Law Commons^™

Obligations In A Global Health Emergency - Authors' Reply, Ezekiel J. Emanuel

Sturm College of Law: Faculty Scholarship

No abstract provided.

Diversity In Innovation Best Practices Guide, Laura Norris, Mary Fuller, Joy Peacock, Sydney Yazzolino

Faculty Publications

In 2020, the USPTO collaborated with the HTLI to propose a study designed to increase diversity in the patenting process, specifically targeted to in-house legal / IP department and their practices. The goal of the study was simple - harvesting the collective knowledge of nationwide IP professionals and producing an “insanely practical” guide to expand inventorship to a more diverse inventor population. By “diverse” we mean underrepresented or historically marginalized groups in the United States patent system. The term "diversity" can be interpreted differently in different countries. The HTLI research team collected this extensive list of over 90 best practice …

Characteristics Of Patent Examiners Who Issue Litigated / Invalidated Patents, S. Sean Tu

Law Faculty Scholarship

No abstract provided.

Arbitration By Ssos As A Preferred Solution For Solving The Frand Licensing Of Seps?, Kung-Chung Liu

Research Collection Yong Pung How School Of Law

In the last decade, the licensing of standard essential patents (SEPs) on fair, reasonable and non-discriminatory (FRAND) terms has been a thorny issue for SEP holders in the US and Europe on the one hand, and major SEP implementers in major Asian economies on the other, such as Japan, Korea, the PRC, Taiwan and even India. With the rise of the Fourth Industrial Revolution, driven by the Internet of Things (IoT), 5G, driverless vehicles, and artificial intelligence (AI), which relies even more on interconnectivity, more and more new standards and SEPs will emerge, and the issue of FRAND licensing of …

Covid-19 As An Example Of Why Genomic Sequence Data Should Remain Patent Ineligible, Jorge L. Contreras

Utah Law Faculty Scholarship

The researchers who determined the genomic sequence of the SARS-CoV-2 virus did not seek to patent it, but instead released it in the publicly-accessible GenBank data repository. Their release of this critical data enabled the scientific community to mobilize rapidly and conduct research on a range of diagnostic, vaccine, and therapeutic applications based on the viral RNA sequence. Had the researchers sought patent protection for their discovery, as earlier research teams had during the SARS, H1N1 and H5N1 outbreaks, global research relating to COVID-19 would have been less efficient and more costly. One of the reasons that patents are no …

Comments To The National Strategy For Expanding American Innovation, Colleen Chien, Ernest Fok

Faculty Publications

The United States Patent and Trademark Office (USPTO) sought input for its National Strategy for Expanding American Innovation to build a more demographically, geographically, and economically inclusive innovation ecosystem. Students in Professor Colleen Chien’s Patent Law course submitted 13 comments on how to make innovation more representative of the United States. This document contains 13 comments that draw heavily from personal and professional experience, and highlights the diversity in Santa Clara Law’s patent course. Here are excerpts:

• Erik Perez and Grant Wanderscheid, drawing from their own undergraduate and graduate experiences in science and engineering, recommend a “shift towards achievement …

Patent Fake News, Jack M. Beermann

Faculty Scholarship

Complaints about the patent system are legion. Critics complain that it is too easy to get a patent, that it is too easy to challenge an existing patent, that many patent denials are rationally inexplicable, that aggressive enforcement of patents stifles innovation, that patent trolls abuse the system to extort money from innocent users of widespread technology, and that inventors leverage modest modifications of existing patents to extend the patent period beyond intended legislative limits. While Janet Freilich’s forthcoming article, Ignoring Information Quality, may not reveal the root of all patent evil, it illuminates an important problem in the …

Navigating The Transition To A More Innovation-Centric Antitrust (Review Of Richard J. Gilbert, Innovation Matters), Jonathan Baker

Book Reviews

Review of Richard J. Gilbert Innovation Matters: Competition Policy for the High-Technology Economy MIT Press 2020

In Juno V. Kite The Federal Circuit Strikes Down Patent Directed Towards Pioneering Innovation In Car T-Cell Therapy, Christopher M. Holman

Faculty Works

Chimeric antigen receptor T-cells (also known as CAR T-cells) are T-cells that have been genetically engineered to produce an artificial T-cell receptor for use in immunotherapy. In recent years CAR-T cell therapy has emerged as an important new modality of cancer treatment, particularly for blood-borne cancers like leukemia. As would be expected, important advances in the development of CAR T-cell therapy have been the subject of extensive patenting and licensing activity. Juno v. Kite, a recent decision of the Court of Appeals of the Federal Circuit striking down a foundational CAR T-cell therapy patent, has raised serious questions as to …

Patents As Signals Of Quality In Crowdfunding, Christopher A. Cotropia

Law Faculty Publications

Patents and crowdfunding both attempt to foster early stage innova-tions. In theory, patents signal quality and value to attract investment and buyers and ultimately facilitate commercialization. Crowdfunding allows multiple individuals to make small contributions to finance start-up ven-tures. This Article reports on two related studies investigating the interac-tion between these two innovation tools by determining the impact of a crowdfunding campaign’s patent status on the campaign’s success and de-livery. The first study examines 9,184 Kickstarter campaigns in patent-eli-gible categories to determine whether patented or patent-pending labeled projects are more likely to reach their funding goal and in turn achieve actual, …

The Aia At Ten - How Much Do The Pre-Aia Prior Art Rules Still Matter?, Colleen Chien, Janelle Barbier, Obie Reynolds

Faculty Publications

As the America Invents Act (AIA) turns 10, patent students across the
country may ask: if the law is already a decade old, why am I spending so much
time studying pre-AIA law? Though patents filed before the transition date will
remain in force up through March 2033, a good 10+ years away, teachers may also
be wondering which regime to emphasize and for how long the pre-AIA rules will
be considered fundamental rather than footnote material.

Immoral Patents, David O. Taylor

Faculty Journal Articles and Book Chapters

Only to a limited extent have U.S. legislators recognized the moral and ethical implications of the patentability of controversial technologies. I find this absence of legislative debate curious for several reasons, including the fact that for decades there has been an intense public debate over the government’s involvement in, and regulation of, research and development related to biotechnology, including reproduction technologies, and particularly the use and destruction of embryonic stem cells, embryos, and fetuses—areas of considerable moral and ethical concern. Nor has there been debate regarding patentability with respect to other areas of concern, such as technologies that damage the …

Comments On Rights To Federally Funded Inventions And Licensing Of Government Owned Inventions, National Institute Of Standards And Technology (Nist), United States Department Of Commerce, Notice Of Proposed Rulemaking. 86 Fr 35. Agency/Docket Number: 201207-0327, Joshua D. Sarnoff, Liza Vertinsky, Yaniv Heled, Ana Santos Rutschman, Cynthia M. Ho

All Faculty Scholarship

This letter is written in response to the notice of proposed rulemaking published in the Federal Register on January 4, 2021, seeking public comments on the revised regulations proposed by NIST to the University and Small Business Patent Procedure Act of 1980 (the “Bayh-Dole Act”). We submit this letter as academics who engage in research on patent law and biomedical innovation. The arguments also reflect practical knowledge that one of us has acquired from a decade of working with U.S. universities and biotech companies in the process of technology transfer as a lawyer practicing in two highly regarded Boston law …

The Federal Circuit Continues To Grapple With The Question Of Patent Eligibility For Diagnostic Methods, Christopher M. Holman

Faculty Works

This article considers the current state of affairs at the Federal Circuit with regard to the patent eligibility of diagnostic methods. Diagnostics v. Mayo Collaborative Servs. I then look at all of the decision decisions I could find in which the court strikes down diagnostic method claims as patent ineligible under Mayo v. Prometheus, of which there are quite a few. Finally, I turn to the handful of cases, all decided in 2018 or later, in which the Federal Circuit has upheld the patent eligibility of diagnostic claims, the most significant of which I believe to be Vanda Pharmaceuticals v. …

The Intellectual Property Of Covid-19, Ana Santos Rutschman

All Faculty Scholarship

The response to COVID-19 is indissolubly tied to intellectual property. In an increasingly globalized world in which infectious disease pathogens travel faster and wider than before, the development of vaccines, treatments and other forms of medical technology has become an integral part of public health preparedness and response frameworks. The development of these technologies, and to a certain extent the allocation and distribution of resulting outputs, is informed by intellectual property regimes. These regimes influence the commitment of R&D resources, shape scientific collaborations and, in some cases, may condition the widespread availability of emerging technologies. As seen throughout this chapter, …

Government Involvement In Pharmaceutical Development Can Come Back To Haunt A Drug Company, Christopher M. Holman

Faculty Works

The U.S. government has long played a significant role in pharmaceutical innovation, often through the funding of research, or collaboration in clinical trials. Unfortunately, government involvement can come at a cost for innovative drug companies, leading to allegations that taxpayers are being required to “pay twice” for the resulting drugs, particularly when the drug is considered essential and is offered at a price that is seen as “unreasonably” high. This Article discusses two aspects of ongoing efforts to leverage government involvement in pharmaceutical development and commercialization as a means for regulating of drug prices. The first is the assertion that …

Intellectual Property Through A Non-Western Lens: Patents In Islamic Law, Tabrez Y. Ebrahim

Faculty Scholarship

The intersection of secular, Western intellectual property law and Islamic law is undertheorized in legal scholarship. Yet the nascent and developing non-Western law of one form of intellectual property—patents—in Islamic legal systems is profoundly important for transformational innovation and economic development initiatives of Muslim-majority countries that comprise nearly one-fifth of the world’s population.

Recent scholarship highlights the tensions of intellectual property in Islamic law because religious considerations in an Islamic society do not fully align with Western notions of patents. As Islamic legal systems have begun to embrace patents in recent decades, theories of patents have presented conceptual and theological …

Preserving The Fruits Of Labor: Impediments To University Inventor Mobility, Brenda M. Simon

Faculty Scholarship

Academic inventors must overcome numerous obstacles when they seek to leave their parent universities. The results of their work are often intertwined in what I call "innovation-essential components," which are important aspects of the. innovative process that create strong ties to the parent university, such as data, patents, trade secrets, grants, contracts, materials, and other agreements and restrictions. Innovation-essential components effectively bind university inventors to their parent institutions, making departure unworkable without the university's approval. Universities sometimes further complicate inventor mobility by entering into unlawful agreements with other academic institutions in their efforts to prevent inventor movement or by engaging …

Branded Drug Companies Are Successfully Asserting The Doctrine Of Equivalents In Hatch-Waxman Litigation, Christopher M. Holman

Faculty Works

This article reports the results of a study analyzing every Federal Circuit decision the author could find dating back to 2005 that applies the doctrine equivalents (DOE) in the context of pharmaceutical patent litigation, and in particular infringement lawsuits brought against Abbreviated New Drug Application (ANDA) applicants by branded drug companies under the Hatch-Waxman Act. The results of this study show that pharmaceutical innovators were prevailing against would-be generic competitors under the DOE both prior to, and subsequent to, a 2007 article by Professors Lemley and Allison describing the demise of the doctrine equivalents, but that patentees’ success rate has …

In Minerva V. Hologic, The U.S. Supreme Court Reins In The Equitable Doctrine Of Assignor Estoppel, Christopher M. Holman

Faculty Works

Assignor estoppel is an equitable remedy that prohibits an assignor of a patent, or one in privity with an assignor, from attacking the validity of that patent when he is sued for infringement by the assignee. On June 29, 2021, the U.S. Supreme Court issued its decision in Minerva v. Hologic, holding that while AE remains a viable doctrine, the Federal Circuit has on many occasions, including the instant case, applied the doctrine in an overly expansive manner, particularly in cases where the patent claims at issue differ substantially from any patent claims that were in existence at the time …

Patent Examination And Examiner Interviews, S. Sean Tu

Law Faculty Scholarship

Examiner interviews are one of the most powerful tools to help both inventors and examiners understand and overcome specific issues during prosecution. Direct discussions between an applicant and an examiner can help bridge the gap between misunderstandings of prior art, the invention, or statements in the specification. When used correctly, examiner interviews can dramatically decrease the time in prosecution and help applicants quickly reach a final disposition. This paper reviews approximately 1.1 million patent applications corresponding to every patent application with an examiner interview between 2007 and June 2020 to determine the effectiveness of examiner interviews. This study establishes that …

Patent Law: An Open-Source Casebook (Chapter 8: Defenses), Dmitry Karshtedt, Mark D. Janis, Ted M. Sichelman

GW Law Faculty Publications & Other Works

Less than a handful of casebooks are truly open source, in the sense of being fully modifiable. Patent Law: An Open-Source Casebook is the first patent law casebook that provides adopting professors, students, and others the ability to fully modify its contents. This chapter of the casebook covers defenses to infringement, including inequitable conduct, patent exhaustion, patent misuse, laches, equitable estoppel, experimental use, and spoliation of evidence.

The Trade Secrecy Standard For Patent Prior Art, Sharon Sandeen, Camilla A. Hrdy

Faculty Scholarship

A fundamental criterion of patentability is that an invention must be new as compared to the prior art—the corpus of preexisting knowledge and technology already available to the public. If an invention is in the prior art, or rendered obvious by it, it cannot be patented.

The U.S. Patent Act has traditionally envisioned a categorical approach for deciding what counts as prior art. Under this approach, courts are supposed to decide whether a particular disclosure about the invention (a reference) falls within one of the categories listed in Section 102 of the Patent Act, such as “described in a printed …

Should The U.S. Government Actively Assert Its Own Patents?, Christopher J. Morten, Barry Datlof, Amy Kapczynski, Donna Meuth, Zain Rizvi

Faculty Scholarship

On March 10, 2021, our journal partnered with the Engelberg Center on Innovation Law and Policy to host a symposium addressing the role and impact of U.S. innovation policy on access to medicine. Our 2021 Symposium Issue — Volume 11, Issue 1 — captures that event.

The following article represents the second of four panels. This panel asked, “Should the U.S. government actively assert its own patents?” The panel was moderated by Christopher Morten, Deputy Director of NYU Law’s Technology Law & Policy Clinic. The panelists included Barry Datlof, Chief of Business Development and Commercialization in the Office of Medical …