Law Commons^™

Evidence Supporting The Value Of Surgical Procedures: Can We Do Better?, Christopher Robertson, Jonathan Darrow, Willard S. Kasoff

Faculty Scholarship

There is an acknowledged need for higher-quality evidence to quantify the benefit of surgical procedures, yet not enough has been done to improve the evidence base. This lack of evidence can prevent fully informed decision-making, lead to unnecessary or even harmful treatment, and contribute to wasteful expenditures of scare health care resources. Barriers to evidence generation include not only the long-recognized technical difficulties and ethical challenges of conducting randomized surgical trials, but also legal challenges that limit incentives to conduct surgical research as well as market-based challenges that make it difficult for those funding surgical research to recoup investment costs. …

Parsing The Impact Of Alice And The Peg, Colleen Chien, Nicholas Halkowski, Maria He, Rodney Swartz

Faculty Publications

Almost two years have passed since the USPTO issued its January 2019 Patent Eligibility Guidance (PEG), itself a response to the Supreme Court’s Alice decision, and what many perceived as its destabilizing impact on the certainty of patent prosecutions. Leveraging new data releases, we report on trends in prosecution following the USPTO’s PEG and the Guidance on 112, finding 1) a decline in subject matter rejections and stabilization of subject matter appeals, 2) no discernable increase in 112 rejections, 3) no evidence that small entities were being left behind in Alice-impacted art units by forum shopping by large entities, …

Certiorari In Patent Cases, Christa J. Laser

Law Faculty Articles and Essays

In the decade from 2010 to 2019, the Supreme Court has decided more patent law cases than in the prior three decades combined. A higher percentage of its docket has been patent cases--5.45%--than in any decade in the last century. A number of scholars have advanced theories of why this rate of review of patent cases has increased and provided quantitative analyses. Yet no scholarship to date has used qualitative data to investigate why the Supreme Court’s patent docket is increasing and what factors the Supreme Court considers in its review of patent cases. This paper shares statistics of the …

Distorted Drug Patents, Erika Lietzan

Faculty Publications

Drug patents are distorted. Unlike most other inventors, drug inventors must complete years of testing to the government’s specifications and seek government approval to commercialize their inventions. All the while, the patent term runs. When a drug inventor finally launches a medicine that embodies the invention, only a fraction of the patent life remains. And yet, conventional wisdom holds — and empirical studies show — that patent life is essential to innovation in the pharmaceutical industry, perhaps more so than any other inventive industry. Congress tried to do something about this in 1984, authorizing the Patent and Trademark Office to …

Expanding Access To Patents For Covid-19, Jorge L. Contreras

Utah Law Faculty Scholarship

Two competing and linked sets of goals must be addressed when considering patent policy in response to a public health emergency. First is the allocation of existing resources among potential users (hospitals, patients, etc.); second is the creation of new technologies over time (innovation). Patents provide financial incentives to develop new technologies. Yet shortages of patented products often plague crisis response. In the case of COVID-19, allocative goals, particularly satisfying demand for patented medical products (e.g., vaccines, ventilators, PPE, and test kits), may be achieved through governmental interventions such as march-in and governmental use rights (compulsory licensing). But in cases …

Chapter 20 – Technical Standards: Fair, Reasonable And Non-Discriminatory (Frand) Licensing, Jorge L. Contreras

Utah Law Faculty Scholarship

This chapter in the forthcoming case book "Intellectual Property Licensing and Transactions" covers licensing transactions involving standards-essential patents (SEPs), including recent legal developments regarding the disclosure (and concealment) of SEPs, fair, reasonable and nondiscriminatory (FRAND) royalty rates, non-discriminatory licensing, the availability of injunctive relief for FRAND-encumbered patents, and transfers of FRAND commitments, as well as specific SDO policy clauses and license text addressing each of these issues.

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 …

The Normative Molecule: Patent Rights And Dna, Saurabh Vishnubhakat

Faculty Scholarship

Throughout the biotechnology age, fears about the distortionary effects of property and other legal institutions upon the health and self-determination of individuals and societies have accompanied more popularly sensational fears about unscrupulous choices within the scientific community itself. Still, for most of that time the prevailing legal regime both in the United States and in Europe remained generally permissive of ownership of, and exclusionary power over, the fruits of much biomedical research, though this leniency took different forms and came about in different ways. In particular, the policy of the United States Patent and Trademark Office to grant patents on …

House Judiciary Inquiry Into Competition In Digital Markets: Statement, Herbert J. Hovenkamp

All Faculty Scholarship

This is a response to a query from the Judiciary Committee of the U.S. House of Representatives, requesting my views about the adequacy of existing antitrust policy in digital markets.

The statutory text of the United States antitrust laws is very broad, condemning all anticompetitive restraints on trade, monopolization, and mergers and interbrand contractual exclusion whose effect “may be substantially to lessen competition or tend to create a monopoly.” Federal judicial interpretation is much narrower, however, for several reasons. One is the residue of a reaction against excessive antitrust enforcement in the 1970s and earlier. However, since that time antitrust …

Engaging First Year Students With Intellectual Property, Marian G. Armour-Gemmen

Faculty & Staff Scholarship

Since intellectual property is so important to engineers, creating enthusiasm from the beginning of their engineering studies is imperative. Since first year students have not learned how to apply technological concepts to real life, demonstrating intellectual property could be a challenge. To engage first year engineering students in the concept and the value of intellectual property, students were introduced to basic concepts and applications. Different concepts were applied to real life examples allowing them to interface with technology from an intellectual property perspective. This paper highlights not only patents, but also trademarks and trade secrets.

Justice Department's New Position On Patents, Standard Setting, And Injunctions, Herbert J. Hovenkamp

All Faculty Scholarship

A deep split in American innovation policy has arisen between new economy and old economy innovation. In a recent policy statement, the Antitrust Division of the Justice Department takes a position that tilts more toward the old economy. Its December, 2019, policy statement on remedies for Standard Essential Patents issued jointly with the U.S. Patent and Trademark Office and the National Institute of Standards and Technology reflects this movement.

The policy statement as a whole contains two noteworthy problems: one is a glaring omission, and the other is a mischaracterization of the scope of antitrust liability. Both positions are strongly …

Patent-Eligible Subject Matter... Still Wielding The Wrong Weapon - 12 Years Later, Kristen Osenga

Law Faculty Publications

I am delighted to have participated in the Second Annual Intellectual Property Redux Conference and to publish this essay. I rarely look back at my older articles, but in Fall 2018 I was asked to give a keynote address at a conference held by the Biotechnology Innovation Organization (BIO), where the organizers asked me to speak about 35 U.S.C. § 101 and patent-eligible subject matter. In preparing my remarks, I had the opportunity to refer back to one of my earliest scholarly pieces—a 2007 article entitled Ants, Elephant Guns, and Statutory Subject Matter, published in the Arizona State Law Journal.1 …

Inclusive Patents For Open Innovation, Toshiko Takenaka

Articles

The post-internet era has greatly affected commercial firms' innovation processes. The complexity and cumulative nature of emerging technologies under the post-internet era has made commercial firms reevaluate their innovation processes and has increased the role of individual innovators. Firms dealing with emerging technologies cannot make products without infringing on patents held by others, as their products are covered by numerous overlapping patents. Many of these firms work with individual innovators and embrace the open-source philosophy that ensures open access to technologies. These firms can no longer use patents for excluding others without risking infringement counterclaims, leading to the development of …

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 …

Patent Eligibility And Investment, David O. Taylor

Faculty Journal Articles and Book Chapters

Have the Supreme Court’s recent patent eligibility cases changed the behavior of venture capital and private equity investment firms, and if so how? This Article provides empirical data about investors’ answers to those important questions. Analyzing responses to a survey of 475 investors at firms investing in various industries and at various stages of funding, this Article explores how the Court’s recent cases have influenced these firms’ decisions to invest in companies developing technology. The survey results reveal investors’ overwhelming belief that patent eligibility is an important consideration in investment decisionmaking, and that reduced patent eligibility makes it less likely …

From Discovery To Delivery: Public Sector Development Of The Rvsv-Zebov Ebola Vaccine, Matthew Herder, Janice Graham, Richard Gold

Articles, Book Chapters, & Popular Press

The discovery and development of the Ebola rVSV-ZEBOV vaccine challenge the common assumption that the research and development for innovative therapeutic products and vaccines is best carried out by the private sector. Using internal government documents obtained through an access to information request, we analyze the development of rVSV-ZEBOV by researchers at Canada’s National Microbiology Laboratory beyond its patenting and licensing to a biotech company in the United States in 2010. According to government documentation, the company failed to make any progress toward a phase 1 clinical trial until after the WHO Public Health Emergency of International Concern freed substantial …

The Hidden Value Of Abandoned Applications To The Patent System, Christopher A. Cotropia, David L. Schwartz

Law Faculty Publications

Some inventors abandon their patent applications without ever receiving a patent. Although patent scholars view such abandoned patent applications as essentially worthless, we question that conventional wisdom. Conducting an empirical analysis of a recently released patent application dataset in light of a 1999 change that requires publication of most abandoned applications, we find that the United States Patent and Trademark Office (USPTO) often uses abandoned applications as “prior art” when examining future patent applications. Abandoned applications thus generate an “administrative disclosure” that prevents the issuance of broader patent rights to later applicants. By narrowing the scope of new patents, abandoned …

The Hidden Value Of Abandoned Applications To The Patent System, Christopher A. Cotropia, David L. Schwartz

Law Faculty Publications

Some inventors abandon their patent applications without ever receiving a patent. Although patent scholars view such abandoned applications as essentially worthless, we question that conventional wisdom. In conducting an empirical analysis of a recently released patent application dataset (in light of a 1999 change requiring publication of most abandoned applications), we find that the United States Patent and Trademark Office (USPTO) often uses abandoned applications as prior art when examining future patent applications. Abandoned applications thus generate an administrative disclosure that prevents the issuance of broader patent rights to later applicants. By narrowing the scope of new patents, abandoned applications …

Congress Should Decline Ill-Advised Legislative Proposals Aimed At Evergreening Of Pharmaceutical Patent Protection, Christopher M. Holman

Faculty Works

There is a widespread perception that drug prices in the U.S. are much higher than they should be, and that the problem is only getting worse. Critics argue that the pharmaceutical industry is improperly gaming the system in a manner that takes advantage of legal loopholes and administrative limitations to the detriment of patients and third-party payers. Both houses of Congress responded in 2019 with a slew of hearings focused on pharmaceutical pricing, and dozens of bills have been introduced that would attempt to bring down the cost of drugs. Much of the discussion, and some of the proposed legislation, …

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 …

Patent Shopping, Janet Freilich

Faculty Scholarship

Over the past decade, scholars have identified many entities who use the patent system in ways that differ from the traditional model of patent use—entities such as patent assertion entities, patent aggregators, or owners of large patent portfolios. This Article presents a model that explains the behavior of some of the biggest and most controversial entities in the patent system. This Article argues that such entities are engaged in “patent shopping” where the plaintiff makes a strategic choice of patent in order to obtain the best facts and substance in a case and thereby maximize the chance of a favorable …

Mapping Misinformation In The Coronavirus Outbreak, Ana Santos Rutschman

All Faculty Scholarship

The coronavirus outbreak has sent ripples of fear and confusion across the world. These sentiments—and our collective responses to the outbreak—are made worse by rampant misinformation surrounding the new strain of the virus, COVID-2019. In this post, I survey some of the most pervasive areas of tentacular coronavirus-related misinformation that has proliferated online -- as well as the responses of social media companies like YouTube, Facebook, Pinterest and TikTok that may ultimately prove inadequate given the magnitude of the problem.

Ajinomoto V. Itc, The Doctrine Of Equivalents, And Biomolecule Claim Limitations At The Federal Circuit, Christopher M. Holman

Faculty Works

The doctrine of equivalents (DOE) allows a court to hold an accused infringer liable for patent infringement in spite of the fact that the accused product (or process) does not fall within the literal scope of the asserted patent claim(s). Prosecution history estoppel (PHE), which can be triggered by a narrowing amendment of a patent claim during patent prosecution, or by arguments made during prosecution, imposes significant constraints on the ability of a patentee to assert the DOE. The 1990s and early 2000’s saw a proliferation of legal commentary postulating that the DOE would play an important role in protecting …

Frand And Antitrust, Herbert J. Hovenkamp

All Faculty Scholarship

This paper considers when a patentee’s violation of a FRAND commitment also violates the antitrust laws. It warns against two extremes. First, is thinking that any violation of a FRAND obligation is an antitrust violation as well. FRAND obligations are contractual, and most breaches of contract do not violate antitrust law. The other extreme is thinking that, because a FRAND violation is a breach of contract, it cannot also be an antitrust violation.

Every antitrust case must consider the market environment in which conduct is to be evaluated. SSOs operated by multiple firms are joint ventures. Antitrust’s role is to …

Vaccines And Ip Preparedness In The Coronavirus Outbreak, Ana Santos Rutschman

All Faculty Scholarship

The COVID-19 pandemic has shed renewed light on the importance of research and development (R&D) on biopharmaceutical products needed to prevent or lessen the burden posed by outbreaks of infectious diseases. Among these, the need for new vaccines has become of paramount importance. While a race to develop different types of vaccines unfolds at unusual speed, there are still significant shortcomings in the ecosystem that leads to the production and dissemination of vaccines targeting infectious diseases like COVID-19.

The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman

All Faculty Scholarship

This Essay examines the ways in which intellectual property regimes influence incentives for the development of new vaccines for infectious diseases. Charting the tension between market forces and public health imperatives, the Essay considers an emerging solution to the long-standing problem of insufficient incentives for vaccine research and development: the rise of public-private partnerships in the health space. The Essay provides a short case study on CEPI, a large-scale public-private partnership dedicated exclusively to funding research on vaccines for infectious diseases. In exploring how the interaction between intellectual property rules and practices affect vaccine innovation, the Essay offers illustrations from …

Ebay, Permanent Injunctions, And Trade Secrets, Elizabeth A. Rowe

UF Law Faculty Publications

This Article presents the first qualitative empirical review of permanent injunctions in trade secret cases. In addition, it explores the extent to which the Supreme Court’s patent decision in eBay v. MercExchange has influenced the analysis of equitable principles in federal trade secret litigation. Among the more notable findings are that while equitable principles are generally applied in determining whether to grant a permanent injunction to a prevailing party after trial, the courts are not necessarily strictly applying the four factors from eBay. The award of monetary relief does not preclude equitable injunctive relief, and courts can find irreparable harm …

The Death Of The Genus Claim, Dmitry Karshtedt, Mark A. Lemley, Sean B. Seymore

GW Law Faculty Publications & Other Works

The central feature of patent law in the chemical, biotechnology, and pharmaceutical industries is the genus claim – a patent that covers not just one specific chemical but a group of related chemicals. Genus claims are everywhere, and any patent lawyer will tell you they are critical to effective patent protection.

But as we show in this article, the law has changed dramatically in the last twenty-five years, to the point where it is no longer possible to have a valid genus claim. Courts almost always hold them invalid. Remarkably, they do this without having acknowledged that they have fundamentally …

Patenting Fast And Slow: Examiner And Applicant Use Of Prior Art, Shine Tu

Law Faculty Scholarship

Previous studies have shown that an applicant's ability to obtain a patent is inexorably linked to the random assignment of a patent examiner. However, not all patent examiners are created equal. Some patent examiners allow patent applications quickly within just one or two Office Actions, resulting in only a few months of substantive patent prosecution. In contrast, other patent examiners constantly reject patents applications, which can result in unnecessarily delaying prosecution and years of substantive patent prosecution. This study focuses on how different examiners use prior art rejections to prolong or compact prosecution. Prior art rejections are one of the …