Recently I reported in this journal1 how it became necessary for a judge to settle a dispute between the pharmaceutical industry and certain Dutch pharmacists. It considered the question of whether a pharmacist is permitted, without prior consultation, to give a patient a generic drug instead of the patent drug mentioned on the prescription.Another dispute has now arisen after the pharmaceutical industry discovered that healthcare insurers were paying general practitioners a bonus if they prescribed generic drugs, such as simvastatin (...) or omeprazol (which reduces the …. (shrink)

In September 1998 the Dutch Ministry of Health together with the Dutch Society of General Practitioners , the Royal Dutch Society of Pharmacists , and the Dutch Patient and Consumer Federation published a pamphlet entitled: The same medicine in a different coat. Drugs without a trademark, equally effective, but cheaper. Patients could obtain a copy at the local pharmacy or in the waiting room of their general practitioner. It deals with the question whether the name of the patent (...) drug should be written on the prescription or only the active component. This is important because, according to the authors, the costs of health care can be reduced without reducing the quality of the care if the doctor prescribes the generic form. It is also mentioned that another advantage of prescribing the generic form is that, contrary to the …. (shrink)

Instead of impeding access to essential medicines in developing countries, the essay explores why and how patents can serve as a source of funding for the much needed access to medicine. Instead of a weakening of patents, prolonged protection periods are suggested in circumstances where there is widespread lack of access. The revenues from extended patents are seen as a source of funding for drug donations to the least developed countries.

In June 2020, Gilead agreed to provide the USA with 500 000 doses of remdesivir—an antiviral drug which at that time was percieved to show promise in reducing the recovery time for patients with COVID-19. This quantity represented Gilead’s then full production capacity for July and 90% of its capacity for August and September. Similar deals are evident around access to proposed vaccines for COVID-19, and such deals are only likely to increase. These attempts to secure preferential access to medicines (...) and vaccines, so-called vaccine/treatment nationalism, jeopardise supplies of life-saving treatments and vaccines available elsewhere, and jeopardise global equitable distribution of such vaccines/treatments more generally. Much of the focus to date has been on States’ role in negotiating such deals. However, such developments also demonstrate the power patent holders have in controlling access to life-saving healthcare, determining who obtains access first and at what price. This article argues that the extent of control currently given to patent holders for COVID-19 must be questioned. This article demonstrates that patents have significant implications for healthcare acting as private governance tools over patented inventions. It is only by greater probing of patent holders’ role in delivering access to medicines, diagnostics and vaccines for COVID-19 that equitable global equitable access can be achieved. (shrink)

This paper offers an economic rationale for compulsory licensing of needed medicines in developing countries. The patent system is based on a trade-off between the “deadweight losses” caused by market power and the incentive to innovate created by increased profits from monopoly pricing during the period of the patent. However, markets for essential medicines under patent in developing countries with high income inequality are characterized by highly convex demand curves, producing large deadweight losses relative to potential profits (...) when monopoly firms exercise profit-maximizing pricing strategies. As a result, these markets are systematically ill-suited to exclusive marketing rights, a problem which can be corrected through compulsory licensing. Open licenses that permit any qualified firm to supply the market on the same terms, such as may be available under licenses of right or essential facility legal standards, can be used to mitigate the negative effects of government-granted patents, thereby increasing overall social welfare. (shrink)

Not all intellectual property rights grant the right to exclude that is indicative of “property rules,” as that term was used by Guido Calabresi and A. Douglas Melamed in their seminal article. Some intellectual property rights are “liability rules,” in which the right holder has an entitlement to compensation for use of the protected invention, not a right to preclude the use. Although patent laws normally grant a right to exclude others from use of the protected invention as a (...) default, most countries’ laws allow the government to convert the patent property rule into a liability rule through a compulsory license. It has been noted, for example, that by the end of the 1950s, the U.S. had issued compulsory licenses covering 40 to 50 thousand patents, including substantial portions of the patent portfolios of AT&T, General Electric, IBM, and Xerox. The U.S. Supreme Court recently expressed a willingness to accept liability rules over injunctions in some patent infringement cases. (shrink)

More than a third of the world's population has no access to essential drugs. More than half of this group of people live in the poorest regions of Africa and Asia. Several factors determine the accessibility of drugs in developing countries. Hardly any medicines for tropical diseases are being developed, but even existing drugs are often not available to the patients who need them.One of the important determinants of access to drugs is the working of the patent system. This (...) paper first maps out some facts about the global patent regime that has emerged as a consequence of the conclusion of the WTO‐TRIPs Agreement in 1994. Attempts to construct a moral justification of the patent system have been based on three grounds: natural rights, distributive justice, and utilitarian arguments. This paper examines to what extent and on which grounds drug patents can be justified. The final section looks at the so‐called ‘Doha Declaration on the TRIPs Agreement and Public Health’, which was adopted by the WTO Ministerial Conference two years ago, recognising the primacy of public health over the interests of patent proprietors. (shrink)

Thomas Pogge has recently argued that the way in which research and development of essential medicines is incentivized, under existing World Trade Organization rules, should be supplemented with an additional incentivizing mechanism. One might hold a stronger view than the one that Pogge currently holds, namely that patent rights for essential medicines are morally unjustified per se. Throughout this paper, ‘the strong view’ refers to this view. The strong view is one that enjoys considerable support both within and outside (...) the academic community. This paper critically discusses one specific argument in favor of the strong view. This argument is named the ‘Poggean argument’. This denominator is appropriate because a number of the essential premises of the argument are constituted by propositions that Pogge at some point has defended. The Poggean argument is valid, and defenders of the strong view also have some grounds for believing that the argument is sound. This belief comes, however, with what is arguably a too high cost, namely that the global institutional order becomes very demanding on taxpaying citizens of high-income countries if it is to be just. One may find acceptance of this cost relatively unproblematic, but this cost is, it is argued, unacceptable to anyone who has views on distributive justice that are sympathetic to the core tenets of libertarianism. (shrink)

It is obvious that every inventor should be rewarded for the intellectual effort, and at the same time be encouraged to successively improve his or her discovery and to work on subsequent innovations. Patents also ensure that patent owners are officially protected against intellectual piracy, but protection of intellectual property may be difficult to accomplish. Nevertheless, it all comes down to this basic question: Does a contradiction exist between medical ethics and the “Medical and Surgical Procedure Patents” system? It (...) may well turn out that medical-procedure patents can have a negative influence on the standard of medical care. Medical-method patents may also interfere with the physician-patient relationship. At present, physicians do not question the usefulness of patent protection for medicines, biotechnology, equipment and devices, but they strongly oppose it for surgical procedures. (shrink)

Whether, and to what degree, do patents granted on human genes cast a shadow of uncertainty over genomics and its applications? Will owners of patents on individual genes or clusters of genes sue those performing whole-genome analyses on human samples for patent infringement? These are related questions that have haunted molecular diagnostics companies and services, coloring scientific, clinical, and business decisions. Can the profusion of whole-genome analysis methods proceed without fear of patent infringement liability?Whole-genome sequencing is proceeding apace. (...) Academic centers have been performing whole-genome and -exome sequencing in research for at least five years, and academic clinical laboratories with national reach have been doing sequencing for clinical applications for almost as long. Companies have also been offering WGS and WES as a clinical service for a few years now. So far as we know, no one has been sued for infringement of “gene patents” for performing WGS. (shrink)

Much international debate over access to medicines focuses on whether patent law accords with international human rights law. This article argues that this is the wrong question to ask. Following an analysis of both patent and human rights law, this article suggests that the better approach is to focus on national debates over the best calibration of patent law to achieve national objectives.

Patents and free trade make strange bedfellows. For most of their history, patents have been instruments deployed to resist trade with other countries, not to enhance it. Whether one looks at Venetian laws that punished citizens who practiced local crafts outside the city, the Mercantilist uses to which patents were put in Elizabethan England, or the cartels of the 19th and 20th centuries created on a foundation of interlocking patent rights, patents have had a distinctly protectionist function. It is (...) thus ironic that it is intellectual property rights in general, and patents in particular, that have been held up in recent years as the poster child of much that is wrong with globalization and free trade. Nowhere is this more so than in debates concerning international human rights law and patents, in particular the position that patents violate an international right to health. (shrink)

ABSTRACTMore than a third of the world's population has no access to essential drugs. More than half of this group of people live in the poorest regions of Africa and Asia. Several factors determine the accessibility of drugs in developing countries. Hardly any medicines for tropical diseases are being developed, but even existing drugs are often not available to the patients who need them.One of the important determinants of access to drugs is the working of the patent system. This (...) paper first maps out some facts about the global patent regime that has emerged as a consequence of the conclusion of the WTO‐TRIPs Agreement in 1994. Attempts to construct a moral justification of the patent system have been based on three grounds: natural rights, distributive justice, and utilitarian arguments. This paper examines to what extent and on which grounds drug patents can be justified. The final section looks at the so‐called ‘Doha Declaration on the TRIPs Agreement and Public Health’, which was adopted by the WTO Ministerial Conference two years ago, recognising the primacy of public health over the interests of patent proprietors. (shrink)

Those objecting to human DNA patenting frequently do so on the grounds that the practice violates or threatens human dignity. For example, from 1993 to 1994, more than thirty organizations representing indigenous peoples approved formal declarations objecting to the National Institutes of Health's bid to patent viral DNA taken from subjects in Papua New Guinea and the Solomon Islands. Although these were not patents on human DNA, the organizations argued that the patents could harm and exploit indigenous peoples and (...) violate their cultural values. NIH eventually dropped one of its patent applications.On May 18, 1995, 180 religious leaders, led by biotechnology critic Jeremy Rifkin, held a press conference objecting to DNA patenting in Washington, D.C. In their “Joint Appeal against Human and Animal Patenting,” these leaders decried any attempt to patent nature. Some of the more outspoken members of the Joint Appeal likened DNA patenting to slavery, while others objected to treating human beings as marketable commodities. In his recent book, The Biotech Century, Rifkin rehashed the objections to DNA patenting voiced by members of the Joint Appeal. (shrink)

Respect for and promotion of the human rights of people with HIV/AIDS is now an entrenched component of the global response to HIV. However, as the global HIV epidemic has turned into a global AIDS epidemic, and as the death toll mounts, one area of human rights—the right to health care—has become fiercely contested. In particular, the degree to which patents on medicines impede what the United Nations High Commissioner for Human Rights has described as the “human right” of access (...) to essential medicines is receiving close scrutiny. The controversy generated by a recent article that argues, “in Africa patents and patent law are not a major barrier to treatment access in and of themselves,” is indicative of the intensity of the debate. (shrink)

Respect for and promotion of the human rights of people with HIV/AIDS is now an entrenched component of the global response to HIV. However, as the global HIV epidemic has turned into a global AIDS epidemic, and as the death toll mounts, one area of human rights—the right to health care—has become fiercely contested. In particular, the degree to which patents on medicines impede what the United Nations High Commissioner for Human Rights has described as the “human right” of access (...) to essential medicines is receiving close scrutiny. The controversy generated by a recent article that argues, “in Africa patents and patent law are not a major barrier to treatment access in and of themselves,” is indicative of the intensity of the debate. (shrink)

The biotechnology patent debates have revealed deep moral concerns about basic genetics research, RD and specific biotechnological products, concerns that are seldom taken into consideration in Technology Assessment. In this paper important moral concerns are examined which appear at the various stages of development of a specific genetic product: a predictive genetic test. The purpose is to illustrate the need for a more contextual approach in technology assessment, which integrates the various forms of interaction between bio-technology and society or (...) societal segments. Such an approach will generate greater insight in the moral issues at all stages of a products life-cycle and this will facilitate decision-making on the morality of a specific biotechnological product. (shrink)

Considerable controversy has recently arisen regarding the patenting of medical and surgical processes in the United States. One such patent, viz. for a "chevron" incision used in ophthalmologic surgery, has especially occasioned heated response including a major, condemnatory ethics policy statement from the American Medical Association as well as federal legislation denying patent protection for most uses of a patented medical or surgical procedure. This article identifies and discusses the major legal, ethical and public policy considerations offered by (...) proponents and opponents of such patents. The existing literature divides up into those who favor such patents essentially without qualification, and those who condemn and wish to outlaw them. We advance a compromise position where administrative and legislative action is called for to provide more specific guidelines regarding the patentability of such processes by the Patent and Trademark Office. Our position, in sum, will be that too much is at stake in this complicated area for either the blanket prohibition, or wholesale, uncritical acceptance, of the patenting of medical and surgical processes or techniques. (shrink)

Though many more patents emerge from industry sources, drug-related patents generated in the non-profit setting appear to have greater importance than patents arising from the commercial sector, which helps demonstrate the value non-profit research institutions can have in driving drug development.

Controversy often follows when patents are obtained in a pioneering area of technology. Patent filing activity in the field of regenerative medicine and in relation to stem cells in particular has not escaped opprobrium, although it is instructive to compare the nature of the debates that are taking place over the patenting of stem cells in the US and Europe. In the US, debate over the early patent applications made by the Wisconsin Alumni Research Foundation has been (...) intense2, but at least it appears to have been grounded firmly in patent law principles. In Europe, the debate has skewed away from the basic patent law tenets of novelty, inventiveness and industrial utility and has entered something of a twilight zone, with the European Patent Office serving as a diffident forum for difficult moral and ethical arguments about the destruction of human embryos and the commercial exploitation of human life. (shrink)

Only 19 new molecular entities and 3 biologics were approved by the Food and Drug Administration in 2007, the lowest rate in 24 years. This disappointing output occurred despite steady clinical trial and regulatory review times, the FDA maintaining high approval rates, and the pharmaceutical industry consistently reporting increasing revenues. A government report suggests that fewer new drug applications have been submitted to the FDA by the pharmaceutical industry in recent years. These data have rekindled the debate as to the (...) origins of pharmaceutical innovation and the comparative importance of public and private sources in contributing to drug discovery. The pharmaceutical industry contends that its research is responsible for most new medicines, and that the primary public institution supporting U.S. biomedical research, the National Institutes of Health, supports medical innovation “distinct from the process of drug development.”. (shrink)

Antibiotic resistance is a serious public health problem on a global scale. In both developed and developing countries, the unpleasant consequences of the phenomenon are being felt. This paper discusses wild-card patent extensions as a means to incentivize research and development of new antibiotics. The thesis defended in the paper is that the implementation of such patent extensions is an appropriate legislative response to the problem of antibiotic resistance. The general idea of wild-card patent extensions is presented (...) in the first part of the paper. A number of objections to the idea are thereafter discussed and rejected. (shrink)

The International Bill of Rights enshrines a right to health, which includes a right to access essential medicines. This right frequently appears to conflict with the intellectual property regime that governs pharmaceutical patents. However, there is also a human right that protects creative works, including scientific productions. Does this right support intellectual property protections, even when they may negatively affect health? -/- This article examines the recent attempt by the Committee on Economic, Social and Cultural Rights to resolve this issue (...) and argues that it fails. This is problematic because it means defenders of the present patent regime can continue using human rights documents to support their position. I offer a new framework for resolving the problem by examining the values that underlie human rights. (shrink)

The 2011 Varsity Medical Debate, between Oxford and Cambridge Universities, brought students and faculty together to discuss the waiving of patents for antiretroviral therapies in the developing world. With an estimated 29.5 million infected by Human Immunodeficiency Virus (HIV) in low- and middle-income countries and only 5.3 million of those being treated, the effective and equitable distribution of anti-retroviral therapy (ART) is an issue of great importance. The debate centred around three areas of contention. Firstly, there was disagreement about whether (...) patents were the real barrier to the access of anti-retroviral therapy in the developing world. Secondly, there were differing views on the effectiveness of a patent pool. Thirdly, concerns were raised over the impact of waiving patents on research to produce new and better anti retro-viral drugs. (shrink)

The rising cost of the opioid antagonist and overdose reversal agent naloxone is an urgent public health problem. The recent and dramatic price increase of Evzio, a naloxone auto-injector produced by Kaléo, shows how pharmaceutical manufacturers entering the naloxone marketplace rely on market exclusivity guaranteed by the patent system to charge prices at what the market can bear, which can restrict access to life-saving medication. We argue that 28 U.S.C. § 1498, a section of the federal code that allows (...) the government to use patent-protected products for its own purposes in exchange for reasonable compensation, could be used to procure generic naloxone auto-injectors, or at least bring Kaléo to the negotiating table. Precedent exists for the use of § 1498 to procure pharmaceuticals, and it could give meaning to the federal government's recent declaration of a public health emergency around the opioid epidemic, discourage new market entrants from charging exorbitant prices, and yield important public health benefits. (shrink)

The European Parliament rejected in 1995 the European Commission proposal to harmonize legal protection of biotechnological inventions. Although it did not seem initially the most contentious of the many issues involved in the current legal and ethical debate around biomedicine and genetics, patenting is now focusing bioethics in Europe.

The rationale of patents on transgenic organisms leads to the startling notion of the human qua infringement. The moral reasons by which we may tenably reject such notion are not conclusive as to human life forms outside the body. A close look at recombinant DNA experimentation reveals ingenious processes, but not entities that the body lacks. Except for artificial genes, the genes of biotechnology are found on chromosomes, albeit nonconsecutively, and their uninterrupted transcripts appear in messenger RNA. An enhanced form (...) of protection for ingenious processes, the human methods patent, is proposed and defended as a replacement for product patents. The proposed patent would pertain to biotechnology manufacturing and genetic intervention in somatic and germ cells. A counterpart could govern nonhuman life forms. It is argued that compulsory licensing protections should be a condition of such patent. Contrary to the conservative assumption that statutory sobriquets suffice, the reckoning of what qualifies as a patentable ingenious process will continue to require systematic scientific guidance. (shrink)

This chapter contains sections titled: Introduction Values Micro‐organisms and Plants Animals Humans Patents References.

While society debates whether and how to use public funds to support work on human embryonic stem cells (hESCs), many scientific groups and businesses debate a different question — the extent to which patents that cover such stem cells should be permitted to limit or to tax their research. The Wisconsin Alumni Research Foundation (WARF), a non-profit foundation that manages intellectual property generated by researchers at the University of Wisconsin at Madison, owns three patents that have been at the heart (...) of the latter controversy The story of WARF's patents and the controversy they have fostered highlights not only continuing tensions between proprietary and nonproprietary approaches to developing science and technology, but also an at least partly reassuring capacity of public and private sectors to deal with those tensions in a way that can render them substantially manageable, and frequently more manageable as a technology matures. More particularly, the cumulative story of WARF's patents features three leitmotifs that suggest how an attentive and engaged public sector might commonly succeed in working with public and private sector actors to achieve workable balances between proprietary rights and more general social interests: (1) right holders' decisions to pursue less than full rights assertion or enforcement; (2) the ability of government and other public sector actors to help bring about such decisions through co-option or pressure; and (3) the frequent availability or development of technological alternatives that limit research bottlenecks. (shrink)

Systems medicine, which is based on computational modelling of biological systems, is emerging as an increasingly prominent part of the personalized medicine movement. It is often promoted as ‘P4 medicine’. In this article, we test promises made by some of its proponents that systems medicine will be able to develop a scientific, quantitative metric for wellness that will eliminate the purported vagueness, ambiguity, and incompleteness—that is, normativity—of previous health definitions. We do so by examining the most (...) concrete and relevant evidence for such a metric available: a patent that describes a systems medicine method for assessing health and disease. We find that although systems medicine is promoted as heralding an era of transformative scientific objectivity, its definition of health seems at present still normatively based. As such, we argue that it will be open to influence from various stakeholders and that its purported objectivity may conceal important scientific, philosophical, and political issues. We also argue that this is an example of a general trend within biomedicine to create overly hopeful visions and expectations for the future. (shrink)

While society debates whether and how to use public funds to support work on human embryonic stem cells, many scientific groups and businesses debate a different question — the extent to which patents that cover such stem cells should be permitted to limit or to tax their research. The Wisconsin Alumni Research Foundation, a non-profit foundation that manages intellectual property generated by researchers at the University of Wisconsin at Madison, owns three patents that have been at the heart of the (...) latter controversy. The story of WARF’s patents and the controversy they have fostered highlights not only continuing tensions between proprietary and nonproprietary approaches to developing science and technology, but also an at least partly reassuring capacity of public and private sectors to deal with those tensions in a way that can render them substantially manageable, and frequently more manageable as a technology matures. (shrink)

Although some have argued that COVID-19 vaccine patents are morally justified, a broader argument on the morality of breaching contracts is necessary. This article explores the ethics of breaching unfair contracts and argues that it is morally justified to breach contracts with pharmaceutical companies concerning vaccine patents. I offer two arguments to support this view. Firstly, contracts may be breachable in some situations. The ones I point out are that contracts can be broken when the costs of not violating vaccine (...) patents are too high or when the process for agreement is not fair, or when an urgent ethical issue needs to be addressed and it is possible to compensate the other party for their loss. Secondly, I argue that because the contracts with the pharmaceutical companies do not treat people as ends in themselves, there is no moral obligation to respect them. (shrink)

After ten years of debate Directive 98/44/EG on the legal protection of biotechnological inventions was adopted in 1998. This directive takes decisions on some controversial bioethical and legal issues and offers the European biotech industries more space to develop their inventions, but leaves a number of philosophical and moral issues unresolved. This paper distinguishes between different layers in the debate and maps its modes of argumentation. Major philosophical, ethical and conceptual issues are located. It is argued that further analysis of (...) these issues can help resolve further ethical and legal difficulties as regards patenting of human DNA. As the allegedly special status of genetic material remains unclear, the status of (human) DNA and its relation to the human body and personal identity should be further explored. (shrink)

In J.E.M. AG Supply, Inc. v. Pioneer Hi-Bred International, Inc., the U.S. Supreme Court held that utility patents may be issued for newly developed, sexually reproduced plants and plant seeds. Specifically, the Court denied the petitioner's contention that the exclusive means of protecting sexually reproduced plants and plant seeds are found in the Plant Patent Act of 1930 and the Plant Variety Protection Act. The Court instead affirmed the decisions of the District Courts and the Federal Circuit and held (...) that 35 U.S.C. § 101 also allows for the patenting of living organisms.The respondent, Pioneer Hi-Bred, a large seed producer, filed suit for patent infringement on the part of the petitioner, J.E.M. AG Supply, doing business as Farm Advantage, Inc., for reselling bags of respondent's patented hybrid seeds. Pioneer is a major producer and manufacturer of hybrid seeds. (shrink)

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. (shrink)

A substantial portion of biomedical R&D is publicly funded. But resulting medicines are typically covered by patents held by private firms, and priced without regard to the public’s investment. The Bayh-Dole Act provides a possible remedy, but its scope is limited.