Patent Clutter

Patent claims are supposed to clearly and succinctly describe the patented invention, and only the patented invention. This Article hypothesizes that a substantial amount of language in patent claims is in fact not about the core invention, which may contribute to well-documented problems with patent claims. I analyze the claims of 40,000 patents and applications, and document the proliferation of “clutter”—language in patent claims that is not about the invention. Although claims are supposed to be exclusively about the invention, clutter appears across industries and makes up approximately 25% of claim language. Patent clutter may contribute several major problems in patent law. Extensive clutter makes patent claims harder to search. Excessive language in patent claims may be the result of over-claiming—when patentees describe potential corollaries they do not possess—thereby making the patent so broad in scope as to be invalid. More generally, it strains the comprehensibility of patents and burdens the resources of patent examiners. After arguing that patent clutter may contribute to these various problems, this Article turns to reforms. Rejections based on prolix, lack of enablement, and lack of written description can be crafted to dispose of the worst offenders, and better algorithms and different litigation rules can allow the patent system to adapt (and even benefit from) the remaining uses of excess language. The Article additionally generates important theoretical insights. Claims are often thought of as entirely synonymous with the invention and all elements of the claim are thought to relate equally strongly to the invention. This Article suggests empirically that these assumptions do not hold in practice, and offers a framework for restructuring conceptions of the relationship between claims and the invention

The Paradox of Legal Equivalents and Scientific Equivalence: Reconciling Patent Law\u27s Doctrine of Equivalents with the FDA\u27s Bioequivalence Requirement

Contrary to popular perception, generic drugs often enter the market before the patents covering their brand name counterparts have expired by making slight changes to the drug to avoid the brand name patent. These generics face a paradox: the U.S. Food and Drug Administration (FDA) requires that the generic not show a significant difference from the reference product, while patent law requires that the generic have substantial differences as compared to the reference product. The generic must be bioequivalent, but not legally equivalent, to the brand name drug. This paradox occurs frequently in the courts but has never been discussed in the literature. This Article analyzes every case to date involving this equivalence paradox to create a normative theory explaining and predicting courts\u27 treatment of these cases. It then explains the implications for patent law. Namely, it demonstrates how courts use these cases as an opportunity to tailor the scope of the patent based on its ability to provide ex post incentives for commercialization and development. Finally, this Article discusses the broader implications of the paradox on FDA law and concludes that these cases demonstrate that, while courts are increasingly skeptical of evergreening, the paradox impedes progress towards cheaper, safer medicine

Ignoring Information Quality

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 on information that is wrong and many decisions about patent grant may also be wrong. While it is well known that patent examiners make frequent errors, the existing scholarship is almost entirely about what this Article terms “matching errors” (where examiners do not find information that actually exists), when “digging errors” (where examiners find information but the information is wrong) may in fact be more common. Digging errors have serious harms: nuisance suits, decreased incentives for research, and slowed technological development. The matching-digging framework introduced by this Article not only reveals new errors, it also makes the case that existing policy tools to address examination errors will not prevent or resolve these errors. Existing policy tools require that errors be visible to the public, which is currently true for matching errors but is not for digging errors. Solutions to digging errors should therefore be information forcing to remedy this asymmetry; and this Article includes several recommendations. Further, this Article uses the matching-digging framework to reconceptualize examination as a system of quasi-registration that defers many decisions about patentability to litigation. Patents should thus not be given a presumption of validity and doctrines of patentability as applied in litigation should not mimic their prosecution counterparts

Patent\u27s New Salience

The vast majority of patents do not matter. They are almost never enforced or licensed and, in consequence, are almost always ignored. This is a well-accepted feature of the patent system and has a tremendous impact on patent policy. In particular, while there are many aspects of patent law that are potentially troubling—including grants of unmerited patents, high transaction costs in obtaining necessary patent licenses, and patents’ potential to block innovation and hinder economic growth—these problems may be insignificant in practice because patents are under-enforced and routinely infringed without consequence. This Article argues that technological developments are greatly increasing the salience of patents by making patents easier and cheaper to find and enforce. These developments—including private platforms’ adjudication systems and AI-driven patent analytics—profoundly impact how the patent system functions and upend the system’s present dependence on under-enforcement and ignorance. Where most patents could previously be safely disregarded, formerly forgotten patents now matter. This Article makes four contributions to the literature. First, this Article explores the technology that is rendering patents newly salient and explains how this alters basic assumptions underlying the patent system. Second, this Article demonstrates that although new technology is increasing the number of patents that can be reviewed and enforced, this transformation sometimes decreases the depth of patent analysis. Because it is difficult to draw conclusions about patent scope or validity without in-depth analysis, this omission means that technological review of patents may give patents unmerited influence. Third, this Article shows a sharp divergence between public policy goals and private use of patents. For several decades, the courts and Congress have been reforming patent policy to decrease the impact of patents to alleviate concerns that patent owners hinder innovation by others. This Article demonstrates, in clear contrast to this goal, an increase in patent salience that is due exclusively to the use of private platforms and technologies. Further, the use of private platforms to find, analyze, and enforce patents creates the risk that choices made by companies and software developers will displace substantive patent law. Finally, this Article suggests policy reform, including ways to improve technology and patents and adjusted approaches to patent doctrine and theory

Prophetic Patents

In most contexts, making up data is forbidden - considered fraudulent, 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 Office and federal courts, but are considered equivalent to factual data in patent doctrine. Though prophetic examples are thought to be common, there are no in-depth studies of the practice, nor any explanation for why fictional data are allowed in patents. Here, I provide the first historical, theoretical, and empirical analysis of prophetic examples. I collect and analyze a novel dataset of over 2 million U.S. patents and applications from the biology and chemistry industries. I find that at least 17% of experiments in this population are fictional. Through both empirical and theoretical analyses, I weigh the potential costs and benefits of prophetic examples and find that the costs prevail. Prophetic examples could be beneficial if they help patentees; but I find little evidence that they do so, even in the specific situations in which they should be the most useful. Instead, prophetic examples likely hinder innovation because they prevent others from conducting their own experiments – even after the patent has expired and even if the prophetic example is incorrect. Prophetic examples also hopelessly confuse scientists – a shocking 99% of scientific articles incorrectly cite prophetic examples as if they contained factual information – which means that made-up results from patents contaminate the scientific literature. Given these harms, I argue for a shift from prophesies to more clearly delimited hypotheses – roadmaps for future research, but nothing more – preserving what value there is in speculation while mitigating the clear harms of the practice. Beyond these concrete policy recommendations, my findings also have rich implications for theoretical debates about the physicality of invention, when and to whom patents should be granted, how patents transmit information, and, ultimately, how best to incentivize innovation

Relating tissue specialization to the differentiation of expression of singleton and duplicate mouse proteins

BACKGROUND: Gene duplications have been hypothesized to be a major factor in enabling the evolution of tissue differentiation. Analyses of the expression profiles of duplicate genes in mammalian tissues have indicated that, with time, the expression patterns of duplicate genes diverge and become more tissue specific. We explored the relationship between duplication events, the time at which they took place, and both the expression breadth of the duplicated genes and the cumulative expression breadth of the gene family to which they belong. RESULTS: We show that only duplicates that arose through post-multicellularity duplication events show a tendency to become more specifically expressed, whereas such a tendency is not observed for duplicates that arose in a unicellular ancestor. Unlike the narrow expression profile of the duplicated genes, the overall expression of gene families tends to maintain a global expression pattern. CONCLUSION: The work presented here supports the view suggested by the subfunctionalization model, namely that expression divergence in different tissues, following gene duplication, promotes the retention of a gene in the genome of multicellular species. The global expression profile of the gene families suggests division of expression between family members, whose expression becomes specialized. Because specialization of expression is coupled with an increased rate of sequence divergence, it can facilitate the evolution of new, tissue-specific functions

A New Approach to Patent Reform

Scholars and policy makers have tried for years to solve the tenacious and harmful crisis of low quality, erroneously granted patents. Far from resolving the problem, these determined efforts have resulted in hundreds of conflicting policy proposals, failed Congressional bills, and no way to evaluate the policies’ value or impact or to decide between the overwhelming multiplicity of policies. This Article provides not only new solutions, but a new approach for designing and assessing policies both in patent law and legal systems more generally. We introduce a formal economic model of the patent system that differs from existing scholarship because it permits us to (1) determine how a policy change to one part of the patent system affects the system as a whole; and (2) quantify the impact of policy changes. Existing scholarship typically analyses a policy by assessing its effect on just the targeted element of the patent system, but legal systems are complex with interrelated components and players react along multiple margins, so these analyses are incomplete and sometimes incorrect. Our approach fixes this problem, providing a comprehensive understanding of how a policy change affects the patent system from beginning-to-end. It also permits us to conduct complex analyses such as varying multiple policies at once. Further, much existing scholarship fails to quantify the magnitude of a policy’s effect, and even empirical scholarship can only measure the effect of an already-implemented policy, not predict the effect of a proposed change. Quantification is critical because policies generally have multiple effects, often in countervailing directions. Quantification—as shown using our model—permits scholars to determine the overall direction and size of a theoretically ambiguous effect. Quantification also allows us to compare the social welfare effects of different reforms so that policy-makers know where to focus their efforts. We apply our model to several of the most prominent policy debates in patent law. We conclude that certain reforms such as regulation of settlement licenses and increased examination intensity yield large gains in social welfare and should be prioritized. Other reforms that are popular with scholars, including decreasing the availability of injunctions and reducing litigation costs produce surprisingly small gains in social welfare. Often existing scholarship operates too much on intuition, which, we show, can be wrong. Our new approach to patent reform provides an approach that offers deeper understanding and a more effective evaluation framework

Relationship between the tissue-specificity of mouse gene expression and the evolutionary origin and function of the proteins.

BACKGROUND: The combination of complete genome sequence information with expression data enables us to characterize the relationship between a protein's evolutionary origin or functional category and its expression pattern. In this study, mouse proteins were assigned into functional and phyletic groups and the gene expression patterns of the different protein groupings were examined by microarray analysis in various mouse tissues. RESULTS: Our results suggest that the proteins that are universally distributed in all tissues are predominantly enzymes and transporters. In contrast, the tissue-specific set is dominated by regulatory proteins (signal transduction and transcription factors). An increased tendency to tissue-specificity is observed for metazoan-specific proteins. As the composition of the phyletic groups highly correlates with that of the functional groups, the data were tested in order to determine which of the two factors -- function or phyletic age -- is dominant in shaping the expression profile of a protein. The observed differences in expression patterns of genes between functional groups were found mainly to reflect their different phyletic origin. The connection between tissue specificity and phyletic age cannot be explained by the recent rate of evolution. Finally, although metazoan-specific proteins tend to be tissue-specific compared with phyletically conserved proteins present in all domains of life, many such 'universal' proteins are also tissue-specific. CONCLUSION: The minimal cellular transcriptome of the metazoan cell differs from that of the ancestral unicellular eukaryote: new functions were added (metazoan-specific proteins), whilst other functions became specialized and no longer took place in all cells (tissue-specific pre-metazoan proteins).RIGHTS : This article is licensed under the BioMed Central licence at http://www.biomedcentral.com/about/license which is similar to the 'Creative Commons Attribution Licence'. In brief you may : copy, distribute, and display the work; make derivative works; or make commercial use of the work - under the following conditions: the original author must be given credit; for any reuse or distribution, it must be made clear to others what the license terms of this work are