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Competing Interests: Competing interests: We have read and understood BMJ policy on declaration of interests and declare the following: JL received payment for writing a brief in an action for side effects of a drug for Michael F Smith, lawyer and a second brief on the role of promotion in generating prescriptions for Goodmans LLP. He is a member of the foundation board of Health Action International. LAB is senior editor for research integrity, Cochrane, for which the University of Colorado receives remuneration. CD is an alternate member representing Health Action International on the European Medicines Agency’s patients and consumers working party. MAG reports serving as an expert witness on behalf of Justice Canada in a case about the constitutionality of patented drug price regulation. Provenance and peer review: Not commissioned; externally peer reviewed.

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., (© 2020 American Medical Association. All Rights Reserved.)

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.

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.

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.

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.

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.

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.

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., (© FEMS 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

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.

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.

This article discusses the patent strategy underlying the world's best selling drug, AbbVie's Humira®. Despite a non-optimal starting position, AbbVie has established an extensive portfolio to fend off biosimilar competition. This article is the first part of a trilogy that discusses IP issues related to anti-Tumor Necrosis factor α (TNFα) biologics.

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.

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.

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.

Patents on biotech products have a scope that goes well beyond what is covered by the most widely applied ethical justifications of intellectual property. Neither natural rights theory from Locke, nor public interest theory of IP rights justifies the wide scope of legal protection. The article takes human genes as an example, focusing on the component that is not invented but persists as unaltered gene information even in the synthetically produced complementary DNA, the cDNA. It is argued that patent on cDNA holds this information captive, or illegitimately appropriates it in limiting other researchers and inventors' opportunity to explore new functions and uses based on this non-invented information. A tighter connection between legal IP protection and the use description stated in the patent claim is suggested. By binding protection to the product's foreseeable functions and use, instead of the product itself and all future uses of it, legitimacy of biotech product patents is restored.

Background: The recent Canadian lawsuit on patent infringement, filed by the Children's Hospital of Eastern Ontario (CHEO), has engendered a significant public debate on whether patenting genes should be legal in Canada. In part, this public debate has involved the use of social networking sites, such as Twitter. This case provides an opportunity to examine how Twitter was used in the context of this gene patent controversy., Methods: We collected 310 English-language tweets that contained the keyword "gene patents" by using TOPSY.com and Twitter's built-in search engine. A content analysis of the messages was conducted to establish the users' perspectives on both CHEO's court challenge and the broader controversy over the patenting of human DNA. More specifically, we analyzed the users' demographics, geographic locations, and attitudes toward the CHEO position on gene patents and the patentability of human genes in principle., Results: Our analysis has shown that messages tweeted by news media and health care organizations were re-tweeted most frequently in Twitter discussions regarding both the CHEO patent infringement lawsuit and gene patents in general. 34.8% of tweets were supportive of CHEO, with 52.8% of the supportive tweets suggesting that gene patents contravene patients' rights to health care access. 17.6% of the supportive tweets cited ethical and social concerns against gene patents. Nearly 40% of tweets clearly expressed that human genes should not be patentable, and there were no tweets that presented perspectives favourable toward the patenting of human genes., Conclusion: Access to healthcare and the use of genetic testing were the most important concerns raised by Twitter users in the context of the CHEO case. Our analysis of tweets reveals an expectation that the CHEO lawsuit will provide an opportunity to clear the confusion on gene patents by establishing a legal precedent on the patentability of human genes in Canada. In general, there were no tweets arguing in favour of gene patents. Given the emerging role of social media in framing the public dialogue on these issues, this sentiment could potentially have an impact on the nature and tone of the Canadian policy debate.

As a result of scientific progress, embryo, once classified as part of the maternal body, gained recognition in particular with medically assisted reproduction. It became a genuine topic of study, from being analyzed in its development to its characteristics of being a reserchers's object of desire due to its multiple possibilities of reserch and study. Despite belonging to the human species, and even though they are not completely classified as objects, supernumerary embryos, out of parental projects, were gradually reified in order to become the object of all genetic engineering fantasies, especially the quest of the perfect child, free of diseases and anomalies. Notwithstanding all the precautions taken by the legislator and the European institutions, future drifts concerning the enlargement of prenatal diagnostics and of living matter under patent possibilities are to be feared.

This article explains the difficulties innovative pharmaceutical firms have in repaying shareholders with attractive dividends. The problem is the result of the expiration of the patents of blockbuster drugs and the difficulties that the firms have in bringing new blockbuster drugs to the market. One of the solutions companies have found has been to accelerate the implementation of clinical trials in order to expedite the commercialization of new drugs. Doing so increases the period in which they can sell drugs at monopoly prices. We therefore discuss how innovative pharmaceutical firms shorten the implementation time of clinical trials in Latin America and the consequences such actions have on the quality of the collected data, the protection of human rights of the subjects of experimentation, and compliance with the ethical principles approved in international declarations.

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.

It is generally accepted that patents are a driving force for innovation through research and development. But the university's involvement in patenting is problematic as well. In particular, it is in tension with the idea of a university itself. If patents entail a restriction on the accessibility of the scientific knowledge that has been patented, and if the main purpose of universities is to produce and disseminate knowledge to the public, then, there is a tension: when universities patent their research innovations, they are making the scientific knowledge they produce less accessible to the public. The paper argues that university patenting contradicts the very idea of a university as an institution whose mission is fundamentally to disseminate the knowledge it produces to the public. The practice of university patenting involves an un-academic attitude thus: by inciting an attitude towards knowledge that is not consistent with the proper attitudes and goals of a university, university patenting hurts university's integrity.

For most of the 20th century, the condom in the United States was a cheap, useful, but largely unmentionable product. Federal and state statutes prohibited the advertising and open display of condoms, their distribution by mail and across state lines, and their sale for the purpose of birth control; in some states, even owning or using condoms was illegal. By the end of World War I, condoms were increasingly acceptable for the prevention of sexually transmitted disease, but their unique dual function--for disease prevention and contraception--created ongoing ambiguities for sellers, consumers, and distributors as well as for legal, political, health, and moral leaders. Not until the 1970s did condoms emerge from the shadows and join other personal hygiene products on open drugstore and supermarket shelves and in national advertisements. Then came the 1980s and AIDS when, despite the rise of Ronald Reagan, the radical right's demonization of condoms, and the initial reluctance of condom merchants to market to gay constituencies, the HIV/AIDS epidemic slowly but inexorably propelled the condom to the top of the prevention agenda. The condom's journey from lewd device to global superstar was fitful, but colorful. The Comstock Act of 1873, prohibiting birth control information and devices, created a vast underground operation--periodically illuminated, however, by arrests, protests, legal proceedings, and media coverage. This essay chronicles one such moment of illumination: the legal battle in the 1920s and 1930s over the legitimacy and legality of the Trojan Brand condom trademark and the unusual series of advertisements produced by the Youngs Rubber Corporation, makers of Trojans, to dramatize the ethical and economic issues of the trademark battle. Culminating in Youngs Rubber Corporation v. C.I. Lee & Co., Inc. (45 F, U.S. Court of Appeals for the Second Circuit 103 [1930]), this landmark case in trademark law established the right of the Trojan Brand condom, despite its ambiguous dual function, to the protection of a federal trademark. I seek to show how the Youngs antipiracy ad series illuminates the paradox of visibility by illuminating the paradox of any binary division: to establish the one depends inevitably on invoking or making visible--even if to suppress--the other. This essay is a case study in the negotiation of such a dialectic.

This article aims to review the relationship between patents and scientific research from an ethical point of view. The recent developments in the law of industrial property led in many cases to patent discoveries, contributions of basic science, and laws of nature. This trend, which denies the central principles of the discipline, creates disturbances in scientific activity, which requires the free movement of knowledge in order to develop their potentialities.

The recent US Supreme Court ruling against gene patenting has been accompanied by the passage at the federal level of the Patient Protection and Affordable Care Act, both events representing a thawing or phase change in policies that will now make preventive techniques, such as BRCA genetic testing to predict risk for familial breast and ovarian cancer, more affordable and accessible. Authors including Yun-Han Huang in this journal have noted the judicial ruling is one step--a significant one--in the process of patent system reform. This commentary links such changes with policy formation and action taken by members of diverse religious communities in the aftermath of the Human Genome Project and continuing in today's genome sequencing area. Religious engagement has acted as a catalyzing force for change in the creation and dissemination of genetic developments. Religious perspectives are needed to solve the new ethical dilemmas posed by population screening for BRCA mutations and the rise of direct-to-consumer and provider marketing of such genetic tests, which have far-reaching consequences at the individual, family, and societal levels.

The method of treatment of suffering in patients, including through surgery and the administration of therapeutic drugs, are essential features of medical professionalism. Few, if any practitioners committed to developing the core professional virtue of loyalty to relief of patient suffering through consistently implementing the basic principles of medical ethics, would consider that such beneficial methods of practice are, or should be, the subject of a patent--requiring the practitioner utilising them to pay a royalty or risk infringement proceedings. Indeed a formal opinion of the American Medical Association declares "the use of patents, trade secrets, confidentiality agreements, or other means to limit the availability of medical procedures places significant limitation on the dissemination of medical knowledge, and is therefore unethical". Yet this could be the direction in which Australian patent law is heading. The decision of the High Court of Australia in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50, upholding a patent over a method of using a known drug to prevent or treat psoriasis, may ultimately force practitioners to re-consider whether their basic ethical obligations to patients are secondary to a requirement to maximise profit for shareholders in companies holding medical patents. This column reviews this decision and its possible implications for health practitioners. It places it in context of other recent court decisions that have expanded the intrusion of corporate-owned intellectual property monopolies into Australian medical practices, and how legislative restrictions upon them in the Patents Act 1990 (Cth) places practitioners and patients at risk of more costly, ineffective or restricted health care. This column concludes by cautioning that Australia's scope to address policy problems caused by this case may be limited should it sign up to the Trans-Pacific Partnership Agreement, particularly if that preferential trade and investment deal includes an Investor-State Dispute Settlement clause that creates a mechanism for multinational corporations to challenge offshore, Australian federal and state policy decisions they perceive undercut their investments.

This article discusses the human right to health in the context of patent protection and access to medicines. It considers the limitations in international human rights law, especially in relation to socioeconomic rights, that make it difficult for the right to health to be a potent justification for derogation from trade or intellectual property agreements. It concludes by taking the view that while the right to health may be somewhat unenforceable in international law, its close association with enforceable rights such as the right to life can be a legitimate basis for making maximum use of the flexibilities in the international intellectual property regime to protect public health. The article takes the view that trade and intellectual property agreements must be interpreted in a way that endeavours as much as possible to resolve any seeming inconsistency with the right to health.

Background: The revision process for and recent publication of the DSM-5 initiated debates about the widening of diagnostic boundaries. The pharmaceutical industry had a major financial stake in the outcome of these debates. This study examines the three-part relationship among DSM panel members, principal investigators (PIs) of clinical trials for new DSM-5 diagnoses, and drug companies., Methods: Financial conflicts of interest (FCOI) of DSM panel members responsible for some new diagnoses in the DSM-5 and PIs of clinical trials for related drug treatments were identified. Trials were found by searching ClinicalTrials.gov. Patent and revenue information about these drugs was found using the US Food and Drug Administration's Orange Book and manufacturer Annual Reports., Results: Thirteen trials met inclusion criteria (testing drugs for some new DSM disorders). Sixty-one percent of the DSM Task Force members and 27% of Work Group members reported FCOI to the trial drug manufacturers. In 5 of the 13 trials (38%), PIs reported ties other than research funding to the drug manufacturer. In 3 of the trials (23%), a PI had financial ties to the drug manufacturer and was also a DSM panel member who had decision-making authority over the revision process., Conclusions: These findings suggest that increased transparency (e.g., registration on ClinicalTrials.gov) and mandatory disclosure policies (e.g., the American Psychiatric Association's disclosure policy for DSM-5 panel members) alone may not be robust enough strategies to prevent the appearance of bias in both the DSM revision process as well as clinical decisions about appropriate interventions for DSM disorders.

Scientific progress in the life sciences is dependent on the governance of tensions between the economic potential of the innovation and the cultural response from society. Ownership of the scientific innovation through patenting is a necessary part of the realization of its economic value yet, in the case of human embryonic stem cell (hESC) science, ownership of the human body and human life may offend fundamental cultural values. In the case of transnational patenting governance by the European Patent Office (EPO) and the European Union (EU), cross-national cultural conflict in the field of hESC science has produced a political demand for a form of governance that can incorporate ethical as well as economic judgements in its decision making. This paper explores how bioethics has responded to this opportunity to establish itself as a form of expert authority for the negotiation and resolution of the cultural conflict. In so doing, it shows how the political struggle that has accompanied this bid for new governance territory has been influenced both by the political tensions between the EPO and EU systems of patenting governance and the resistance of competing experts in law and science to a bioethical presence., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

The proliferation of patents on human genes has raised important ethical questions centered on the conflict of patient rights and intellectual property rights. With the Supreme Court's June 2013 decision that altered the patent eligibility of genetic material, it is important to reexamine the ethical implications of gene patents as a concept. Such patents suggest an ownership of genetic material that may hinder access to healthcare and inhibit medical progress. The application of the current patent system to genetic material thus violates patients' rights without fulfilling the system's goal of promoting innovation, suggesting a need for a revised incentives infrastructure.