A New Paradigm for Intellectual Property Rights in Software

A Winter 2004 article by Bradford L. Smith and Susan O. Mann of Microsoft published in The University of Chicago Law Review suggests that the development and growth of the software industry in the U.S. is a direct outgrowth of the implementation of intellectual property regimes, specifically copyright and patent, with respect to software in the late 1970s and early 1980s. This paper suggests that such patents were neither the sole nor the principal factor for the development of the software industry, that concerns about patents manifested prior to or soon after their application to software have proven true, and that patents are, in fact, not serving the interests of either the U.S. software industry or the consuming public. To that end, this paper advances recommendations for reforming the U.S. patent system as well as consideration of a new schema for protecting software

Patent Landscape of Influenza A Virus Prophylactic Vaccines and Related Technologies

Executive Summary: This report focuses on patent landscape analysis of technologies related to prophylactic vaccines targeting pandemic strains of influenza. These technologies include methods of formulating vaccine, methods of producing of viruses or viral subunits, the composition of complete vaccines, and other technologies that have the potential to aid in a global response to this pathogen. The purpose of this patent landscape study was to search, identify, and categorize patent documents that are relevant to the development of vaccines that can efficiently promote the development of protective immunity against pandemic influenza virus strains. The search strategy used keywords which the team felt would be general enough to capture (or “recall”) the majority of patent documents which were directed toward vaccines against influenza A virus. After extensive searching of patent literature databases, approximately 33,500 publications were identified and collapsed to about 3,800 INPADOC families. Relevant documents, almost half of the total, were then identified and sorted into the major categories of vaccine compositions (about 570 families), technologies which support the development of vaccines (about 750 families), and general platform technologies that could be useful but are not specific to the problems presented by pandemic influenza strains (about 560 families). The first two categories, vaccines and supporting technologies, were further divided into particular subcategories to allow an interested reader to rapidly select documents relevant to the particular technology in which he or she is focused. This sorting process increased the precision of the result set. The two major categories (vaccines and supporting technologies) were subjected to a range of analytics in order to extract as much information as possible from the dataset. First, patent landscape maps were generated to assess the accuracy of the sorting procedure and to reveal the relationships between the various technologies that are involved in creating an effective vaccine. Then, filings trends are analyzed for the datasets. The country of origin for the technologies was determined, and the range of distribution to other jurisdictions was assessed. Filings were also analyzed by year, by assignee, and by inventor. Finally, the various patent classification systems were mapped to find which particular classes tend to hold influenza vaccine-related technologies. Besides the keywords developed during the searches and the landscape map generation, the classifications represent an alternate way for further researchers to identify emerging influenza technologies. The analysis included creation of a map of keywords, as shown above, describing the relationship of the various technologies involved in the development of prophylactic influenza A vaccines. The map has regions corresponding to live attenuated virus vaccines, subunit vaccines composed of split viruses or isolated viral polypeptides, and plasmids used in DNA vaccines. Important technologies listed on the map include the use of reverse genetics to create reassortant viruses, the growth of viruses in modified cell lines as opposed to the traditional methods using eggs, the production of recombinant viral antigens in various host cells, and the use of genetically-modified plants to produce virus-like particles. Another major finding was that the number of patent documents related to influenza being published has been steadily increasing in the last decade, as shown in the figure below. Until the mid-1990s, there were only a few influenza patent documents being published each year. The number of publications increased noticeably when TRIPS took effect, resulting in publication of patent applications. However, since 2006 the number of vaccine publications has exploded. In each of 2011 and 2012, about 100 references disclosing influenza vaccine technologies were published. Thus, interest in developing new and more efficacious influenza vaccines has been growing in recent years. This interest is probably being driven by recent influenza outbreaks, such as the H5N1 (bird flu) epidemic that began in the late 1990s and the 2009 H1N1 (swine flu) pandemic. The origins of the vaccine-related inventions were also analyzed. The team determined the country in which the priority application was filed, which was taken as an indication of the country where the invention was made or where the inventors intended to practice the invention. By far, most of the relevant families originated with patent applications filed in the United States. Other prominent priority countries were the China and United Kingdom, followed by Japan, Russia, and South Korea. France was a significant priority country only for supporting technologies, not for vaccines. Top assignees for these families were mostly large pharmaceutical companies, with the majority of patent families coming from Novartis, followed by GlaxoSmithKline, Pfizer, U.S. Merck (Merck, Sharpe, & Dohme), Sanofi, and AstraZeneca. Governmental and nonprofit institutes in China, Japan, Russia, South Korea and the United States also are contributing heavily to influenza vaccine research. Lastly, the jurisdictions were inventors have sought protection for their vaccine technologies were determined, and the number of patent families filing in a given country is plotted on the world map shown on page seven. The United States, Canada, Australia, Japan, South Korea and China have the highest level of filings, followed by Germany, Brazil, India, Mexico and New Zealand. However, although there are a significant number of filings in Brazil, the remainder of Central and South America has only sparse filings. Of concern, with the exception of South Africa, few other African nations have a significant number of filings. In summary, the goal of this report is to provide a knowledge resource for making informed policy decisions and for creating strategic plans concerning the assembly of efficacious vaccines against a rapidly-spreading, highly virulent influenza strain. The team has defined the current state of the art of technologies involved in the manufacture of influenza vaccines, and the important assignees, inventors, and countries have been identified. This document should reveal both the strengths and weaknesses of the current level of preparedness for responding to an emerging pandemic influenza strain. The effects of H5N1 and H1N1 epidemics have been felt across the globe in the last decade, and future epidemics are very probable in the near future, so preparations are necessary to meet this global health threat

Patent Landscape of Helminth Vaccines and Related Technologies

Executive Summary This report focuses on patent landscape analysis of technologies related to vaccines targeting parasitic worms, also known as helminths. These technologies include methods of formulating vaccines, methods of producing of subunits, the composition of complete vaccines, and other technologies that have the potential to aid in a global response to this pathogen. The purpose of this patent landscape study was to search, identify, and categorize patent documents that are relevant to the development of vaccines that can efficiently promote the development of protective immunity against helminths. The search strategy used keywords which the team felt would be general enough to capture (or “recall”) the majority of patent documents which were directed toward vaccines against helminths. After extensive searching of patent literature databases, approximately 2847 publications were identified and collapsed to about 446 INPADOC families. Relevant patent families, almost half of the total relevant families (210 being total number of relevant families), were then identified and sorted into the categories of trematodes, cestodes, nematodes or nonspecific helminth. The 210 patent families that were divided into these four major categories were then further divided into sub categories relating to common fields of technology (e.g. DNA vaccine, vaccine formulations, methods to produce subunits) This sorting process increased the precision of the result set. The four major categories (cestodes, nematodes, trematodes, and non specific applications) as well as the overall data set of the 210 relevant family members were subjected to a range of analytics in order to extract as much information as possible from the dataset. First, patent landscape maps were generated to assess the accuracy of the sorting procedure and to reveal the relationships between the various technologies that are involved in creating an effective vaccine. Then, filings trends are analyzed for the overall dataset of the 210 relevant families as well as by the categories of trematodes, cestodes, and nematodes. The country of origin each member of the 210 relevant families was determined, and the range of distribution to other jurisdictions was assessed. Filings were also analyzed by year, by assignee. Finally, the various patent classification systems were mapped to find which particular classes tend to hold helminth vaccine-related technologies. Besides the keywords developed during the searches and the landscape map generation, the classifications represent an alternate way for further researchers to identify emerging helminth vaccine technologies. The analysis included creation of a map of keywords describing the relationship of the various technologies involved in the development of helminth vaccines. The map has regions corresponding to plasmids and other gene based technologies used in DNA vaccines for Japonicum Schistosoma. Important technologies listed on the map include the use of reverse genetics to create reassorted viruses targeted for the use in veterinary applications. Additionally, the map suggests that numerous subunits exist for use in vaccines targeting cestodes, trematodes, and nematodes. Another major finding was that the number of patent documents related to helminths being published has been steadily increasing in the last decade, as shown in the figure below. Until the early-1990s, there were only a few helminth vaccine related patent documents being published each year. The number of publications increased noticeably when TRIPS took effect, resulting in publication of patent applications. However, since 2006 the number of vaccine publications has exploded. In the years 2011 and 2012, about 23 references disclosing parasitic worm vaccine technologies were published each year. Thus, interest in developing new and more efficacious helminth vaccines has been growing in recent years. The origin of the vaccine-related inventions was also analyzed. The team determined the country in which the priority application was filed, which was taken as an indication of the country where the invention was made or where the inventors intended to practice the invention. By far, most of the relevant families originated with patent applications filed in the United States and China. Other prominent priority countries were the United Kingdom, Japan, Brazil, Australia and France. Countries with the most filings were also analyzed. Countries that were heavily targeted for patent filings included the United States, Australia, Canada, and New Zealand. Top assignees for these families were mostly large pharmaceutical companies, with the majority of patent families coming from Heska, followed by Merck & Co., Institute Pasteur, AusBiotech Biotechnology, and Biological Sciences Research Council. Lastly, the jurisdictions were inventors have sought protection for their vaccine technologies were determined, and the number of patent families filing in a given country is plotted on the world map shown (Fig. 25). The United States, Canada, Australia, Japan, New Zealand and France have the highest level of filings, followed by Germany, Brazil, India, United Kingdom and Spain. However, although there are a significant number of filings in Brazil, the remainder of Central and South America has only sparse filings. Of concern, with the exception of South Africa, few other African nations have a significant number of filings. In summary, the goal of this report is to provide a knowledge resource for making informed policy decisions and for creating strategic plans concerning the assembly of vaccines targeting highly prevalent helminth infections. The ITTI team has defined the current state of the art of technologies involved in the manufacture of helminth vaccines, and the important assignees, inventors, and countries have been identified. This document should aid in evaluating the current state of vaccines technologies targeting helminths and the potential outgrows of these technological fields. Furthermore, as this report illustrates, the steady increase in helminth patenting, expanded diversity of assignees and greater global filings, indicates that intellectual property protection does not inhibit the development of crucial innovations for this class of neglected diseases, but, on the contrary, appears to be a driver of accelerated research and development

Current policy issues in the governance of the European patent system

The European Parliament has been working towards building a discussion platform and a resource for further policy actions in the field of intellectual property rights. The Science and Technology Options Assessment Panel has set the goal of further enlarging the area of investigation in light of recent policy developments at the European level. In particular, the current study covers current policy issues in the governance of the European patent system, such as the backlog issue, the enhancement of patent awareness within the European Parliament, patent enforcement, the regional dimension of intellectual property in Europe, patents and standardisation, the use of existing patents, and patents and competition. These issues were discussed in the conference with stakeholders from European to national patent offices, from private to public sector actors. As a result of the conference, it was stated the need for an IP strategy for Europ

Chemoinformatics Research at the University of Sheffield: A History and Citation Analysis

This paper reviews the work of the Chemoinformatics Research Group in the Department of Information Studies at the University of Sheffield, focusing particularly on the work carried out in the period 1985-2002. Four major research areas are discussed, these involving the development of methods for: substructure searching in databases of three-dimensional structures, including both rigid and flexible molecules; the representation and searching of the Markush structures that occur in chemical patents; similarity searching in databases of both two-dimensional and three-dimensional structures; and compound selection and the design of combinatorial libraries. An analysis of citations to 321 publications from the Group shows that it attracted a total of 3725 residual citations during the period 1980-2002. These citations appeared in 411 different journals, and involved 910 different citing organizations from 54 different countries, thus demonstrating the widespread impact of the Group's work

Public or private economies of knowledge: The economics of diffusion and appropriation of bioinformatics tools

The past three decades have witnessed a period of great turbulence in the economies of biological knowledge, during which there has been great uncertainty as to how and where boundaries could be drawn between public or private knowledge especially with regard to the explosive growth in biological databases and their related bioinformatic tools. This paper will focus on some of the key software tools developed in relation to bio-databases. It will argue that bioinformatic tools are particularly economically unstable, and that there is a continuing tension and competition between their public and private modes of production, appropriation, distribution, and use. The paper adopts an ?instituted economic process? approach, and in this paper will elaborate on processes of making knowledge public in the creation of ?public goods?. The question is one of continuously creating and sustaining new institutions of the commons. We believe this critical to an understanding of the division and interdependency between public and private economies of knowledge

Importation and Innovation

Importation of drugs into the U.S. would result in a decline in U.S. drug prices. The purpose of this paper is to assess the consequences of importation for new drug development. A simple theoretical model of drug development suggests that the elasticity of innovation with respect to the expected price of drugs should be at least as great as the elasticity of innovation with respect to expected market size (disease incidence). I examine the cross-sectional relationship between pharmaceutical innovation and market size among a set of diseases (different types of cancer) exhibiting substantial exogenous variation in expected market size. I analyze two different measures of pharmaceutical innovation: the number of distinct chemotherapy regimens for treating a cancer site, and the number of articles published in scientific journals pertaining to drug therapy for that cancer site. Both analyses indicate that the amount of pharmaceutical innovation increases with disease incidence. The elasticity of the number of chemotherapy regimens with respect to the number of cases is 0.53. The elasticity of MEDLINE drug cites with respect to cancer incidence throughout the world is 0.60. In the long run, a 10% decline in drug prices would therefore be likely to cause at least a 5-6% decline in pharmaceutical innovation.

Intellectual Property and Public Health – A White Paper

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions. Led by the moderator, participants at the Forum focused generally on three broad questions. First, are there alternatives to either the patent system or specific patent doctrines that can provide or help provide sufficient incentives for health-related innovation? Second, is health information being used proprietarily and if so, is this type of protection appropriate? Third, does IP conflict with other non-IP values that are important in health and how does or can IP law help resolve these conflicts? This report addresses each of these questions in turn

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

Finding Cures for Tropical Diseases: Is Open Source an Answer?

We construct polar codes for binary relay channels with orthogonal receiver components. We show that polar codes achieve the cut-set bound when the channels are symmetric and the relay-destination link supports compress-and-forward relaying based on Slepian-Wolf coding. More generally, we show that a particular version of the compress-and-forward rate is achievable using polar codes for Wyner-Ziv coding. In both cases the block error probability can be bounded as O(2-Nβ) for 0 &lt; β &lt; 1/2 and sufficiently large block length N.Personal use of this material is permitted. Permission from IEEE must be obtained for all other uses, in any current or future media, including reprinting/republishing this material for advertising or promotional purposes, creating new collective works, for resale or redistribution to servers or lists, or reuse of any copyrighted component of this work in other works. QC 20111207</p