Law Commons^™

Defending Breakthrough Innovation: The History And Future Of The State Of Patent Law, Max Oppenheimer

All Faculty Scholarship

Congress, while enacting at least six major revisions to patent law since 1793, has left the definition of patentable subject matter essentially unchanged. The Supreme Court, on the other hand, has been uncomfortable with the concept for more than a century. Despite this long-standing discomfort, it has struggled to advance a theoretical basis for its concern. In a series of recent cases, it has finally developed a theory as to why certain types of inventions, although embraced by the statutory definition, are nonetheless unpatentable. The theory, in effect, abandons the federal government’s role in protecting those inventions. This article explores …

Do Patent Challenges Increase Competition?, Stephen Yelderman

Journal Articles

This Article is the first to seriously scrutinize the claim that patent challenges lead to increased competition. It identifies a number of conditions that must hold for a patent challenge to provide this particular benefit, and evaluates the reasonableness of assuming that the pro-competitive benefits of patent challenges are generally available. As it turns out, there are a number of ways these conditions can and regularly do fail. This Article synthesizes legal doctrine, recent empirical scholarship, and several novel case studies to identify categories of challenges in which the potential benefits for competition are smaller than previously thought or, in …

A Crisis Of Faith & The Scientific Future Of Patent Theory, Oskar Liivak

Cornell Law Faculty Publications

The current reward framing for the patent system has resisted all attempts to either confirm or to refute the benefits of the system. Yet that should not surprise us. We should be surprised that we ever thought that the system could be justified at all. The reward framing has infected the patent system with pathological defects that make the system both unjustifiable and unfalsifiable. An alternate framing that focuses on ex ante technology transfer can support and explain many of the doctrinal features of the current patent system, but it can do so while avoiding the pathologies that plague today's …

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 …

Full Federal Circuit Curbs On Sale Bar's Threat To Patents, Zong-Qiang Bill Tian, Matthew D'Amore

Cornell Law Faculty Publications

No abstract provided.

Funding Antibiotic Innovation With Vouchers: Recommendations On How To Strengthen A Flawed Incentive Policy, Kevin Outterson, Anthony Mcdonnell

Faculty Scholarship

A serious need to spur antibiotic innovation has arisen because of the lack of antibiotics to combat certain conditions and the overuse of other antibiotics leading to greater antibiotic resistance. In response to this need, proposals have been made to Congress to fund antibiotic research through a voucher program for new antibiotics, which would delay generic entry for any drug, even potential blockbuster lifesaving generics. We find this proposal to be inefficient, in part because of the mismatch between the private value of the voucher and the public value of the antibiotic innovation. However, vouchers have the political advantage in …

Commil Usa, Llc V. Cisco Systems: Joining Policy And Prose To Foster A Good Faith Analysis, Theresa E. Durante

Maryland Law Review Online

No abstract provided.

The Patent Spiral, Roger Allan Ford

Law Faculty Scholarship

Examination — the process of reviewing a patent application and deciding whether to grant the requested patent — improves patent quality in two ways. It acts as a substantive screen, filtering out meritless applications and improving meritorious ones. It also acts as a costly screen, discouraging applicants from seeking low-value patents. Yet despite these dual roles, the patent system has a substantial quality problem: it is both too easy to get a patent (because examiners grant invalid patents that should be filtered out by a substantive screen) and too cheap to do so (because examiners grant low-value nuisance patents that …

Patent Exhaustion And Federalism: A Historical Note, Herbert J. Hovenkamp

All Faculty Scholarship

This essay, written as a response to John F. Duffy and Richard Hynes, Statutory Domain and the Commercial Law of Intellectual Property, 102 VA. L. REV. 1 (2016), argues that the patent exhaustion (first sale) doctrine developed as a creature of federalism, intended to divide the line between the law of patents, which by that time had become exclusively federal, and the law of patented things, which were governed by the states. Late nineteenth and early twentieth century courts were explicit on the point, in decisions stretching from the 1850s well into the twentieth century.

By the second half of …

Some Key Things U.S. Entrepreneurs Need To Know About The Law And Lawyers, Lawrence J. Trautman, Anthony J. Luppino, Malika Simmons

Faculty Works

New business formation is a powerful economic engine that creates jobs. Diverse legal issues are encountered as a start-up entity approaches formation, initial capitalization and fundraising, arrangements with employees and independent contractors, and relationships with other third parties. The endeavors of a typical start-up in the United States will likely implicate many of the following areas of law: intellectual property; business organizations; tax laws; employment and labor laws; securities regulation; contracts and licensing agreements; commercial sales; debtor-creditor relations; real estate law; health and safety laws/codes; permits and licenses; environmental protection; industry specific regulatory laws and approval processes; tort/personal injury, products …

Big Data, Patents, And The Future Of Medicine, W. Nicholson Price Ii

Articles

Big data has tremendous potential to improve health care. Unfortunately, intellectual property law isn’t ready to support that leap. In the next wave of data- driven medicine, black-box medicine, researchers use sophisticated algorithms to examine huge troves of health data, finding complex, implicit relationships and making individualized assessments for patients. Black-box medicine offers potentially immense benefits, but also requires substantial high investment. Firms must develop new datasets, models, and validations, which are all nonrivalrous information goods with significant spillovers, requiring incentives for welfare-optimizing investment. Current intellectual property law fails to provide adequate incentives for black- box medicine. The Supreme Court …

Antibiotic Reimbursement In A Model Delinked From Sales: A Benchmark-Based Worldwide Approach, Kevin Outterson, John Rex

Faculty Scholarship

Despite the life-saving ability of antibiotics and their importance as a key enabler of all of modern health care, their effectiveness is now threatened by a rising tide of resistance. Unfortunately, the antibiotic pipeline does not match health needs because of challenges in discovery and development, as well as the poor economics of antibiotics. Discovery and development are being addressed by a range of public-private partnerships; however, correcting the poor economics of antibiotics will need an overhaul of the present business model on a worldwide scale. Discussions are now converging on delinking reward from antibiotic sales through prizes, milestone payments, …

The Law Of The Platform, Orly Lobel

Faculty Scholarship

New digital platform companies are turning everything into an available resource: services, products, spaces, connections, and knowledge, all of which would otherwise be collecting dust. Unsurprisingly then, the platform economy defies conventional regulatory theory. Millions of people are becoming part-time entrepreneurs, disrupting established business models and entrenched market interests, challenging regulated industries, and turning ideas about consumption, work, risk, and ownership on their head. Paradoxically, as the digital platform economy becomes more established, we are also at an all-time high in regulatory permitting, licensing, and protection. The battle over law in the platform is therefore both conceptual and highly practical. …

Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai

Articles

As finding breakthrough small-molecule drugs becomes more difficult, drug companies are increasingly turning to "large molecule" biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings. This Article provides a fresh diagnosis of and prescription for this major public policy problem. It argues that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of Food and …

Knowledge Sharing Among Inventors: Some Historical Perspectives, James Bessen, Alessandro Nuvolari

Faculty Scholarship

This chapter documents instances from past centuries where inventors freely shared knowledge of their innovations with other inventors. It is widely believed that such knowledge sharing is a recent development, as in Open Source Software. Our survey shows, instead, that innovators have long practiced “collective invention” at times, including inventions in such key technologies as steam engines, iron, steel, and textiles. Generally, innovator behavior was substantially richer than the heroic portrayal often found in textbooks and museums. Knowledge sharing promoted innovation, sometimes coexisting with patents, at other times, not, suggesting that policy should foster both knowledge sharing and invention incentives.

Brief Amici Curiae Of 37 Intellectual Property Professors In Support Of Petition For Certiorari, Mark A. Lemley, Mark Mckenna

Court Briefs

This case presents two issues that justify this Court’s review.

First, the Federal Circuit upheld a finding of design patent infringement based on the very same Apple designs that it found functional under trade dress law. Such a counterintuitive outcome is possible because the Federal Circuit has constructed a highly constrained definition of functionality in design patent law, which is at odds with this Court’s precedent in both utility patent and trade dress cases. Coupled with its recent re-interpretation of the design patent infringement standard, the Federal Circuit’s approach to functionality makes it quite likely that defendants will be held …

The Law Of 180-Day Exclusivity, Erika Lietzan, Julia Post

Faculty Publications

In 1984, Congress created a statutory pathway for approval of generic drug applications and included an incentive for generic applicants to challenge the patents claiming the reference drugs on which they based their applications. The first generic applicant to file an ANDA with a patent challenge is eligible for 180 days of generic market exclusivity. This article is the fourth in a series of articles describing the resulting body of law, as interpreted and applied by FDA (in regulations, guidances, citizen petition responses, and individual decisions awarding and denying exclusivity) and the courts. The heart of the article is section …

A Handbook For Inventors And Innovators: Technology Commercialization At The University Of Nebraska–Lincoln

NUtech Ventures: Publications

OVERVIEW: Director’s Message * Commercialization * Technology Transfer Process * Benefits * Resources

SPONSORED RESEARCH: Process * Bayh-Dole Act * Funding Resources

INVENTION DISCLOSURE: Who * What * When * Why

INTELLECTUAL PROPERTY: Patent * Other Forms of Intellectual Property * Criteria * Barriers to Patenting * Life of a Patent * University Ownership

COMMERCIALIZATION: Licenses and Licensing Process

NUtech Ventures’ mission is to commercialize technologies generated from the research and creative activities of the University of Nebraska–Lincoln. Namely, NUtech Ventures seeks to facilitate the transfer of innovations from the “lab to the marketplace” for the benefit of society. This …

Confusing Patent Eligibility, David O. Taylor

Faculty Journal Articles and Book Chapters

Patent law — and in particular the law governing patent eligibility — is in a state of crisis. This crisis is one of profound confusion. Confusion exists because the current approach to determining patent eligibility confuses the relevant policies underlying numerous discrete patent law doctrines, and because the current approach lacks administrability. Ironically, the result of all this confusion is seemingly clear: the result seems to be that, when challenged, patent applications and issued patents probably do not satisfy the requirement of eligibility. At least that is the perception. A resulting concern, therefore, is that the current environment substantially reduces …

Horizontal Innovation And Interface Patents, Bernard Chao

Sturm College of Law: Faculty Scholarship

Scholars understandably devote a great deal of effort to studying how well patent law works to incentive the most important inventions. After all, these inventions form the foundation of our new technological age. But very little time is spent focusing on the other end of the spectrum, inventions that are no better than what the public already has. At first blush, studying such “horizontal” innovation seems pointless. But this inquiry actually reveals much about how patents can be used in unintended, and arguably, anticompetitive ways.

This issue has roots in one unintuitive aspect of patent law. Despite the law’s goal …

Empirical Scholarship On The Prosecution Process At The Pto, Michael D. Frakes, Melissa F. Wasserman

Faculty Scholarship

In this book chapter, we summarize empirical scholarship examining the patent prosecution process at the United States Patent and Trademark Office.

The Emergence Of Classical American Patent Law, Herbert J. Hovenkamp

All Faculty Scholarship

One enduring historical debate concerns whether the American Constitution was intended to be "classical" -- referring to a theory of statecraft that maximizes the role of private markets and minimizes the role of government in economic affairs. The most central and powerful proposition of classical constitutionalism is that the government's role in economic development should be minimal. First, private rights in property and contract exist prior to any community needs for development. Second, if a particular project is worthwhile the market itself will make it occur. Third, when the government attempts to induce development politics inevitably distorts the decision making. …

Patented Electric Guitar Pickups And The Creation Of Modern Music Genres, Sean M. O'Connor

Articles

This Essay provides an overview of how patents played a core role in developing world-changing musical genres. This may be surprising, as normally copyright law is associated with incentivizing advances in the creative arts. But as this Conference’s theme [The IP Platform: Supporting Invention and Inspiration] and presentations emphasize, the whole range of intellectual property (“IP”), especially when viewed as a platform, supports innovation across the spectrum of human ingenuity and creativity.

This Essay is also intended to be read in conjunction with a viewing of the live-music demonstration of how pickups transformed popular music, delivered at the Conference and …

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: …

Comment To The Sec In Support Of The Enhanced Disclosure Of Patent And Technology License Information, Colleen V. Chien, Jorge Contreras, Carol Corrado, Stuart Graham, Deepak Hedge, Arti K. Rai, Saurabh Vishnubhakat

Faculty Scholarship

Intangible assets like IP constitute a large share of the value of firms, and the US economy generally. Accurate information on the intellectual property (IP) holdings and transactions of publicly-traded firms facilitates price discovery in the market and reduces transaction costs. While public understanding of the innovation economy has been expanded by a large stream of empirical research using patent data, and more recently trademark information this research is only as good as the accuracy and completeness of the data it builds upon. In contrast with information about patents and trademarks, good information about IP licensing is much less publicly …

Protecting Products Versus Platforms, Jacob S. Sherkow

Articles & Chapters

Patents have long been the most important legal assets of biotech companies. Increasingly, however, biotech firms find themselves on one side of a divide: as either traditional product companies or platform companies. Given the differences between these two types of business models, the merits of intellectual property (IP) protection vary between them. This article explores how those differences relate to biotech startups and entrepreneurs seeking to protect their inventions.

The Changing Life Science Patent Landscape, Arti K. Rai, Jacob S. Sherkow

Articles & Chapters

Over the past two decades, patent law in the life sciences has been buffeted by numerous controversies. With courts, legislatures and patent offices all responding, one could be forgiven for believing that the main constant has been change. In the following article, we look back at some of the major events in life science intellectual property (IP) law and business practice over the past 20 years and then suggest where IP practice in the life sciences may be heading in the coming years.

Describing Drugs: A Response To Professors Allison And Ouellette, Jacob S. Sherkow

Articles & Chapters

Profs. Allison and Ouellette’s Article, How Courts Adjudicate Patent Definiteness and Disclosure, 65 Duke L.J.609 (2015), on courts’ adjudication of certain patent disputes presents some surprising data: pharmaceutical patents litigated to judgment fare substantially worse on written-description analyses if they are not part of traditional pioneer-generic litigation. This Response engages in several hypotheses for this disparity and examines the cases that make up Allison and Ouellette’s dataset. An analysis of these cases finds that the disparity can be best explained by technological and judicial idiosyncrasies in each case, rather than larger differences among pharmaceutical patent cases. This finding contextualizes …

Patent Institutions: Shifting Interactions Between Legal Actors, Arti K. Rai

Faculty Scholarship

This contribution to the Research Handbook on Economics of Intellectual Property Rights (Vol. 1 Theory) addresses interactions between the principal legal institutions of the U.S. patent system. It considers legal, strategic, and normative perspectives on these interactions as they have evolved over the last 35 years. Early centralization of power by the U.S. Court of Appeals for the Federal Circuit, newly created in 1982, established a regime dominated by the appellate court's bright-line rules. More recently, aggressive Supreme Court and Congressional intervention have respectively reinvigorated patent law standards and led to significant devolution of power to inferior tribunals, including newly …