European stem cell patents: taking the moral high road?

A European law that prevents the patenting of discoveries that contravene morality is causing confusion when it comes to human embryonic stem cells. The ensuing debate is markedly different from the one in the United States, where the scope of stem cell patents and their licensing are under challenge.

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.

The ethics and economics of pharmaceutical pricing.

The cost of drugs is a major and rapidly rising component of health-care expenditures. We survey recent literature on the ethics and economics of skyrocketing pharmaceutical prices and find that advances in economic research have increased the sharpness and focus of the ethically based calls to increase access by modifying patent protection and reducing prices. In some cases, research supports ethical arguments for broader access. Other research suggests that efforts to broaden access result in unintended consequences for innovation and the medical needs of patients. Both ethicists and economists need to be more cognizant of the real clinical settings in which physicians practice medicine with real patients. Greater cross-disciplinary interaction among economists, ethicists, and physicians can help reduce the disjunction between innovation and access and improve access and patient care. This dialogue will impact private industry and may spur new multistakeholder paradigms for drug discovery, development, and pricing.

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.

The fate and future of patents on human genes and genetic diagnostic methods.

Since the 1970s, patents on human genes and genetic diagnostic methods have been granted under the assumption that they stimulate the development of diagnostic methods and therapeutic products. However, the principles and practices of patenting vary between jurisdictions. Do patent holders, researchers, clinicians and patients really benefit from this heterogeneous patent system? We discuss the problems that result from the current system and suggest how they might be solved by altering the way in which patents are granted and/or licensed.

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.

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.

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.

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.

Healthcare in Australia.

No single issue has dominated health practitioners' ethical debates in 2014 in Australia, but a controversial decision on gene patenting and the media focus on "Dr. Death," euthanasia campaigner Dr. Philip Nitschke, have given new life to these two familiar (and global) debates. Currently a dying with dignity bill, drafted by the Australian Green Party, is under examination. The Senate inquiry into the bill received more than 663 submissions, with 57% opposed and 43% in support of the bill, which has now been referred to a Senate committee. Will this be another of Australia's failed attempts to legalize euthanasia? The trial of Dr. Nitschke begins on November 10, 2014.

Authority and ownership: the growth and wilting of medicine patenting in Georgian England.

Secret, owned, Georgian medicines were normally known as patent medicines, though few had a current patent. Up to 1830, just 117 medicines had been patented, whilst over 1,300 were listed for taxation as 'patent medicines'. What were the benefits of patenting? Did medicine patenting affect consumer perception, and how was this used as a marketing tool? What were the boundaries of medical patenting? Patents for therapeutic preparations provided an apparent government guarantee on the source and composition of widely available products, while the patenting of medical devices seems to have been used to grant a temporary monopoly for the inventor's benefit.

Pharmaceutical patenting and the transformation of American medical ethics.

The attitudes of physicians and drug manufacturers in the US toward patenting pharmaceuticals changed dramatically from the mid-nineteenth century to the mid-twentieth. Formerly, physicians and reputable manufacturers argued that pharmaceutical patents prioritized profit over the advancement of medical science. Reputable manufactures refused to patent their goods and most physicians shunned patented products. However, moving into the early twentieth century, physicians and drug manufacturers grew increasingly comfortable with the idea of pharmaceutical patents. In 1912, for example, the American Medical Association dropped the prohibition on physicians holding medical patents. Shifts in wider patenting cultures therefore transformed the ethical sensibilities of physicians.