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)

Intellectual property law has been interacting with software for over sixty years. Despite this, the law in this area remains confused and uncertain: this is particularly evident in patent law. Focusing on U.S. patent law from the 1960s through to the mid-1970s, this article argues that a key reason for this confusion relates to the particular way that the subject matter was construed. While the early discussions about subject matter eligibility were framed in terms of the question “is (...) software patentable?”, what was really at stake in these debates was the preliminary ontological question: what is software? Building on work that highlights the competing ways that software was construed by different parts of the information technology industry at the time, the article looks at the particular way that the law responded to these competing interpretations and how in so doing it laid the foundation for the confusion that characterizes the area. When engaging with new types of subject matter, patent law has consistently relied on the relevant techno-scientific communities not only to provide the law with a relatively clear understanding of the nature of the subject matter being considered; they have also provided the means to allow the law to describe, demarcate, and identify that new subject matter. The inherently divided nature of the nascent information technology industry meant that this was not possible. As a result, the law was forced to develop its own way of dealing with the would-be subject matter. (shrink)

Criticisms of patent laws for technological innovations in the United States reveal a multifaceted milieu of problems centered around the protection of short-term economic gain and individual property rights. In this article, we consider this a conflict between current patent laws and the innovation capabilities of organizations. We propose a solution that enables the company to assure its long-term survival in the face of these restrictions. This presumes that the firm will at least maintain its innovation capacities (...) while preserving the company's ethical values and those of its social environment. We offer a theoretical model that is designed to help managers and policymakers reorient their governance strategies for managing the innovation process, using the “ethics of responsibility,” which establishes the link to individual moral values at the beginning of a governance process as well as the consequences of a decision. Our integrated causal model of ethical innovation for patents is presented and implications for global organizations and possible solutions for patent law process failure are offered. (shrink)

Recent anthropological, archaeological, and psychological findings support the view that humans have long been driven by a deep sense of curiosity that needs little if any special external material reward. Apart from being inherently interesting, these findings also turn out to have some wide-ranging consequences for central debates in other social sciences—such as economics. In particular, it is still often thought that, without extensive patent protections, economic actors lack the incentive to engage in innovative activity. However, as this chapter (...) makes clear, the recent anthropological, archaeological, and psychological findings concerning human curiosity provide compelling reasons for thinking that this material interest-based view of innovative activity is unconvincing. In this manner, the chapter has two key upshots: first and most importantly, it shows how and why paying attention to anthropological, archaeological, and psychological findings can have wide-ranging implications throughout the social sciences. Second, it develops reasons for being skeptical about the need for the kinds of extensive patent regimes seen in many countries. (shrink)

For obscure reasons, courts exclude some statutorily patentable inventions (‘judicial exceptions’) from patent protection. These exclusions have been criticized for impeding innovation, contrary to the purpose of patent law. I argue that freedom requires these exclusions even if they impede innovation. Patents, like property, can be unilaterally acquired, limiting others’ freedom without their consent. Kant explains why, to reconcile property with equal freedom, only rivalrous objects in acquirers’ first possession can be unilaterally acquired. States can rightfully authorize (...) unilateral acquisition of only these objects. Drawing from Kant, I explain how patent protection conflicts with equal freedom unless patented inventions involve inventive uses of rivalrous objects external to human bodies. Enabled by inventive concepts, these uses would be impossible without these concepts, and are thus in the first possession of their inventors. I then show how the most recent United States Supreme Court judicial exception decisions limit patent protection to inventive uses of rivalrous external objects. (shrink)

Mit der vorliegenden Arbeit werden die gesetzlichen Instrumentarien zum Schutz geistigen Eigentums in der Schiffbauindustrie, die für das Design von Schiffen - also den ästhetischen Aspekt - in Betracht kommen können, dargestellt und untersucht. Dabei stellt sich die Frage, inwiefern ein Schiff in seiner Gesamtheit oder in seinen einzelnen Bestandteilen konkret urheber- und/oder geschmacksmusterrechtlich geschützt werden kann. Von Bedeutung ist darüber hinaus eine Absicherung mittels vertraglicher Klauseln (mit Vereinbarungen zur Geheimhaltung, vertraglichen Absicherungsklauseln zur Sicherung der Designrechte etc.). Die Frage, wie (...) dieser Schutz gesetzlich und vertraglich ausgestaltet ist bzw. sich ausgestalten lässt, bildet den Schwerpunkt der Untersuchung. (shrink)

The framers of the U.S. Constitution believed that intellectual property rights were crucial to scientific advancement. Yet, the framers also recognized the need to balance innovation, privatization, and public use. The courts’ expansion of patent protection for biotechnology innovations in the last 30 years raises the question whether the patent system effectively balances these concerns. While the question is not new, only through a thorough and thoughtful examination of these issues can the current system be evaluated. It (...) is then a policy decision for Congress if any change is necessary. (shrink)

Patents have been issued in the United States for genes and gene sequences since 1980. Patent protection has provided incentives to aggressively probe the genome of humans and non-humans alike in search of profitable applications. Yet it is not clear that patent protection should have been afforded to genes and gene sequences and it is increasingly clear that patent protection, as currently formulated, is not an appropriate means to realize the full benefits of genetic (...) research. As we stand on the threshold on a genetically enhanced future, in which we shall have the power to consciously steer our evolution as a species, we need to carefully consider how to shape the benefits of genetic research and how to recognize and contain its detriments. (shrink)

Patents have been issued in the United States for genes and gene sequences since 1980. Patent protection has provided incentives to aggressively probe the genome of humans and non-humans alike in search of profitable applications. Yet it is not clear that patent protection should have been afforded to genes and gene sequences and it is increasingly clear that patent protection, as currently formulated, is not an appropriate means to realize the full benefits of genetic (...) research. As we stand on the threshold on a genetically enhanced future, in which we shall have the power to consciously steer our evolution as a species, we need to carefully consider how to shape the benefits of genetic research and how to recognize and contain its detriments. (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)

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 this presentation, principles of ethics are confronted with the desire of the inventor to make a profit. To this end the presentation is focused on patent protection. Patents should guarantee the return of an inventor’s investment and profit and, on the other side, ensure availability — by patent disclosure — of the invention for the society when the patent terminates. Recent patent applications made by inventors are infringing this principle and societies are paying an (...) unexpected price for these practices. Patent claims are too broad and disclosures too poor. Extreme examples will be discussed. (shrink)

In response to the great crises of the COVID-19 coronavirus, virtually all new technologies protected by patent rights have been used in practice from diagnostics, therapeutic, medical equipment, and vaccine to prevention, tracking, and containment of COVID-19. However, the moral justification of patent rights is questioned when pharmaceutical patents conflict with public health. This paper proposes a revised approach of deciding on how to address the conflicts between business ethics and patent protections and then compares the different (...) mechanisms of clearing patent thickets. Our findings highlight that patent pledges may not only contribute to achieving the maximized substantive justice of the public but also help patent pledgors fulfill procedural justice. The advantages of patent pledges have attracted many patent holders to make public statements during the COVID-19 pandemic. In contrast, the disadvantages of a free license may make patent pledges not sustainable for a long time without the related supporting measures. Our findings will be helpful for policymakers or company managers to make an appropriate decision on rationally utilizing patent portfolios for fighting against public health crises. (shrink)

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. 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. 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 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. 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. (shrink)

When one examines the emerging debate about genetic patenting, it becomes clear that those who oppose so-called misunderstand genetics or apply inappropriate moral and jurisprudential theory. In this brief essay I examine some arguments against gene patents of the variety, and conclude that patents on methods for detecting the presence of a genetic correlation with disease-related (and other) phenotypes can be appropriate, and that with several precautions the U.S. Patent and Trademark Office should continue granting patent protection (...) to investigators who generate genetic disease diagnostic innovations. (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)

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)

Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] 304 ALR 1At the heart of some disputes regarding medical treatment is the conceptual difficulty of finding the appropriate legal framework. The diagnosis and treatment of medical conditions are clearly subject to professional standards and thus sit within the negligence framework, but what of those who develop and provide that diagnosis and treatment? Do innovative approaches give rise to a patentable interest and can the intellectual property in a method of treatment (...) be protected under existing patent law? This question was recently addressed by the High Court in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] 304 ALR 1.The technical arguments are clearly set out in the judgment and do not warrant repetition. For present purposes it is sufficient to highlight the central legal question, which was whether a method of medical treatment could be a “manner of manufacture” and therefore patentable.The DecisionThe High Court .. (shrink)

A patent is a property granted to any new shape, configuration or arrangement of elements, of any device, tool, instrument, mechanism or other object or part thereof, that allows for a better or different operation, use or manufacture of the object that incorporates it or that provides it with some utility, advantage or technical effect that it did not have before. As a document, a patent really is a title that recognizes the right to exploit the patented invention (...) exclusively, preventing others from making, selling or using it without the consent of the owner. The fact of making a patent is motivated by the fact of promoting creativity, hindering competition in the market as only one person holds the patent, thus protecting the initial investment and fighting against plagiarism. Patents are available to the public for dissemination and general knowledge. It is generally recognized in the specialized literature that patents can be used as an indicator to calculate the results generated by research and development activities, being a very useful indicator to measure various social, economic or technological aspects. For this reason, it is of relevant interest to have tools or systems that allow us to obtain the patents developed in a specific period of time and to carry out analyses of various economic and social factors. These analyses can serve to obtain a social perspective of society’s progress in the technological field, and this is why an analysis of patents is of our interest. This paper proposes a platform specifically designed to obtain knowledge about patents as an indicator of Spanish social, economic or technological aspects. For this purpose, the platform retrieves, analyses and visualizes functionalities that represent data on the landscape of patents obtained from the Spanish Patent and Trademark Office as a particular case of study. (shrink)

In this note, we try to evaluate how effective the patent system is to foster innovation. We first develop the microeconomic reasoning underlying the legal protection of intellectual property. We then try to assess whether this legal protection does indeed fulfil its mission.We show that due to the difficulty of measuring innovative output, it is hard to reach any conclusive answer. We can at best provide a bundle of partial answers, which cast serious doubts on the necessity (...) to strengthen patent rights, but which provide no argument either for discarding the patent system altogether. (shrink)

Although the U.S. Patent and Trademark Office (“PTO”) has granted patents on genes for over 20 years, the prudence of gene patenting continues to stir controversy. Some have questioned the ethics of monopolizing a resource that is so fundamental and basic to all living organisms. It has also been argued that patents unfairly restrict the use of genes, impeding both basic and commercial research. For the biotechnology industry, however, gene patents are the currency it uses to protect its investment (...) in research and development, and eventually, the products it brings to market. This paper examines the eligibility of genes for patenting, and considers whether the policy reasons that have led courts to decide that certain categories of subject matter are unpatentable, apply to the realm of genes. Even if this were the case, this does not mean that biotech companies have no way of protecting their inventions. Methods and processes of using the genes do not invoke the same policy considerations, and may provide a more appropriate way of rewarding industry for the narrow discovery of a gene’s specific use. (shrink)

The systems of patent rights in force in Europe today, both at the level of national law and on the regional level, contain general clauses prohibiting the patenting of inventions whose publication and exploitation would be contrary to “ordre public” or morality. Recent years have brought frequent discussion about limiting the possibility of patent protection for biotechnological inventions for ethical reasons. This is undoubtedly a result of the dynamic development in this field in the last several years. (...) Human genome sequencing, the first successful cloning of mammals, and the progress in human stem cell research present humanity with many new questions of an ethical nature. Directive 98/44 of the European Parliament and of the Council of July 6, 1998, on the Legal Protection of Biotechnological Inventions created a new basis for patent protection in this field of technology. Based on the European experience to now, however, it must be said that patent law is not the right place to legislate the consequences of the morality of an invention. (shrink)

The Patent Cooperation Treaty (PCT) is an international treaty that was concluded in 1970 as a special agreement under the 1883 Paris Convention for the Protection of Industrial Property. It establishes an international system for the filing and examination of patent applications and the conduct of “prior art” (technical literature) searches that is administered by a network of national and regional patent offices acting as Receiving Offices, International Searching Authorities and/or International Preliminary Examining Authorities. Its specific (...) purpose is to help inventors obtain a patent for the same invention in two or more PCT countries by allowing them to assert their claim internationally have it subjected to preliminary assessment before committing to one or more local applications. It thus reduces the risk of wasted expenditure by enabling an applicant to postpone the decision to pursue an application to grant until confident of its success. By creating a series of pre-grant procedures with recognised validity in each of the PCT’s nearly 140 countries, it also provides a basis for the harmonisation of patentability standards and facilitates the move toward the creation of an international patent. (shrink)

The view of patents as well-defined property rights is as simplistic as it is ubiquitous. This article argues that in newly arising or immature technologies, patents are subject to intrinsic and extrinsic uncertainty that make them very opaque representations of the underlying inventions. The opacity is a result of unsettled legal doctrine and scientific terminology, uncertain commercial and technological prognosis, and leads to considerable ambiguity in property parameters. Patents in immature technologies do not solve Arrow's information paradox of non-rivalrous goods (...) because they do not represent the sharp exclusive right that is central to his thesis. In such cases patents ought to be reclassified in terms of their perceived and actual function as credence goods. The difficulty in discovering the value of these patents necessitates credence verifiers, further increasing the transaction costs of encouraging innovation. The theoretical and empirical implications of credence explored in this article are based primarily on the Anglo-American legal protection of biotechnological inventions, but may be equally relevant to patents in general and patents in other newly arising technologies, in particular. (shrink)

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. (shrink)

The term “patent” is an abbreviation of “letters patent”, the open form of document historically issued by the Crown for the purpose of conferring a right or privilege or otherwise communicating the royal will. In contemporary law it denotes the species of intellectual property that is granted as an inducement for the creation and disclosure of novel, inventive and industrially applicable inventions. In the UK that property is conferred under the Patents Act 1977, or with similar effect the (...) European Patent Convention (EPC), and comprises the exclusive right to use and sell a protected invention for up to 20 years. A protected invention may be any subject matter having technical character; a definition derived from the Act’s express exclusion from patentability of (among other things) discoveries, scientific theories, business methods and computer programs “as such”. Also excluded are surgical, therapeutic and diagnostic methods (for lack of industrial applicability), and inventions the commercial exploitation of which would be contrary to public policy or morality. In these and other respects the Patents Act follows the EPC, which it was the explicit purpose of that Act to implement. Patents are territorial, and are thus only valid and infringed in their country of issue. For a UK inventor to obtain protection outside the UK s/he must therefore obtain a patent from that country, either directly by applying under its laws, or if it is a party to the EPC or other intergovernmental agreement, indirectly by applying under that agreement. Inventors seeking protection for an invention in more than one country will often do so by means of the Patent Cooperation Treaty. (shrink)

Patents for genetic material in theindustrialized North have expandedsignificantly over the past twenty years,playing a crucial role in the currentconfiguration of the agricultural biotechnologyindustries, and raising significant ethicalissues. Patents have been claimed for genes,gene sequences, engineered crop species, andthe technical processes to engineer them. Mostcritics have addressed the human and ecosystemhealth implications of genetically engineeredcrops, but these broad patents raise economicissues as well. The Catholic social teachingtradition offers guidelines for critiquing theeconomic implications of this new patentregime. The Catholic principle of (...) the universaldestination of goods implies that genes, genesequences, and engineered crop varieties areineligible for patent protection, although theprocesses to engineer these should be eligible.Religious leaders are likely to make a moresubstantive contribution to debates aboutagricultural biotechnology by addressing theselife patents than by speculating that geneticengineering is ``playing God.''''. (shrink)

In order to enlarge the pool of knowledge available in the public domain, temporary exclusive rights are granted to innovators who are willing to fully disclose the information needed to reproduce their invention. After the 20-year patent protection period elapses, society should be able to make free use of the publicly available knowledge described in the patent document, which is deemed useful. Resistance to pesticides destroys however the usefulness of information listed in patent documents over time. (...) The invention, here pesticides, will have a decreased effectiveness once it enters the public domain. In some cases pesticides lose most of their efficacy shortly after temporary exclusive rights expire. Society’s share of the patent bargain—having new useful knowledge available in the public domain—is lost. Resistance can be slowed down, if pesticide use is limited by optimal compliance. Stimulating proper use is generally not compatible with existing market incentives for patent holders, since these have to be able to maximize profits in order to recoup research and development costs and satisfy obligations to the company’s stakeholders. Another incentive system is needed to ensure longevity of pesticides, which at the same time does not hamper future research. (shrink)

Universities are regarded as key institutions in the knowledge economy. Traditionally, the concept of scientific progress has been linked with an ideal of free and open dissemination of scientific information.At present, however, there is a growing strain to cash in the commercial potential created by academic research, and to regard academic knowledge as targets for opportunities for creating income. The major question is how to reconcile the traditional academic mission of knowledge production and science sharing with the current trend towards (...) knowledge protection and appropriation through patenting. In balancing the sharing and shielding of knowledge, two major sets of measures should be contemplated.A first set of measures aims at safeguarding individual and collective research from the harm patents might have on research practice and scientific conduct, and at cautiously watching potential conflicts of interest. The appointment of an ombudsperson for science, a mandatory system of whistle blowing, a code of conduct, and a set of conflict-of-interest guidelines are explored as helpful instruments in this regard.A second set of tools aims at designing institutional strategies to balance the ethos of sharing and profit maximalisation through patents. Public patents, open access patents, and two-tiered patent license strategies are examined in order to find a new balance in the growing conflict between private and public knowledge with which contemporary universities are faced. (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.

Drugs are much more expensive whilst they are subject to patent protection than once patents expire: patented drugs make up only 20% of NHS drugs prescriptions, but consume 80% of the total NHS drugs bill. This article argues that, given the relatively uncontroversial assumption that we should save the greater number in cases where all are equally deserving and we cannot save both groups, it is more difficult than is usually thought to justify why publicly funded healthcare systems (...) should pay for patented treatments. The claim to medical treatment of those who will be sick with a given condition once the patent runs out is just as strong as those who are sick with it now, but we will be able to treat more people with the same unit of resource in the future. Hence, when resource constraints entail that both cannot be funded, publicly funded healthcare systems ought to wait until patents expire before approving drugs for general use in the publicly funded system. (shrink)

As recent newspaper headlines show the topic of patents/patent laws is still heavily disputed. In this paper I will approach this topic from a theoretical-historical and history of economic thought-perspective. In this regard I will link the patent controversy of the nineteenth century with Walter Eucken's Ordoliberalism – a German version of neoliberalism. My paper is structured as follows: The second chapter provides the reader with a historical introduction. At the heart of this paragraph are the controversy and (...) discourse on patent laws in nineteenth century Europe as well as the pro and contra arguments presented by the anti-patent/free-trade movement respectively by the advocates of patent protection. The focus of my paper is on the struggle for the protection of inventions and innovations in nineteenth century Germany, since Walter Eucken, main representative of the Freiburg School of Law and Economics, picks up the counter-arguments presented in the national debate and in particular by the Kongress deutscher Volkswirthe. The third chapter deals intensively with the question whether patent laws are just 'nonsense upon stilts' from an ordoliberal perspective. Here, Eucken's arguments against the current patent system are elaborated in great detail. The paper ends with a summary of my main findings. Read the Open Peer Discussion on this paper ». (shrink)

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)

To date, over 5,000 applications have been filed with United States Patent Office for patents on human genes. More than 1,500 of these applications have been granted. Other jurisdictions are experiencing a similar rush to mine and protect genomic gold. This paper argues that although many jurisdictions allow the patenting of human genes, this is ethically indefensible and amounts to an unjustified appropriation of a general human heritage. Economic and legal arguments in favour of patenting are considered and rejected. (...) Reference is made to the Wellcome Trust Consortium's initiative and the Merck Gene Index Project, which place patented genetic information into the public domain. (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)

According to the judgement of the European Court of Justice in 2014, human parthenogenetic stem cells are excluded from the patenting prohibition of procedures based on hESC by the European Biopatent Directive, because human parthenotes are not human embryos. This article is based on the thesis that in light of the technological advances in the field of stem cell research, the attribution of the term ‘human embryo’ to certain entities on a descriptive level as well as the attribution of a (...) normative protection status to certain entities based on the criterion of totipotency, are becoming increasingly unclear. The example of human parthenotes in particular demonstrates that totipotency is not at all a necessary condition for the attribution of the term ‘human embryo’. Furthermore, the example of hiPSC and somatic cells particularly shows that totipotency is also not a sufficient condition for the attribution of a normative protection status to certain entities. Therefore, it is not a suitable criterion for distinguishing between human embryos worthy of protection and human non-embryos not worthy of protection. Consequently, this conclusion has repercussions for the patenting question. The strict delineation between an ethically problematic commercial use of human embryos and the concomitant patenting prohibition of hESC-based procedures and an ethically unproblematic commercial use of human non-embryos and the therefore either unrestrictedly permitted or even unregulated patenting of procedures based on these alleged alternatives becomes increasingly blurred. (shrink)

Three attempts are usually made to justify patents: natural rights, distributive justice, and consequentialist arguments, all of which I contest.The natural rights argument is traced back to John Locke, defender of the ‘labour theory of property,’ who essentially holds that persons have a right to property insofar as they have mixed their labour with it, and insofar as they have appropriated natural things without exhausting them or taking more than their share. Yet, the inventor’s mixing of labour is often the (...) last step of a longer historical process, and patents seem to encourage waste, since they restrict the use of an idea.The distributive justice argument holds that patents reward the initiative of inventors – with out this reward, ‘free riders’ would be able to compete unfairly; the exclusivity granted by patents corrects this hole in the free market. However, our current system does not necessarily reflect this principle; it is difficult to clarify the criteria on which an inventor deserves a reward; unsuccessful inventors and basic researchers also invest much initiative, and yet are not rewarded; it is unclear that justice should reward someone by granting them the exclusive right to determine what is done with knowledge; and no link exists between the social usefulness of an invention and the scope of protection granted by a patent.The consequentialist justification holds that patents encourage innovation, and the disclosure of knowledge. Although it is clear that patents encourage inventions, it is not clear that they encourage progress – they may even limit progress by restricting use of previous knowledge. As for the disclosure of knowledge: such knowledge is hard to keep secret in the first place, and patent offices grant overly broad patents.In conclusion, this paper offers some suggestions concerning the true costs of the patent system. (shrink)

The European Patent Convention (EPC) establishes “a system of law, common to the Contracting States, for the grant of patents for inventions” (article 1) and an organisation, the European Patent Organisation, to administer it. A patent granted under the EPC is called a European patent but takes effect as a bundle of national patents under the laws of the Contracting States in which protection is sought.

The extension of intellectual property rights into the realm of biology has emerged as an increasing focus of controversy in relation to science,2 biodiversity,3 agriculture,4 health,5 development,6 human rights7 and trade.8 This paper presents the results of a review of international trends in activity for patent protection between 1990-2000 and provisional data to 2004 and 2005 from over 70 national patent offices, four regional patent offices and the World Intellectual Property Organisation using the European Patent (...) Office esp@cenet worldwide database.9 The review employed patent publication counts as an indicator of activity for traditional medicines, pharmaceuticals, agriculture, and biotechnology. The research provides insights into the internationalisation of patent activity in multiple areas of biology. The review emphasises the need to combine the further development of quantitative methods with qualitative analysis of the implications of international patent activity in relation to biological and genetic material for science, society and policy. (shrink)

Thus far, the philosophical study of patenting has primarily focused on sociopolitical, legal, and ethical issues, such as the moral justifiability of patenting living organisms or the nature of (intellectual) property. In addition, however, the theory and practice of patenting entails many important problems that can be fruitfully studied from the perspective of the philosophy of science and technology. The principal aim of this article is to substantiate the latter claim. For this purpose, I first provide a concise review of (...) the main features of the theory and practice of the patenting of scientific and technological inventions. Second, I discuss several philosophical issues implied by these features and explore the possible contributions of the philosophy of science and technology to the clarification, or resolution, of these issues. The seven features discussed are: patents as commercial monopolies on scientific and technological inventions, the contrast between natural and non-natural subject matter, the distinction between inventions and discoveries, the reproducibility of inventions, the question of the sameness of two inventions, the distinction between the invented and the protected object, and the contrast between material objects versus concepts and theories. The article concludes with some observations on the problems and prospects of the philosophical study of the theory and practice of patenting scientific and technological inventions. (shrink)

In order to take ethical considerations of patenting biological material into account, the so-called “ordre public or morality clause” was implemented as Article 6 in the EC directive on the legal protection of biotechnological inventions, 98/44/EC. At first glance, this seems to provide a significant advantage to the European patent system with respect to ethics. The thesis of this paper argues that the ordre public or morality clause does not provide sufficient protection against ethically problematic uses of (...) the patent system within the area of life. On the contrary, there are worrisome obstacles to any effective and comprehensive critical analysis of the ethical aspects of bio-patenting, especially in the field of agriculture. These obstacles can be seen as indirect consequences of the implementation of ethical considerations in form of the ordre public and morality clause in the EC Directive. Therefore, Article 6 of the EC Directive on the legal protection of biotechnological inventions seems to ultimately weaken the position of ethics in the debate concerning bio-patenting because the ordre public and morality clause is usually interpreted in an exclusively bio-ethical way in the sense of an “intrinsic ethics,” which is primarily interested in questions regarding the moral status of particular entities. It is argued that an important cause of this phenomenon is that the decisive reasons against bio-patenting are concerns of social ethics, and not bio-ethics. (shrink)

Over the last two decades, the ethical implications of patents for biological materials and processes have been the subject of spirited public debate between the many individuals and groups on which the patent system impacts. Whereas copyright, trade marks, and other species of Intellectual Property Rights (IPR) are widely acceptable, the patent system evokes criticism from many quarters, especially in relation to the legal protection of inventions in the Life Sciences. Some of these criticisms expressed by prestigious (...) public organisations are addressed here from the patent professional standpoint. (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 (...) class='Hi'>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)

The scale is the most famous emblem of the law, including intellectual property (IP). Because IP rights impose social costs on the public by limiting access to protected work, the law can be justified only to the extent that, on balance, it encourages enough creation and dissemination of new works to offset those costs. The scale is thus a potent rhetorical trope of fairness and objectivity, but also an instrument the law thinks with – one that is constantly invoked to (...) justify or to question the extent of available IP protection. The balancing act that underlies the legitimacy of IP is, however, literally impossible to perform. Because we are unable to measure the benefits that IP has for inventors or the costs it has for the public, the scale has nothing to weigh. It conveys a clear sense that IP law can be balanced, but in fact propagates only a visible simulacrum of balance – one that is as empty as it is powerful. (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)