United States Patent System Research Articles

Far Out: The Extended Denial of Public Access to Psychedelic Therapeutics

The United States patent regime is designed to promote dissemination of information that undergirds a particular innovation. To incentivize disclosure, inventors are granted a time-limited right to exclude others from practicing the invention, thereby affording the inventor a period in which to commercialize and financially benefit from their inventive contribution. The disclosure provides information sufficient for one of skill in the relevant art to make and use the invention, and the public may freely do so upon the patent’s expiry. Global advancement of human medicine is fundamentally intertwined with the United States patent system; medical progress largely depends upon the exclusionary protections United States patents confer. Ordinarily, the expiry of patents covering therapeutic products and methods yields substantial price reduction, as new market participants seek to establish market share by undercutting the expired patent holder and others. The patent system also yields to the public not only access to new and improved medical technology but also a delayed, unencumbered freedom to make and use the invention upon the patent’s exhaustion. Recently, psychoactive chemical compounds have garnered renewed and international attention. Although many psychedelic substances have had a long history of human use, including within therapeutic contexts, the Controlled Substances Act and related legislation significantly stifled research directed toward developing these substances for medical use. This “artificial” impediment to therapeutic innovation effectively delayed public access to the fruits of earlier innovation.

Strategic Citation: A Reassessment

AbstractThe United States patent system is unique in that it requires applicants to cite documents they know to be relevant to the examination of their patent applications. Lampe (2012) presents evidence that applicants strategically withhold 21%–33% of relevant citations from patent examiners, suggesting that many patents are fraudulently obtained. We challenge this view. We first show that Lampe's empirical design is inconsistent with both legal standards and standard operating procedures, including how courts identify strategic withholding. We then compile comprehensive data to reassess the empirical basis for Lampe's main claim. We find no evidence that applicants withhold citations.

How public investment fuels innovation: Clues from government-subsidized USPTO patents

• This study is among the first attempts to depict a full picture of the public-subsidized innovation scheme. • This study proposes a multi-dimension framework for learning public-subsidized innovation schemes—the innovation promotor, innovator, and innovation area. • Government agencies are more and more involved in collaborative relationships. • Non-government innovators have shown more powerful vitality than government innovators. • Federal agencies vary in preferences to select subsidized recipients and technological fields. Considerably little effort has been devoted to systematically exploring the landscape of government-funded innovation schemes, leaving policymakers and academics little empirical evidence with which to grasp the overall situation of national R&D funding strategies. In the United States (US), patents with a government right or financial interest are flagged, offering a window through which we can examine the landscape of today's patterns of government support for innovation. We conduct the examination from the perspectives of the leading government agencies, the promotor-recipient relationship, and the common concerns of different participants. The results show that the R&D project funding by federal agencies has, among other factors, contributed to the growth in the number of patent records. The Departments of Defense (DoD), Energy (DoE), and Health and Human Services (HHS), and the National Science Foundation (NSF) have issued the most funding and hold rights to more patent records than any other agencies. Moreover, reforms to the US patent system made 40 years ago to afford more protection to non-government assignees appear to have significantly impacted patenting activity. Universities, companies, and individuals have become far more active in fulfilling government-funded projects, with remarkable innovations as a result. In recent years, funding priorities have shifted toward research in biomedicine, fields related to human life, and computer science. However, the four dominant agencies responsible for most government funding differ in their investment priorities and frequently adjust which areas of innovation they support. This study is among the first attempts to support the landscape of the public-invested innovation using the full government-subsidized patent dataset. The analyses in this paper are instructive in understanding the dynamics of US government funding for innovation and informing effective policymaking around innovation.

A critical librarianship approach for teaching patent searching: Who becomes an inventor in America?

The ways in which a technology is invented, owned, and approved are strongly influenced by the same oppressive and exclusionary structures that critical librarianship interrogates. Patents, limited-term grants of rights to inventions, are issued to inventors in exchange for detailed specifications of the invention. This paper examines current practices used by business librarians in teaching students how find patents and how these practices could be critically informed given the nature of the United States patent system as it exists today. An output of this work is a suggested lesson plan with recommended resources.

Non-Practicing Entities & Patent Reform

The patent system is designed to promote innovation and supply a blueprint for innovative minds to improve upon, but the behavior of some patent owners is contrary to these principles. Non-practicing entities obtain patent rights, and rather than produce the product claimed in the patent, they assert their exclusionary rights broadly and aggressively against businesses producing similar products in order to induce settlement or licensing payments. These assertions account for a significant percentage of infringement claims and threaten a potentially innocent business with expensive litigation. The actions of these entities have a substantial effect on the patent system and have been the motivation behind reform and recent Supreme Court decisions. Each of the three branches of government has significant influence over the patent system, and each has the potential to promote change to reduce the impact of non-practicing entities on the United States patent system and on the United States economy.

Brief of the R Street Institute and the Electronic Frontier Foundation as Amici Curiae in Support of Appellees

Allergan, the holder of several pharmaceutical patents, entered a patent assignment and licensing transaction with the Saint Regis Mohawk Tribe. The sole purpose of that transaction was to prevent inter partes review of several Allergan patents based on the Tribe's sovereign immunity. Other patent holders and tribes could easily replicate this sovereign immunity transaction, and there are strong incentives for others to take advantage of this method of circumventing inter partes review and other post-grant proceedings. As a result, there is no reason to believe that this case is a unique one-off situation; should this Court deem sovereign immunity transactions an effective loophole to escape inter partes review, it is likely that many, if not most, patentees will take advantage of that loophole. Widespread evasion of inter partes review would lead to at least two serious harms. First, it would upset the basic balance of the patent system, with problematic fallout for all parties. Inter partes review was developed as the result of Congress weighing the tradeoffs between pre-grant examination and post-grant reconsideration of patents; in crafting the America Invents Act, Congress determined that it made policy and economic sense to correct erroneous patent grants after the fact, rather than to place the burden of accuracy entirely on pre-grant examination. If patent owners can easily avoid post-grant procedure, then pre-grant examination would need to become far more stringent, rendering patents potentially more expensive and difficult to obtain. Sovereign immunity transactions for circumventing inter partes review could thus have unintended negative ramifications for patent applicants and the public. Second, use of tribal transactions to avoid inter partes review negatively reflects on the reputation and integrity of the United States patent system as a whole. Allergan's transaction with the Tribe has been roundly criticized, and that criticism reveals a growing view that American patent law is not a driver of innovation but rather a game for lawyers to play. With intellectual property law's leading role in global policy today, it would be a step backwards to approve of a sovereign immunity stratagem that makes the patent system look illegitimate. Certainly, inter partes review is not perfect; indeed, amici have called for improvements to the proceeding. But insofar as complaints about inter partes review are the sole policy justification offered by Allergan and the Tribe for their position, this case is the wrong vehicle for those complaints, and the policy concerns laid out above militate strongly against dismantling the proceeding entirely to answer those complaints. The decision of the Board should be affirmed.

The United States Patent System and Engineering Education: An Alliance for Innovation

The United States Patent System and Engineering Education: An Alliance for Innovation

Canadian Inventors of U.S. Patents: An Empirical Study for the Canadian Ministry of Innovation, Science and Economic Development

In January 2016, the Canadian Ministry of Innovation, Science and Economic Development (the “Ministry”) commissioned this study to gain insight into technological innovation in Canada through the lens of the United States (“U.S.”) patent system. Comprehensive patent data of the sort required to make direct measurements of the Canadian patent system is not yet available in a form that lends itself to direct analysis, in particular patent data and metadata available as bulk downloads. In lieu of this, we use two massive data sets that we have assembled: (1) a dataset containing detailed information about patent prosecution in the U.S. from 1976 to the present, and (2) a dataset containing all federal U.S. patent litigations from 2000 to 2014 that resulted in a published opinion or order. We parsed these two datasets to derive a data subset containing all U.S. patents having at least one Canadian inventor (“Canadian-Contribution” or “CanCon” patents). The detailed information in the CanCon data subset has allowed direct analysis of such variables as inventor nationality (e.g., Canadian), numbers of inventors, application and issuance years, technology areas, assignees, prosecuting United States Patent and Trademark Office (“USPTO”) examiners, prosecuting attorneys, and/or prosecuting law firms. We constructed a comprehensive patent citation graph of all post-1975 patents, and used this graph to determine patent importance within this network using eigenfactor centrality methods. The results of our analyses offer new insights into the inventive behavior of Canadians and owners of patents that co-invent with Canadians. For example, in total there are 170,067 U.S. patents having at least one Canadian inventor. The mean importance of these patents is 1.133, which means that CanCon patents are, on average, 13% more important than the mean importance for all U.S. patents, which is 1.00. By comparison, the mean importance of all U.S. patents having at least one foreign inventor is 0.95, or of slightly below average importance. The technological fields having the largest numbers of CanCon patents tend to involve telecommunications, computers and computer software, pharmaceuticals, molecular biology, chemistry, land vehicles, and the design of furnishings. With respect to patents litigated in U.S. federal courts, CanCon patents are less likely to be the subject of a federal lawsuit, and, those CanCon patents that are litigated tend to be of lower importance than the average for litigated patents.

The Dark Side of Altruism in the Context of Patent Incentives: Are You Really Here for Me? Taking Off the Rose-Colored Glasses

Intellectual property rights exist to create self-renewing incentive structures that continually replenish the push for product improvement and innovation investment. This Paper turns the traditional analysis on its head by considering tort-like liability of patent holders for victims of product defects, specifically, robotic medical devices. Robotic surgical devices, or da Vinci robots, are gaining popularity in the medical community – despite, and perhaps due to, the novelty of remote surgical technology. However, the complexity lies not in the application of tort law to the United States patent system. The uncertain fit of tort law within patent law will remain for future discussion. In fact, the liability treated in this Paper is identified as tort-like, precisely to avoid the clumsy applicability of tort law to patent holders. Rather, the recent expansion in geographic scope of patient care – via wireless control, or disintermediation – creates the situation this Paper seeks to illuminate: A physician operating from California using a patented stint-placement in complex heart surgery on a patient in Guam, is sued when the stint-placement malfunctions and ruptures. The patient lives but, due to loss of blood to the brain, will live out the remainder of her life with significant neurological damage. In this case, who makes this patient whole? This Paper concludes by considering the difficultly involved when contemplating tort-like liability for injured patients, assuming robotic surgical malfunction.

Patent Assertions: Are We Any Closer to Aligning Reward to Contribution?

The 2011 America Invents Act (AIA) was the most significant reform to the United States patent system in over 50 years. However, the AIA did not address a number of major problems associated with patent litigation in the United States. In this paper, we provide an economic analysis of post-AIA developments relating to patent assertion entities (PAEs) and standard-essential patents (SEPs). For PAEs and SEPs, we examine the alignment, or lack of alignment, between the rewards provided to patent holders and their social contributions. Our report is mixed. Regarding PAEs, we see significantly closer alignment between rewards and contributions, largely due to a series of rulings by the Supreme Court. Legislation currently under consideration in Congress would further limit certain litigation tactics used by PAEs that generate rewards unrelated to contribution. We also see some notable developments relating to SEPs, especially with the recent reform to the patent policies of the Institute of Electrical and Electronics Engineers (IEEE), a leading standard-setting organization (SSO) and with several recent court decisions clarifying what constitutes a fair, reasonable and nondiscriminatory (FRAND) royalty rate. However, other steps that could better align rewards with contributions on the SEP front have largely stalled out, particularly because other major SSOs do not seem poised to follow the lead of the IEEE. Antitrust enforcement in this area could further align rewards and contributions.

From Dissertation to Litigation: The First-to-Invent System Versus the First-to-File System: A Comparative Analysis in Light of the Legal Dispute Over the CRISPR CAS9

With the recent implementation of the Leahy-Smith Act (America Invents Act), the landscape of the United States patent system has undergone a massive transformation. This reform aimed to substantially harmonize in an international level certain aspects of patent law. The purpose of this paper is to elucidate the differences between the first-to-invent system and the first to file system concerning the creation of priority rights in patents. The paper will also deal with the interpretation of 35 U.S.C. §102, §103 and §112 and the applicable legal standard for evaluating patentability. The same analysis, on the legal standards applied to patentability, is also considered in light of the European Patent Convention. The approach taken for this investigation is a practical one. This paper analyses a case currently ongoing in two major jurisdictions, U.S. and Europe. Centering on a new and revolutionary technology named CRISPR Cas9. CRISPR Cas9 is a method for gene editing created a few years ago by studying bacterial immune response. This method has had a significant impact in biomedicine and is considered as the next generation of genetics.

Patent Assertions: Are We Any Closer to Aligning Reward to Contribution?

The 2011 America Invents Act was the most significant reform to the United States patent system in over fifty years. However, the AIA did not address a number of major problems associated with patent litigation in the United States. In this paper, we provide an economic analysis of post-AIA developments relating to Patent Assertion Entities (PAEs) and Standard-Essential Patents (SEPs). For PAEs and SEPs, we examine the alignment, or lack of alignment, between the rewards provided to patent holders and their social contributions. Our report is mixed. Regarding PAEs, we see significantly improved alignment between rewards and contributions, largely due to a series of rulings by the Supreme Court. Legislation currently under consideration in Congress would further limit certain litigation tactics used by PAEs that generate rewards unrelated to contribution. We also see some notable developments relating to SEPs, especially with the recent reform to the patent policies of the IEEE, a leading Standard-Setting Organization (SSO) and with several recent court decisions clarifying what constitutes a Fair, Reasonable and Non-Discriminatory (FRAND) royalty rate. However, other steps that could better align rewards with contributions on the SEP front have largely stalled out, particularly because other major SSOs do not seem poised to follow the lead of the IEEE. Antitrust enforcement in this area could further improve the alignment of rewards and contributions.

AIA First-to-File and 35 USC 102

In general, after March 16, 2013, two significant changes will occur to the United States Patent System, the first relating to the necessity to be the first inventor to either file an application or publish information about an invention, and the second which modifies information to be included within Prior Art under 35 U.S.C. §102.

DIMINISHING THE ATTRACTIVENESS OF TROLLING: THE IMPACTS OF RECENT JUDICIAL ACTIVITY ON NON-PRACTICING ENTITIES

The United States patent system has increasingly been faced with complications presented by a type of non-practicing entity known as ‗patent trolls‘—patent owner entities that do not actively innovate, develop or manufacture patented material but instead seek to profit from patent ownership through licensing agreements and litigation. This article explores arguments on both sides of the non-practicing entity debate and evaluates perceptions of this activity as both an accessible secondary commodities market and a litigation-based business model.

Priority Among Competing Patent Applicants Under the American Invents Act

This Paper evaluates a historic shift in the United States patent system on how priority is awarded when two or more independent inventors each seek a patent on the same invention. The America Invents Act (AIA) alters the to invent priority principle, which has been a feature of the United States patent system since the earliest statutes in 1790 and 1793. The AIA adopts instead a inventor to file priority principle. The AIA retains a grace period of one year for inventor pre-filing date disclosures. It provides remedies for instances in which a first-to-file applicant an invention from a second-to-file applicant.Using a hypothetical example, the Paper describes the AIA's priority provisions in detail. It identifies features of the AIA that are ambiguous. For example, the effective date of the shift is unclear and may be subject to manipulation. The status of a doctrine limiting the prior art effect of previously-filed patent applications (Wertheim) is left uncertain. A fundamental question about a new proceeding begs for an answer: is it limited to instances where a second applicant asserting derivation by a first applicant claims substantially the same invention as the first applicant? The Paper also identifies aspects of the AIA that are clear but perplexing in terms of policy. For example, why was the right to bring a derived patent suits limited to a junior-filing patent owner suing within one year of issuance of a senior-filing patent owner's patent?

Patentable Subject Matter: Morally Neutral and Context Free

AMP v. USPTO otherwise known as the ACLU/Myriad "gene patenting" case has famously pitted the American Civil Liberties Union (ACLU) against Myriad Genetics. DNA patent litigation is not novel, but this case is distinct from typical cases involving commercial rivals; heretofore neither side has an interest in the commercially suicidal attacking of the underlying concept of DNA patents. The ACLU, representing the plaintiffs, has no such qualms. And the ACLU is fighting dirty: the United States patent system is effectively moral and social-context neutral, but the ACLU has succeeded in making social and political concerns the highlight of their legal case, even reframing DNA as per our human understanding, as information, and as distinct from a simple double helical macromolecule. The relevance of the case exceeds the bounds of DNA patents, as reflected in the number of amicus briefs filed, and threatens many other industries, particularly those that rely on extracted biomaterials.

Introduction to the United States Patent System

Introduction to the United States Patent System

Patent Information in Science, Technical, and Medical Library Instruction

Patent information is now freely available online from many patenting authorities. Online tutorials for patent searching are available from engineering, business, and other library Web sites. This article highlights some areas to consider covering in library instruction, reviews patent tutorials, and gives some suggestions for delivering patent searching information to our students and library patrons. Copyright © 2007 Haworth Press. Patent Information in Science, Technical, and Medical Library Instruction “It is dangerous for modern design engineers not to be familiar with the role of patents in a competitive industry.” Charles A. Garris Jr. We can open the door of the world of patent searching to our science, technical, and medical (STM) students. While Garris, as a Professor of Engineering, calls for an understanding of such concepts as designing around a patent, patent litigation, and patent rights as assets, it is easily within our purview to explain the basics of patent searching in the United States patent system, as well as in the systems of other patenting authorities. When we instruct our students in searching databases that cover patent literature we are potentially exposing them to records for patents. Varying by database, Compendex, Inspec, and SciFinder Scholar records provide the following: title, assignee, inventors, patent number, filing date, patent issue date, country of application, and abstract. Compendex only indexes selected patents before 1970. With additional subscriptions, later United States Patent and Trademark Office (USPTO) patents and European patents are included. Inspec only includes selective patents and all are from 1976 or earlier. Almost all of the Patents included come from the U.S. and U.K. SciFinder Scholar searches USPTO, European, and Japanese granted patents and USPTO and World patent applications and gives the International Patent Classification (IPC) code of the invention. Patent information is now freely available online from many patenting authorities. Online tutorials for patent searching are available from engineering, business, and other library Web sites. The following highlights some areas to consider covering in library instruction, reviews patent tutorials, and gives some suggestions for delivering patent searching information to our students and library patrons. SEARCHING UNITED STATES PATENTS Searching patents on the United States Patent and Trademark Office (USPTO) Web site at http://www.uspto.gov has major drawbacks: keyword searching is not available prior to 1976 and accessing and printing the patent image is not seamless.

Modeling innovation by a kinetic description of the patent citation system

This paper reports results of a network theory approach to the study of the United States patent system. We model the patent citation network as a discrete time, discrete space stochastic dynamic system. From patent data we extract an attractiveness function, A ( k , l ) , which determines the likelihood that a patent will be cited. A ( k , l ) shows power law aging and preferential attachment. The exponent of the latter is increasing since 1993, suggesting that patent citations are increasingly concentrated on a relatively small number of patents. In particular, our results appear consistent with an increasing patent “thicket”, in which more and more patents are issued on minor technical advances.

Ending Abuse of Patent Continuations

One of the oddest things to an outsider about the United States patent system is that due to continuation practice it is impossible for the U.S. Patent and Trademark Office (PTO) ever to finally reject a patent application. Continuation applications have led to abuse of the patent prosecution process. They serve very little useful purpose, and what benefits they confer may be outweighed by their potential for mischief. In an effort to study the pervasiveness of continuation practice, we compiled an original dataset comprising 2,224,379 patents, every patent issued from 1976 through 2000. We found that while continuations are filed in 23% of all patent applications, patents based on continuation applications represent 52% of all litigated patents. Although continuations are used in a minority of all patents, it is the most important minority because it is the minority most likely to end up in litigation. We examine the efforts undertaken to control the problems associated with continuation patents (changing the patent term, publishing applications, prosecution laches) and find them insufficient. The world would probably be a better place if they were abolished. Recognizing, however, that the abuse of continuation practice is not as pervasive as some might think, we propose a number of means by which Congress and the courts could strengthen existing rules designed to limit their abuse while preserving the practice. At a minimum, the empirical data we present can provide litigants and judges with a baseline for assessing the reasonableness of delay caused by the filing of multiple continuations by the patentee in determining the applicability of equitable remedies such as prosecution laches.