three sets of decisions: to submit an application of certain quality (by the applicant), to grant the patent (by the patent office), and to renew a patent and keep it in force (by the applicant/patentee). Startling, there is no consensus way to measure patent quality. This …

Recalibrarting Patent Venue, Colleen V. Chien, Michael Risch

Faculty Publications

For most of patent law’s 200-year plus history, the rule has been that patentholders are permitted to sue defendants only in the district they inhabit. In 1990, the Federal Circuit changed this by enlarging the scope of permissible venue to all districts with personal jurisdiction over the defendant. Since then, patentees have flocked to fewer districts, and in 2015, brought more than 40% of their cases in a single rural district with 1% of the US population, the Eastern District of Texas. Fueled in particular by concerns that non-practicing entities (NPEs), who bring the majority of cases in the Eastern …

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.

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.

Evaluating Flexibility In International Patent Law, Sarah R. Wasserman Rajec

Faculty Publications

Global patent law has raced toward harmonization over the past decades. Countries with vastly different industries, values, and levels of development now offer robust patent rights with similar contours through membership in the World Trade Organization and consequent adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”). However, patent law is still far from harmonized among countries or static within countries. Jurisdictions tailor their patent laws to accommodate differences between industries, unforeseen inefficiencies, and diverse views of the costs and benefits associated with offering patent rights to stimulate innovation. Prior scholarly work consists of either doctrinal analyses …

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 …

Self-Replicating Technologies, Jeremy N. Sheff

Faculty Publications

Self-replicating technologies pose a challenge to the legal regimes we ordinarily rely on to promote a balance between innovation and competition. This Article examines recent efforts by the federal courts to deal with the leading edge of this policy challenge in cases involving the quintessential self-replicating technology: the seed. In a recent series of cases involving the invocation of the patent exhaustion defense by purchasers of Monsanto’s “Roundup-Ready” genetically engineered herbicide-resistant crop technologies, farmers have argued that Monsanto’s patent rights do not extend to the second generation of soybeans grown from a patented first-generation seed. In each case, the Federal …

A Statistical Analysis Of The Patent Bar: Where Are The Software-Savvy Patent Attorneys?, Ralph D. Clifford, Thomas G. Field Jr., Jon R. Cavicchi

Faculty Publications

Among the many factors that impact the declining quality of U.S. patents is the increasing disconnect between the technological education patent bar members have and the fields in which patents are being written. Based on an empirical study, the authors show that too few patent attorneys and agents have relevant experience in the most often patented areas today, such as computer science. An examination of the qualification practices of the U.S. Patent and Trademark Office (“PTO”) suggests that an institutional bias exists within the PTO that prevents software-savvy individuals from registering with the Office. This paper concludes with suggestions of …

Legal Forms And The Common Law Of Patents, Craig Allen Nard

Faculty Publications

The question of institutional choice is important in all areas of the law, but particularly in the context of patent law with its divergent stakeholders, decentralized variance among industries regarding how the patent system is viewed and relied upon, and a persistent focus on reform in recent years. For over two hundred years, the courts have been the dominant force in the development of patent law. It should therefore come as no surprise to learn that a significant portion of American patent law, including some of the most important and controversial patent law doctrines, is either built upon judicial interpretation …

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 …

Of Trolls, Davids, Goliaths, And Kings: Narratives And Evidence In The Litigation Of High-Tech Patents, Colleen V. Chien

Faculty Publications

While each patent dispute is unique, most fit the profile of one of a limited number of patent litigation stories. A dispute between an independent inventor and a large company, for instance, is often cast in "David v. Goliath" terms. When two large companies fight over patents, in contrast, they are said to be playing the "sport of kings." Some corporations engage in "defensive patenting" in order to deter others from suing them. Patent licensing and enforcement entities who sue have been labeled "trolls." Finally, observers of the patent system call the use of patent litigation to impose or exploit …

Constitutionalizing Patents: From Venice To Philadelphia, Craig Allen Nard, Andrew P. Morriss

Faculty Publications

Patent law today is a complex institution in most developed economies and the appropriate structure for patent law is hotly debated around the world. Despite their differences, one crucial feature is shared by the diverse patent systems of the industrialized world even before the recent trend toward harmonization: modern patent regimes include self-imposed restrictions of executive and legislative discretion, which we refer to as "constitutionalized" systems. Given the lucrative nature of patent monopolies, the long history of granting patents as a form of patronage, and the aggressive pursuit of patronage in most societies, the choice to confine patents within a …

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.

Cheap Drugs At What Price To Innovation: Does The Compulsory Licensing Of Pharmaceuticals Hurt Innovaton?, Colleen V. Chien

Faculty Publications

The patent system is built on the premise that patents provide an incentive for innovation by offering a limited monopoly to patentees. The inverse assumption that removing patent protection will hurt innovation has largely prevented the widespread use of compulsory licensing-the practice of allowing third parties to use patented inventions without patentee permission. In this Article, I empirically test this assumption. I compare rates of patenting and other measures of inventive activity before and after six compulsory licenses over drug patents issued in the 1980s and 1990s. As reported below, observe no uniform decline in innovation by companies affected by …

The Anti-Monopoly Origins Of The Patent And Copyright Clause, Tyler T. Ochoa, Mark Rose

Faculty Publications

The British experience with patents and copyrights prior to 1787 is instructive as to the context within which the Framers drafted the Patent and Copyright Clause. The 1624 Statute of Monopolies, intended to curb royal abuse of monopoly privileges, restricted patents for new inventions to a specified term of years. The Stationers' Company, a Crown-chartered guild of London booksellers, continued to hold a monopoly on publishing, and to enforce censorship laws, until 1695. During this time, individual titles were treated as perpetual properties held by booksellers. In 1710, however, the Statute of Anne broke up these monopolies by imposing strict …

Harmony And Diversity In Global Patent Law, John F. Duffy

Faculty Publications

The second half of the twentieth century saw the rise of a broad movement to harmonize patent laws across nation-states. The most recent, and most significant, manifestation of this movement is the 1994 TRIPS Agreement, which requires signatory nations to adopt uniform rules on many major issues of patent law. The TRIPS Agreement has now been implemented by well over one hundred countries, including almost all major industrial nations, and it heralds a new level of international uniformity in patent law.

This Article, while acknowledging the value of some harmonization of national law , explores the possible costs of the …

What's New In Intellectual Property - Business Is Booming In Copyright, Trademark And Patent Law, Richard C. Reuben

Faculty Publications

Forget the trendy law practice areas of the 1980s, such as mergers and acquisitions, real estate and antitrust. Intellectual property is where the action will be in the 1990s.