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Managing University Intellectual Property in the Public Interest
Thirty years ago federal policy underwent a major change through the Bayh-Dole Act of 1980, which fostered greater uniformity in the way research agencies treat inventions arising from the work they sponsor. Before the Act, if government agencies funded university research, the funding agency retained ownership of the knowledge and technologies that resulted. However, very little federally funded research was actually commercialized. As a result of the Act's passage, patenting and licensing activity from such research has accelerated.
Although the system created by the Act has remained stable, it has generated debate about whether it might impede other forms of knowledge transfer. Concerns have also arisen that universities might prioritize commercialization at the expense of their traditional mission to pursue fundamental knowledge-for example, by steering research away from curiosity-driven topics toward applications that could yield financial returns.
To address these concerns, the National Research Council convened a committee of experts from universities, industry, foundations, and similar organizations, as well as scholars of the subject, to review experience and evidence of the technology transfer system's effects and to recommend improvements. The present volume summarizes the committee's principal findings and recommendations.
eBook
Intellectual Property
A new edition of the trusted book on intellectual property
Intellectual Property simplifies the process of attaching a dollar amount to intellectual property and intangible assets, be it for licensing, mergers and acquisitions, loan collateral, investment purposes, and determining infringement damages.
Written by Russell L. Parr, an expert in the valuation/intellectual property field, this book comprehensively addresses IP Valuation, the Exploitation Strategies of Licensing and Joint Ventures, and determination of Infringement Damages. The author explains commonly used strategies for determining the value of intellectual property, as well as methods used to set royalty rates based on investment rates of returns.
This book examines the business economics of strategies involving intellectual property licensing and joint ventures, provides analytical models that can be used to determine reasonable royalty rates for licensing and for determining fair equity splits in joint venture arrangements.
Key concepts in this book are brought to life by presenting real-world examples of exploitation strategies being used by major corporations.
* Provides practical tools for and examines the business economics for determining the value intellectual property in licensing and joint venture decisions
* Presents analytical models for determining reasonable royalty rates for licensing and for determining fair equity splits in joint venture arrangements
* Provides a detailed discussion about determining intellectual property infringement damages focusing on lost profits and reasonable royalties.
eBook
Intellectual property : valuation, exploitation, and infringement damages
This book is designed to simplify the process of attaching a dollar amount to intangible assets, be it for licensing, mergers and acquisitions, loan collateral, or investment purposes. It provides practical tools for evaluating the investment aspects of licensing and joint venture decisions, and discusses the legal, tax, and accounting practices and procedures related to such arrangements; examines the business economics of strategies involving intellectual property licensing and joint ventures; and provides analytical models that can be used to determine reasonable royalty rates for licensing and for determining fair equity splits in joint venture arrangements.
eBook
The case for criminal IP enforcement
Historically, few IP owners have enforced their intellectual property in the United States through criminal procedures. The criminal authorities have been largely uninterested in IP cases or unable to commit resources. This is changing as the US government dedicates more money to IP cases and makes it clear that IP is a priority. If you are to pursue a criminal case in the US, it is necessary to do sufficient work internally, to turn over a complete and convincing case to the authorities, and to argue for the broader significance of the infringement. Prosecution by US federal or state authorities can lead to serious consequences for infringers. If the case is pursued by the government to a successful conviction, any prison sentence or other punishment sends a strong message of deterrence. It may also be possible to recoup any financial losses through court-ordered restitution. Under the right circumstances, referring an IP case to law enforcement can be the most effective tool in a company's arsenal.
Trade Publication Article
Innovation and Its Discontents
The United States patent system has become sand rather than lubricant in the wheels of American progress. Such is the premise behind this provocative and timely book by two of the nation's leading experts on patents and economic innovation.
eBook
The Economics of Patents: Lessons from Recent U.S. Patent Reform
U.S. patent reform over the past two decades has strengthened the legal enforcement of patent rights and has extended protection to new subject matter, such as genetically engineered life forms and business methods. This paper highlights these and other policy changes and the debate that this apparent increase in protection has sparked. While the case for stronger patents as a spur to innovation is a weak one, as revealed by recent theoretical and empirical research, evidence that they encourage disclosure and technology transfer is persuasive. The paper discusses the social costs and benefits of these effects from the policy changes and proposals for alleviating the costs through further patent reform.
Journal Article
Why Biologics and Biosimilars Remain So Expensive: Despite Two Wins for Biosimilars, the Supreme Court’s Recent Rulings do not Solve Fundamental Barriers to Competition
Biologics and biosimilars are medicines made from living cells that treat common and serious diseases such as cancer, diabetes, rheumatoid arthritis, and other inflammatory diseases. They are highly targeted, efficacious, and represent an increasingly important part of physicians’ armamentaria in the combat against these medical conditions. Yet they are extremely expensive, costing on average $10,000–$30,000 per year and exceed $500,000 for the most expensive biologics. The advent of biosimilar drugs, or high similar copies of biologics, was supposed to help reduce costs, but thus far the cost of treatment with biologics or biosimilars has not fallen sharply in the USA. We argue that a primary hurdle is the extent of patent protection for the reference biologics that impedes greater numbers of biosimilars entering into the market. To date, of the 12 biosimilars approved for marketing by the US Food and Drug Administration (FDA), only five are commercially available. All but one of the remaining biosimilars are withheld from commercialization due to patent disputes. We argue that the market for biologics and biosimilars will become price competitive only if more biosimilars are available to patients. To this end, the process to eliminate marginally inventive patents held by the reference drug makers must be streamlined and improved. In this perspective article, we suggest actions to improve the pre-FDA approval patent resolution process known as the patent dance, the streamlined patent invalidation process known as Inter Partes Reviews, and the process of granting patents.
Journal Article
The FDA De Novo medical device pathway, patents and anticompetition
The interaction between patents and FDA’s De Novo and 510(k) regulatory pathways has the potential to threaten follow-on innovation for medical devices.
Journal Article
FAKE TRADEMARK SPECIMENS
United States trademark law requires that a mark be used in commerce for it to qualify for registration at the U.S. Patent and Trademark Office (PTO). Applicants prove that they have met the use requirement by submitting to the PTO photographic specimens of their use of the mark in commerce. This Piece reports the results of new empirical work showing that an appreciable number of U.S. trademark applications originating in China include fraudulent specimens of use. In particular, with respect to use-based applications originating in China that were filed at the PTO in 2017 solely for apparel goods, we estimate that 66.9% of such applications included fraudulent specimens. Yet 59.8% of these fraudulent applications proceeded to publication, and 38.9% then proceeded to registration. If these applications are representative of the overall population of Chinese-origin applications in that year, then approximately 14.0% of all such use-based applications filed with the PTO in 2017 were fraudulent. Fraudulent registrations worsen the problems of trademark depletion and clutter, undermine the integrity of the trademark register, and hurt legitimate businesses that may benefit from using these marks. We therefore recommend legislative action to make it easier for third parties and the PTO to cull these marks from the register and systematic improvement by the PTO to ensure that applications with fraudulent specimens are not registered in the first instance.
Journal Article