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Articles 1 - 20 of 20
Full-Text Articles in Law
Standards And The Law, Cary Coglianese
Standards And The Law, Cary Coglianese
All Faculty Scholarship
The world of standards and the world of laws are often seen as separate, but they are more closely intertwined than many professionals working with laws or standards realize. Although standards are typically considered to be voluntary and non-binding, they can intersect with and affect the law in numerous ways. They can serve as benchmarks for determine liability in tort or contract. They can facilitate domestic and international transactions. They can prompt negotiations over the licensing of patents. They can govern the development of forensic evidence admissible in criminal courts. And standards can even become binding law themselves when they …
Defective Patent Deference, Tejas N. Narechania
Defective Patent Deference, Tejas N. Narechania
Washington Law Review
The Supreme Court’s implicit deference to the Office of the Solicitor General in patent cases is well-documented: What the Solicitor General requests, the Solicitor General typically receives. But we know far less about how the Solicitor General arrives at these preferred policy positions, or why the Solicitor General comes to advocate for some outcomes over others. This is problematic. In practically every other corner of the administrative state, an agency earns substantial deference to its views only where robust procedural protections attend to the policymaking process, where the agency’s outcome reflects its substantive expertise, and where the agency may, through …
A Functional Approach To Judicial Review Of Ptab Rulings On Mixed Questions Of Law And Fact, Rebecca S. Eisenberg
A Functional Approach To Judicial Review Of Ptab Rulings On Mixed Questions Of Law And Fact, Rebecca S. Eisenberg
Articles
The Court of Appeals for the Federal Circuit (“Federal Circuit”) has long relied on active appellate review to bring uniformity and clarity to patent law. It initially treated the PTO the same as the federal district courts, reviewing its factual findings for clear error and its legal conclusions de novo. Following reversal by the Supreme Court in Dickinson v. Zurko, the Federal Circuit began giving greater deference to PTO factual findings. But it continued to review the PTO’s legal conclusions de novo, while coding an expansive list of disputed issues in patent cases as legal conclusions, even when they …
The "Broadest Reasonable Interpretation" And Applying Issue Preclusion To Administrative Patent Claim Construction, Jonathan I. Tietz
The "Broadest Reasonable Interpretation" And Applying Issue Preclusion To Administrative Patent Claim Construction, Jonathan I. Tietz
Michigan Law Review
Inventions are tangible. Yet patents comprise words, and words are imprecise. Thus, disputes over patents involve a process known as “claim construction,” which formally clarifies the meaning of a patent claim’s words and, therefore, the scope of the underlying property right. Adversarial claim construction commonly occurs in various Article III and Article I settings, such as district courts or the Patent Trial and Appeal Board (PTAB). When these proceedings ignore each other’s claim constructions, a patent’s scope can become inconsistent and unpredictable. The doctrine of issue preclusion could help with this problem. The Supreme Court recently reemphasized in B & …
Rent-Seeking And Inter Partes Review: An Analysis Of Invalidity Assertion Entities In Patent Law, W. Michael Schuster
Rent-Seeking And Inter Partes Review: An Analysis Of Invalidity Assertion Entities In Patent Law, W. Michael Schuster
Michigan Telecommunications & Technology Law Review
This Essay is the first analysis of a recent entrant on the patent landscape: the Invalidity Assertion Entity (IAE). IAEs engage in rent-seeking by demanding payment from patent holders in exchange for not attempting to invalidate their patents through administrative action before the U.S. Patent and Trademark Office. The response to IAEs has been uniformly negative. Reflexive proposals have been raised in Congress (unsurprisingly) to terminate the IAE business model. In contrast to the common response to IAEs, this Essay discusses how profit-driven IAEs may generate socially beneficial externalities and why legislating to end the IAE business model is imprudent.
Trademark Laundering, Useless Patents, And Other Ip Challenges For The Marijuana Industry, Sam Kamin, Viva R. Moffat University Of Denver College Of Law
Trademark Laundering, Useless Patents, And Other Ip Challenges For The Marijuana Industry, Sam Kamin, Viva R. Moffat University Of Denver College Of Law
Washington and Lee Law Review
No abstract provided.
Patent Punting: How Fda And Antitrust Courts Undermine The Hatch-Waxman Act To Avoid Dealing With Patents, Rebecca S. Eisenberg, Daniel A. Crane
Patent Punting: How Fda And Antitrust Courts Undermine The Hatch-Waxman Act To Avoid Dealing With Patents, Rebecca S. Eisenberg, Daniel A. Crane
Michigan Telecommunications & Technology Law Review
Under the Hatch-Waxman Act, patent law and FDA regulation work together to determine the timing of generic entry in the market for drugs. But FDA has sought to avoid any responsibility for reading patents, insisting that its role in administering the patent provisions of the Hatch-Waxman Act is purely ministerial. This gap in regulatory oversight has allowed innovators to use irrelevant patents to defer generic competition. Meanwhile, patent litigation has set the stage for anticompetitive settlements rather than adjudication of the patent issues in the courts. As these settlements have provoked antitrust litigation, antitrust courts have proven no more willing …
Regulatory Monopoly And Differential Pricing In The Market For Patents , Neel U. Sukhatme
Regulatory Monopoly And Differential Pricing In The Market For Patents , Neel U. Sukhatme
Washington and Lee Law Review
Patents are limited-term monopolies awarded to inventors to incentivize innovation. But there is another monopoly that has been largely overlooked at the heart of patent law: the monopoly of the U.S. Patent and Trademark Office (PTO) over the granting of patents. This Article addresses this topic by developing the notion of a regulatory monopoly, where a single governmental actor has the power to set prices in a regulatory area. The Article explains how regulatory monopolists like the PTO could enhance social welfare via differential pricing—by charging regulated entities differing fees based on their willingness and ability to pay. In particular, …
Facing Down The Trolls: States Stumble On The Bridge To Patent-Assertion Regulation , David Lee Johnson
Facing Down The Trolls: States Stumble On The Bridge To Patent-Assertion Regulation , David Lee Johnson
Washington and Lee Law Review
No abstract provided.
Faster Resolutions In Tariff Classification Litigation: Using Patent Law As A Model, Lawrence Friedman
Faster Resolutions In Tariff Classification Litigation: Using Patent Law As A Model, Lawrence Friedman
Lawrence Friedman
This article draws a previously unmade analogy between patent litigation and customs cases before the U.S. Court of International Trade. The article posits that tariff classification litigation can be made more efficient by inverting the current focus on developing the facts through discovery and, instead, moving quickly to resolve controlling questions of law through motions for partial summary judgment, court-annexed mediation, or, if necessary, revised rules of procedure.
Interpreting Biological Similarity: Ongoing Challenges For Diverse Decision Makers, Sarah M. Cork
Interpreting Biological Similarity: Ongoing Challenges For Diverse Decision Makers, Sarah M. Cork
Michigan Telecommunications & Technology Law Review
Similarity is an elusive and complicated concept facing comparisons of biological molecules, as even minute changes to a molecule's structure can dramatically affect its function in the body. Yet the flood of biologic drugs on the market will increasingly force these similarity comparisons. These concerns are particularly relevant to two groups of drugs: families of biologic drugs that closely resemble each other in structure and function, here termed "similar-impact biologics," and the biosimilars, which are intended to closely approximate generic forms of biologic drugs. In bringing biologic drugs to the market, manufacturers are likely to face dual obstacles: FDA approval …
Burying, Robert Brendan Taylor
Burying, Robert Brendan Taylor
Michigan Telecommunications & Technology Law Review
When applying for a patent, applicants must provide the examiner with all known material prior art. Those who fail to do so can be charged with inequitable conduct. But applicants can still effectively hide material prior art references by submitting them along with large quantities of immaterial prior art to the examiner. This deceptive practice, known as "burying," is generally not considered inequitable conduct. This Essay summarizes the current legal landscape concerning burying, discusses the costs associated with the practice, and suggests ways to deter and punish those who do it.
It Is Time: Why The Fda Should Start Disclosing Drug Trial Data, Mustafa Ünlü
It Is Time: Why The Fda Should Start Disclosing Drug Trial Data, Mustafa Ünlü
Michigan Telecommunications & Technology Law Review
Although [drug] manufacturers bear the cost of research data generation, it is oftentimes a worthwhile investment that also confers significant commercial advantages. Consequently, they have argued that research data should be considered a trade secret and kept confidential. The FDA's longstanding position has been to accept this proposition. Even when Congress appeared to mandate disclosure or weaken the underlying rationale for secrecy, the FDA has continued to treat research data as confidential. A strong argument against a default posture of confidentiality is that research data disclosure would promote broad public interests by eliminating the societal costs brought about by keeping …
Does The Supreme Court Still Matter?, Timothy B. Dyk
Does The Supreme Court Still Matter?, Timothy B. Dyk
American University Law Review
No abstract provided.
Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz
Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz
Michigan Telecommunications & Technology Law Review
Before a new drug can be marketed, the Food and Drug Administration must be satisfied that it is safe and effective. According to conventional wisdom, the cost and delay involved in this process diminish the incentives to invest in the development of new drugs. Accordingly, several reforms aimed at restoring such incentives have been implemented or advocated. This Article challenges the central argument that drug regulation and drug innovation are necessarily at odds with one another. Although intuitively appealing, the argument that drug regulation negatively affects the incentives to innovate does not fully capture the role that regulation plays in …
The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg
The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg
Michigan Telecommunications & Technology Law Review
This Article reexamines the role of FDA regulation in motivating investment in biopharmaceutical innovation. I begin by challenging the standard story that it is the patent system that makes drug development profitable, and drug regulation that makes it costly, by showing how patents add to costs and how drug regulation works in tandem with patents to protect profits. I then compare FDA-administered exclusive rights to patents as a means of fortifying drug development incentives, suggesting ways that FDA-administered rights might be preferable both from the perspective of policy makers and from the perspective of firms. In the remainder of the …
The Problem Of New Uses, Rebecca S. Eisenberg
The Problem Of New Uses, Rebecca S. Eisenberg
Articles
Discovering new uses for drugs that are already on the market seems like it ought to be the low-lying fruit of biopharmaceutical research and development (R&D). Firms have already made significant investments in developing these drugs and bringing them to market, including testing them in clinical trials, shepherding them through the FDA regulatory approval process, building production facilities, and training sales staff to market them to physicians. By this point, the drugs have begun to enjoy goodwill among patients and physicians and casual observations in the course of clinical experience may point to potential new uses. One might expect that …
Learning The Value Of Drugs - Is Rofecoxib A Regulatory Success Story?, Rebecca S. Eisenberg
Learning The Value Of Drugs - Is Rofecoxib A Regulatory Success Story?, Rebecca S. Eisenberg
Articles
Controversy over recent revelations concerning the adverse cardiovascular effects of selective cyclooxygenase- 2 (COX-2) inhibitors has generally been framed as a story of regulatory failure, in which the Food and Drug Administration (FDA) has failed in its mission to protect the public from unsafe products. But this simplistic understanding of the mission of the FDA seems to make failure all but inevitable, if the reliable observation of the risks and benefits of a drug requires rigorous long-term studies. Perhaps in an earlier era the goal of drug regulation was simply to protect the public from poisons. Today, drug regulation guides …
Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg
Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg
Other Publications
It's a great honor for me to be invited to deliver the Levine Distinguished Lecture at Fordham, and a great opportunity to try out some new ideas before this audience. As some of you know, I've been studying the role of patents in biomedical research and product development ("R&D") for close to twenty years now, with a particular focus on how patents work in "upstream" research in universities and biotechnology companies that are working on research problems that arise prior to "downstream" product development. But, of course, the patent strategies of these institutions are designed around the profits that everyone …
Re-Examining The Role Of Patents In Appropriating The Value Of Dna Sequences, Rebecca S. Eisenberg
Re-Examining The Role Of Patents In Appropriating The Value Of Dna Sequences, Rebecca S. Eisenberg
Articles
As public and private sector initiatives race to complete the sequence of the human genome, patent issues have played a prominent role in speculations about the significance of this achievement. How much of the genome will be subject to the control of patent holders, and what will this mean for future research and the development of products for the improvement of human health? Is a patent system developed to establish rights in mechanical inventions of an earlier era up to the task of resolving competing claims to the genome on behalf of the many sequential innovators who elucidate its sequence …