The patent system appears to make three ontological assumptions often associated with scientific realism: there is a natural world that is independent of human knowledge and technology; invented products can be unobservable things; and invented products have causal powers. Although a straightforward reading of patent laws implies these ontological commitments, it is not at all clear that what the patent system has to say about the world has any bearing on issues of scientific realism. While (...) realists might embrace the patent system’s apparent ontology as providing additional support for their view, anti-realists could propose an alternative interpretation of patent law that does not involve realist ontological commitments. Thus, questions about the patent system’s ontology depend on whether one takes patent laws at face value or defends an interpretation of patent law motivated by philosophical theory. Philosophers of science should pay attention to the practice of patenting, even if they ultimately reject the patent system’s apparent ontology and offer an alternative interpretation. (shrink)

This paper uses John Rawls' theory of justice to defend the patent system against charges that it has an unfair effect on access to medications, from the perspective of national and international justice. The paper argues that the patent system is fair in a national context because it respects intellectual property rights and it benefits the least advantaged members of society by providing incentives for inventors, investors, and entrepreneurs. The paper also argues that the patent (...) system is fair in an international context, provided that developed nations take steps to help disease-stricken countries secure internal justice. Fairness in a national or international context also requires that the patent system should include emergency exceptions to deal with short-term inequities. (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)

Department of Economics, University of Calgary, 2500 University Dr NW, Calgary AB, T2N 1N4, Canada. Tel.: +1403220 5861; Fax: +1403220 5861; Email: ahollis{at}ucalgary.ca ' + u + '@' + d + ' '//--> . Abstract The Health Impact Fund has been proposed as an optional, comprehensive advance market commitment system offering financial payments or ‘prizes’ to patentees of new drugs, which are sold globally at an administered low price. The Fund is designed to offer payments based on the therapeutic (...) impact of the drugs or vaccines, so that innovators will have efficient incentives to develop drugs that maximize health gains. Consumers would have improved access to such drugs because of low prices. CiteULike Connotea Del.icio.us What's this? (shrink)

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. (shrink)

In 1791, the Loi relative aux découvertes utiles instituted a new patent system in France. Because patents were seen as the expression of the natural right of inventors, prior examination was abolished. However, only a few years after the law was passed, an unofficial examination was reinstated, and it was entrusted to the Comité Consultatif des Arts et Manufactures – a consultative body composed of prominent scientists. I analyze the political significance of the involvement of the savants in (...) the patent system, and based on the archives of the Comité, I study the scope and practicalities of the examination process, paying close attention to the ways through which the savants of the Comité directly intervened in the writing and drawing of specifications. I show how a distinct regime of intellectual property emerged in France and how it was constructed by the interests and norms of scientists, eager as they were to distinguish ‘science’ from ‘industry’ and establish the superiority of the former over the latter. (shrink)

Attempts to justify the patent system can be based on three grounds: (1) natural rights; (2) distributive justice; and (3) utilitarian (economic) arguments. Each of these arguments is problematic in many ways. The first two are dealt with very briefly. The utilitarian argument is discussed more in depth.

New research and a government investigation have shed light on an anticompetitive practice called “Product Hopping” and specifically how it was employed in the case of the multiple sclerosis treatment glatiramer acetate beginning in 2014, which cost payers billions of dollars. We examine this case as well as a separate, impending instance of product hopping.

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)

Patent landscaping is the process of finding patents related to a particular topic. It is important for companies, investors, governments, and academics seeking to gauge innovation and assess risk. However, there is no broadly recognized best approach to landscaping. Frequently, patent landscaping is a bespoke human-driven process that relies heavily on complex queries over bibliographic patent databases. In this paper, we present Automated Patent Landscaping, an approach that jointly leverages human domain expertise, heuristics based on (...) class='Hi'>patent metadata, and machine learning to generate high-quality patent landscapes with minimal effort. In particular, this paper describes a flexible automated methodology to construct a patent landscape for a topic based on an initial seed set of patents. This approach takes human-selected seed patents that are representative of a topic, such as operating systems, and uses structure inherent in patent data such as references and class codes to “expand” the seed set to a set of “probably-related” patents and anti-seed “probably-unrelated” patents. The expanded set of patents is then pruned with a semi-supervised machine learning model trained on seed and anti-seed patents. This removes patents from the expanded set that are unrelated to the topic and ensures a comprehensive and accurate landscape. (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)

The scientific challenges and ethical controversies facing human embryonic stem cell (hESC) research continue to command attention. The issues posed by patenting hESC technologies have, however, largely failed to penetrate the discourse, much less result in political action. This paper examines U.S. and European patent systems, illustrating discrepancies in the patentability of hESC technologies and identifying potential negative consequences associated with efforts to make available hESC research tools for basic research purposes while at same time strengthening the position of (...) certain patent-holders' rights. Differences between the U.S. and the European contexts may in part explain why the course of hESC research in those jurisdictions ultimately diverges. Nevertheless, questions about whether and how patenting, related agreements, and licensing practices progress and shape the field of hESC research in both the U.S., Europe, and elsewhere must no longer be marginalised. These questions are fundamentally important in determining what benefits are likely to result from hESC research. Assuring these benefits is the moral issue with which patent systems are most intrinsically concerned, and that governments must begin to directly address rather than assume or ignore. (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)

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)

A topic of growing importance within philosophy of science is the epistemic implications of the organization of research. This paper identifies a promising approach to social epistemology—nonideal systems design—and uses it to examine one important aspect of the organization of research, namely the system of patenting and licensing and its role in structuring the production and dissemination of knowledge. The primary justification of patenting in science and technology is consequentialist in nature. Patenting should incentivize research and thereby promote the (...) development of knowledge, which in turn facilitates social progress. Some have disputed this argument, maintaining that patenting actually inhibits knowledge production. In this paper, I make a stronger argument; in some areas of research in the US—in particular, research on GM seeds—patents and patent licenses can be, and are in fact being, used to prohibit some research. I discuss three potential solutions to this problem: voluntary agreements, eliminating patents, and a research exemption. I argue against eliminating patents, and I show that while voluntary agreements and a research exemption could be helpful, they do not sufficiently address the problems of access that are discussed here. More extensive changes in the organization of research are necessary. (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)

This paper discusses the genesis of human DNA patents and the legal confusion and ramifications that ensued. Beginning in the mid-1970s with policymakers and lawmakers in the United States, confronted with an economy impacted by an oil crisis, inflation, growing and persistent unemployment and the fledgling biotechnology industry, this paper tracks the development of the practice until its banning in the US Supreme Court in June 2013. The paper raises serious questions regarding the relevance of a patent system—a (...) system that, as the patenting of naturally occurring biological materials demonstrates, is so easily manipulated through the use of legal contrivances. The paper outlines that potential future manipulation poses as a significant threat to the national economy and security of the United States if history is allowed to repeat itself in the context of biological materials. (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)

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)

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)

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)

What accounts for the continued lack of clarity over the legal procedures for the patenting of DNA sequences? The patenting system was built for a "bricks-and-mortar" world rather than an information economy. The fact that genes are both material molecules and informational systems helps explain the difficulty that the patent system is going to continue to have.

In May 2011, the Brazilian Ministry of Health announced the distribution of the first batch of locally produced generic tenofovir disoproxil fumarate (TDF) to support its program of universal and free access for the treatment of HIV/AIDS. The inclusion of TDF in the public health program illustrates what has been considered the ‘Brazilian model’ of HIV/AIDS response, as it illustrates the current phase of the Brazilian pharmaceutical economy. Brazil is known for having managed to control the expansion of HIV/AIDS through (...) a unique initiative combining the public health and the industrial production of generics. But, if at first local manufacturers could freely copy ARVs and produce cheaper generic versions that were delivered to the Ministry of Health, since the country started to grant patents on drugs in 1996, the sustainability of this policy has been challenged by the high cost of patented second-line HIV/AIDS treatments. In order to assure continuity of the local production of ARVs, and keep the program of public health alive, Brazilians are now forced to deal with conflicts of drugs' intellectual property rights in order to open the path to generic production. This article aims to describe the experiences surrounding TDF in Brazil and the unprecedented conflicts and challenges it has brought for our different interviewees. Blurring the frontier between the public and the private, the TDF case was driven at the same time by an ethic of drug access and regulation of drug quality, which has inspired Brazilians to intervene and transform the world they live in. (shrink)

This paper is a critique of the current US patent system along general consequentialist lines. I present a pro tanto case against it because of its effects on scientific inquiry. The patent system is often thought to be justified because it provides incentives to innovate. I challenge this concern. Economists and legal scholars have spent a good portion of time analyzing particular aspects of the patent system. I here synthesize their work, showing how it (...) amounts to a pro tanto moral case against patents. This is the case even though patents are said to incentivize innovation, its disclosure, and its transfer to interested parties. I explore all of these possibilities, finding them to only weakly support the institution of patent rights. Juxtaposing this weak case for patents along with various problems that patents cause for science, we find a pro tanto case against our current patent system. To my knowledge, no one has tried to synthesize the various concerns I raise, with particular attention to not only the patent’s system purported ability to incentivize innovation, but also to disclose and transfer technology. (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 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)

This paper offers a few elements of an answer to the question to what extent drug patents can be morally justified. Justifications based on natural rights, distributive justice and utilitarian arguments are discussed and criticized. The author recognizes the potential of the patents to benefit society but argues that the system is currently evolving in the wrong direction, particularly in the field of drugs. More than a third of the world’s population has no access to essential drugs. The working (...) of the patent system is an important determinant of access to drugs. This paper argues that drug patents are not easily justified and that the ‘architecture’ of the patent system should be rethought in view of its mission of benefiting society. (shrink)

In patent law most of the crucial legal questions such as patentability and infringement are linked to the patent claims. The European Patent Office regards patent claims as a set of independent features which are examined separately in a more or less formal way. The author has found that this approach allows for developing a simple mathematical model which treats patent claim features as logical statements and patent claims as compound statements wherein the individual (...) statements are connected by logical connectives. The proposed mathematical model provides a uniform system for examining various legal questions that are dealt with separately under current case law, moreover, it allows for developing an expert system for resolving complex legal situations and for automating the evaluation of a large number of patent claim variants that is currently not possible. (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)

Just as human embryonic stem cell research has generated controversy about the uses of human embryos for research and therapeutic applications, human embryonic stem cell patents raise fundamental ethical issues. The United States Patent and Trademark Office has granted foundational patents, including a composition of matter (or product) patent to the Wisconsin Alumni Research Foundation (WARF), the University of Wisconsin-Madison’s intellectual property office. In contrast, the European Patent Office rejected the same WARF patent application for ethical (...) reasons. This article assesses the appropriateness of these patents placing the discussion in the context of the deontological and consequentialist ethical issues related to human embryonic stem cell patenting. It advocates for a patent system that explicitly takes ethical factors into account and explores options for new types of intellectual property arrangements consistent with ethical concerns. (shrink)

This paper offers a few elements of an answer to the question to what extent drug patents can be morally justified. Justifications based on natural rights, distributive justice and utilitarian arguments are discussed and criticized. The author recognizes the potential of the patents to benefit society but argues that the system is currently evolving in the wrong direction, particularly in the field of drugs. More than a third of the world’s population has no access to essential drugs. The working (...) of the patent system is an important determinant of access to drugs. This paper argues that drug patents are not easily justified and that the ‘architecture’ of the patent system should be rethought in view of its mission of benefiting society. (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 filing of patent applications by universities remains a debatable issue in Europe more than 25 years after the Bayh Dole Act in the U.S.A. The European Commission and several national governments are currently exerting pressure on universities to take a more active part in the innovation process.The importance of university research as a source of technology is increasing in the knowledge economy, which is characterized by open innovation. The funding of research may eventually be at stake. Patent (...) applications are essential instruments in the knowledge-transfer process. They enable universities to reconcile their mission of disseminating knowledge with a direct participation in innovation. They contribute to the development of new products, to the funding of more collaborative research with industry, and to the creation of new companies.This article offers guidelines for making the filing of patent applications by universities consistent or even synergistic with their other missions. Yet, despite all these considerations, the propensity of European universities to file patent applications is 5 times lower than in the U.S.A., which is also reflected in the other knowledge-transfer indicators.This article suggests two reasons for this lower propensity: the mindset of the mostly independent European universities based on the Humboldt model and the much less attractive European patent system for universities. (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)

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)

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)

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)

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.

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)

With the aim of understanding current problematizations of embryonic stem cell patenting this article rehearses the history of social entitlements related to reproductive material derived from women seeking care in institutions for reproductive health in Denmark. Our interest lies in the emergence of commercial exchange of material derived from embryos. Such exchange is characterized by contestation of the status of the embryo: is it a person or a commodity? To understand the modus operandi of the exchanges, we first explore how (...) the concepts of personhood and morality, of commodity and ownership tend to be related in the ideal type of capitalist exchange. Historical context then helps us understand the contingency of exchange systems. Historically Danish women have had much less influence on the dissemination of material derived from them than they do today. However, today their entitlements have also found their limits, in particular with respect to commercial transactions. We claim that, ironically, material derived from institutionally mediated reproduction gains unprecedented personhood from confrontation with a capitalist exchange form which potentially designates it as a mere commodity. (shrink)

The purpose of the patent system is to provide incentives for the development of new and useful products and processes. Such products and processes are generally referred to as ‘inventions’. Whilst patents have historically been sought and granted for mechanical and chemical inventions only, the biotechnology revolution of the last 30 years has radically changed this by precipitating a mass of patent applications in respect of living and biological matter. Applications of this nature have forced a re-examination (...) by courts and policy makers of traditional understandings of what can be patented. In particular, they have forced consideration of the extent (if any) to which life and nature can be viewed as ‘inventions’ so as to be capable of supporting a patent. In considering this question the central guiding principle has been the distinction, on which all of patent law is said to rest, between man-made inventions on the one hand and discoveries of nature on the other. (shrink)