Science and Technology Law Commons^™

Patent Pending: How The Current Patent Utility Requirement Hinders Biotechnological Innovation, Madison Drlik

Journal of Law and Health

The legal system is always playing catch up to adapt to new legal landscapes, doctrines, and technology; however, patent law needs help to compete with biotechnological research in the race towards innovation. Biotechnological research in the realm of human health and medicine often involves the use of therapeutic drugs. The field of healthcare biotechnology takes biological systems and processes and generates novel, creative solutions to a number of human health conditions. However, the translation process for a new drug, therapy, or process is long and expensive which requires investors to help the researchers and scientists move their creations from inception …

Inconsistencies At The International Trade Commission And The United States Federal District Courts, Christine Dedoulis

Catholic University Journal of Law and Technology

This article will analyze Section 337 of the Tariff Act of 1930, under which the International Trade Commission (Commission) conducts unfair import investigations, as it applies to patent infringement cases. Further, this article will explore different outcomes regarding parallel litigation at the Commission and District Courts, including what remedies are available and the effect of duplicative and inconsistent determinations on the patentee. In light of these comparisons, this article will provide suggestions on how to minimize inconsistencies between the Commission and District Courts, with particular emphasis on determining if some middle ground exists and if a classification system could be …

Design Patent Law's Three Little Words, Mark D. Janis

Indiana Law Journal

U.S. design patent law protects the visual characteristics of articles of manufacture. For many years, major manufacturers of athletic footwear have protected their visually iconic designs with design patents, fueling a global market valued at nearly $100 billion. Today, however, shoe design has arrived in the digital universe. Digital sneakers such as Gucci’s Virtual 25 and Nike’s “Our Force Ones” can be “worn” only in virtual worlds but have substantial real world economic value. Yet U.S. design patent law makes it difficult—some would say impossible—to protect those designs, on the ground that they do not satisfy the statutory requirement for …

Scientific Educations Among U.S. Judges, Christa J. Laser

American University Law Review

Should more judges have technical and scientific educations than are currently prevalent in the federal judiciary? This empirical study of the educational background of federal judges reports the undergraduate and graduate majors of active U.S. federal Article III judges. Information on the subject area of study is largely not publicly available, especially for judges appointed decades ago. This is the first and only publicly available research study of the subject areas of study of U.S. judges, collected via phone and email surveys to U.S. judges. The results of this study show that only 7.35% of federal judges have majors in …

Certainly Uncertain: An Analysis Of The Patent Eligibility Restoration Act Of 2023, Charles Duan

American University Business Law Review

Patentable subject matter eligibility has been a topic of major policy debate over many years, culminating in the recent introduction of a bill that would entirely overhaul current law. This article reviews the proposed legislation in view of its historical context, the purported need to reduce uncertainty, and the likely effects of the bill. Based on this analysis, the article concludes that the legislation is unnecessary, ill conceived, and likely to be harmful to scientific research, a variety of industries, and the public good.

Brief Of Law Scholars As Amicus Curiae In Support Of Appellees And Affirmance, Charles Duan

Amicus Briefs & Court Filings

Amici are law professors and scholars who focus their scholarship and teaching on intellectual property law, property law, regulatory law, and health law.2 They write to address the plaintiff’s, Novo Nordisk Inc., et al. (Novo), overarching contention that the Medicare drug price negotiation program constitutes an unconstitutional price control. Amici submit this brief to provide the Court with the historical and legal background regarding the constitutionality of government price negotiations and price regulations. The amici explain how Courts have historically ruled on these questions, as well as the far-reaching consequences that a ruling in Novo’s favor would have on the …

Brief Of 15 Scholars Of Law And Medicine As Amici Curiae In Support Of The Petition For Rehearing En Banc, Charles Duan

Amicus Briefs & Court Filings

The panel decision announces an over-expansive, ill-defned doctrine of inducement, in which well-pled allegations may be based on nothing more than ordinary marketing materials and mandatory labeling--even when those materials never recite or describe the claimed invention. This unprecedented and erroneous expansion of inducement liability leaves the law uncertain. It is now unclear, among other things, what statements a generic frm may make about its own product's equivalence and how much of the generic product's labeling information must be revised--assuming that such revisions are even regulatorily allowed--in order to avoid the risk of an inducement lawsuit.

Seed Patents: Enabling Innovation Beyond Biological Deposits, Ellaina Sanders

American University Law Review

In J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc., the Supreme Court held that new sexually reproducing plant varieties are patentable subject matter. This allowed breeders and seed companies to protect their intellectual property in new seeds by obtaining utility patents so long as they meet the other statutory requirements, such as enablement. Unlike other intellectual property protection for new plant varieties, utility patents require the patent disclosure to include enough information that a person of ordinary skill in the art could make and use the invention without undue experimentation. In In re Wands, the Federal Circuit …

The Social Value Of Intellectual Property, Alina Ng Boyte

IP Theory

No abstract provided.

Don’T Cite Funk, Oskar Liivak

Catholic University Law Review

For patent eligibility the Supreme Court continues to rely on its 1947 opinion in Funk Brothers Seed v. Kalo Inoculant. It is one of the most cited cases for patent eligibility and the Supreme Court relies heavily upon it. It forms one of the foundations of the current eligibility test in Mayo v. Prometheus. This article argues that this reliance is in error. Funk is just not appropriate for modern patent eligibility. Interestingly this view is not new. Ever since its appearance in Flook, the Supreme Court’s use of Funk has been dogged by criticism that faults the Court for …

The Power Of Local: Nearby Innovators Dominate Patented Technology Development, Richard Gruner

Northwestern Journal of Technology and Intellectual Property

Advances by nearby innovators – close enough to interact in person – play key roles in patented technology development. Patents frequently cite nearby innovations, identifying these local innovations as the background for further patented inventions. Such citations reveal narrow geographic areas with intensely active innovation communities advancing similar projects and technologies. Local innovators – working within a commutable distance of 40 miles or less of each other – accounted for 25 percent of all patent citations between 2010 and 2019 and about 21 percent of citations by disinterested patent examiners reviewing patent applications. These percentages of citations to local advances …

Patent-Infringement Suits And The Right To A Jury Trial, H. Tomas Gomez-Arostegui, Sean Bottomley

American University Law Review

This Article analyzes whether the Seventh Amendment affords a right to a jury trial in suits in which the owner of a patent seeks only equitable relief against an accused infringer. The existence of jury rights carries important consequences for litigants. Like many issues involving application of the Constitution, the availability and scope of the right to a jury depends on eighteenth-century English legal history. Current doctrine holds that litigants in equity had no right to a jury in patent cases in England c.1791 and therefore that litigants today who seek only injunctive relief possess no such right either. But …

On The Appeal Of Drug Patent Challenges, Charles Duan

American University Law Review

Administrative patent challenge proceedings, the most prominent form of which is inter partes review, have attracted much controversy. In particular, the pharmaceutical industry and its supporters have criticized the proceedings as unfairly biased toward canceling valuable drug patents. Yet there has been little study of the real-world, practical impact of these administrative proceedings on drug patents or pharmaceutical markets.

This Article reviews the universe of administrative challenges on drug patents that have proceeded through appeal to the Federal Circuit. The majority of patents challenged this way are deemed unpatentable at both the agency and appellate levels, and that administrative cancellation …

It Takes Two To Incorporate: The Role Of Patent Co-Ownership In Inventor Choice Of Business Form, Shawn P. Miller

American University Law Review

The literature on the theory of the firm and the reasons why entrepreneurs choose one type of business organization over another is massive. However, few empirical studies have been conducted to test the importance of the various proposed determinants of choice of legal form of organization in real-world industries. This paper helps fill that gap through an econometric investigation of the differences in the characteristics of two groups of independent inventors engaged in the business of patent monetization: inventors operating as sole proprietors and those operating through business organizations, almost always LLCs or close corporations.

The results suggest that commonly …

Enabling Science Fiction, Camilla A. Hrdy, Daniel H. Brean

Michigan Technology Law Review

Patent law promotes innovation by giving inventors 20-year-long exclusive rights to their inventions. To be patented, however, an invention must be “enabled,” meaning the inventor must describe it in enough detail to teach others how to make and use the invention at the time the patent is filed. When inventions are not enabled, like a perpetual motion machine or a time travel device, they are derided as “mere science fiction”—products of the human mind, or the daydreams of armchair scientists, that are not suitable for the patent system.

This Article argues that, in fact, the literary genre of science fiction …

Ignoring Information Quality, Janet Freilich

Faculty Scholarship

Entry into the patent system is guarded by an examination process to screen out applications that impose undue costs on the public without commensurate benefit. To do this, patent examiners rely heavily on various pieces of information-both provided by the patent applicant and independently discovered by the examiner-to assess whether an application should be granted. This Article shows that there are few mechanisms at the U.S. Patent and Trademark Office for questioning the veracity of this information, even though it may be incorrect. Rather, patent examination often assumes that existence of information equals accuracy of information. Consequently, examiners may rely …

Reconstructing Patent Eligibility, Talha Syed

American University Law Review

Patent law’s doctrine of ineligible subject matter is widely agreed to be in a bad state of repair. Even those welcoming the Supreme Court’s return to express subject-matter bars have been left disoriented by the Court’s pronouncements in this area. Which subject matter is ineligible, why it is ineligible, and how it might become eligible have all remained enshrouded in mystery.

The nub of the problem, this Article contends, is two-fold. First, from its nineteenth-century origins to the present, courts grappling with ineligibility doctrine have remained in the grip of a series of “physicalist” misconceptions of the object of patent …

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

American University Law Review

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 …

Association For Molecular Pathology V. Myriad Genetics: A Critical Reassessment, Jorge L. Contreras

Michigan Technology Law Review

The Supreme Court’s 2013 decision in Association for Molecular Pathology v. Myriad Genetics is an essential piece of the Court’s recent quartet of patent eligibility decisions, which also includes Bilski v. Kappos, Mayo v. Prometheus, and Alice v. CLS Bank. Each of these decisions has significantly shaped the contours of patent eligibility under Section 101 of the Patent Act in ways that have been both applauded and criticized. The Myriad case, however, was significant beyond its impact on Section 101 jurisprudence. It was seen, and litigated, as a case impacting patient rights, access to healthcare, scientific freedom, …

The Replicability Crisis In Patent Law, Janet Freilich

Faculty Scholarship

There is a “replicability crisis” in the scientific literature. Scientists attempting to redo experiments in reputable, peer-reviewed journals have found that staggering numbers of these experiments—up to 90%—do not work. Patents, like scientific articles, contain experiments. These experiments often form the backbone of the patent and provide crucial support for patentability. Patent examiners use these experiments to evaluate whether the invention works, and thus whether the patent should be granted. The replicability crisis in the scientific literature is therefore of utmost importance to the patent system. Transferring the insights of the replicability crisis to patents begs the question of whether …

Artificial Intelligence Inventions & Patent Disclosure, Tabrez Y. Ebrahim

Faculty Scholarship

Artificial intelligence (“AI”) has attracted significant attention and has imposed challenges for society. Yet surprisingly, scholars have paid little attention to the impediments AI imposes on patent law’s disclosure function from the lenses of theory and policy. Patents are conditioned on inventors describing their inventions, but the inner workings and the use of AI in the inventive process are not properly understood or are largely unknown. The lack of transparency of the parameters of the AI inventive process or the use of AI makes it difficult to enable a future use of AI to achieve the same end state. While …

Prophetic Patents, Janet Freilich

Faculty Scholarship

In most contexts, making up data is forbidden - considered fraudulent or even immoral. Not so in patents. Patents often contain experimental data and it is perfectly acceptable for these experiments to be entirely fictional. These so-called "prophetic examples" are not only explicitly permitted by both the Patent and Trademark Office and federal courts, but are considered almost equivalent to factual data in patent doctrine. Though prophetic examples are thought to be common, there are no studies of these experiments, no explanation for why fictional data are allowed in patents, and no evaluation of the practice.

Here, I provide the …

Saliency, Anchors & Frames: A Multicomponent Damages Experiment, Bernard Chao

Michigan Technology Law Review

Modern technology products contain thousands, sometimes hundreds of thousands, of different features. Nonetheless, when electronics manufacturers are sued for patent infringement, these suits typically accuse only one feature, or in more complex suits, a handful of features, of actual patent infringement. But damages verdicts often do not reflect the relatively small contribution an individual patent makes to an infringing product. One study observed that verdicts in these types of cases average 9.98% of the price of the entire product. While both courts and commentators have blamed the law of patent damages, the role cognitive biases play in these outsized damages …

Patents For Sharing, Toshiko Takenaka

Michigan Technology Law Review

Spurred by the Internet, emerging technologies have changed the way commercial firms innovate and have made it possible for individuals to play an important role in that innovation. Producers in the Information Communication Technologies (ICT), and other sectors dealing with complex technologies with many separately patentable components, find it increasingly difficult to make products without infringing on patents held by others. Numerous overlapping patents often cover such products. Producers have developed a new way to use patents: as inclusive rights for sharing their technologies with others through cross-licensing and other private ordering arrangements in order to ensure the freedom to …

Computational Experimentation, Tabrez Y. Ebrahim

Faculty Scholarship

Experimentation conjures images of laboratories and equipment in biotechnology, chemistry, materials science, and pharmaceuticals. Yet modern day experimentation is not limited to only chemical synthesis, but is increasingly computational. Researchers in the unpredictable arts can experiment upon the functions, properties, reactions, and structures of chemical compounds with highly accurate computational techniques. These computational capabilities challenge the enablement and utility patentability requirements. The patent statute requires that the inventor explain how to make and use the invention without undue experimentation and that the invention have at least substantial and specific utility. These patentability requirements do not align with computational research capabilities, …

Automation And Predictive Analytics In Patent Prosecution: Uspto Implications And Policy, Tabrez Y. Ebrahim

Faculty Scholarship

Artificial-intelligence technological advancements bring automation and predictive analytics into patent prosecution. The information asymmetry between inventors and patent examiners is expanded by artificial intelligence, which transforms the inventor-examiner interaction to machine-human interactions. In response to automated patent drafting, automated office-action responses, "cloems" (computer-generated word permutations) for defensive patenting, and machine-learning guidance (based on constantly updated patent-prosecution big data), the United States Patent and Trademark Office (USPTO) should reevaluate patent-examination policy from economic, fairness, time, and transparency perspectives. By conceptualizing the inventor-examiner relationship as a "patenting market," economic principles suggest stronger efficiencies if both inventors and the USPTO have better information …

Data-Centric Technologies: Patent And Copyright Doctrinal Disruptions, Tabrez Y. Ebrahim

Faculty Scholarship

Data-centric technologies create information content that directly controls, modifies, or responds to the physical world. This information content resides in the digital world yet has profound economic and societal impact in the physical world. 3D printing and artificial intelligence are examples of data-centric technologies. 3D printing utilizes digital data for eventual printing of physical goods. Artificial intelligence learns from data sets to make predictions or automated decisions for use in physical applications and systems. 3D printing and artificial intelligence technologies are based on digital foundations, blur the digital and physical divide, and dramatically improve physical goods, objects, products, or systems. …

Universities: The Fallen Angels Of Bayh-Dole?, Rebecca S. Eisenberg, Robert Cook-Deegan

Articles

The Bayh-Dole Act of 1980 established a new default rule that allowed nonprofit organizations and small businesses to own, as a routine matter, patents on inventions resulting from research sponsored by the federal government. Although universities helped get the Bayh-Dole Act through Congress, the primary goal, as reflected in the recitals at the beginning of the new statute, was not to benefit universities but to promote the commercial development and utilization of federally funded inventions. In the years since the passage of the Bayh-Dole Act, universities seem to have lost sight of this distinction. Their behavior as patent seekers, patent …

Brief For The R Street Institute And Engine Advocacy As Amici Curiae In Support Of Respondents, Charles Duan

Amicus Briefs & Court Filings

Under 35 U.S.C. § 102, an inventor may not obtain a patent on an invention that has been “on sale” for more than a year. The question is whether, from this so-called on-sale bar, certain classes of sales should be exempted— sales under a confidentiality agreement, in Petitioner’s view; and sales to those other than the ultimate customers, according to the government.

Our 19th Century Patent System, Gregory Reilly

IP Theory

The patent system is in flux. Concerns abound about the imperfect fit between traditional patent rights and the Information Age, excessive numbers of patents, overbroad patent rights, poor patent quality, and allegedly exploitative actors, like so-called “patent trolls.” In response, courts, commentators, and Congress have proposed, debated, and sometimes adopted a series of reforms and changes to patent rights, patent doctrines, and patent institutions. The America Invents Act of 2011 (AIA) introduced the most significant changes to the patent system since 1952 and was even described by one commentator (hyperbolically, as we will see) as “the most significant overhaul to …