Inequitable Conduct and Invalidation of Patents Related to Food and Drug Administration-Regulated Products.

This study examines the frequency of drug patent invalidations based on inequitable conduct.

Can International Patent Law Help Mitigate Cancer Inequity in LMICs?

Although low- and middle-income countries (LMICs) bear 75% of the cancer burden globally, their available resources to treat cancer constitute less than 5% of global health resources. This inequity makes it imperative to take appropriate measures to treat and prevent cancer in LMICs, which should include consideration of trade and patent policies. This article highlights some impediments to effective use of existing policies to promote access to treatment and prevention measures in LMICs and offers recommendations about next steps.

Las tres Europas ante la encrucijada genómica / The Three Europes at the genomic crossroad / Les Tres Europes enfront de la cruïlla genómica

La reciente aceleración de las investigaciones en ingeniería genética ha situado a Europa en una aporía de difícil solución. Pues bien, no queremos renunciar a determinados valores, aun cuando suponga no poder seguir el ritmo de China o de Estados Unidos; pero si no lo hacemos, corremos el riesgo de ser objeto de una forma de colonialismo muy diferente a la que hemos observado en los siglos precedentes

The recent acceleration of research in genetic engineering has placed Europe in an aporia of difficult solution. On the one hand, it is in the midst of two contending blocs, China and the United States, which in their struggle for world primacy have reissued the Cold War, only with biotechnology as a mechanism of domination. On the other, Europe is institutionally divided into three overlapping entities, the Council of Europe, the European Union and the European Patent Office, with notable differences in terms of democratic legitimacy and normative effectiveness. So, we do not want to give up certain values, even if it means not being able to keep pace with China or the United States; but if we do not, we run the risk of being the object of a form of colonialism very different from that we have observed in previous centuries

La recent acceleració de les recerques en enginyeria genètica ha situat a Europa en una aporia de difícil solució. D'una banda, es troba enmig de dos blocs contendents, la Xina i els Estats Units, en una reedició de la Guerra Freda, només que amb la biotecnologia com a mecanisme de dominació; d'un altre, Europa es troba institucionalment fraccionada en tres entitats superposades, el Consell d'Europa, la Unió Europea i l'Oficina Europea de Patents, amb diferències notables quant a legitimitat democràtica i a eficàcia normativa. Doncs bé, no volem renunciar a determinats valors, tot i que suposi no poder seguir el ritme de la Xina o dels Estats Units; però si no ho fem, correm el risc de ser objecte d'una forma de colonialisme molt diferent a la que hem observat en els segles precedents

Características de patentes de dispositivos para rehabilitación física registradas en los Estados Unidos / Characteristics of patents of physical rehabilitation devices registered in the United States

Introducción: La rehabilitación física puede verse beneficiada con el uso de dispositivos, los cuales en su mayoría suelen ser patentados. La oficina de patentes y marcas de los Estados Unidos (USPTO) es una de las oficinas de patentes y marcas más grandes y reconocidas. Resulta de interés evaluar las características y la evolución de las patentes para la rehabilitación física; sin embargo, existen pocos estudios al respecto. Objetivo: Identificar las características de las patentes de dispositivos de rehabilitación física de extremidades, registradas en la oficina de patentes y marcas de los Estados Unidos. Material y métodos: Estudio descriptivo transversal. Se realizó una búsqueda en UPSTO usando una lista de palabras clave relacionadas con la rehabilitación. Se eligieron 10 grupos de patentes relacionados con la rehabilitación. Las variables estudiadas fueron: número de la patente, fecha de publicación, país, titular, área de la patente, extremidades para las cuales es útil la patente y portabilidad. Se realizó un análisis descriptivo usando STATA v.14. Resultados: Se analizaron 1971 patentes, de las cuales 16,2 por ciento fueron incluidas en los grupos de rehabilitación y 83,8 por ciento en ejercicio físico. El 36,6 por ciento de todas las patentes fueron patentadas por un titular corporativo, el 29,9 por ciento fueron portables, y el 46,3 por ciento tenían utilidad para ambas extremidades. Conclusiones: De las patentes encontradas las enfocadas para ejercicio físico fueron las predominantes. Existe una mayor cantidad de patentes útiles para ambas extremidades. Además, existe una tendencia ascendente en el tiempo, en el número de patentes del área de rehabilitación y de las invenciones portables(AU)

ABSTRACT Introduction: Physical rehabilitation can be benefitted from the use of devices, which are usually patented. The United States Patent and Trademark Office (USPTO) is one of the largest and most recognized patent and trademark offices. The characteristics and evolution of patents for physical rehabilitation is of great interest; however, there are few studies in this respect. Objective: To identify the characteristics of patents of physical rehabilitation devices for the physical rehabilitation of damaged limbs registered the United States Patent and Trademark Office. Material and methods: A cross-sectional descriptive study was conducted. A search was made at UPSTO using a list of keywords related to rehabilitation. Ten groups of patents related to rehabilitation were chosen. The variables studied were: patent number, publication date, country, holder, patent area, limbs for which the patent is useful, and portability. A descriptive analysis was performed by using STATA v.14. Results: A total of 1971 patents were analyzed, of which 16.2 percent were included in the rehabilitation groups and 83.8 percent in the physical exercise groups. The 36.6 percent of them were corporate-owned patents, 29.9 percent were portable, and 46.3 percent had usability which demonstrated to be useful for both extremities. Conclusions: Of the patents found, those focused on physical exercise were predominant. There is a greater number of useful patents for both extremities. In addition, there is an upward trend over time, the number of patents in the area of ​​rehabilitation, and portable inventions(AU)

Mind the Gap! How the Digital Turn Upsets Intellectual Property.

Intellectual property is one of the highly divisive issues in contemporary philosophical and political debates. The main objective of this paper is to explore some sources of tension between the formal rules of intellectual property (particularly copyright and patents) and the emerging informal norms of file sharing and open access in online environments. We look into the file sharing phenomena not only to illustrate the deepening gap between the two sets of norms, but to cast some doubt on the current regime of intellectual property as an adequate frame for the new type of interactions in online environments. Revisiting the classic Arrow-Demsetz debate about intellectual property and the epistemological issues involved in assessing institutions, we suggest that seeking out new institutional arrangements aligned with the norms-in-use seems to be a more promising strategy in the new technological setting than attempting to reinforce the current legal framework. Moreover, such a strategy is less prone to committing the so-called 'Nirvana fallacies'. As a secondary task, we try to cast some doubt on the two most common moral justifications of intellectual property as being able to ground the full extent of the current intellectual property regime.

Alienation from the Objectives of the Patent System: How to Remedy the Situation of Biotechnology Patent.

Some fundamental biotechnologies hold unprecedented potential to eradicate many incurable diseases. However, in absence of regulations, the power of patent makes the future use of some important biotechnology in few institution's hands. The excessive patents restrict researcher access to the fundamental technologies. It generates concerns and complaints of deteriorating the public health and social welfare. Furthermore, intellectual curiosities, funding, respect among colleagues etc., rather than patents, are the real motivations driving a major ground-breaking discoveries in biotechnology. These phenomena reveal that some biotechnology patents are alienated from the purpose of patent system. Therefore, it is necessary to take some approaches to stop over-patenting these fundamental biotechnology inventions. This article proposes a model regulatory framework for controlling biotechnology patent alienating from the purpose of patent system.

Patenting human genes: Chinese academic articles' portrayal of gene patents.

BACKGROUND: The patenting of human genes has been the subject of debate for decades. While China has gradually come to play an important role in the global genomics-based testing and treatment market, little is known about Chinese scholars' perspectives on patent protection for human genes. METHODS: A content analysis of academic literature was conducted to identify Chinese scholars' concerns regarding gene patents, including benefits and risks of patenting human genes, attitudes that researchers hold towards gene patenting, and any legal and policy recommendations offered for the gene patent regime in China. RESULTS: 57.2% of articles were written by law professors, but scholars from health sciences, liberal arts, and ethics also participated in discussions on gene patent issues. While discussions of benefits and risks were relatively balanced in the articles, 63.5% of the articles favored gene patenting in general and, of the articles (n = 41) that explored gene patents in the Chinese context, 90.2% supported patent protections for human genes in China. The patentability of human genes was discussed in 33 articles, and 75.8% of these articles reached the conclusion that human genes are patentable. CONCLUSION: Chinese scholars view the patent regime as an important legal tool to protect the interests of inventors and inventions as well as the genetic resources of China. As such, many scholars support a gene patent system in China. These attitudes towards gene patents remain unchanged following the court ruling in the Myriad case in 2013, but arguments have been raised about the scope of gene patents, in particular that the increasing numbers of gene patents may negatively impact public health in China.

Fortune and hindsight: gene patents' muted effect on medical practice.

Introduction: Physicians have long worried about gene patents' potential to restrict their medical practices. Fortune and hindsight have proven these worries exaggerated both in the UK and elsewhere. Neither current nor future medical practices appear to be impinged by gene patents, although they may be subject to future intellectual property disputes. Sources of data: Qualitative and quantitative (survey) studies of gene patents' effects on medical practice; recent developments in patent law. Areas of agreement: Traditional gene patents do not appear to have restricted medical practice in the UK, although their effect elsewhere has been more nuanced. Areas of controversy: Whether patents will restrict the spread of newer medical technologies is unresolved. Areas timely for developing research: Continuing survey data on practitioners' views concerning patents' role in the distribution of newer technologies would be beneficial.

Patenting Foundational Technologies: Lessons From CRISPR and Other Core Biotechnologies.

In 2012, a new and promising gene manipulation technique, CRISPR-Cas9, was announced that seems likely to be a foundational technique in health care and agriculture. However, patents have been granted. As with other technological developments, there are concerns of social justice regarding inequalities in access. Given the technologies' "foundational" nature and societal impact, it is vital for such concerns to be translated into workable recommendations for policymakers and legislators. Colin Farrelly has proposed a moral justification for the use of patents to speed up the arrival of technology by encouraging innovation and investment. While sympathetic to his argument, this article highlights a number of problems. By examining the role of patents in CRISPR and in two previous foundational technologies, we make some recommendations for realistic and workable guidelines for patenting and licensing.

Patent Ethics: The Misalignment of Views Between the Patent System and the Wider Society.

Concerns have been voiced about the ethical implications of patenting practices in the field of biotechnology. Some of these have also been incorporated into regulation, such as the European Commission Directive 98/44 on the legal protection of biotechnological inventions. However, the incorporation of ethically based restrictions into patent legislation has not had the effect of satisfying all concerns. In this article, we will systematically compare the richness of ethical concerns surrounding biotech patenting, with the limited scope of ethical concerns actually addressed in the patent system. As sources of our analyses we will use literature and document studies and a survey with important stakeholders and experts related to Norwegian patenting in the aquacultural biotechnology sector. We will structure the analyses with an ethical matrix, developed for this purpose. Showing the misalignment of the discussions within and outside the patent system, we suggest that an important reason for the ethical controversy still surrounding patenting is that ethical questions keep being framed in a narrow way within the system. Until a richer set of ethical considerations is addressed head-on within the patent system, the patent system will continue to evoke academic and interest group criticism, potentially contributing to a legitimacy crisis of the whole system.

Patent protection for microbial technologies.

Microbial technologies often serve as the basis of fundamental research tools in molecular biology. These present a variety of ethical, legal and social issues concerning their patenting. This commentary presents several case studies of these issues across three major microbiological tools: CRISPR, viral vectors and antimicrobial resistance drugs. It concludes that the development of these technologies-both scientifically and commercially-depend, in part, on the patent regime available for each, and researchers' willingness to enforce those patents against others.

Returning to the Patent Landscapes for Nanotechnology: Assessing the Garden that It Has Grown Into.

The patent landscape, like a garden, can tell you much about its designers and users; their motivations, biases, and general interests. While both patent landscapes and gardens may appear to the casual observer as refined and ordered, an in-depth exploration of the terrain is likely to reveal unforeseen challenges including, for example, alien species, thickets, and trolls. As this Chapter illustrates, patent landscapes are dynamic and have been forced to continually evolve in response to technological innovation. While emerging technologies, such as biotechnology and information communication technology have challenged the traditional patent landscape, resulting in the pruning of certain elements here and there, the overarching framework and design has largely remained intact. But will this always be the case? As the field of nanotechnology continues to evolve and mature, the aim of this Chapter is to map how the technology has evolved and grown within the confines of existing structures and underlying foundation of the patent landscape and the implications thereof for the technology, industry, and the public more generally. The Chapter concludes by asking the question whether the current patent landscape will be able to withstand the ubiquitous nature of the technology, or whether nanotechnology, in combination with other emerging technologies, will be a catalyst for governments and policy makers to completely redesign the patent landscape.

Patent eligibility of stem cells in Europe: where do we stand after 8 years of case law?

Since 2006, some of the highest ranking European Courts have issued decisions related to the patent eligibility of human embryonic stem cells. The question of patent eligibility of human embryonic stem cells remains, however, still erratic, at least in some aspects. This article will give a short comprehensive overview of the case history, and discuss questions still unsolved.